Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Depression, Dizziness, Fall, Gait disturbance, Hypoaesthesia
Clinical narrative: came down with a right sided stroke 7 months ago, 2days after last infusion/ stroke affected his right foot; neuropathy in right foot ankle/ neuropathy in right leg; Sometimes I feel like I have a little bit of dementia; a blood blister on his left hand after receiving the injection in his right arm / Blister was 3/4 by 1/2; mark on my hand where it used to be; depression; Difficulty walking; Broke his ribs; Hurt his side; Chills; Fever; fell without any reason, fell two days ago; hair loss; Weakness in left arm / weakness in his left side; lightheadedness in his head; numbness / numb in his right foot; This spontaneous case was reported by a patient and describes the occurrence of CEREBROVASCULAR ACCIDENT (came down with a right sided stroke 7 months ago, 2days after last infusion/ stroke affected his right foot), NEUROPATHY PERIPHERAL (neuropathy in right foot ankle/ neuropathy in right leg) and DEMENTIA (Sometimes I feel like I have a little bit of dementia) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product VINCRISTINE solution for injection for Non-Hodgkin's lymphoma.    The patient's past medical history included COVID-19 (first infusion was in Nov in which after he got COVID, without the respiratory symptoms) on 13-Nov-2020, Cancer (cancer is gone now and he has his balance now), Heartburn, Urination frequency of, Thymoma (operated on for a thymoma between his lungs in FEB 2018, removed the thymoma, this was very serious, before it became malignant) in February 2018, Tingling feet/hands and Ileostomy (had colon taken out) since 2000. Concurrent medical conditions included Non-Hodgkin's lymphoma (was taking infusion for his Non-Hodgkin's Lymphoma) in October 2020 and Blood pressure high (take 3 different meds diagnosed 20 years ago). Concomitant products included RITUXIMAB (RITUXAN) from an unknown date to 22-Feb-2021 for Non-Hodgkin's lymphoma.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started VINCRISTINE (unknown route) every 3 week. On 18-Feb-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). On 24-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (came down with a right sided stroke 7 months ago, 2days after last infusion/ stroke affected his right foot) (seriousness criteria hospitalization, medically significant and life threatening). In 2021, the patient experienced NEUROPATHY PERIPHERAL (neuropathy in right foot ankle/ neuropathy in right leg) (seriousness criteria hospitalization and medically significant), FALL (fell without any reason, fell two days ago), ALOPECIA (hair loss), MUSCULAR WEAKNESS (Weakness in left arm / weakness in his left side), DIZZINESS (lightheadedness in his head) and HYPOAESTHESIA (numbness / numb in his right foot). On an unknown date, the patient experienced DEMENTIA (Sometimes I feel like I have a little bit of dementia) (seriousness criterion medically significant), BLOOD BLISTER (a blood blister on his left hand after receiving the injection in his right arm / Blister was 3/4 by 1/2), SKIN DISCOLOURATION (mark on my hand where it used to be), DEPRESSION (depression), GAIT DISTURBANCE (Difficulty walking), RIB FRACTURE (Broke his ribs) and INJURY (Hurt his side). At the time of the report, CEREBROVASCULAR ACCIDENT (came down with a right sided stroke 7 months ago, 2days after last infusion/ stroke affected his right foot) had not resolved, NEUROPATHY PERIPHERAL (neuropathy in right foot ankle/ neuropathy in right leg), DEMENTIA (Sometimes I feel like I have a little bit of dementia), BLOOD BLISTER (a blood blister on his left hand after receiving the injection in his right arm / Blister was 3/4 by 1/2), SKIN DISCOLOURATION (mark on my hand where it used to be), DEPRESSION (depression), FALL (fell without any reason, fell two days ago), ALOPECIA (hair loss), MUSCULAR WEAKNESS (Weakness in left arm / weakness in his left side), DIZZINESS (lightheadedness in his head), HYPOAESTHESIA (numbness / numb in his right foot), GAIT DISTURBANCE (Difficulty walking), CHILLS (Chills), PYREXIA (Fever) and RIB FRACTURE (Broke his ribs) outcome was unknown and INJURY (Hurt his side) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, SARS-CoV-2 test: (Positive) Positive. In 2021, White blood cell count: went down to 0.7. On an unknown date, Magnetic resonance imaging: he had moderate neuropathy in his right foot. On an unknown date, Nerve stimulation test: he had moderate neuropathy in his right foot. On an unknown date, SARS-CoV-2 test: (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had had 6 injections, 3 weeks apart starting from 06 Nov 2020, his last injection was 22 Feb 2021. Since the 7 months, patient was been taking physical therapy and electrical stimulus and his right foot is reacting to that well for which he was able to raise his right toes. Patient was unable to read tot number for the first dose. No treatment medication was provided by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a spontaneous case concerning a 73-year-old male patient with medical history of high blood pressure and Non-Hodgkin's lymphoma (ongoing chemotherapy), who experienced the unexpected, serious (life threatening, hospitalization and medically significant) adverse event of special interest of Cerebrovascular accident, the unexpected, serious (hospitalization and medically significant) event of Neuropathy peripheral and the unexpected, serious (medically significant) event of Dementia. The event Cerebrovascular accident occurred 6 days after receiving the first dose of mRNA-1273 vaccine. The event Neuropathy peripheral and Dementia occurred on unknown date. The patient is currently doing physical therapy as treatment. At the time of the report, the event Cerebrovascular accident had not resolved and the outcome of the events Neuropathy peripheral and Dementia were unknown. Medical history of high blood pressure and ongoing chemotherapy for Non-Hodgkin's lymphoma remain as risk factors for the event of Cerebrovascular accident. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-333582, MOD-2021-378080 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Follow-up received include no new information added. On 27-Sep-2021: Follow-up received include Date of vaccination (COVID-19 Moderna Vaccine ) added, seriousness added for stroke. On 06-Oct-2021: Follow-up received include event onset added. On 25-Oct-2021: Follow-up received include reporter details updated. On 16-Nov-2021: Follow-up received include Onset date added for events .; Sender's Comments: This is a spontaneous case concerning a 73-year-old male patient with medical history of high blood pressure and Non-Hodgkin's lymphoma (ongoing chemotherapy), who experienced the unexpected, serious (life threatening, hospitalization and medically significant) adverse event of special interest of Cerebrovascular accident, the unexpected, serious (hospitalization and medically significant) event of Neuropathy peripheral and the unexpected, serious (medically significant) event of Dementia. The event Cerebrovascular accident occurred 6 days after receiving the first dose of mRNA-1273 vaccine. The event Neuropathy peripheral and Dementia occurred on unknown date. The patient is currently doing physical therapy as treatment. At the time of the report, the event Cerebrovascular accident had not resolved and the outcome of the events Neuropathy peripheral and Dementia were unknown. Medical history of high blood pressure and ongoing chemotherapy for Non-Hodgkin's lymphoma remain as risk factors for the event of Cerebrovascular accident. The benefit-risk relationship of mRNA-1273 is not affected by this report.