Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Acute cardiac event, Body temperature, Hypoaesthesia, Paraesthesia, Pneumonia
Clinical narrative: pneumonia; The patient developed acute cardiac problems and was hospitalized; Numbness of limbs; Tingling feet/hands.; This spontaneous case was reported by a physician and describes the occurrence of ACUTE CARDIAC EVENT (The patient developed acute cardiac problems and was hospitalized) and PNEUMONIA (pneumonia) in an 82-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032089) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lung cancer, Prostate cancer, Stent placement, Enlargement heart, Discomfort, Numbness and Lung lobectomy (right lobectomy).    On 15-Dec-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 15-Dec-2023, the patient experienced PNEUMONIA (pneumonia) (seriousness criteria hospitalization and medically significant), HYPOAESTHESIA (Numbness of limbs) and PARAESTHESIA (Tingling feet/hands.). In December 2023, the patient experienced ACUTE CARDIAC EVENT (The patient developed acute cardiac problems and was hospitalized) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from sometime in December 2023 to sometime in December 2023 due to PNEUMONIA. At the time of the report, ACUTE CARDIAC EVENT (The patient developed acute cardiac problems and was hospitalized) and PNEUMONIA (pneumonia) was resolving and HYPOAESTHESIA (Numbness of limbs) and PARAESTHESIA (Tingling feet/hands.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: 103-104 F.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Patients received the Spikevax 2023-2024 vaccine on 15 DEC 2023 from lot number 3032089. With in 6 hours of receiving the vaccine, patient was on floor and had to be admitted to hospital. He had a marked reaction with moderna immunization on Dec 2023. He developed acute cardiac problems and was hospitalized. He had temperature of 103-104 F and was diagnosed with pneumonia at hospital. He did experience additional adverse reaction which include numbness and tingling of his hands and feet HCP states that he had never seen something like this happen before. Additionally, he had difficulty breathing and confusion. Before he received the Spikevax, he had some discomfort and numbness but those went away. After receiving the injection, his reactions were "full blown." He remained at the hospital for 3-4 days. He was gradually getting better now, but still hadn't recovered fully.   treatment information was not reported.  Company comment:  This spontaneous case concerns an 82  year  old male patient, with medical history of lung neoplasm malignant, lobectomy, cardiomegaly, and stent replacement, who received a dose of Spikevax 2023-2024 PFS vaccine (Andusomeran) and experienced the unexpected, serious (hospitalization and medically significant) events of acute cardiac event (AESI) and pneumonia The report stated that within 6 hours of receiving the vaccine, patient had pyrexia, "was on the floor" and was admitted to hospital with diagnose of pneumonia. He remained at the hospital for 3-4 days. Latency for the event acute cardiac event cannot be properly assessed since exact onset date was not provided. The outcome of the events was recovering. No further clinical details were provided for medical reviewing. Patient´s age and medical history of remains as confounders for the events. The benefit-risk relationship of Spikevax 2023-2024 PFS vaccine (Andusomeran) is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jan-2024: Live significant follow-up received relevant history, new event, patient details, product and reference updated.