Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Aphasia, Dysstasia, Fall, Malaise
Clinical narrative: couldn't talk; memory started to go/ memory was getting worse/ couldn't remember what day it was; tried to get out of bed and fell; getting anxiety ridden; Tremor/hand was shaking was dropping things/whole body just shakes; had trouble standing; feeling sick; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Tremor/hand was shaking was dropping things/whole body just shakes), DYSSTASIA (had trouble standing), MALAISE (feeling sick), APHASIA (couldn't talk), MEMORY IMPAIRMENT (memory started to go/ memory was getting worse/ couldn't remember what day it was), FALL (tried to get out of bed and fell) and ANXIETY (getting anxiety ridden) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L2DA and 016M20A) for COVID-19 vaccination.     The patient's past medical history included Lyme disease. Concomitant products included FAMOTIDINE (PEPCID AC) for Acid reflux (esophageal), PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOPRAZOLE 40) for Acid reflux (oesophageal), CYCLOBENZAPRINE for Antiinflammatory therapy, ATORVASTATIN CALCIUM (LIPITOR) for High cholesterol, TRAZODONE for Insomnia, HYDROXYCHLOROQUINE, CLARITHROMYCIN, AMOXICILLIN and DOXYCYCLINE for Lyme disease, PREGABALIN (LYRICA), DIAZEPAM (VALIUM) and CLONAZEPAM (KLONOPIN) for Nerve pain, OXYCODONE and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2021, the patient experienced TREMOR (Tremor/hand was shaking was dropping things/whole body just shakes) (seriousness criterion hospitalization), DYSSTASIA (had trouble standing) (seriousness criterion hospitalization) and MALAISE (feeling sick) (seriousness criterion hospitalization). On an unknown date, the patient experienced APHASIA (couldn't talk) (seriousness criterion hospitalization), MEMORY IMPAIRMENT (memory started to go/ memory was getting worse/ couldn't remember what day it was) (seriousness criterion hospitalization), FALL (tried to get out of bed and fell) (seriousness criterion hospitalization) and ANXIETY (getting anxiety ridden) (seriousness criterion hospitalization). At the time of the report, TREMOR (Tremor/hand was shaking was dropping things/whole body just shakes) had not resolved and DYSSTASIA (had trouble standing), MALAISE (feeling sick), APHASIA (couldn't talk), MEMORY IMPAIRMENT (memory started to go/ memory was getting worse/ couldn't remember what day it was), FALL (tried to get out of bed and fell) and ANXIETY (getting anxiety ridden) outcome was unknown.            The patient thought that the tremors might have been due to the Hydroxychloroquine and because she was also feeling sick, she stopped taking the Hydroxychloroquine, but continued taking the Clarithromycin. The tremors continued. Her doctor advised her to resume taking the Hydroxychloroquine, starting with ¼ pill, then ½ pill working her way up in dosing. The patient reported that her hand tremors never stopped.  Action taken with mRNA-1273 in response to the events was not Applicable.  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. Further information has been requested.   This case was linked to MOD-2021-023753 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Mar-2021: No specific follow-up information recorded.; Reporter'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. Further information has been requested.