Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Breast pain, Confusional state, Dehydration, Dyspepsia
Clinical narrative: sharp pain in calf; sharp breast pain; stomach was on fire; heart beating in her ears; headache; lost her balance; lips went numb all the way up to the corner of her eye; something seems off and wrong, fuzzy, foggy,  almost like she is going up a mountain and her ears will not pop; confused; waking up in the middle of the night with severe leg cramps; dehydrated; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (lost her balance), HYPOAESTHESIA ORAL (lips went numb all the way up to the corner of her eye), FEELING ABNORMAL (something seems off and wrong, fuzzy, foggy,  almost like she is going up a mountain and her ears will not pop), CONFUSIONAL STATE (confused) and MUSCLE SPASMS (waking up in the middle of the night with severe leg cramps) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A023m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included Factor V deficiency (Not clear what type but mentioned "brother and other family member" as well) since an unknown date. Concurrent medical conditions included DVT (Another blood clot 2020, right leg. Found out she had "Factor 5") since 2020, Vestibular migraine (On-going, takes topiramate and uses fiorcet for breakthrough migraine), Penicillin allergy, Drug hypersensitivity and Drug hypersensitivity ("Red, skin peeled"). Concomitant products included RIVAROXABAN (XARELTO) for DVT, BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) for Migraine, TOPIRAMATE for Vestibular migraine, RIVAROXABAN (XARELTO), TOPIRAMATE and Fiorcet for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced FEELING ABNORMAL (something seems off and wrong, fuzzy, foggy,  almost like she is going up a mountain and her ears will not pop), CONFUSIONAL STATE (confused), MUSCLE SPASMS (waking up in the middle of the night with severe leg cramps), DEHYDRATION (dehydrated), FEELING ABNORMAL (foggy), the first episode of FEELING ABNORMAL (foggy comes and goes almost like she is going up a mountain and her ears will not pop) and the second episode of FEELING ABNORMAL (foggy comes and goes almost like she is going up a mountain and her ears will not pop). On 25-Feb-2021, the patient experienced BALANCE DISORDER (lost her balance), HYPOAESTHESIA ORAL (lips went numb all the way up to the corner of her eye) and HEADACHE (headache). On 28-Feb-2021, the patient experienced BREAST PAIN (sharp breast pain), DYSPEPSIA (stomach was on fire) and PALPITATIONS (heart beating in her ears). On 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (sharp pain in calf). At the time of the report, FEELING ABNORMAL (something seems off and wrong, fuzzy, foggy,  almost like she is going up a mountain and her ears will not pop) and the last episode of FEELING ABNORMAL (foggy comes and goes almost like she is going up a mountain and her ears will not pop) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  The patient's medical history of blood clots and vestibular migraines remains the contributing factors.