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Write-up: Threatened premature labor; Maternal exposure during pregnancy; Asthenia; Vaccination site pain; This is a spontaneous report from a contactable consumer from the WEB, regulatory authority number FR-AFSSAPS-2021072533. A 32-years-old pregnant female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in the left arm on 04Jun2021 (Batch/Lot Number: FA8016) as dose 1, single (at the age of 32 years-old) for COVID-19 immunisation. Medical history included allergic rhinitis, adenoids surgery, unexplored penicillin hypersensitivity. The patient had no previous obstetric history. Concomitant medications included ascorbic acid, ferrous sulfate (TIMOFEROL) from an unknown date for an unspecified indication. On 04Jun2021 the patient experienced threatened premature labor, asthenia, and vaccination site pain. The mother was 29 Weeks + 6 days pregnant at the onset of the event (04Jun2021). No data if spontaneous pregnancy, G1P0. Date of LMP was 08Nov2020, either estimate DDR 08Nov2020 or early pregnancy 21Nov2020. The mother was due to deliver on 15Aug2021. The patient was hospitalized from 05Jun2021 to 08Jun2021 for threat of premature delivery. Clinical course is as follows: on 04Jun2021, 5 hours after vaccination onset of pain at the injection site, onset also on the same day of asthenia, 15 hours after vaccination onset of contraction episodes (at night) leading to an emergency room visit. On 05Jun2021 the patient underwent lab tests and procedures which included: an ultrasound of the cervix was performed with results: cervix at 26 mm with minimal image of the water pocket. The uterus was contractile with painful contractions. Negative infective workup with pyretism, sterile cytobacteriological examination of urine, negative vaginal swab, negative throat swab and negative COVID PCR. On 08Jun2021 Relay by SPASFON, Ultrasound of the exit cervix: cervix at 29-30 mm. The patient no longer presented with painful uterine contractions. Monitoring was reassuring. The differential diagnosis was provided as: infectious causes: negative assessment, afebrile; maternal causes: G1P0, age less than 35 years, minimal water bag rate but no data on socio-economic level, tobacco / toxic, NF (anemia?), type of work, trauma, T2 / T3 metrorrhagia, long daily trips; Obstetric history: 0; ovular causes: not mentioned but a priori no hydramnios or placenta preavia. The patient was healing and discharge from the hospital on 08Jun2021 with prescription for AT from 05Jun2021 to 11Jun2021, SPASFON 80mg 2-2-2 PARACETAMOL 1g 1-1-1, with recommendations of Midwife follow-up at home twice a week until childbirth and for patient to change position every 2 hours, avoid long journeys by car, avoid intense physical activity, and keep walking at a moderate pace. Therapeutic measures were taken as a result of threatened premature labor and included establishment of an ADALATE LP 20mg protocol for 48h and the patient also benefited from corticosteroid therapy with CELESTENE in IM 2 times at 24 hour intervals for fetal lung maturation. The clinical outcome of the event threatened premature labor was recovered on 08Jun2021, asthenia recovered on an unknown date and vaccination site pain recovered on 05Jun2021. No follow-up attempts possible. No further information expected.
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