Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Renal impairment, Sigmoidoscopy normal, Unresponsive to stimuli, Urinary tract infection
Clinical narrative: unresponsive to stimuli; urinary tract infections; candida in her throat; dehydrated; neuropathy in both legs and has fallen 3 times; She had lost 25 lbs but she had gained back 3 lbs; nausea; vomiting; fever; chills; diarrhea; started using a cane and progressed to a walker; fallen 3 times; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of UNRESPONSIVE TO STIMULI (unresponsive to stimuli) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Essential tremor and Kidney transplant. Concomitant products included CEVIMELINE for Dry mouth, VITAMIN B3, VACCINIUM MACROCARPON FRUIT (CRANBERRY [VACCINIUM MACROCARPON FRUIT]), CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), TACROLIMUS, MYCOPHENOLIC ACID, PREDNISONE, PRIMIDONE, RABEPRAZOLE, ROSUVASTATIN CALCIUM and FLUOXETINE HYDROCHLORIDE (PROZAC) for Kidney disorder, LORAZEPAM (ATIVAN) for Nerve pain, ACETAMINOPHEN for Pain, FLUTICASONE PROPIONATE (PROAIR [FLUTICASONE PROPIONATE]) for an unknown indication.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced WEIGHT DECREASED (She had lost 25 lbs but she had gained back 3 lbs), DIARRHOEA (diarrhea), NAUSEA (nausea), VOMITING (vomiting), PYREXIA (fever) and CHILLS (chills). On 13-Mar-2021, the patient experienced NEUROPATHY PERIPHERAL (neuropathy in both legs and has fallen 3 times) and DEHYDRATION (dehydrated). In March 2021, the patient experienced WALKING AID USER (started using a cane and progressed to a walker) and FALL (fallen 3 times). On 12-Apr-2021, the patient experienced ORAL CANDIDIASIS (candida in her throat). On 20-May-2021, the patient experienced URINARY TRACT INFECTION (urinary tract infections). On an unknown date, the patient experienced UNRESPONSIVE TO STIMULI (unresponsive to stimuli) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 12-May-2021 to 16-May-2021 due to UNRESPONSIVE TO STIMULI. The patient was treated with PARACETAMOL (TYLENOL) on 13-Mar-2021 for Fever, at an unspecified dose and frequency; ONDANSETRON (ZOFRAN [ONDANSETRON]) for Candida of mouth, at an unspecified dose and frequency; PROMETHAZINE HYDROCHLORIDE (PHENERGAN [PROMETHAZINE HYDROCHLORIDE]) on 19-Apr-2021 for Candida infection, at an unspecified dose and frequency; DOXYCYCLINE for Urinary tract infection, at an unspecified dose and frequency; FLUCONAZOLE (DIFLUCAN) at an unspecified dose and frequency and PHOSPHORUS at an unspecified dose and frequency. On 09-Apr-2021, PYREXIA (fever) had resolved. On 14-Apr-2021, ORAL CANDIDIASIS (candida in her throat) had resolved. At the time of the report, UNRESPONSIVE TO STIMULI (unresponsive to stimuli), NEUROPATHY PERIPHERAL (neuropathy in both legs and has fallen 3 times), WEIGHT DECREASED (She had lost 25 lbs but she had gained back 3 lbs), WALKING AID USER (started using a cane and progressed to a walker), FALL (fallen 3 times) and URINARY TRACT INFECTION (urinary tract infections) outcome was unknown and DIARRHOEA (diarrhea), DEHYDRATION (dehydrated), NAUSEA (nausea), VOMITING (vomiting) and CHILLS (chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Blood magnesium: low (Low) low. On 14-May-2021, Blood phosphorus: low (Low) low. On 14-May-2021, Endoscopy: candida in throat (abnormal) candida in  throat. On 14-May-2021, Renal impairment: normal (normal) normal. On 14-May-2021, Sigmoidoscopy normal: normal (normal) normal.         By 19 Apr 2021, the transplant team office was called as she was not responding. They ran bloodwork and found the Diflucan had caused issues with the tacrolimus which she takes for the kidney transplant. They went to the hospital on 10 May 2021 and 11 May 2021 but could not wait. She was finally admitted on 12 May 2021. On 14 May 2021 another endoscopy showed that the candida was better. Bloodwork indicated her phosphorus was critically low and magnesium was low. She was given fluids and phosphorus. Her kidney function test was normal. She was released on 16 May 2021.  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. However subject's use of steroids can be a confounding factor to oral candidiasis. Furthermore the interaction between Diflucan and Tacrolimus can also be a confounding factor.   This case was linked to MOD-2021-169089 (Patient Link).; 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. However subject's use of steroids can be a confounding factor to oral candidiasis. Furthermore the interaction between Diflucan and Tacrolimus can also be a confounding factor.