Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Inappropriate schedule of product administration
Clinical narrative: Shortness of breath; Discomfort on her chest; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Discomfort on her chest) and DYSPNOEA (Shortness of breath) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006b21a and 017c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 11-Oct-2021, the patient experienced CHEST DISCOMFORT (Discomfort on her chest) (seriousness criterion medically significant). On 12-Oct-2021, the patient experienced DYSPNOEA (Shortness of breath) (seriousness criterion medically significant). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 05-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, CHEST DISCOMFORT (Discomfort on her chest) and DYSPNOEA (Shortness of breath) had not resolved.            Other concomitant medication reported was unspecified blood pressure medication.  Company comment: This case concerns a 58-year-old, female patient with no reported relevant medical history, who experienced the serious events of dyspnoea and chest discomfort. The events occurred approximately 4 months after the second dose of Spikevax. The rechallenge was not applicable as the events occurred after the second dose, no additional dose is expected to be given, and no details were provided about the first dose. Although no medical history was reported, patient's concomitant medication includes a blood pressure medicine, condition which could be a confounding factor. The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-350382 (Patient Link).; Sender's Comments: This case concerns a 58-year-old, female patient with no reported relevant medical history, who experienced the serious events of dyspnoea and chest discomfort. The events occurred approximately 4 months after the second dose of Spikevax. The rechallenge was not applicable as the events occurred after the second dose, no additional dose is expected to be given, and no details were provided about the first dose. Although no medical history was reported, patient's concomitant medication includes a blood pressure medicine, condition which could be a confounding factor. The benefit-risk relationship of Spikevax is not affected by this report.