Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Cystoscopy, Hypertonic bladder, Nocturnal dyspnoea
Clinical narrative: waking up choking (feeling unable to breath) more frequently; waking up coughing more frequently; Waking up 3-5 times a night to urinate; Sneezing; Overactive bladder; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of NOCTURNAL DYSPNOEA (waking up choking (feeling unable to breath) more frequently), COUGH (waking up coughing more frequently), POLLAKIURIA (Waking up 3-5 times a night to urinate), SNEEZING (Sneezing) and HYPERTONIC BLADDER (Overactive bladder) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Food allergy (Coffee(pain around neck and ear)) since 19-Jul-2019, Hypothyroidism (Hypoactive thyroid), Blood pressure high and Overactive bladder (slight improvement) since 08-May-2021. Concomitant products included LISINOPRIL from 2016 to an unknown date for Hypertension, LEVOTHYROXINE from 2015 to an unknown date for Hypothyroidism, ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) from 01-Nov-1984 to an unknown date for Vitamin supplementation, VITAMIN C [ASCORBIC ACID] from 14-Jun-2001 to an unknown date and VITAMIN D [VITAMIN D NOS] from 2016 to an unknown date for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced HYPERTONIC BLADDER (Overactive bladder). On an unknown date, the patient experienced NOCTURNAL DYSPNOEA (waking up choking (feeling unable to breath) more frequently), COUGH (waking up coughing more frequently), POLLAKIURIA (Waking up 3-5 times a night to urinate) and SNEEZING (Sneezing). an unknown date, the patient experienced CHILLS (Chills) and PYREXIA (Fever). The patient was treated with MIRABEGRON (MYRBETRIQ) for Hyperactive bladder, at an unspecified dose and frequency; MIRABEGRON (MYRBETRIQ) ongoing from 05-Aug-2021 for Hyperactive bladder, at an unspecified dose and frequency; MIRABEGRON (MYRBETRIQ) on 23-Jul-2021 for Hyperactive bladder, at a dose of 1 UNK and XYLOMETAZOLINE HYDROCHLORIDE (SUDAFED [XYLOMETAZOLINE HYDROCHLORIDE]) ongoing since an unknown date for Hyperactive bladder, at an unspecified dose and frequency. At the time of the report, NOCTURNAL DYSPNOEA (waking up choking (feeling unable to breath) more frequently) and COUGH (waking up coughing more frequently) had not resolved, POLLAKIURIA (Waking up 3-5 times a night to urinate) and SNEEZING (Sneezing) outcome was unknown, HYPERTONIC BLADDER (Overactive bladder) was resolving and CHILLS (Chills) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jul-2021, Cystoscopy: abnormal (abnormal) Confirmed overactive bladder. On 14-Jul-2021, Urodynamics measurement: abnormal (abnormal) Confirmed overactive bladder.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient was taking Myrbetriq 25 mg and there was little improvement during night. On 05-Aug-2021, the dose was increased to 50 mg. The patient was going for a sleep apnea test on 07-Aug-2021 because the patient was waking up coughing/choking (feeling unable to breath) more frequently since the second vaccination.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: live follow up received - Patient demographics added, allergy in current condition added, new concomitant medications added and dose and indication updated of suspect vaccine