Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity, Reading disorder, SARS-CoV-2 test
Clinical narrative: patient had problems reading; voice changed; Tested positive for COVID-19; numbness in the right leg/feels like electric shocks; can't walk/the vaccine changed my leg/I need a walking stick/feel like I'm going to fall/it's like a bone is sticking; intense and horrible pain in the leg,I have pain in my leg even when I'm laying down/arm hurt; interval between doses was less than 25 days; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in the right leg/feels like electric shocks), GAIT INABILITY (can't walk/the vaccine changed my leg/I need a walking stick/feel like I'm going to fall/it's like a bone is sticking), PAIN IN EXTREMITY (intense and horrible pain in the leg,I have pain in my leg even when I'm laying down/arm hurt), COVID-19 (Tested positive for COVID-19) and READING DISORDER (patient had problems reading) in a 51-year-old female patient 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 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval between doses was less than 25 days). In September 2021, the patient experienced HYPOAESTHESIA (numbness in the right leg/feels like electric shocks), GAIT INABILITY (can't walk/the vaccine changed my leg/I need a walking stick/feel like I'm going to fall/it's like a bone is sticking) and PAIN IN EXTREMITY (intense and horrible pain in the leg,I have pain in my leg even when I'm laying down/arm hurt). On 23-Sep-2021, the patient experienced COVID-19 (Tested positive for COVID-19). On an unknown date, the patient experienced READING DISORDER (patient had problems reading) and DYSPHONIA (voice changed). On 26-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (interval between doses was less than 25 days) had resolved. At the time of the report, HYPOAESTHESIA (numbness in the right leg/feels like electric shocks), GAIT INABILITY (can't walk/the vaccine changed my leg/I need a walking stick/feel like I'm going to fall/it's like a bone is sticking) and PAIN IN EXTREMITY (intense and horrible pain in the leg,I have pain in my leg even when I'm laying down/arm hurt) had not resolved and COVID-19 (Tested positive for COVID-19), READING DISORDER (patient had problems reading) and DYSPHONIA (voice changed) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Sep-2021, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Blood pressure measurement: high (High) High.         No concomitant medications were provided. No treatment medications were provided. This case concerns a 51-year-old female patient, with no relevant medical history, who experienced the non-serious unexpected AESI of COVID 19. Inappropriate schedule of product administration was also identified. The event of COVID-19 occurred approximately 5 months after receiving the second dose of Spikevas, which was given 23 days apart from the first dose. The rechallenge is not applicable considering the nature of the event. The benefit-risk relation of Spikevax is not affected by this report. Sender's Comments: This case concerns a 51-year-old female patient, with no relevant medical history, who experienced the non-serious unexpected AESI of COVID 19. Inappropriate schedule of product administration was also identified. The event of COVID-19 occurred approximately 5 months after receiving the second dose of Spikevas, which was given 23 days apart from the first dose. The rechallenge is not applicable considering the nature of the event. The benefit-risk relation of Spikevax is not affected by this report.