Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Vaccination site erythema, Vaccination site pain, Vomiting
Clinical narrative: Looked like she had a stroke; Muscle pain; Disabled; Brain does not work with her body; She cannot use her legs; Swelling of hands and feet; Nausea; Felt Sick (After First Vaccine); Slurring words; Throwing up; Fever 100.3 F (After First Vaccine); Loss of Taste (After First Vaccine); Pain in arm; Redness in arm; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DISABILITY (Disabled), CEREBROVASCULAR ACCIDENT (Looked like she had a stroke), CEREBRAL DISORDER (Brain does not work with her body), MALAISE (Felt Sick (After First Vaccine)), DYSARTHRIA (Slurring words), LOSS OF CONTROL OF LEGS (She cannot use her legs) and NAUSEA (Nausea) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain in arm), VACCINATION SITE ERYTHEMA (Redness in arm) and CHILLS (Chills). On 04-Feb-2021, the patient experienced AGEUSIA (Loss of Taste (After First Vaccine)) and PYREXIA (Fever 100.3 F (After First Vaccine)). On 03-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Looked like she had a stroke) (seriousness criteria hospitalization and life threatening), MALAISE (Felt Sick (After First Vaccine)) (seriousness criterion medically significant), DYSARTHRIA (Slurring words) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and VOMITING (Throwing up). On 04-Mar-2021, the patient experienced LOSS OF CONTROL OF LEGS (She cannot use her legs) (seriousness criterion medically significant) and PERIPHERAL SWELLING (Swelling of hands and feet). On 14-Apr-2021, the patient experienced CEREBRAL DISORDER (Brain does not work with her body) (seriousness criterion medically significant). On an unknown date, the patient experienced DISABILITY (Disabled) (seriousness criterion disability) and MYALGIA (Muscle pain). On 16-Feb-2021, VACCINATION SITE PAIN (Pain in arm), VACCINATION SITE ERYTHEMA (Redness in arm) and CHILLS (Chills) had resolved. On 25-Feb-2021, AGEUSIA (Loss of Taste (After First Vaccine)) and PYREXIA (Fever 100.3 F (After First Vaccine)) had resolved. On 14-Apr-2021, PERIPHERAL SWELLING (Swelling of hands and feet) had resolved. At the time of the report, DISABILITY (Disabled), CEREBROVASCULAR ACCIDENT (Looked like she had a stroke), CEREBRAL DISORDER (Brain does not work with her body), DYSARTHRIA (Slurring words), LOSS OF CONTROL OF LEGS (She cannot use her legs), NAUSEA (Nausea), MYALGIA (Muscle pain) and VOMITING (Throwing up) outcome was unknown and MALAISE (Felt Sick (After First Vaccine)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start dates of the event, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-076475 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: stroke, on hospice. On 22-Apr-2021: Additional info; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-076475:CROSS LINKED WITH DOSE 2