Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Felt bad), VACCINATION SITE PRURITUS (swelling in that same area and itches), VACCINATION SITE SWELLING (Large red swollen where it was given/arm started swelling in that same area) and PYREXIA (Had fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Felt bad), VACCINATION SITE PRURITUS (swelling in that same area and itches), VACCINATION SITE SWELLING (Large red swollen where it was given/arm started swelling in that same area), PYREXIA (Had fever), VACCINATION SITE ERYTHEMA (Large red swollen where it was given) and MATERNAL EXPOSURE DURING PREGNANCY (7.5 months pregnant). At the time of the report, PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (Felt bad), PYREXIA (Had fever), VACCINATION SITE ERYTHEMA (Large red swollen where it was given) and MATERNAL EXPOSURE DURING PREGNANCY (7.5 months pregnant) had resolved and VACCINATION SITE PRURITUS (swelling in that same area and itches) and VACCINATION SITE SWELLING (Large red swollen where it was given/arm started swelling in that same area) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. It was reported that the patient was 7.5 months pregnant when she got the first shot. The patient felt bad the day after, had sore arm etc. The patient had fever and a large red swollen where the vaccine was given, as reported. After a few days it went away. Later, reported as "last night", the patient's arm started swelling in that same area and itches. No Concomitant medications were reported. No treatment details were provided. This is a case of maternal exposure during pregnancy for this female patient of an unknown age. The patient experienced associated adverse events of feeling abnormal, pyrexia, vaccination site pruritus, vaccination site swelling, vaccination site erythema and pain in extremity. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The Company causality for the event of maternal exposure during pregnancy is not applicable. Patient will continue to be contacted for further monitoring of AEs during the pregnancy, as well as for further monitoring of pregnancy outcome. Sender's Comments: This is a case of maternal exposure during pregnancy for this female patient of an unknown age. The patient experienced associated adverse events of feeling abnormal, pyrexia, vaccination site pruritus, vaccination site swelling, vaccination site erythema and pain in extremity. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. The Company causality for the event of maternal exposure during pregnancy is not applicable. Patient will continue to be contacted for further monitoring of AEs during the pregnancy, as well as for further monitoring of pregnancy outcome.