Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Suspected COVID-19
Clinical narrative: Suspected COVID-19 infection; Angioedema (tongue swelling), Skin erythema; Muscle heaviness; Revaccination with different COVID-19 vaccine; Interchange of vaccine products; Maternal exposure before pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of ANGIOEDEMA (Angioedema (tongue swelling), Skin erythema) in a 39-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) for COVID-19 prophylaxis and NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Food allergy (gets rash from wheat) and Pregnant. Concomitant products included DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) from 20-Jul-2022 to 21-Jul-2022 and GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE (MUCINEX D) from 13-Jul-2022 to 14-Jul-2022 for an unknown indication.   On 19-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (COVID-19 VACCINE JANSSEN) (unknown route) 1 dosage form. On 10-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (Oral) at an unspecified dose. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 01-Sep-2022. On 10-Nov-2021, the patient experienced COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure before pregnancy). On 24-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANGIOEDEMA (Angioedema (tongue swelling), Skin erythema) (seriousness criterion medically significant) and MUSCLE DISCOMFORT (Muscle heaviness). On an unknown date, the patient experienced SUSPECTED COVID-19 (Suspected COVID-19 infection). On 10-Nov-2021, MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure before pregnancy) had resolved. At the time of the report, ANGIOEDEMA (Angioedema (tongue swelling), Skin erythema) and MUSCLE DISCOMFORT (Muscle heaviness) had not resolved and SUSPECTED COVID-19 (Suspected COVID-19 infection), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ANGIOEDEMA (Angioedema (tongue swelling), Skin erythema), MUSCLE DISCOMFORT (Muscle heaviness), SUSPECTED COVID-19 (Suspected COVID-19 infection), COVID-19 IMMUNISATION (Revaccination with different COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) and MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure before pregnancy) to be related.    Treatment medications was not reported. Last menstrual period (LMP) was reported on 25-Nov-2021.  Company Comment: This spontaneous case concerns a 39-year-old female patient, with relevant history of food allergy, who experienced unexpected, serious (medically significant) event angioedema and unexpected, non-serious AESI Suspected Covid19, after receiving a dose of mRNA-1273 (second dose in a Covid19 vaccination schedule).  Maternal exposure before pregnancy was also reported.  She received mRNA-1273 around 2 weeks prior to her last menstrual period; she is currently pregnant.  Around 8 months after mRNA-1273 vaccination, she was suspected to have Covid19 and started treatment with Nirmatrelvir/Ritonavir (Paxlovid).  On the third day of Paxlovid intake, she developed angioedema with skin erythema and tongue swelling.  Treatment not reported.  The outcome of angioedema was not recovered, while the outcome of suspected Covid19 was unknown.  Additionally, the patient previously received one dose of a different Covid19 vaccine Janssen (interchange of vaccine products/revaccination with different Covid19 vaccine).  The patient's history of food allergy could be a confounding factor for angioedema.  The ongoing Covid19 pandemic could be a contributory factor for suspected Covid19.  The benefit risk relationship of mRNA-1273 is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2022: Significant follow up received on 18-Aug-2022 contains updated suspect product information, co-suspect information, gravida information and events were added.; Sender's Comments: This spontaneous case concerns a 39-year-old female patient, with relevant history of food allergy, who experienced unexpected, serious (medically significant) event angioedema and unexpected, non-serious AESI Suspected Covid19, after receiving a dose of mRNA-1273 (second dose in a Covid19 vaccination schedule).  Maternal exposure before pregnancy was also reported.  She received mRNA-1273 around 2 weeks prior to her last menstrual period; she is currently pregnant.  Around 8 months after mRNA-1273 vaccination, she was suspected to have Covid19 and started treatment with Nirmatrelvir/Ritonavir (Paxlovid).  On the third day of Paxlovid intake, she developed angioedema with skin erythema and tongue swelling.  Treatment not reported.  The outcome of angioedema was not recovered, while the outcome of suspected Covid19 was unknown.  Additionally, the patient previously received one dose of a different Covid19 vaccine Janssen (interchange of vaccine products/revaccination with different Covid19 vaccine).  The patient's history of food allergy could be a confounding factor for angioedema.  The ongoing Covid19 pandemic could be a contributory factor for suspected Covid19.  The benefit risk relationship of mRNA-1273 is not affected by this report.