Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Hypoaesthesia, Somnolence, Vision blurred
Clinical narrative: Numbness in fingers of right hand for 5  minutes after first shot; Blurred vision on both eyes for 10 minutes  after first shot; vaccine was administered on 17May2021 but expiration date is 19Apr2021; Sleepy after first shot; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy after first shot), HYPOAESTHESIA (Numbness in fingers of right hand for 5  minutes after first shot), VISION BLURRED (Blurred vision on both eyes for 10 minutes  after first shot) and EXPIRED PRODUCT ADMINISTERED (vaccine was administered on 17May2021 but expiration date is 19Apr2021) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, the patient experienced SOMNOLENCE (Sleepy after first shot) and EXPIRED PRODUCT ADMINISTERED (vaccine was administered on 17May2021 but expiration date is 19Apr2021). On 18-May-2021, the patient experienced HYPOAESTHESIA (Numbness in fingers of right hand for 5  minutes after first shot) and VISION BLURRED (Blurred vision on both eyes for 10 minutes  after first shot). On 17-May-2021, EXPIRED PRODUCT ADMINISTERED (vaccine was administered on 17May2021 but expiration date is 19Apr2021) had resolved. On 18-May-2021, HYPOAESTHESIA (Numbness in fingers of right hand for 5  minutes after first shot) and VISION BLURRED (Blurred vision on both eyes for 10 minutes  after first shot) had resolved. At the time of the report, SOMNOLENCE (Sleepy after first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.  Company Comment: This is a spontaneous case of expired product administered for this 27-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious events of somnolence, hypoaesthesia and blurred vision. The events occurred beginning on the same day and up to 1 day after administration of the first dose of the Moderna mRNA-1273. The patient visited the emergency room but no tests were done. She was told that her symptoms were not related to the vaccine. The rechallenge was not applicable as the events occurred after the first dose. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report. Further information has been requested.; Sender's Comments: This is a spontaneous case of expired product administered for this 27-year-old, female patient with no relevant medical history, who experienced the unexpected, non-serious events of somnolence, hypoaesthesia and blurred vision. The events occurred beginning on the same day and up to 1 day after administration of the first dose of the Moderna mRNA-1273. The patient visited the emergency room but no tests were done. She was told that her symptoms were not related to the vaccine. The rechallenge was not applicable as the events occurred after the first dose. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report. Further information has been requested.