Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Back pain, Confusional state, Depressed mood, Eye pruritus
Clinical narrative: Swollen hands; Heavy periods; chopped her hair since she sweats a lot in her scalp; Body aches; Headache; Fatigue; Bleeding started; Cannot think straight; Hot flashes; Back hurts; Itchy in eyes; Confused; Anxiety increased; Feels depressed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMORRHAGE (Bleeding started) and MENTAL IMPAIRMENT (Cannot think straight) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), LORAZEPAM, MELOXICAM, BLACK COHOSH [CIMICIFUGA RACEMOSA], ESTRADIOL, NORETHISTERONE ACETATE (ESTRADIOL AND NORETHINDRONE), CLOBETASOL PROPIONATE and ESTRADIOL for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced HAEMORRHAGE (Bleeding started) (seriousness criterion medically significant), MENTAL IMPAIRMENT (Cannot think straight) (seriousness criterion medically significant), HOT FLUSH (Hot flashes), BACK PAIN (Back hurts), EYE PRURITUS (Itchy in eyes), CONFUSIONAL STATE (Confused), ANXIETY (Anxiety increased), DEPRESSED MOOD (Feels depressed), HEAVY MENSTRUAL BLEEDING (Heavy periods), HYPERHIDROSIS (chopped her hair since she sweats a lot in her scalp), PAIN (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue). On 06-May-2021, the patient experienced PERIPHERAL SWELLING (Swollen hands). At the time of the report, HAEMORRHAGE (Bleeding started), MENTAL IMPAIRMENT (Cannot think straight), HOT FLUSH (Hot flashes), BACK PAIN (Back hurts), EYE PRURITUS (Itchy in eyes), CONFUSIONAL STATE (Confused), ANXIETY (Anxiety increased), DEPRESSED MOOD (Feels depressed), PERIPHERAL SWELLING (Swollen hands), HEAVY MENSTRUAL BLEEDING (Heavy periods), HYPERHIDROSIS (chopped her hair since she sweats a lot in her scalp), PAIN (Body aches), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.            Patient stated that her OBGYN told her she is going thru menopause for which she was prescribed estrogen and she started getting a period. Treatment included Tylenol.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Very limited information regarding this events has been provided at this time.  The events are assessed unlikely related to product.   This case was linked to MOD-2021-110270 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: New concomitant drugs (Black Cohosh, Estradiol/norethindrone, Clobetasol propionate, Estradiol cream) were added, New events (Bleeding, back hurts, had period, itchy in eyes, cannot think straight, confused, body aches, heavy period, anxiety increased and feels depressed) were added and Suspect vaccine dosing details were updated.; Sender's Comments: Very limited information regarding this events has been provided at this time.  The events are assessed unlikely related to product.