Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Throat tightness, Urticaria
Clinical narrative: obviously cannot get the 2nd dose; pregnant; allergic reaction to the first dose; hives all over my body; lips swelling; Throat swelling; bruises on her body from scratching so hard; throat was closing up; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (allergic reaction to the first dose), URTICARIA (hives all over my body), LIP SWELLING (lips swelling), PHARYNGEAL SWELLING (Throat swelling) and CONTUSION (bruises on her body from scratching so hard) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Apr-2021, 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 05-Jan-2022. On 19-Apr-2021, the patient experienced ALLERGY TO VACCINE (allergic reaction to the first dose), URTICARIA (hives all over my body), LIP SWELLING (lips swelling), PHARYNGEAL SWELLING (Throat swelling), CONTUSION (bruises on her body from scratching so hard) and THROAT TIGHTNESS (throat was closing up). In May 2021, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (pregnant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (obviously cannot get the 2nd dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and ALUMINIUM HYDROXIDE, MAGNESIUM TRISILICATE, SODIUM ALGINATE (PEPCID [ALUMINIUM HYDROXIDE;MAGNESIUM TRISILICATE;SODIUM ALGINATE]) for Adverse event, at an unspecified dose and frequency. On 20-Apr-2021, ALLERGY TO VACCINE (allergic reaction to the first dose), URTICARIA (hives all over my body), LIP SWELLING (lips swelling), PHARYNGEAL SWELLING (Throat swelling), CONTUSION (bruises on her body from scratching so hard) and THROAT TIGHTNESS (throat was closing up) had resolved. In May 2021, MATERNAL EXPOSURE BEFORE PREGNANCY (pregnant) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (obviously cannot get the 2nd dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No concomitant medication was reported.  She also reported that her throat was closing up. Her husband made her take Benadryl. The caller stated that she had bruises on her body because she was scratching so hard. She did go to the emergency room. They kept her in the waiting room, took her blood pressure and gave her a Pepcid. By the next morning everything was better. Patient found out she was pregnant in May-2021. Patient stated that she did not receive the second dose in the series.  Company Comment: This prospective pregnancy case concerns a 25-year-old female patient with no relevant medical history who experienced non-serious unexpected events of maternal exposure before pregnancy, allergy to vaccine, urticaria, lip swelling, pharyngeal swelling, contusion, and throat tightness and product dose omission issue. The events occurred approximately within 24 hours after the first dose of Spikevax. Rechallenge was not applicable since action taken in response to the product is withdrawn. The events were consistent with the current understanding of the mechanism of action of the medication . The benefit-risk relationship of drug is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Significant follow up received, reporter's address updated, patient's demographics updated, pregnancy information added, vaccine details added, events outcome updated to recovered, new event Throat tightness, Contusion, Maternal exposure before pregnancy added and treatment details added.; Sender's Comments: This prospective pregnancy case concerns a 25-year-old female patient with no relevant medical history who experienced non-serious unexpected events of maternal exposure before pregnancy, allergy to vaccine, urticaria, lip swelling, pharyngeal swelling, contusion, and throat tightness and product dose omission issue. The events occurred approximately within 24 hours after the first dose of Spikevax. Rechallenge was not applicable since action taken in response to the product is withdrawn. The events were consistent with the current understanding of the mechanism of action of the medication . The benefit-risk relationship of drug is not affected by this report.