Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nephrostomy, Pain in extremity, Rash
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NEPHROSTOMY (nephrostomy bleeding) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Urostomy, Nephrostomy and Colostomy. Concurrent medical conditions included Lymphoma (stage 4 lymphoma cancer), Renal failure (stage 4 renal failure) and Neuropathy NOS (chemo related neuropathy).    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm pain), DYSPNOEA (labored breathing), ASTHENIA (very weak), RASH (got rash on both of his forearms), HEADACHE (headaches), FATIGUE (fatigue) and CHILLS (he had chills). On 27-Apr-2021, the patient experienced NEPHROSTOMY (nephrostomy bleeding) (seriousness criterion hospitalization prolonged) and DEHYDRATION (he was dehydrated). On an unknown date, the patient experienced MYALGIA (hurting all over). The patient was hospitalized on 28-Apr-2021 due to NEPHROSTOMY. At the time of the report, NEPHROSTOMY (nephrostomy bleeding), DEHYDRATION (he was dehydrated), PAIN IN EXTREMITY (arm pain), DYSPNOEA (labored breathing), ASTHENIA (very weak), RASH (got rash on both of his forearms), HEADACHE (headaches), MYALGIA (hurting all over), FATIGUE (fatigue) and CHILLS (he had chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. After the patient got the vaccine, he was very fatigue for a few days. He had a lot of arm pain. The doctors noticed that he got rash on both of his forearms. He complained of headaches and it was hurting all over. He was very weak and had chills. He had labored breathing. His nephrostomy was bleeding a lot in the tubes so they had to hospitalize him. He went to hospital on 27-Apr-2021 and was currently in the hospital. He had blood transfusions and he was very dehydrated. He was put on IV saline. He took Eliquis but doctors wanted to stop it because his kidneys were not in good shape.  Company comment: Based on the information provided which indicates patient's underlying history of nephrostomy, a causal association between the event of nephrostomy bleeding and dehydration and the administration of mRNA-1273 and the events is assessed as unlikely as  the event is common local complication from nephrostomy tube placement,  The other events are temporarily associated with the product use and a causal relationship cannot be excluded.; Sender's Comments: Based on the information provided which indicates patient's underlying history of nephrostomy, a causal association between the event of nephrostomy bleeding and dehydration and the administration of mRNA-1273 and the events is assessed as unlikely as  the event is common local complication from nephrostomy tube placement,  The other events are temporarily associated with the product use and a causal relationship cannot be excluded.