Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Myalgia, Pain, Pyrexia, Sleep disorder
Clinical narrative: balance was really bad; trouble making a thought and speaking/ slowness in the brain/felt like they were dragging a 1000 pound weight when trying to put a thought together/is still not thinking clearly.; stayed up the rest of the night; does not feel great/ is still not well; developed a whole body reaction to an antibiotic; punctured wound on their hand; very very worse period of their life/70 days have passed and the patient has not got a period; extreme menstrual cramps that broke me out in a cold sweat/very bad cramping; extreme menstrual cramps that broke me out in a cold sweat/cold sweats; pain; trouble making a thought and speaking extremely slow with words like having a CVA; mental fog; extreme dizziness; ataxia/a lot of trouble standing and walking, what they called ataxia; body pain; felt feverish (low grade)/fever, not high; extreme headache/very bad headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (mental fog), DIZZINESS (extreme dizziness), ATAXIA (ataxia/a lot of trouble standing and walking, what they called ataxia), DYSMENORRHOEA (extreme menstrual cramps that broke me out in a cold sweat/very bad cramping) and COLD SWEAT (extreme menstrual cramps that broke me out in a cold sweat/cold sweats) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Gluten intolerance, Drug allergy (Bactrim), Shellfish allergy, Food allergy (cantaloupe), Food allergy (eggplant), Drug allergy (Cipro), Drug allergy (Amoxicillin), Drug allergy (SLS/SLES) and Drug allergy (fluoride). Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE) for ADHD, MULTI VITAMIN & MINERAL and LEPIDIUM MEYENII ROOT (MACA 2H) for an unknown indication, FISH OIL.   On 09-Feb-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced FEELING ABNORMAL (mental fog), DIZZINESS (extreme dizziness), ATAXIA (ataxia/a lot of trouble standing and walking, what they called ataxia), SLOW SPEECH (trouble making a thought and speaking extremely slow with words like having a CVA), MYALGIA (body pain), PYREXIA (felt feverish (low grade)/fever, not high) and HEADACHE (extreme headache/very bad headache). On 21-Mar-2021, the patient experienced DYSMENORRHOEA (extreme menstrual cramps that broke me out in a cold sweat/very bad cramping), COLD SWEAT (extreme menstrual cramps that broke me out in a cold sweat/cold sweats), PAIN (pain) and MENSTRUAL DISORDER (very very worse period of their life/70 days have passed and the patient has not got a period). In April 2021, the patient experienced ADVERSE DRUG REACTION (developed a whole body reaction to an antibiotic) and WOUND (punctured wound on their hand). On an unknown date, the patient experienced BALANCE DISORDER (balance was really bad), BRADYPHRENIA (trouble making a thought and speaking/ slowness in the brain/felt like they were dragging a 1000 pound weight when trying to put a thought together/is still not thinking clearly.), SLEEP DISORDER (stayed up the rest of the night) and MALAISE (does not feel great/ is still not well). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form; IBUPROFEN for Adverse event, at a dose of UNK dosage form; SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) for Wound, at a dose of UNK dosage form and NAPROXEN for Adverse event, at a dose of UNK dosage form. On 10-Mar-2021, FEELING ABNORMAL (mental fog), DIZZINESS (extreme dizziness) and HEADACHE (extreme headache/very bad headache) had resolved, ATAXIA (ataxia/a lot of trouble standing and walking, what they called ataxia), MYALGIA (body pain) and PYREXIA (felt feverish (low grade)/fever, not high) outcome was unknown. At the time of the report, DYSMENORRHOEA (extreme menstrual cramps that broke me out in a cold sweat/very bad cramping), COLD SWEAT (extreme menstrual cramps that broke me out in a cold sweat/cold sweats), PAIN (pain), SLOW SPEECH (trouble making a thought and speaking extremely slow with words like having a CVA), BALANCE DISORDER (balance was really bad), BRADYPHRENIA (trouble making a thought and speaking/ slowness in the brain/felt like they were dragging a 1000 pound weight when trying to put a thought together/is still not thinking clearly.), MENSTRUAL DISORDER (very very worse period of their life/70 days have passed and the patient has not got a period), SLEEP DISORDER (stayed up the rest of the night), MALAISE (does not feel great/ is still not well), ADVERSE DRUG REACTION (developed a whole body reaction to an antibiotic) and WOUND (punctured wound on their hand) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that Neurological symptoms was resolved in 24 hours. Patient adds that in April they had to take an antibiotic for a punctured wound on their hand from gardening. The antibiotic was Bactrim and on day 8 out of 10 days indication, patient developed a whole body reaction (patient thinks this had happened to them before) and landed on the ER. Patient is really concern this situation could catapult them into early menopause.   This case was linked to MOD-2021-023391 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Products, Patient and events tab updated.