Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound antenatal screen, Urinary sediment present, Urine analysis, Urine ketone body, Urine leukocyte esterase
Clinical narrative: premature delivery; Contractions 5 days after first shot; hemorrhage in early pregnancy; Leaking amniotic fluids after first shot; Ruptured,membranes,premature; Acute cystitis with hematuria; Threatened miscarriage; hemorrhage in early pregnancy; Oligohydramnios; Severe diarrhea 7 hours after first shot; 19 weeks pregnant received first dose; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of PREMATURE LABOUR (Contractions 5 days after first shot), the first episode of HAEMORRHAGE IN PREGNANCY (hemorrhage in early pregnancy), AMNIORRHOEA (Leaking amniotic fluids after first shot), PREMATURE RUPTURE OF MEMBRANES (Ruptured,membranes,premature), CYSTITIS (Acute cystitis with hematuria), ABORTION THREATENED (Threatened miscarriage), OLIGOHYDRAMNIOS (Oligohydramnios), the second episode of HAEMORRHAGE IN PREGNANCY (hemorrhage in early pregnancy) and PREMATURE DELIVERY (premature delivery) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 27-Jun-2022. On 31-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced the first episode of HAEMORRHAGE IN PREGNANCY (hemorrhage in early pregnancy) (seriousness criteria hospitalization and medically significant), AMNIORRHOEA (Leaking amniotic fluids after first shot) (seriousness criterion hospitalization), DIARRHOEA (Severe diarrhea 7 hours after first shot) and MATERNAL EXPOSURE DURING PREGNANCY (19 weeks pregnant received first dose). On 04-Feb-2022, the patient experienced PREMATURE LABOUR (Contractions 5 days after first shot) (seriousness criterion hospitalization prolonged). On 05-Feb-2022, the patient experienced PREMATURE DELIVERY (premature delivery) (seriousness criterion hospitalization). On an unknown date, the patient experienced PREMATURE RUPTURE OF MEMBRANES (Ruptured,membranes,premature) (seriousness criterion hospitalization), CYSTITIS (Acute cystitis with hematuria) (seriousness criterion hospitalization), ABORTION THREATENED (Threatened miscarriage) (seriousness criterion hospitalization), OLIGOHYDRAMNIOS (Oligohydramnios) (seriousness criterion medically significant) and the second episode of HAEMORRHAGE IN PREGNANCY (hemorrhage in early pregnancy) (seriousness criterion hospitalization). The patient was hospitalized from 04-Feb-2022 to 06-Feb-2022 due to ABORTION THREATENED, CYSTITIS, HAEMORRHAGE IN PREGNANCY and PREMATURE RUPTURE OF MEMBRANES. The delivery occurred  on 04-Feb-2022, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion w Cong Anomaly. The patient was treated with NITROFURANTOIN (oral) for Adverse event, at a dose of 100 milligram. On 31-Jan-2022, MATERNAL EXPOSURE DURING PREGNANCY (19 weeks pregnant received first dose) had resolved. On 04-Feb-2022, PREMATURE LABOUR (Contractions 5 days after first shot), AMNIORRHOEA (Leaking amniotic fluids after first shot) and DIARRHOEA (Severe diarrhea 7 hours after first shot) had resolved. On 05-Feb-2022, PREMATURE DELIVERY (premature delivery) had resolved. At the time of the report, PREMATURE RUPTURE OF MEMBRANES (Ruptured,membranes,premature), CYSTITIS (Acute cystitis with hematuria), ABORTION THREATENED (Threatened miscarriage), OLIGOHYDRAMNIOS (Oligohydramnios) and the last episode of HAEMORRHAGE IN PREGNANCY (hemorrhage in early pregnancy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2022, Alanine aminotransferase (13-56): 30 u/l (normal) 30 U/L. On 01-Feb-2022, Albumin globulin ratio (1.1-2.2): 0.8 (Low) 0.8. On 01-Feb-2022, Anion gap (6-16): 4meq/l (Low) 4meq/L. On 01-Feb-2022, Aspartate aminotransferase (15-37): 10 u/l (Low) 10 U/L. On 01-Feb-2022, Bacterial test: light (abnormal) Light. On 01-Feb-2022, Basophil count (0.00-0.22): 0 k/ul (normal) 0 k/uL and 0 percent 0 Percent. On 01-Feb-2022, Bilirubin urine: pos 3+ (abnormal) Pos 3+. On 01-Feb-2022, Blood albumin (3.4-5.0): 3.0 g/dl (Low) 3.0 g/dl. On 01-Feb-2022, Blood alkaline phosphatase (45-117): 67 u/l (normal) 67 U/L. On 01-Feb-2022, Blood bilirubin (0.2-1.0): 0.1 mg/dl (Low) 0.1 mg/dl. On 01-Feb-2022, Blood calcium (8.5-10.1): 8.7 mg/dl (normal) 8.7 mg/dl. On 01-Feb-2022, Blood chloride (98-107): 110 meq/l (High) 110 meq/L. On 01-Feb-2022, Blood creatinine (0.55-1.01): 0.60 mg/dl (normal) 0.60 mg/dl. On 01-Feb-2022, Blood glucose (70-99): 105 mg/dl (High) 105 mg/dl. On 01-Feb-2022, Blood potassium (3.5-5.1): 3.6 meq/l (normal) 3.6 meq/L. On 01-Feb-2022, Blood sodium (136-145): 138 meq/l (normal) 138 meq/L. On 01-Feb-2022, Blood urea (7-18): 7 mg/dl (normal) 7 mg/dl. On 01-Feb-2022, Blood urea nitrogen/creatinine ratio (07-25): 12 (normal) 12. On 01-Feb-2022, Carbon dioxide (21-32): 24 meq/l (normal) 24 meq/L. On 01-Feb-2022, Chromaturia: red (abnormal) Red. On 01-Feb-2022, Crystal urine: present (abnormal) Present. On 01-Feb-2022, Differential white blood cell count: auto diff Auto diff. On 01-Feb-2022, Eosinophil count (0.00-0.55): 0.15 k/ul (normal) 0.15 K/uL and 1 percent 1 percent. On 01-Feb-2022, Globulin (2.4-3.5): 3.9 g/dl (High) 3.9 g/dl. On 01-Feb-2022, Glomerular filtration rate: >120 ml/min/1.73m2 (normal) >120 mL/min/1.73m2 and >120 ml/min/1.73m2 (normal) >120 mL/min/1.73m2. On 01-Feb-2022, Glucose urine: negative (Negative) Negative. On 01-Feb-2022, Haematocrit (36-47): 34.9 percent (Low) 34.9 percent. On 01-Feb-2022, Haemoglobin (12-16): 11.8 g/dl (Low) 11.8 g/dl. On 01-Feb-2022, Human chorionic gonadotropin (0-4): 19,632 miu/ml (High) 19,632 mIU/mL and positive (Positive) Positive, Pregnancy urine positive. On 01-Feb-2022, Immature granulocyte count: 1 percent 1 Percent. On 01-Feb-2022, Lymphocyte count (0.90-4.95): 2.04 k/ul (normal) 2.04 k/uL and 14 percent 14 percent. On 01-Feb-2022, Mean cell haemoglobin (27-33): 31.1 pg (normal) 31.1 pg. On 01-Feb-2022, Mean cell haemoglobin concentration (32-36.5): 33.8 percent (normal) 33.8 percent. On 01-Feb-2022, Mean cell volume (80-99): 91.8 fl (normal) 91.8 fL. On 01-Feb-2022, Mean platelet volume (8.5-12.0): 9.7 fl (normal) 9.7 fL. On 01-Feb-2022, Monocyte count: 5 percent 5 percent and 0.73 k/ul (normal) 0.73 k/uL. On 01-Feb-2022, Neutrophil count (2.07-8.08): 11.53 k/ul (High) 11.53 k/uL, 79 percent (normal) 79 percent and 11.53 k/ul (High) 11.53 k/uL. On 01-Feb-2022, Nitrite urine: negative (Negative) Negative. On 01-Feb-2022, Platelet count (140-440): 327 k/ul (normal) 327 k/uL. On 01-Feb-2022, Protein total (6.4-8.2): 6.9 g/dl (normal) 6.9 g/dl. On 01-Feb-2022, Protein urine: pos 2+ (abnormal) Pos 2+. On 01-Feb-2022, Red blood cell count (4-5.40): 3.80 m/ul (Low) 3.80 M/uL. On 01-Feb-2022, Red blood cells urine (0-3): 100/hpf (abnormal) 100/hpf. On 01-Feb-2022, Red cell distribution width (10-14.5): 12.4 percent (normal) 12.4 percent and 41.1/fl (normal) 41.1/fL. On 01-Feb-2022, Specific gravity urine (1.005-1.030): 1.010 (normal) 1.010. On 01-Feb-2022, Ultrasound antenatal screen: single viable intrauterine pregnancy is visualized Single viable intrauterine pregnancy is visualized. On 01-Feb-2022, Urinary sediment present: few/lpf (normal) Few/lpf and absent Absent. On 01-Feb-2022, Urine analysis: present (abnormal) Present and sl cloudy (abnormal) Sl cloudy. On 01-Feb-2022, Urine ketone body: negative (Negative) Negative. On 01-Feb-2022, Urine leukocyte esterase: negative (Negative) Negative. On 01-Feb-2022, Urobilinogen urine (0.2-1.0): 0.2 ehrilch/dl (normal) 0.2 Ehrilch/dL. On 01-Feb-2022, White blood cell count (4.5-11.0): 14.6  k/µl (High) 14.6  k/µl. On 01-Feb-2022, White blood cells urine (0-5): 6-10/hpf (abnormal) 6-10/hpf. On 01-Feb-2022, pH urine (5.0-8.0): 7.0 (normal) 7.0. On an unknown date, Blood pressure measurement: 117/76 117/76. On an unknown date, Body temperature: 98.6 degree fahrenheit 98.6 degree Fahrenheit. On an unknown date, Heart rate: 80 80. On an unknown date, Oxygen saturation: 99 percent 99 percent. On an unknown date, Respiratory rate: 18 18.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that 7 hours after vaccination patient had severe diarrhea. Eventually patient was leaking amniotic fluids and had vaginal bleeding. Patient's water broke. Patient visited an emergency room (First Hospital contact info). 5 days later, on 04FEB2022 patient had contractions and visited the emergency room (2nd Hospital contact information). patient delivered the baby at 20 weeks gestation, and the baby died.  Company comment:  This spontaneous case concerns a 24-year-old pregnant female patient with no LMP of EDC reported with no relevant medical history who experienced the serious (hospitalization) events of hemorrhage in early pregnancy (IME), amniorrhea, oligohydramnios (IME), cystitis and threatened abortion the day of; premature rupture of membranes, premature labor, hemorrhage  in early pregnancy and premature delivery 5 days after, the first dose of mRNA-1273. Testing involved a fetal ultrasound that showed a live fetus at an estimated 19 weeks 1 day gestation on 31JAN2022 and lack of amniotic fluid, a metabolic panel with no significant findings and a urinalysis with evidence of cystitis. The possible cystitis is a confounder as it can be related to PTL. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  Ultrasound findings-The cervix contains small amount of fluid with a length of 6.6 cm. Marked oligohydramnios. Placenta is fundal.  No detectable amniotic fluid. Fetal measurements -Biparietal diameter-4.3 cm/19 weeks 0 days, abdominal circumference-14.3 cm /19 weeks 4 days, femur length -9 cm /19 weeks 1 day. Fetal heart rate -161 bpm.  Patient was asked to stop metronidazole 500 mg ORAL Tablet(FLAGYL)  No concomitant medications were reported.   This case was linked to MOD-2022-486841 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Feb-2022: Significant follow-up document was received on 17-FEB-2022. New reporters, lab data, treatment, concomitnt medications, new events were added.; Sender's Comments: This spontaneous case concerns a 24-year-old pregnant female patient with no LMP of EDC reported with no relevant medical history who experienced the serious (hospitalization) events of hemorrhage in early pregnancy (IME), amniorrhea, oligohydramnios (IME), cystitis and threatened abortion the day of; premature rupture of membranes, premature labor, hemorrhage in early pregnancy and premature delivery 5 days after, the first dose of mRNA-1273. Testing involved a fetal ultrasound that showed a live fetus at an estimated 19 weeks 1 day gestation on 31JAN2022 and lack of amniotic fluid, a metabolic panel with no significant findings and a urinalysis with evidence of cystitis. The possible cystitis is a confounder as it can be related to PTL. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.