Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypotension, Inappropriate schedule of product administration, Malaise, Yellow skin
Clinical narrative: very agitated; couldn't breathe/ lungs were low; stroke; weak/ very bad; yellow; was sweating a lot; I am not feeling well; blood pressure was very low; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke), AGITATION (very agitated), DYSPNOEA (couldn't breathe/ lungs were low), ASTHENIA (weak/ very bad), YELLOW SKIN (yellow), HYPERHIDROSIS (was sweating a lot), MALAISE (I am not feeling well) and HYPOTENSION (blood pressure was very low) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stomach ulcer. Concurrent medical conditions included Bone cancer (In treatment for past 5 years), Hypercholesteremia and Hypertension.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 11-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ASTHENIA (weak/ very bad) (seriousness criterion hospitalization), YELLOW SKIN (yellow) (seriousness criterion hospitalization), HYPERHIDROSIS (was sweating a lot) (seriousness criterion hospitalization), MALAISE (I am not feeling well) (seriousness criterion hospitalization) and HYPOTENSION (blood pressure was very low) (seriousness criterion hospitalization). On 12-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria death, hospitalization and medically significant). On an unknown date, the patient experienced AGITATION (very agitated) (seriousness criterion hospitalization) and DYSPNOEA (couldn't breathe/ lungs were low) (seriousness criterion hospitalization). The patient was hospitalized from 11-Apr-2021 to 12-Apr-2021 due to AGITATION, ASTHENIA, CEREBROVASCULAR ACCIDENT, DYSPNOEA, HYPERHIDROSIS, HYPOTENSION, MALAISE and YELLOW SKIN. On 21-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. On 12-Apr-2021, HYPOTENSION (blood pressure was very low) outcome was unknown. The patient died on 12-Apr-2021. The reported cause of death was Stroke. It is unknown if an autopsy was performed. At the time of death, AGITATION (very agitated), DYSPNOEA (couldn't breathe/ lungs were low), ASTHENIA (weak/ very bad), YELLOW SKIN (yellow), HYPERHIDROSIS (was sweating a lot) and MALAISE (I am not feeling well) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, Blood pressure measurement: low (Low) Low.         Relevant concomitant medications included, cancer medications, cholesterol medications, blood pressure medications and some other unspecified medications were reported.  Treatment information was not provided.  The reporter was not sure if the patient has got Moderna vaccine itself. Patient was in treatment for cancer for past 5 years. His doctor has changed the pills a few years ago and he was not able to tolerate this change of pills as they were too strong. In an appointment with the doctor, patient was very agitated and could not breathe.  Patient's lungs were mentioned as too low. So the patient was with a machine that helped him to breathe properly. On 11-April-2021, patient was sent to the hospital. On 12-April-2021 past midnight, the patient died of a stroke. Company comment: This is a case of inappropriate schedule of vaccine administered for this 77-year-old male patient with medical history of stomach ulcer, hypercholesteremia and hypertension, who experienced the unexpected events of cerebrovascular accident, agitation, dyspnoea, asthenia, yellow skin, hyperhidrosis, malaise and hypotension. The events of asthenia yellow skin, hyperhidrosis, occurred 22 days after the second dose of mRNA-1273, and the remaining events occurred a day later. The rechallenge was not applicable as the events occurred after the second dose and no information about the first dose was disclosed. Causality for the events was not provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Cerebrovascular accident is confounder by the history of bonecancer, hypercholesteremia, hypertension and advanced age.   Reporter did not allow further contact; Sender's Comments: This is a case of inappropriate schedule of vaccine administered for this 77-year-old male patient with medical history of stomach ulcer, hypercholesteremia and hypertension, who experienced the unexpected events of cerebrovascular accident, agitation, dyspnoea, asthenia, yellow skin, hyperhidrosis, malaise and hypotension. The events of asthenia yellow skin, hyperhidrosis, occurred 22 days after the second dose of mRNA-1273, and the remaining events occurred a day later. The rechallenge was not applicable as the events occurred after the second dose and no information about the first dose was disclosed. Causality for the events was not provided by the reporter. The benefit-risk relationship of mRNA-1273 is not affected by this report. Cerebrovascular accident is confounder by the history of bonecancer, hypercholesteremia, hypertension and advanced age.; Reported Cause(s) of Death: Stroke