Sex: F
Vaccine: COVID19
Symptoms: Malaise, Near death experience, Urinary tract infection
Clinical narrative: UTI; Infection in her intestine/gastritis; GERD; Kidney infection; Woke up sick; I have been sick; I feel like I'm dying; Intentional product use issue; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I have been sick), NEAR DEATH EXPERIENCE (I feel like I'm dying), MALAISE (Woke up sick), KIDNEY INFECTION (Kidney infection), URINARY TRACT INFECTION (UTI), GASTRITIS (Infection in her intestine/gastritis) and GASTROOESOPHAGEAL REFLUX DISEASE (GERD) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 12-May-2021, the patient experienced ILLNESS (I have been sick) (seriousness criterion hospitalization) and NEAR DEATH EXPERIENCE (I feel like I'm dying) (seriousness criteria hospitalization and medically significant). On 13-May-2021, the patient experienced MALAISE (Woke up sick) (seriousness criterion hospitalization). On 07-Jun-2021, the patient experienced KIDNEY INFECTION (Kidney infection) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced URINARY TRACT INFECTION (UTI) (seriousness criterion hospitalization), GASTRITIS (Infection in her intestine/gastritis) (seriousness criterion hospitalization), GASTROOESOPHAGEAL REFLUX DISEASE (GERD) (seriousness criterion hospitalization) and INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for Adverse event, at a dose of Medication regimen was finished 2 weeks ago.; LEVOFLOXACIN (LEVAQUIN) for Adverse event, at an unspecified dose and frequency and LEVOFLOXACIN (LEVAQUIN) (intravascular) for Adverse event, at an unspecified dose and frequency. On 20-May-2021, MALAISE (Woke up sick) had resolved. On 11-Jun-2021, KIDNEY INFECTION (Kidney infection) outcome was unknown. At the time of the report, ILLNESS (I have been sick), NEAR DEATH EXPERIENCE (I feel like I'm dying), URINARY TRACT INFECTION (UTI), GASTRITIS (Infection in her intestine/gastritis) and GASTROOESOPHAGEAL REFLUX DISEASE (GERD) outcome was unknown and INTENTIONAL PRODUCT USE ISSUE (Intentional product use issue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant treatment was reported. Treatment include unspecified antibiotics and PPI inhibitors.  Company comment: Very limited information regarding the events has been provided at this time.  Further information has been requested.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow-up contains non-significant information. On 04-Aug-2021: Significant follow up received on 04-Aug-2021, updated reporter information (reporter address), vaccine information (dose number, batch/lot number and anatomical location) and additional events (kidney infection, UTI, Gastritis and GERD).; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.