Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Computerised tomogram, Haemorrhage, Metastatic neoplasm, Positron emission tomogram
Clinical narrative: patient got COVID-19; previous cancer spread; periodic bleeding; This spontaneous case was reported by a patient and describes the occurrence of METASTATIC NEOPLASM (previous cancer spread) and HAEMORRHAGE (periodic bleeding) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bladder cancer (bladder cancer, malignant tumor with abdomen metastasis removed on 2019) in 2010, Appendicitis, Surgery in 2019 and Nephrectomy in 2017. Concurrent medical conditions included Allergy to antibiotic, Pain, Fever and Sleep disorder NOS. Concomitant products included PARACETAMOL (TYLENOL) for Pain and Fever, ALPRAZOLAM (XANAX) for Sleep disorder NOS.    On 28-Mar-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2022, the patient experienced HAEMORRHAGE (periodic bleeding) (seriousness criterion medically significant). In July 2022, the patient experienced METASTATIC NEOPLASM (previous cancer spread) (seriousness criterion medically significant). On 07-Sep-2022, the patient experienced COVID-19 (patient got COVID-19). On 20-Sep-2022, COVID-19 (patient got COVID-19) had resolved. At the time of the report, METASTATIC NEOPLASM (previous cancer spread) and HAEMORRHAGE (periodic bleeding) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, Computerised tomogram: previous cancer spread again. In 2022, Positron emission tomogram: previous cancer spread again. On 20-Sep-2022, SARS-CoV-2 test: (Negative) 13 days later.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Flu shot on 01-Oct-2022. The patient took multivitamin supplements. No treatment medications were reported.  Company Comment:  This is a spontaneous case, reported by a patient, concerning an 87-year-old female patient with relevant medical history of Bladder cancer with abdominal metastasis, who experienced the unexpected serious (medically significant) events of Metastatic neoplasm and Haemorrhage, which occurred approximately 4 months after receiving the fourth dose of mRNA-1273 vaccine as the first booster dose of COVID-19 vaccine. Patient also received 3 doses of Moderna COVID-19 vaccine prior and 1 dose of Bivalent Moderna COVID-19 vaccine after. It was reported that the patient's previous cancer had spread and also had periodic bleeding. Patient also had COVID-19 infection approximately 5 months and 1 week post mRNA-1273 vaccination, and was resolved after 13 days confirmed by a negative SARS-CoV-2 test. Patient also underwent CT scan and PET scan which revealed spread of the previous cancer. No further details about the clinical course and treatments were provided. Outcome of the events Metastatic neoplasm and Haemorrhage were unknown. The medical history of Bladder cancer with abdominal metastasis remain as confounders for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-673532, US-MODERNATX, INC.-MOD-2021-291235, US-MODERNATX, INC.-MOD-2021-674168, US-MODERNATX, INC.-MOD-2021-674162 (Linked Report).; Sender's Comments: This is a spontaneous case, reported by a patient, concerning an 87-year-old female patient with relevant medical history of Bladder cancer with abdominal metastasis, who experienced the unexpected serious (medically significant) events of Metastatic neoplasm and Haemorrhage, which occurred approximately 4 months after receiving the fourth dose of mRNA-1273 vaccine as the first booster dose of COVID-19 vaccine. Patient also received 3 doses of Moderna COVID-19 vaccine prior and 1 dose of Bivalent Moderna COVID-19 vaccine after. It was reported that the patient's previous cancer had spread and also had periodic bleeding. Patient also had COVID-19 infection approximately 5 months and 1 week post mRNA-1273 vaccination, and was resolved after 13 days confirmed by a negative SARS-CoV-2 test. Patient also underwent CT scan and PET scan which revealed spread of the previous cancer. No further details about the clinical course and treatments were provided. Outcome of the events Metastatic neoplasm and Haemorrhage were unknown. The medical history of Bladder cancer with abdominal metastasis remain as confounders for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report. US-MODERNATX, INC.-MOD-2022-673532:Bivalent booster US-MODERNATX, INC.-MOD-2021-291235:Dose 3 US-MODERNATX, INC.-MOD-2021-674168:Dose 2 US-MODERNATX, INC.-MOD-2021-674162:Dose 1