Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Somnolence, Urinary retention
Clinical narrative: kidney unable to urinate/Within 3 hours of the vaccine could not urinate/very little if any urine would pass; very tired/very fatigue; urination trouble after the shot, he couldn't urinate anything,could'nt get out anything out of his body; sore arm; slept a lot after the shot; did not have any antibodies after the first vaccine of Moderna; very bad lower back pain both sides within a few hours of the injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY RETENTION (kidney unable to urinate/Within 3 hours of the vaccine could not urinate/very little if any urine would pass) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Herpes virus infection (Improved after Shingles Vaccine.) on 24-Jun-2008. Previously administered products included for an unreported indication: SHINGRIX (First dose- Oct-2019 and Second dose-Feb-2020) from October 2019 to February 2021. Concurrent medical conditions included HIV infection since 18-Feb-1998, Renal agenesis (born without left kidney), Drug allergy (Fluroquine allergy), Contrast media allergy, Asthma since 24-Jun-2008, Mitral valve disease since 12-Apr-2010 and Diarrhea (Improved with daily Morphine ER) since 10-Jan-1996. Concomitant products included AMLODIPINE for Blood pressure management, RITONAVIR, ABACAVIR, DOLUTEGRAVIR SODIUM (TIVICAY), DARUNAVIR ETHANOLATE (PREZISTA) and ABACAVIR SULFATE (ZIAGEN) for HIV infection, ACYCLOVIR [ACICLOVIR], MORPHINE, PRAVASTATIN and FINASTERIDE for an unknown indication.    On 12-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced BACK PAIN (very bad lower back pain both sides within a few hours of the injection). On 12-Mar-2021 at 1:30 PM, the patient experienced URINARY RETENTION (kidney unable to urinate/Within 3 hours of the vaccine could not urinate/very little if any urine would pass) (seriousness criteria hospitalization and medically significant). On 22-Mar-2021, the patient experienced DRUG INEFFECTIVE (did not have any antibodies after the first vaccine of Moderna). On an unknown date, the patient experienced DYSURIA (urination trouble after the shot, he couldn't urinate anything,could'nt get out anything out of his body), PAIN IN EXTREMITY (sore arm), SOMNOLENCE (slept a lot after the shot) and FATIGUE (very tired/very fatigue). The patient was hospitalized on 15-Mar-2021 due to URINARY RETENTION. On 13-Mar-2021, URINARY RETENTION (kidney unable to urinate/Within 3 hours of the vaccine could not urinate/very little if any urine would pass) had resolved with sequelae. On 22-Mar-2021, DRUG INEFFECTIVE (did not have any antibodies after the first vaccine of Moderna) outcome was unknown. At the time of the report, DYSURIA (urination trouble after the shot, he couldn't urinate anything,could'nt get out anything out of his body), PAIN IN EXTREMITY (sore arm), SOMNOLENCE (slept a lot after the shot) and FATIGUE (very tired/very fatigue) outcome was unknown and BACK PAIN (very bad lower back pain both sides within a few hours of the injection) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood creatine: (High) Elevated creatine numbers.. On 22-Mar-2021, Antibody test: (Inconclusive) No antibodies were developed 10 days after 1st dose of vaccination.. On 22-Mar-2021, Blood creatine:.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient reported that he was born with only one kidney(Right).  The patient was enrolled in a COVID-19 study for the last several months.   Sequelae for the event of urinary retention included elevated creatine. No treatment was reported for the events.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Event urinary retention was upgraded to serious. Seriousness criteria hospitalization was included for urinary retention. Lab data for antibody test and creatine test were added. Allergy (Fluroquine,contrast dye), historical vaccine(Shingles Vaccine), historical condition(Herpes Virus Infection) were updated in other relevant history. Current condition asthma, mitral valve disease and diarrhea were also added. On 12-May-2021: Additional information provided on 12-May-2021 included an additional event.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.