Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Finally around 11:30 - 12 at night, his wife took him to the emergency room at the local hospital, due to the continuing epigastric pain, lethargy, and general fatigue; He says that he cannot see any reason other that the Spikevax shot that he got that could have caused his coagulopathy leading to loss of renal function; A CT of the abdomen and pelvis was done, which showed a non-functioning left kidney (especially the upper portion); He also mentioned during the call that his blood pressure while at the ER, was fluctuating and elevated. His blood pressure normally is around 110/70, but at the ER was fluctuating between 150-160/90-100; A day after receiving the Spikevax, on 18OCT2023, patient says that he had a mild fall off in activity level. He was able to get around the house, but was somewhat lethargic, with no energy level, and had minimal soreness at the injection site; A day after receiving the Spikevax, on 18OCT2023, patient says that he had a mild fall off in activity level. He was able to get around the house, but was somewhat lethargic, with no energy level, and had minimal soreness at the injection site; He says that around noon on that day, he started having severe epigastric pain, which he felt was due to hyper acidity which he occasionally does experience; A day after receiving the Spikevax, on 18OCT2023, patient says that he had a mild fall off in activity level. He was able to get around the house, but was somewhat lethargic, with no energy level, and had minimal soreness at the injection site; This spontaneous case was reported by a physician and describes the occurrence of ASTHENIA (A day after receiving the Spikevax, on 18OCT2023, patient says that he had a mild fall off in activity level. He was able to get around the house, but was somewhat lethargic, with no energy level, and had minimal soreness at the injection site), LETHARGY (A day after receiving the Spikevax, on 18OCT2023, patient says that he had a mild fall off in activity level. He was able to get around the house, but was somewhat lethargic, with no energy level, and had minimal soreness at the injection site), ABDOMINAL PAIN UPPER (He says that around noon on that day, he started having severe epigastric pain, which he felt was due to hyper acidity which he occasionally does experience), FATIGUE (Finally around 11:30 - 12 at night, his wife took him to the emergency room at the local hospital, due to the continuing epigastric pain, lethargy, and general fatigue), COAGULOPATHY (He says that he cannot see any reason other that the Spikevax shot that he got that could have caused his coagulopathy leading to loss of renal function), RENAL IMPAIRMENT (A CT of the abdomen and pelvis was done, which showed a non-functioning left kidney (especially the upper portion)) and BLOOD PRESSURE FLUCTUATION (He also mentioned during the call that his blood pressure while at the ER, was fluctuating and elevated. His blood pressure normally is around 110/70, but at the ER was fluctuating between 150-160/90-100) in an 84-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030535) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Medical History/Conditions: liposarcoma in right leg occurred in late 2019/early 2020 - surgically removed as soon as it was diagnosed, recurrence was removed 8-9 months later, monitored every 6 months; diagnosed in 2022 enlarged left ventricular septum - EF of 35-50, assessment by cardiology was that it's been there for a long time, no cardiac symptoms. Allergy: Propafol eye drops possibly. Previous COVID-19 diagnosis: 2020 positive COVID test but mild symptoms.  The patient's past medical history included Liposarcoma, Left ventricular hypertrophy and COVID-19 on 15-Jun-2020. Previously administered products included for COVID-19 prophylaxis: Moderna (1st Dose, Lot #: 013L20A) on 25-Jan-2021, Moderna (2nd Dose, Lot #: 031M20A) on 22-Feb-2021, Moderna (3rd Dose: Lot #: 067F21A) on 15-Nov-2021, Moderna (4th Dose, Lot #: 058A22A-2A) on 02-Jun-2022 and Pfizer Bivalent (5th Dose) on 08-Nov-2022; for an unreported indication: RSV VACCINE and INFLUENZA. Past adverse reactions to the above products included No adverse event with Moderna, Moderna, Moderna, Moderna and Pfizer Bivalent.    On 17-Oct-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 18-Oct-2023, the patient experienced ASTHENIA (A day after receiving the Spikevax, on 18OCT2023, patient says that he had a mild fall off in activity level. He was able to get around the house, but was somewhat lethargic, with no energy level, and had minimal soreness at the injection site) (seriousness criterion hospitalization), LETHARGY (A day after receiving the Spikevax, on 18OCT2023, patient says that he had a mild fall off in activity level. He was able to get around the house, but was somewhat lethargic, with no energy level, and had minimal soreness at the injection site) (seriousness criterion hospitalization), ABDOMINAL PAIN UPPER (He says that around noon on that day, he started having severe epigastric pain, which he felt was due to hyper acidity which he occasionally does experience) (seriousness criterion hospitalization), FATIGUE (Finally around 11:30 - 12 at night, his wife took him to the emergency room at the local hospital, due to the continuing epigastric pain, lethargy, and general fatigue) (seriousness criterion hospitalization), COAGULOPATHY (He says that he cannot see any reason other that the Spikevax shot that he got that could have caused his coagulopathy leading to loss of renal function) (seriousness criterion hospitalization), RENAL IMPAIRMENT (A CT of the abdomen and pelvis was done, which showed a non-functioning left kidney (especially the upper portion)) (seriousness criteria hospitalization and medically significant), BLOOD PRESSURE FLUCTUATION (He also mentioned during the call that his blood pressure while at the ER, was fluctuating and elevated. His blood pressure normally is around 110/70, but at the ER was fluctuating between 150-160/90-100) (seriousness criterion hospitalization) and VACCINATION SITE PAIN (A day after receiving the Spikevax, on 18OCT2023, patient says that he had a mild fall off in activity level. He was able to get around the house, but was somewhat lethargic, with no energy level, and had minimal soreness at the injection site). The patient was hospitalized from 20-Oct-2023 to 22-Oct-2023 due to ABDOMINAL PAIN UPPER, ASTHENIA, BLOOD PRESSURE FLUCTUATION, COAGULOPATHY, FATIGUE, LETHARGY and RENAL IMPAIRMENT. The patient was treated with MORPHINE (intravenous use) in October 2023 for Pain, at an unspecified dose and frequency; HEPARIN in October 2023 for Anticoagulant therapy, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) in October 2023 for Epigastric pain, at an unspecified dose and frequency and APIXABAN (ELIQUIS) on 22-Oct-2023 for Anticoagulant therapy, at a dose of 5 milligram every twelve hours. On 22-Oct-2023, ASTHENIA (A day after receiving the Spikevax, on 18OCT2023, patient says that he had a mild fall off in activity level. He was able to get around the house, but was somewhat lethargic, with no energy level, and had minimal soreness at the injection site), LETHARGY (A day after receiving the Spikevax, on 18OCT2023, patient says that he had a mild fall off in activity level. He was able to get around the house, but was somewhat lethargic, with no energy level, and had minimal soreness at the injection site), ABDOMINAL PAIN UPPER (He says that around noon on that day, he started having severe epigastric pain, which he felt was due to hyper acidity which he occasionally does experience), FATIGUE (Finally around 11:30 - 12 at night, his wife took him to the emergency room at the local hospital, due to the continuing epigastric pain, lethargy, and general fatigue), COAGULOPATHY (He says that he cannot see any reason other that the Spikevax shot that he got that could have caused his coagulopathy leading to loss of renal function), RENAL IMPAIRMENT (A CT of the abdomen and pelvis was done, which showed a non-functioning left kidney (especially the upper portion)), BLOOD PRESSURE FLUCTUATION (He also mentioned during the call that his blood pressure while at the ER, was fluctuating and elevated. His blood pressure normally is around 110/70, but at the ER was fluctuating between 150-160/90-100) and VACCINATION SITE PAIN (A day after receiving the Spikevax, on 18OCT2023, patient says that he had a mild fall off in activity level. He was able to get around the house, but was somewhat lethargic, with no energy level, and had minimal soreness at the injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: His blood pressure normally is around 110/70, but at the ER was fluctuating between 150-160/90-100.. On an unknown date, Computerised tomogram: Showed a non-functioning left kidney (especially the upper portion).. On an unknown date, Myocardial necrosis marker: all levels came back as normal. On an unknown date, SARS-CoV-2 test: Negative.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   A day after receiving the Spikevax, on 18OCT2023, patient says that he had a mild fall off in activity level. On 19OCT2023, he felt pretty good. He got up and went into the yard to rake leaves. He was fairly active. He cut some grass and does some chores in the yard. However, on 20OCT2023, he had a complete "wipeout." He says that around noon severe epigastric pain, which he felt was due to hyper acidity which he occasionally does experience. He took several antacids during the day with no relief at all. He also took Tylenol and felt no relief from that. Finally, around 11:30 - 12 at night, his wife took him to the emergency room at the local hospital, due to the continuing epigastric pain, lethargy, and general fatigue. They did a complete workup at the ER at Community Hospital, after which he was admitted into the hospital.  Company comment:  This is a spontaneous case concerning an 84-year-old male patient with no relevant medical history who experienced the unexpected and serious (hospitalization and medically significant) AESI renal impairment and the unexpected and serious (hospitalization) events asthenia, lethargic, abdominal pain upper, fatigue, coagulopathy and blood pressure fluctuation after a dose of SPIKEVAX 2023-2024 vaccine, given as a sixth dose of COVID vaccine schedule, was administered. Previously 4 doses of mRNA-1273 vaccine and a dose of PFIZER bivalent vaccine were given. It was reported that a day after receiving the Spikevax, patient had a mild fall off in activity level. He was able to get around the house, but was somewhat lethargic, with no energy level, and had minimal soreness at the injection site. On the following day he felt pretty good. He got up and went into the yard and did some chores. However, the following day he started having a complete "wipeout." He says that around noon on that day, he started having severe epigastric pain, which he felt was due to hyper acidity which he occasionally does experience. He took several antacids during the day with no relief at all. He also took paracetamol and felt no relief from that. Finally, around 11:30 - 12 at night, his wife took him to the emergency room at the local hospital, due to the continuing epigastric pain, lethargy, and general fatigue. They did a complete workup at the ER, after which he was admitted into the hospital. Amongst the tests that were done, a chest x-ray did not reveal anything. A CT of the abdomen and pelvis was done, which showed a non-functioning left kidney (especially the upper portion). He says that he has never had any kidney issues in the past. A COVID test was done at the hospital as well which was negative. Additionally, testing of cardiac enzymes was done and all levels came back as normal. They proceeded to give him IV morphine for the pain and heparin for anticoagulation. For the next 24 hours or so, he was quite lethargic and at time not well oriented. Two days later, he started feeling much better and requested to be discharged from the hospital. His pain was completely gone at this point and he felt much more alert. He says that the primary prescription he received upon discharge from the hospital was apixaban. He had to take a 5 mg tablet twice every 12 hours in a day, after which he started taking one tablet a day for at least 6 months. After his discharge from the hospital, he saw his family physician who has been monitoring his renal function. So far, his renal function has been normal with his urine output remaining normal as well. He also mentioned during the call that his blood pressure while at the ER, was fluctuating and elevated. His blood pressure normally is around 110/70, but at the ER was fluctuating between 150-160/90-100. By the time he was discharged, his blood pressure was back to normal. He says that he cannot see any reason other than the Spikevax shot that he got that could have caused his coagulopathy leading to loss of renal function. The benefit-risk relationship of the SPIKEVAX 2023-2024 vaccine is not affected by this report.