Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pollakiuria, Presyncope, SARS-CoV-2 test, Somnolence, Speech disorder
Clinical narrative: Inappropriate schedule of vaccine administered; COVID-19; Diagnosed with pelvic floor dysfunction/Pelvic pain; Lost 14 pounds in 3 weeks; Both arms have weakness; Start sweating profusely down to her ankles/Would get damp and hot; Couldn't control her bladder because it was dysfunctioning/ was constantly going to the bathroom; tingling going down into hands/ tingling going down into feet; Flushing; couldn't lie down or got worse; Vertigo; A week where she couldn't talk right; Felt like adrenaline rush; was constantly going to the bathroom; Headaches; Really tired; heart racing; high blood pressure; slept a lot for a couple of days; When driving, vision changed/Vision was bad; Going to faint; Both arms have pain/Pain going down hands/Pain going down into feet; Vaccination site pain, sore arm the next day; significant joint pain; significant muscle pain; sometimes can't even walk; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Going to faint), GAIT DISTURBANCE (sometimes can't even walk), PELVIC FLOOR DYSFUNCTION (Diagnosed with pelvic floor dysfunction/Pelvic pain), COVID-19 (COVID-19) and VISUAL IMPAIRMENT (When driving, vision changed/Vision was bad) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced PAIN IN EXTREMITY (Both arms have pain/Pain going down hands/Pain going down into feet) and VACCINATION SITE PAIN (Vaccination site pain, sore arm the next day). On 22-May-2021, the patient experienced PRESYNCOPE (Going to faint), VISUAL IMPAIRMENT (When driving, vision changed/Vision was bad), SOMNOLENCE (slept a lot for a couple of days) and FATIGUE (Really tired). 22-May-2021, the patient experienced PALPITATIONS (heart racing) and BLOOD PRESSURE INCREASED (high blood pressure). On 12-Jun-2021, the patient experienced MUSCULAR WEAKNESS (Both arms have weakness), HYPERHIDROSIS (Start sweating profusely down to her ankles/Would get damp and hot), BLADDER DYSFUNCTION (Couldn't control her bladder because it was dysfunctioning/ was constantly going to the bathroom), PARAESTHESIA (tingling going down into hands/ tingling going down into feet), FLUSHING (Flushing), DISCOMFORT (couldn't lie down or got worse), VERTIGO (Vertigo), SPEECH DISORDER (A week where she couldn't talk right), FEELING ABNORMAL (Felt like adrenaline rush) and HEADACHE (Headaches). 12-Jun-2021, the patient experienced POLLAKIURIA (was constantly going to the bathroom). On 14-Jun-2021, the patient experienced WEIGHT DECREASED (Lost 14 pounds in 3 weeks). In 2021, the patient experienced GAIT DISTURBANCE (sometimes can't even walk), ARTHRALGIA (significant joint pain) and MYALGIA (significant muscle pain). On 14-Jul-2021, the patient experienced PELVIC FLOOR DYSFUNCTION (Diagnosed with pelvic floor dysfunction/Pelvic pain). On 20-Oct-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, PRESYNCOPE (Going to faint), GAIT DISTURBANCE (sometimes can't even walk), PELVIC FLOOR DYSFUNCTION (Diagnosed with pelvic floor dysfunction/Pelvic pain), VISUAL IMPAIRMENT (When driving, vision changed/Vision was bad), MUSCULAR WEAKNESS (Both arms have weakness), HYPERHIDROSIS (Start sweating profusely down to her ankles/Would get damp and hot), BLADDER DYSFUNCTION (Couldn't control her bladder because it was dysfunctioning/ was constantly going to the bathroom), PARAESTHESIA (tingling going down into hands/ tingling going down into feet), FLUSHING (Flushing), DISCOMFORT (couldn't lie down or got worse), VERTIGO (Vertigo), SPEECH DISORDER (A week where she couldn't talk right), WEIGHT DECREASED (Lost 14 pounds in 3 weeks), PAIN IN EXTREMITY (Both arms have pain/Pain going down hands/Pain going down into feet), SOMNOLENCE (slept a lot for a couple of days), FEELING ABNORMAL (Felt like adrenaline rush), PALPITATIONS (heart racing), BLOOD PRESSURE INCREASED (high blood pressure), POLLAKIURIA (was constantly going to the bathroom), VACCINATION SITE PAIN (Vaccination site pain, sore arm the next day), ARTHRALGIA (significant joint pain), FATIGUE (Really tired), MYALGIA (significant muscle pain) and HEADACHE (Headaches) had not resolved, COVID-19 (COVID-19) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-May-2021, Blood pressure measurement: high (High) Blood pressure was high.. On 22-May-2021, Heart rate: high (High) Heart started racing. On 12-Jun-2021, Blood pressure measurement: high (High) Blood pressure was high 170s. On 12-Jun-2021, Heart rate: high (High) Heart rate started racing over 110. On 14-Jun-2021, Electrocardiogram: normal (normal) Electrocardiogram was Normal. On 06-Jul-2021, Blood pressure measurement: abnormal (abnormal) abnormal. On 06-Jul-2021, Heart rate: high (High) Heart racing. On 14-Jul-2021, Blood pressure measurement: high (High) high blood pressure.. On 14-Jul-2021, Computerised tomogram: normal (normal) CT scan was normal. On 14-Jul-2021, Heart rate: high (High) heart rate was high. On 14-Jul-2021, Magnetic resonance imaging: normal (normal) MRI of head was normal and normal (normal) MRI of pelvic area was normal. On 14-Jul-2021, Ultrasound scan: normal (normal) ultrasound was normal. On 20-Oct-2021, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Colonoscopy: normal (normal) Normal. On an unknown date, Laboratory test: normal (normal) Endocrinologist who ran a whole lot of tests (pituitary glands, etc). Everything came back normal..         Company comment: This case concerns a 52-year-old, female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19. The event occurred approximately 6 months after the second dose of mRNA-1273 vaccine. Inappropriate schedule of product administration was also observed in the case (36 days between dose 1 and dose 2). The patient mentioned she would not receive the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  As per the MR guidance event pelvic pain was taken under pelvic floor dysfunction, Event LOE was removed and Urinary frequency,Increased blood pressure, heart racing was added.   This case was linked to MOD-2021-278846.   Most recent FOLLOW-UP information incorporated above includes: On 03-Dec-2021: Follow up received: New event (COVID-19 and lack of drug) were added. Event outcome updated to not recovered/resolved. I narrative updated accordingly.; Sender's Comments: This case concerns a 52-year-old, female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19. The event occurred approximately 6 months after the second dose of mRNA-1273 vaccine. Inappropriate schedule of product administration was also observed in the case (36 days between dose 1 and dose 2). The patient mentioned she would not receive the booster dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.