Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dysgeusia, Fatigue, Feeling hot, Hypersensitivity
Clinical narrative: Vaccine has affected me neurologically causing a lot of mental confusion this is pretty extreme for me/ Everything has worsened my organizational thinking; Balance problems; This feels the same as the time I contracted mononucleosis I'm having functional difficulty sensitivity to light; I have a lot of allergies; Excessive sleepiness; The vaccine has made all of my medical conditions worse; Arthritis has gotten worse; She has extreme fatigue/After a trip to the pharmacy I was in bed for four days due to extreme exhaustion; Immediately after the second dose I had a hot metallic feeling that went up my arm then to back up my throat then to my mouth it was awful; Immediately after the second dose I had a hot metallic feeling that went up my arm then to back up my throat then to my mouth it was awful; Later that night I had chills and bone throbbing specially in my legs it was pretty bad but it subsided by the next afternoon; Pain and aches; Later that night experienced chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Immediately after the second dose I had a hot metallic feeling that went up my arm then to back up my throat then to my mouth it was awful), DYSGEUSIA (Immediately after the second dose I had a hot metallic feeling that went up my arm then to back up my throat then to my mouth it was awful), BONE PAIN (Later that night I had chills and bone throbbing specially in my legs it was pretty bad but it subsided by the next afternoon), PAIN (Pain and aches) and CONFUSIONAL STATE (Vaccine has affected me neurologically causing a lot of mental confusion this is pretty extreme for me/ Everything has worsened my organizational thinking) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Sleep apnea, Depression, Anxiety, Acid reflux (oesophageal), Fibromyalgia, Sjogren's syndrome and Arthritis. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), CLONAZEPAM, DULOXETINE HYDROCHLORIDE (CYMBALTA), BECLOMETASONE DIPROPIONATE (QNASL), BECLOMETASONE DIPROPIONATE (QVAR), CROMOGLICATE SODIUM (NASALCROM), BUDESONIDE, SODIUM CHLORIDE, ALBUTEROL;IPRATROPIUM, MONTELUKAST, MACROGOL 400, PROPYLENE GLYCOL (SYSTANE), VITAMIN D NOS, VITAMIN B12 [VITAMIN B12 NOS], HYDROCORTISONE, OLOPATADINE, DICLOFENAC (VOLTAREN [DICLOFENAC]), ARNICA MONTANA (ARNICARE), PANCRELIPASE (ZENPEP), METHYLSCOPOLAMINE, ESTRADIOL (VAGIFEM), LIDOCAINE (LIDODERM) and GLUCOSE OXIDASE, LACTOFERRIN, LACTOPEROXIDASE, LYSOZYME, SODIUM FLUOROPHOSPHATE (BIOTENE [GLUCOSE OXIDASE;LACTOFERRIN;LACTOPEROXIDASE;LYSOZYME;SODIUM FLUOROPHOSPHATE]) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced FEELING HOT (Immediately after the second dose I had a hot metallic feeling that went up my arm then to back up my throat then to my mouth it was awful), DYSGEUSIA (Immediately after the second dose I had a hot metallic feeling that went up my arm then to back up my throat then to my mouth it was awful), BONE PAIN (Later that night I had chills and bone throbbing specially in my legs it was pretty bad but it subsided by the next afternoon), PAIN (Pain and aches) and CHILLS (Later that night experienced chills). On an unknown date, the patient experienced CONFUSIONAL STATE (Vaccine has affected me neurologically causing a lot of mental confusion this is pretty extreme for me/ Everything has worsened my organizational thinking), BALANCE DISORDER (Balance problems), PHOTOPHOBIA (This feels the same as the time I contracted mononucleosis I'm having functional difficulty sensitivity to light), HYPERSENSITIVITY (I have a lot of allergies), SOMNOLENCE (Excessive sleepiness), CONDITION AGGRAVATED (The vaccine has made all of my medical conditions worse), ARTHRITIS (Arthritis has gotten worse) and FATIGUE (She has extreme fatigue/After a trip to the pharmacy I was in bed for four days due to extreme exhaustion). At the time of the report, FEELING HOT (Immediately after the second dose I had a hot metallic feeling that went up my arm then to back up my throat then to my mouth it was awful), DYSGEUSIA (Immediately after the second dose I had a hot metallic feeling that went up my arm then to back up my throat then to my mouth it was awful), BONE PAIN (Later that night I had chills and bone throbbing specially in my legs it was pretty bad but it subsided by the next afternoon), PAIN (Pain and aches), CONFUSIONAL STATE (Vaccine has affected me neurologically causing a lot of mental confusion this is pretty extreme for me/ Everything has worsened my organizational thinking), BALANCE DISORDER (Balance problems), PHOTOPHOBIA (This feels the same as the time I contracted mononucleosis I'm having functional difficulty sensitivity to light), HYPERSENSITIVITY (I have a lot of allergies), SOMNOLENCE (Excessive sleepiness), CONDITION AGGRAVATED (The vaccine has made all of my medical conditions worse), ARTHRITIS (Arthritis has gotten worse), CHILLS (Later that night experienced chills) and FATIGUE (She has extreme fatigue/After a trip to the pharmacy I was in bed for four days due to extreme exhaustion) had not resolved.            The patient actively sook medical care.  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.; 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.