Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Anaemia, Asthenia, Blood sodium, Body temperature, Chest pain
Clinical narrative: Vascular occlusion; Urinary tract infection; Bruising; Anemic; Chest pain; Loss of energy; lowheart rate; This spontaneous case was reported by a consumer and describes the occurrence of VASCULAR OCCLUSION (Vascular occlusion), URINARY TRACT INFECTION (Urinary tract infection) and CONTUSION (Bruising) in a 62-year-old female 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 IBRUTINIB (IMBRUVICA) tablet for Lymphoma.    The patient had no known allergies.  The patient's past medical history included Chemotherapy (Bad reaction). Concurrent medical conditions included Type II diabetes mellitus, Non-smoker, Abstains from alcohol, Waldenstrom's macroglobulinemia and Rheumatoid arthritis. Concomitant products included APREMILAST (OTEZLA) for Psoriatic arthritis and Rheumatoid arthritis, PANTOPRAZOLE for Stomach discomfort.   In 2018, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram. In January 2021, IBRUTINIB (IMBRUVICA) (Oral) dosage was changed to 420 milligram. On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced CHEST PAIN (Chest pain) and ASTHENIA (Loss of energy). In June 2021, the patient experienced ANAEMIA (Anemic). In 2021, the patient experienced HEART RATE DECREASED (lowheart rate). In August 2021, the patient experienced VASCULAR OCCLUSION (Vascular occlusion) (seriousness criterion hospitalization), URINARY TRACT INFECTION (Urinary tract infection) (seriousness criterion hospitalization) and CONTUSION (Bruising) (seriousness criterion hospitalization). The patient was treated with FERROUS SULFATE at an unspecified dose and frequency; SODIUM at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency; METOPROLOL at an unspecified dose and frequency; ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency; ROSUVASTATIN CALCIUM (CRESTOR) at an unspecified dose and frequency and OXYGEN at an unspecified dose and frequency. At the time of the report, VASCULAR OCCLUSION (Vascular occlusion) and ANAEMIA (Anemic) was resolving, URINARY TRACT INFECTION (Urinary tract infection), CONTUSION (Bruising), CHEST PAIN (Chest pain) and ASTHENIA (Loss of energy) had resolved and HEART RATE DECREASED (lowheart rate) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Body temperature: 104 F. In January 2021, SARS-CoV-2 test: (Positive) Positive. In August 2021, Blood sodium: Low. In August 2021, Heart rate: Low. In August 2021, Platelet count: Low. In November 2021, Echocardiogram: Improvement on Low Heart Beat.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that, the patient had covid 19, urinary tract infection, low heart rate, clogged heart vein and bruising due to low platelet.  The patient was admitted in the hospital twice due to Covid 19. The patient was admitted in Jan-2021 and stayed for eight days and thought she was release too soon and was readmitted in Mar-2021 due to Covid 19 and difficulty of breathing and stayed for three to four days. The patient was given antibiotics and oxygen while in the hospital. The patient had to stopped Imbruvica while she was in the hospital since the physician did not know much about it. The patient was admitted in the hospital in Aug-2021 due to her reaction to Covid 19 Vaccine.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   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 spontaneous case concerns a 62 year old female patient with concurrent Waldenstrom's macroglobulinemia, Type II diabetes mellitus and past history of COVID 19, who experienced the unexpected serious (hospitalized) events of Vascular occlusion, Urinary tract infection and Contusion, unknown days after receiving the first dose of mRNA-1273 vaccine. Her blood sodium and platelets were reported as low, body temperature was 104 degree F. SARS COV 2 test was positive on an unknown date. Echocardiogram showed improvement. No information on exact date of the event, detailed clinical course, relevant investigations with exact timelines and relevant treatment details was available in the report. Concurrent Waldenstrom's macroglobulinemia, Type II diabetes mellitus could be risk factors for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 62 year old female patient with concurrent Waldenstrom's macroglobulinemia, Type II diabetes mellitus and past history of COVID 19, who experienced the unexpected serious (hospitalized) events of Vascular occlusion, Urinary tract infection and Contusion, unknown days after receiving the first dose of mRNA-1273 vaccine. Her blood sodium and platelets were reported as low, body temperature was 104 degree F. SARS COV 2 test was positive on an unknown date. Echocardiogram showed improvement. No information on exact date of the event, detailed clinical course, relevant investigations with exact timelines and relevant treatment details was available in the report. Concurrent Waldenstrom's macroglobulinemia, Type II diabetes mellitus could be risk factors for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.