Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Feeling abnormal, Feeling cold
Clinical narrative: Wasn't feeling good at all; Had no energy; Sweat tremendously from the waist up; He felt a little bit funny; Shivering tremendously/shivering severely all over his body; Micro shakes all over the body/shaking from toe to head; Couldn't stay warm; Kidney score was very bad/drop in the filtering of the kidney; This spontaneous case was reported by a consumer and describes the occurrence of RENAL IMPAIRMENT (Kidney score was very bad/drop in the filtering of the kidney), TREMOR (Micro shakes all over the body/shaking from toe to head), FEELING COLD (Couldn't stay warm), MALAISE (Wasn't feeling good at all) and ASTHENIA (Had no energy) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A and 024C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Kidney cancer. Concomitant products included MONTELUKAST for Cancer, DEXAMETHASONE for Cancer (NOS), DARATUMUMAB, HYALURONIDASE FIHJ (DARZALEX FASPRO) for an unknown indication.   On 14-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. On 14-Dec-2021, the patient experienced TREMOR (Micro shakes all over the body/shaking from toe to head), FEELING COLD (Couldn't stay warm) and CHILLS (Shivering tremendously/shivering severely all over his body). 14-Dec-2021, the patient experienced FEELING ABNORMAL (He felt a little bit funny). On 15-Dec-2021, the patient experienced MALAISE (Wasn't feeling good at all), ASTHENIA (Had no energy) and HYPERHIDROSIS (Sweat tremendously from the waist up). In December 2021, the patient experienced RENAL IMPAIRMENT (Kidney score was very bad/drop in the filtering of the kidney). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 15-Dec-2021, CHILLS (Shivering tremendously/shivering severely all over his body) had resolved. At the time of the report, RENAL IMPAIRMENT (Kidney score was very bad/drop in the filtering of the kidney) and FEELING ABNORMAL (He felt a little bit funny) outcome was unknown and TREMOR (Micro shakes all over the body/shaking from toe to head), FEELING COLD (Couldn't stay warm), MALAISE (Wasn't feeling good at all), ASTHENIA (Had no energy) and HYPERHIDROSIS (Sweat tremendously from the waist up) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Dec-2021, Body temperature: low (Low) A little low. On an unknown date, Renal function test: drop in the filtering of the kidney (abnormal) drop in the filtering of the kidney.         The patient stated he didn´t experience any side effects after receiving the first and second dose.  No treatment medication details were provided.  Company Comment: This case concerns a 75-year-old male patient, with relevant medical history of Kidney cancer, who experienced the unexpected events of Renal impairment, Feeling abnormal, Feeling cold, Tremor, Asthenia, Malaise, Hyperhidrosis and the expected event of Chills. The events occurred approximately 1 day after the third dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was resolving. The rechallenge is not applicable since no further dosing is expected. The patient's medical history of Kidney cancer remain as a confounder for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 75-year-old male patient, with relevant medical history of Kidney cancer, who experienced the unexpected events of Renal impairment, Feeling abnormal, Feeling cold, Tremor, Asthenia, Malaise, Hyperhidrosis and the expected event of Chills. The events occurred approximately 1 day after the third dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was resolving. The rechallenge is not applicable since no further dosing is expected. The patient's medical history of Kidney cancer remain as a confounder for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.