Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary incontinence
Clinical narrative: I was getting into my pajamas that night; Feels unusal/feeling poorly/feel unwell again; I feel like I am getting over the Flu; Muscle aches muscel ache which starts in the back of my head and goes down my neck into my shoulders and way down the rest of my body; Joint aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of URINARY INCONTINENCE (I was getting into my pajamas that night), MALAISE (Feels unusal/feeling poorly/feel unwell again), INFLUENZA (I feel like I am getting over the Flu), MYALGIA (Muscle aches muscel ache which starts in the back of my head and goes down my neck into my shoulders and way down the rest of my body) and ARTHRALGIA (Joint aches) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vaginal delivery (Given birth vaginally 8 times with no real problems). Concurrent medical conditions included Drug allergy (Bad reaction to trazodone), Hypercholesterolemia (High Cholesterol) since 2005 and Prediabetes since 2010. Concomitant products included ATORVASTATIN from 2005 to an unknown date for Hypercholesteraemia.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URINARY INCONTINENCE (I was getting into my pajamas that night), MALAISE (Feels unusal/feeling poorly/feel unwell again), INFLUENZA (I feel like I am getting over the Flu), MYALGIA (Muscle aches muscel ache which starts in the back of my head and goes down my neck into my shoulders and way down the rest of my body), ARTHRALGIA (Joint aches) and CHILLS (Chills). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Muscle ache and Joint ache, at a dose of 1 to 2 every 6 hours and PARACETAMOL (TYLENOL) at a dose of every 6 to 12 hours. At the time of the report, URINARY INCONTINENCE (I was getting into my pajamas that night), INFLUENZA (I feel like I am getting over the Flu) and CHILLS (Chills) outcome was unknown and MALAISE (Feels unusal/feeling poorly/feel unwell again), MYALGIA (Muscle aches muscel ache which starts in the back of my head and goes down my neck into my shoulders and way down the rest of my body) and ARTHRALGIA (Joint aches) had not resolved.            Patient was feeling the same condition even after the days turned to weeks and weeks turned to months. Patient was fully not recovered,still have the symptoms Patient had no miscarriages. When patient discontinued the treatment the symptoms came back and feeling unwell Action taken with mRNA-1273 in response to the events is not applicable.   This case was linked to MOD-2021-138793, MOD-2021-138793 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Additional information received includes Patient Medical history Birth vaginally 8 times.Treatment information includes acetaminophen was updated.Events includes Chills, Feel I am getting over the flu and Urinary incontinence were added.Outcome of the events Muscle ache,Joint paint,Feeling unwell were changed from Unknown to not recovered. On 06-Jun-2021: Additional information includes Initials were updated. Patient demographics were updated.Medical History includes bad reaction to trazodone,High Cholesterol,Prediabetes were added.Concomitant product information includes Atorvastatin was updated. .