Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Maternal exposure during pregnancy, Pain, Vaccination site pain
Clinical narrative: pain; tenderness at the injection site; General fatigue; Pregnant patient received Moderna's newBivalent Booster; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PAIN (pain), VACCINATION SITE PAIN (tenderness at the injection site), FATIGUE (General fatigue) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received Moderna's newBivalent Booster) in a female patient of an unknown age who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Allergy to antibiotic (Ceftin Allergy). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.  On 07-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced PAIN (pain), VACCINATION SITE PAIN (tenderness at the injection site), FATIGUE (General fatigue) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received Moderna's newBivalent Booster). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (pain), VACCINATION SITE PAIN (tenderness at the injection site), FATIGUE (General fatigue) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant patient received Moderna's newBivalent Booster) had resolved.      Patient received concomitant as supplements prenatal. Patient not had COVID test positive or diagnosis before. Patient not had acute and chronic illnesses at the time of vaccination.  Patient not received other vaccines within 1 month prior to Moderna COVID-19 vaccine. Patient did not require medical care (office visit, Urgent care, ER, hospitalized). Patient experienced a similar event in the past, during last vaccination.  Company comment: This spontaneous case concerns a pregnant woman of unspecified age with medical history of drug allergy, who received the booster dose of mRNA-1273.222 vaccine during her pregnancy (reported as Pregnant patient received Moderna's new Bivalent Booster). The event maternal exposure during pregnancy occurred unknown days after receiving the fourth dose (second booster) of mRNA-1273.222 vaccine in COVID-19 vaccination series. It was reported that the patient had received the first two doses of Moderna vaccine at an interval of 30 days and third dose 220 days later. The date of last menstrual period, and the gestational age at the time of administration of vaccine is not provided. No further information regarding patient's medical history, menstrual history , obstetric history, last menstrual period, estimated date of delivery, outcome of pregnancy, relevant imaging studies, concomitant medications and treatment received were provided. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.   This case was linked to MOD-2022-643573 (Patient Link).; Sender's Comments: This spontaneous case concerns a pregnant woman of unspecified age with medical history of drug allergy, who received the booster dose of mRNA-1273.222 vaccine during her pregnancy (reported as Pregnant patient received Moderna's new Bivalent Booster). The event maternal exposure during pregnancy occurred unknown days after receiving the fourth dose (second booster) of mRNA-1273.222 vaccine in COVID-19 vaccination series. It was reported that the patient had received the first two doses of Moderna vaccine at an interval of 30 days and third dose 220 days later. The date of last menstrual period, and the gestational age at the time of administration of vaccine is not provided. No further information regarding patient's medical history, menstrual history , obstetric history, last menstrual period, estimated date of delivery, outcome of pregnancy, relevant imaging studies, concomitant medications and treatment received were provided. The benefit-risk relationship of mRNA-1273.222 is not affected by this report.