Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cerebrovascular accident, Incoherent, Memory impairment, Paralysis
Clinical narrative: Paralyzed for 2 days after 3rd dose/Could not move after 3rd dose; Stroke after 3rd dose; Fever 103 F after 3rd dose; Incoherent on the floor; Does not remember what happened after 3rd dose/No recollection of what happened on 9 & 10SEP2021; Hot left arm injection site after 3rd dose; Inflamed left arm after 3rd dose; Red injection site shoulder to elbow after 3rd dose; This spontaneous case was reported by a patient and describes the occurrence of PARALYSIS (Paralyzed for 2 days after 3rd dose/Could not move after 3rd dose), CEREBROVASCULAR ACCIDENT (Stroke after 3rd dose) and PYREXIA (Fever 103 F. after 3rd dose) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced PARALYSIS (Paralyzed for 2 days after 3rd dose/Could not move after 3rd dose) (seriousness criteria hospitalization prolonged and medically significant), CEREBROVASCULAR ACCIDENT (Stroke after 3rd dose) (seriousness criteria hospitalization prolonged and medically significant), PYREXIA (Fever 103 F. after 3rd dose) (seriousness criterion hospitalization prolonged), INCOHERENT (Incoherent on the floor), MEMORY IMPAIRMENT (Does not remember what happened after 3rd dose/No recollection of what happened on 9 & 10SEP2021), VACCINATION SITE WARMTH (Hot left arm injection site after 3rd dose), VACCINATION SITE INFLAMMATION (Inflamed left arm after 3rd dose) and VACCINATION SITE ERYTHEMA (Red injection site shoulder to elbow after 3rd dose). The patient was hospitalized from 10-Sep-2021 to 12-Sep-2021 due to CEREBROVASCULAR ACCIDENT, PARALYSIS and PYREXIA. The patient was treated with DOXYCYCLINE (oral) for Adverse event, at an unspecified dose and frequency. On 12-Sep-2021, PARALYSIS (Paralyzed for 2 days after 3rd dose/Could not move after 3rd dose), CEREBROVASCULAR ACCIDENT (Stroke after 3rd dose), INCOHERENT (Incoherent on the floor) and MEMORY IMPAIRMENT (Does not remember what happened after 3rd dose/No recollection of what happened on 9 & 10SEP2021) had resolved, PYREXIA (Fever 103 F after 3rd dose) outcome was unknown. At the time of the report, VACCINATION SITE WARMTH (Hot left arm injection site after 3rd dose), VACCINATION SITE INFLAMMATION (Inflamed left arm after 3rd dose) and VACCINATION SITE ERYTHEMA (Red injection site shoulder to elbow after 3rd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Sep-2021, Body temperature: 103 (High) 103 F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Patient reported that he received the third dose of Moderna Covid-19 Vaccine and 10 hours later, he had to go to the hospital, and he was released from the hospital on Sunday 12-Sep-2021 with a prescription for Doxycycline oral.  Company Comment: o~This case concerns a 69 year-old, male subject with no relevant medical history reported, who experienced the unexpected events of cerebrovascular accident, paralysis and pyrexia leading to hospitalization after the third dose of mRNA-1273. The events occurred approximately 7 months and 14 days after the first dose, 6 month and 15 days after the second dose, and between a few hours and one day after the third dose of mRNA-1273. The benefit-risk relationship of the product is not affected by this report. Further information has been requesting regarding the events and patient´s medical history.   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Hospitalization start date was updated.; Sender's Comments: o~This case concerns a 69 year-old, male subject with no relevant medical history reported, who experienced the unexpected events of cerebrovascular accident, paralysis and pyrexia leading to hospitalization after the third dose of mRNA-1273. The events occurred approximately 7 months and 14 days after the first dose, 6 month and 15 days after the second dose, and between a few hours and one day after the third dose of mRNA-1273. The benefit-risk relationship of the product is not affected by this report. Further information has been requesting regarding the events and patient´s medical history.