Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Procedural pain, Sepsis
Clinical narrative: Diagnosed with sepsis; BP dropped 57/35; He ended up getting an infection after the cystoscopy; Severe pain from cystoscopy infection; Dripping blood from his semen; This spontaneous case was reported by a consumer and describes the occurrence of SEPSIS (Diagnosed with sepsis) and HYPOTENSION (BP dropped 57/35) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high.   On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced SEPSIS (Diagnosed with sepsis) (seriousness criteria hospitalization and medically significant), HYPOTENSION (BP dropped 57/35) (seriousness criterion hospitalization) and HAEMATOSPERMIA (Dripping blood from his semen). On an unknown date, the patient experienced POST PROCEDURAL INFECTION (He ended up getting an infection after the cystoscopy) and PROCEDURAL PAIN (Severe pain from cystoscopy infection). The patient was hospitalized from sometime in November 2021 to sometime in November 2021 due to HYPOTENSION and SEPSIS. At the time of the report, SEPSIS (Diagnosed with sepsis), HYPOTENSION (BP dropped 57/35), HAEMATOSPERMIA (Dripping blood from his semen), POST PROCEDURAL INFECTION (He ended up getting an infection after the cystoscopy) and PROCEDURAL PAIN (Severe pain from cystoscopy infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 57/35 (Low) dropped 57/35 when in and high (High) he normally has high blood pressure. On an unknown date, Cystoscopy: abnormal (abnormal) he ended up getting an infection after the cystoscopy and was hospitalized for 6 nights..         No concomitant drugs were reported. No treatment information was reported.  He ended up getting an infection after the cystoscopy and was hospitalized for 6 nights. He was released around Nov29 and was diagnosed with sepsis based on hospital report.  Company comment: This case concerns 84-year-old male patient with relevant medical history of high blood pressure, who experienced the unexpected serious events of Sepsis and Hypotension and unexpected non-serious events of Haematospermia. Additionally, patient experienced unexpected non-serious events of Post procedural infection, Post procedural pain. The events Haematospermia occurred on the evening of 22 Oct 2021 after the booster dose of mRNA-1273 vaccine. Haematospermia lasted for one month and, patient visited ER, however despite several tests etiology of the event couldn't be found and finally patient had undergone cystoscopy followed by the events Post procedural infection, Post procedural pain and Hypotension. The patient has been hospitalized for 6 nights and Sepsis was diagnosed during hospitalization. The event Post procedural infection is a contributory factor for Sepsis, and Hypotension seems to be one of the symptoms of sepsis. The rechallenge is not applicable as the events occurred after the third dose and no other dose is expected at this moment. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns 84-year-old male patient with relevant medical history of high blood pressure, who experienced the unexpected serious events of Sepsis and Hypotension and unexpected non-serious events of Haematospermia. Additionally, patient experienced unexpected non-serious events of Post procedural infection, Post procedural pain. The events Haematospermia occurred on the evening of 22 Oct 2021 after the booster dose of mRNA-1273 vaccine. Haematospermia lasted for one month and, patient visited ER, however despite several tests etiology of the event couldn't be found and finally patient had undergone cystoscopy followed by the events Post procedural infection, Post procedural pain and Hypotension. The patient has been hospitalized for 6 nights and Sepsis was diagnosed during hospitalization. The event Post procedural infection is a contributory factor for Sepsis, and Hypotension seems to be one of the symptoms of sepsis. The rechallenge is not applicable as the events occurred after the third dose and no other dose is expected at this moment. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.