Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vulvovaginal pain, Vulvovaginal swelling, Walking aid user
Clinical narrative: can't think straight; urine retention decreased to a fourth of its normal capacity; flu like symptoms/She had a bad case of flu; hot flushes; stomach ache; diarrhea; extreme pain in her foot; extreme pain in her right side/pain in her crest and hips; extreme pain in her lower back; she had an infection somewhere; pain in the vaginal area like her vagina was partially swollen, it felt like she had had sex ut she hasn't had in 20 years; talking in her sleep; cane; She did not feel like herself at all; She woke up 3 times at nights; Elevated enzyems; swollen vagina; She forgot what she was doing, like putting ice cream in the fridge and forgetting about it; chills; muscle pain/muscle aches that traveled around her body; joint pain; tired all the time; nausea real bad; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (can't think straight) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Knee injury. Concurrent medical conditions included Cholesterol high. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for Cholesterol.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MENTAL IMPAIRMENT (can't think straight) (seriousness criterion medically significant), URINARY TRACT DISORDER (urine retention decreased to a fourth of its normal capacity), INFLUENZA LIKE ILLNESS (flu like symptoms/She had a bad case of flu), HOT FLUSH (hot flushes), ABDOMINAL PAIN UPPER (stomach ache), DIARRHOEA (diarrhea), PAIN IN EXTREMITY (extreme pain in her foot), PAIN (extreme pain in her right side/pain in her crest and hips), BACK PAIN (extreme pain in her lower back), INFECTION (she had an infection somewhere), VULVOVAGINAL PAIN (pain in the vaginal area like her vagina was partially swollen, it felt like she had had sex ut she hasn't had in 20 years), SLEEP TALKING (talking in her sleep), WALKING AID USER (cane), FEELING ABNORMAL (She did not feel like herself at all), SLEEP DISORDER (She woke up 3 times at nights), ENZYME LEVEL INCREASED (Elevated enzyems), VULVOVAGINAL SWELLING (swollen vagina), MEMORY IMPAIRMENT (She forgot what she was doing, like putting ice cream in the fridge and forgetting about it), CHILLS (chills), MYALGIA (muscle pain/muscle aches that traveled around her body), ARTHRALGIA (joint pain), FATIGUE (tired all the time) and NAUSEA (nausea real bad). At the time of the report, MENTAL IMPAIRMENT (can't think straight), URINARY TRACT DISORDER (urine retention decreased to a fourth of its normal capacity), PAIN IN EXTREMITY (extreme pain in her foot), PAIN (extreme pain in her right side/pain in her crest and hips), BACK PAIN (extreme pain in her lower back), INFECTION (she had an infection somewhere), VULVOVAGINAL PAIN (pain in the vaginal area like her vagina was partially swollen, it felt like she had had sex ut she hasn't had in 20 years), SLEEP TALKING (talking in her sleep), WALKING AID USER (cane), FEELING ABNORMAL (She did not feel like herself at all), SLEEP DISORDER (She woke up 3 times at nights), ENZYME LEVEL INCREASED (Elevated enzyems), VULVOVAGINAL SWELLING (swollen vagina), MEMORY IMPAIRMENT (She forgot what she was doing, like putting ice cream in the fridge and forgetting about it), MYALGIA (muscle pain/muscle aches that traveled around her body), ARTHRALGIA (joint pain) and FATIGUE (tired all the time) outcome was unknown and INFLUENZA LIKE ILLNESS (flu like symptoms/She had a bad case of flu), HOT FLUSH (hot flushes), ABDOMINAL PAIN UPPER (stomach ache), DIARRHOEA (diarrhea), CHILLS (chills) and NAUSEA (nausea real bad) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Laboratory data included:  On 01-JUL-2021, a blood test  was done (patient had 4 in total).  When the blood work came back, he said she had an infection somewhere and that her "CP" was up. No treatment information was reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Concomitant medical conditions could be potentially confounders for the 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 events, a causal relationship cannot be excluded. Concomitant medical conditions could be potentially confounders for the events.