Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cerebrovascular accident, Device issue, SARS-CoV-2 test, Weight
Clinical narrative: There was problem in the catheter that caused that caused him to go back to the hospital; Positive for COVID virus; Stroke; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke), COVID-19 (Positive for COVID virus) and DEVICE ISSUE (There was problem in the catheter that caused that caused him to go back to the hospital) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) tablet for COVID-19.    The patient's past medical history included Head and neck cancer. Concurrent medical conditions included Facial droop (survivor of head and neck cancer with radiation that caused a facial droop on left side), Blood pressure high (developed prior to vaccination) and Heart disease, unspecified (developed prior to vaccination).   In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 03-Dec-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). On 24-Jan-2022, the patient experienced COVID-19 (Positive for COVID virus) (seriousness criterion hospitalization). On an unknown date, the patient experienced DEVICE ISSUE (There was problem in the catheter that caused that caused him to go back to the hospital) (seriousness criterion hospitalization). The patient was hospitalized on 04-Dec-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) had resolved with sequelae, COVID-19 (Positive for COVID virus) had not resolved and DEVICE ISSUE (There was problem in the catheter that caused that caused him to go back to the hospital) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2022, SARS-CoV-2 test: (Positive) positive. In 2022, Weight: losing weight.         Patient's height and weight was estimated to be 173 cm and  72.57 kg respectively. Patient took lot of medication. Patient received Moderna vaccine on Jan-2021 and booster dose was received on Nov-2021. Was diagnosed with COVID and prescribed with Paxlovid. They were having trouble getting Paxlovid medication. The patient had been losing weight since the stroke because the food was bad in the rehab facility, patient did not want to eat that.  Patient was in the hospital after stroke and he had been transferred to the rehab hospital. There was a problem with the catheter and that caused him to go back to the hospital in Jan-2022, and currently back to the rehab since then.  Patient seemed to be pretty well. Facial droop had been increased and they believed it was as a result of stroke.  He initially had some trouble speaking but had improved significantly. His speech was slow and he had to give more effort. As a result of being in hospital bed for 2 weeks, he was having difficulty walking and it could be stroke related or from just being 81-year-old. The Covid condition was the same and he had congestion.   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 regarding a 81-year-old male patient with medical history of head and neck cancer treated with radiation that caused left side facial paralysis, high blood pressure and heart disease who received a booster dose of mRNA-1273 vaccine in November 2021 and experienced serious event of cerebrovascular accident on 03-Dec-2021. He was hospitalized and transferred to a rehab facility for physical therapy. Symptoms of stroke included increased facial droop, slow speech and walking difficulty. In Jan 2022, a not specified problem with a catheter caused him to go back to the hospital. Additionally, patient was diagnosed with COVID-19 on 24-Jan-2022 and Paxlovid was prescribed. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Medical conditions of high blood pressure and heart disease and advanced patient's age are risk factors for cerebrovascular accident. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case regarding a 81-year-old male patient with medical history of head and neck cancer treated with radiation that caused left side facial paralysis, high blood pressure and heart disease who received a booster dose of mRNA-1273 vaccine in November 2021 and experienced serious event of cerebrovascular accident on 03-Dec-2021. He was hospitalized and transferred to a rehab facility for physical therapy. Symptoms of stroke included increased facial droop, slow speech and walking difficulty. In Jan 2022, a not specified problem with a catheter caused him to go back to the hospital. Additionally, patient was diagnosed with COVID-19 on 24-Jan-2022 and Paxlovid was prescribed. No further details regarding clinical course, diagnostic tests or treatment performed were disclosed. Medical conditions of high blood pressure and heart disease and advanced patient's age are risk factors for cerebrovascular accident. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.