Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Tremor, Urinary incontinence, Urinary tract infection
Clinical narrative: Chest tightness; After two to three weeks later still dizzy; Groin pain; Tired un able to get up; Vomiting; Vertigo; couldn't get out of bed/ couldn't move; shakes really bad; Sore throat; Urinary tract infection; Yeast infection; Bladder not in control/ Difficulty in holding urine; other arm hurt more than the arm i got shot in, vaccination site pain; Headache; Fever; Chills; Pain and Myalgia; Coughing; Bladder pain; Bladder always feels bloated; Sensation of throat closing; Nausea/vomiting; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection), FUNGAL INFECTION (Yeast infection) and URINARY INCONTINENCE (Bladder not in control/ Difficulty in holding urine) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B212A and 040B27A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (Sensation of throat closing), BLADDER DISCOMFORT (Bladder always feels bloated) and BLADDER PAIN (Bladder pain). 14-May-2021, the patient experienced NAUSEA (Nausea/vomiting). On 15-May-2021, the patient experienced URINARY TRACT INFECTION (Urinary tract infection) (seriousness criterion medically significant), FUNGAL INFECTION (Yeast infection) (seriousness criterion medically significant), URINARY INCONTINENCE (Bladder not in control/ Difficulty in holding urine) (seriousness criterion medically significant), MALAISE (couldn't get out of bed/ couldn't move), TREMOR (shakes really bad), OROPHARYNGEAL PAIN (Sore throat), PAIN (Pain and Myalgia), COUGH (Coughing), VACCINATION SITE PAIN (other arm hurt more than the arm i got shot in, vaccination site pain), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills). On 20-Jun-2021, the patient experienced VERTIGO (Vertigo). On an unknown date, the patient experienced CHEST DISCOMFORT (Chest tightness), DIZZINESS (After two to three weeks later still dizzy), GROIN PAIN (Groin pain), FATIGUE (Tired un able to get up) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at a dose of 1 dosage form. On 17-May-2021, MALAISE (couldn't get out of bed/ couldn't move), TREMOR (shakes really bad), OROPHARYNGEAL PAIN (Sore throat), VACCINATION SITE PAIN (other arm hurt more than the arm i got shot in, vaccination site pain), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) had resolved. On 28-May-2021, URINARY INCONTINENCE (Bladder not in control/ Difficulty in holding urine) had resolved. At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) and FUNGAL INFECTION (Yeast infection) had resolved, VERTIGO (Vertigo), CHEST DISCOMFORT (Chest tightness), OROPHARYNGEAL DISCOMFORT (Sensation of throat closing), DIZZINESS (After two to three weeks later still dizzy), PAIN (Pain and Myalgia), BLADDER DISCOMFORT (Bladder always feels bloated), BLADDER PAIN (Bladder pain), GROIN PAIN (Groin pain), FATIGUE (Tired un able to get up), NAUSEA (Nausea/vomiting) and VOMITING (Vomiting) outcome was unknown and COUGH (Coughing) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-May-2021, Body temperature: 101.6 (High) Fever 101.6. On 19-May-2021, Urine analysis: abnormal (abnormal) UTI-Yeast infection.. On an unknown date, Body temperature: 101.9 (High) 101.9.         Concomitant product was not reported. Reporter was  provided treatment information that include 7 day course of antibiotics, yeast infection medicine, over the counter yeast infection medicine and vertigo medication.  Company comment: 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.   This case was linked to MOD-2021-231189 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow-up received and added new events.; 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.