Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Limb discomfort, Pain in extremity
Clinical narrative: Stroke; Right feet hurt a little bit; Left feet was frozen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right feet hurt a little bit), LIMB DISCOMFORT (Left feet was frozen) and CEREBROVASCULAR ACCIDENT (Stroke) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 103A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced PAIN IN EXTREMITY (Right feet hurt a little bit) (seriousness criterion hospitalization). On 19-May-2021 at 10:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). In 2021, the patient experienced LIMB DISCOMFORT (Left feet was frozen) (seriousness criterion hospitalization). The patient was hospitalized on sometime in May 2021 due to LIMB DISCOMFORT. The patient was treated with Surgery (special surgery for his feet) for Pain in extremity and Surgery (special surgery for his feet) for Limb discomfort. At the time of the report, PAIN IN EXTREMITY (Right feet hurt a little bit) and LIMB DISCOMFORT (Left feet was frozen) outcome was unknown and CEREBROVASCULAR ACCIDENT (Stroke) had resolved.            The concomitant medications were not reported.  The patient stated that the next day after getting his 2nd dose of the Moderna COVID 19 vaccine, at about 10 am, he had a stroke. An ambulance came and took him to the hospital. Before the shot, he did not have any problem. He was given some medicine at the hospital and was sent home after 2 to 3 days. He was taken to the hospital again because his right foot hurt a little bit but his left foot was frozen, and he had a special surgery for his feet. He said he has gone to the doctor so many times.  He takes three medications in the morning, in the afternoon and 3 at nighttime. He could not provide the name of the medications because he can't see it very well.  Company comment: This spontaneous case concerns a 75-year-old, male patient with no medical history reported, who experienced the unexpected, serious AESI of cerebrovascular accident and the unexpected, serious events of pain in extremity and limb discomfort. The event cerebrovascular accident, which resulted in hospitalization, occurred 1 day after administration of the second dose of the Moderna mRNA-1273. He was treated with unspecified medicines and was discharged after 2 to 3 days. On an unspecified date in 2021, he was brought to the hospital again due to right foot pain and because his left foot was 'frozen'. He underwent an unspecified 'special surgery' for his feet. He is currently taking three (unspecified) medications three times daily. The outcomes of the events pain in extremity and limb discomfort were unknown at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow-up received on 19-Nov-2021 and does not contain any new information.; Sender's Comments: This spontaneous case concerns a 75-year-old, male patient with no medical history reported, who experienced the unexpected, serious AESI of cerebrovascular accident and the unexpected, serious events of pain in extremity and limb discomfort. The event cerebrovascular accident, which resulted in hospitalization, occurred 1 day after administration of the second dose of the Moderna mRNA-1273. He was treated with unspecified medicines and was discharged after 2 to 3 days. On an unspecified date in 2021, he was brought to the hospital again due to right foot pain and because his left foot was 'frozen'. He underwent an unspecified 'special surgery' for his feet. He is currently taking three (unspecified) medications three times daily. The outcomes of the events pain in extremity and limb discomfort were unknown at the time of the report. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report. Further information has been requested.