Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Loss of personal independence in daily activities, Muscular weakness, Tremor
Clinical narrative: Difficulty walking; Balance was off; Legs are weak; Feels like dishwasher rag (no energy) / Weak; Shortness of breath / Pants breathing (shallow breathing and fast); She can't do normal household chores; She been going to bed earlier and sleeping later; had a headache in the morning; Felt bad; She was freezing could not get warm; Violently shaking; Pressure in her head (Headache) in the forehead area; Extremely fatigue / Completely exhausted / Completely wipe out; Chills; This spontaneous case was reported by a patient family member or friend and describes the occurrence of TREMOR (Violently shaking), HEAD DISCOMFORT (Pressure in her head (Headache) in the forehead area), GAIT DISTURBANCE (Difficulty walking), BALANCE DISORDER (Balance was off) and MUSCULAR WEAKNESS (Legs are weak) in a 94-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer (1st dose, Lot number-EN6203) on 25-Feb-2021, Pfizer (2nd dose, Lot number: EN6208) on 18-Mar-2021, Pfizer (1st booster, Lot number: FF2589) on 15-Oct-2021, Pfizer (2nd booster and Lot number: FM0698) on 21-Apr-2022. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Drug allergy (Extremely sensitive to medication (antihistamine)). Concomitant products included DIGOXIN, LEVOTHYROXINE, COLECALCIFEROL (VITAMIN D3), KRILL OIL, FAMOTIDINE (PEPCID [FAMOTIDINE]), CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), SUPER B COMPLEX WITH C and CRANBERRY [VACCINIUM MACROCARPON] for an unknown indication.    On 08-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 08-Sep-2022, the patient experienced TREMOR (Violently shaking), HEAD DISCOMFORT (Pressure in her head (Headache) in the forehead area), FEELING COLD (She was freezing could not get warm), FATIGUE (Extremely fatigue / Completely exhausted / Completely wipe out) and CHILLS (Chills). On 16-Sep-2022, the patient experienced FEELING ABNORMAL (Felt bad). On 18-Sep-2022, the patient experienced HEADACHE (had a headache in the morning). On an unknown date, the patient experienced GAIT DISTURBANCE (Difficulty walking), BALANCE DISORDER (Balance was off), MUSCULAR WEAKNESS (Legs are weak), ASTHENIA (Feels like dishwasher rag (no energy) / Weak), DYSPNOEA (Shortness of breath / Pants breathing (shallow breathing and fast)), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (She can't do normal household chores) and INSOMNIA (She been going to bed earlier and sleeping later). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg as needed and IBUPROFEN (MOTRIN [IBUPROFEN]) for Headache, at an unspecified dose and frequency. At the time of the report, TREMOR (Violently shaking), HEAD DISCOMFORT (Pressure in her head (Headache) in the forehead area), GAIT DISTURBANCE (Difficulty walking), BALANCE DISORDER (Balance was off), MUSCULAR WEAKNESS (Legs are weak), ASTHENIA (Feels like dishwasher rag (no energy) / Weak), DYSPNOEA (Shortness of breath / Pants breathing (shallow breathing and fast)), FEELING ABNORMAL (Felt bad), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (She can't do normal household chores), FEELING COLD (She was freezing could not get warm), INSOMNIA (She been going to bed earlier and sleeping later) and CHILLS (Chills) outcome was unknown, FATIGUE (Extremely fatigue / Completely exhausted / Completely wipe out) had not resolved and HEADACHE (had a headache in the morning) was resolving.            It was reported that patient never had COVID positive test. Patient daughter stated she did not really had medical issues. No other vaccine was given prior to Moderna COVID-19.  She was freezing could not get war. She took Tylenol (500mg) twice, half hour apart a total 1000 mg. Patients daughter stated that she had to put a large hitting pad over her mother to try to get her warm. Then 4 blankets and bed spread.   Patient felt weak on 15-Sep-2022. On 18-Sep-2022, she did not feel too bad, had a headache in the morning and Motrin did help. On 19-Sep-2022 she was completely exhausted. She went to lay down around 5 pm.