Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness, Erythema, Fall
Clinical narrative: Fell out of the sofa onto the floor; Had to crawled because I couldn't lift myself up, was on the floor from Friday to Sunday; Diarrhea; Weakness; Dizziness, still dizzy; First shot on 15 May2021 and Second shot on 05 Aug2021; Right arm was swollen; Right arm was red; Really tired; It hurt when the needle entered; Vertigo; Weakness in legs; Muscles between the knees and ankles are tight; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), DIZZINESS (Dizziness, still dizzy), MUSCLE TIGHTNESS (Muscles between the knees and ankles are tight), FALL (Fell out of the sofa onto the floor) and MOBILITY DECREASED (Had to crawled because I couldn't lift myself up, was on the floor from Friday to Sunday) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Patient was hospitalized.) in November 2020, Arm discomfort and Tooth extraction NOS (All the bottom teeth were pulled as she has jagged teeth underneath the bridge.) on 18-May-2021. Concurrent medical conditions included Blood disorder. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), GABAPENTIN and PARACETAMOL (TYLENOL) for an unknown indication.   On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First shot on 15 May2021 and Second shot on 05 Aug2021), PERIPHERAL SWELLING (Right arm was swollen), ERYTHEMA (Right arm was red) and FATIGUE (Really tired). On 06-Aug-2021, the patient experienced ASTHENIA (Weakness), DIZZINESS (Dizziness, still dizzy), FALL (Fell out of the sofa onto the floor), MOBILITY DECREASED (Had to crawled because I couldn't lift myself up, was on the floor from Friday to Sunday) and DIARRHOEA (Diarrhea). In August 2021, the patient experienced MUSCLE TIGHTNESS (Muscles between the knees and ankles are tight), VERTIGO (Vertigo), MUSCULAR WEAKNESS (Weakness in legs) and VACCINATION SITE PAIN (It hurt when the needle entered). On 05-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First shot on 15 May2021 and Second shot on 05 Aug2021) had resolved. On 08-Aug-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, ASTHENIA (Weakness) and DIZZINESS (Dizziness, still dizzy) had not resolved, MUSCLE TIGHTNESS (Muscles between the knees and ankles are tight), FALL (Fell out of the sofa onto the floor), MOBILITY DECREASED (Had to crawled because I couldn't lift myself up, was on the floor from Friday to Sunday), VERTIGO (Vertigo), MUSCULAR WEAKNESS (Weakness in legs), FATIGUE (Really tired) and VACCINATION SITE PAIN (It hurt when the needle entered) outcome was unknown and PERIPHERAL SWELLING (Right arm was swollen) and ERYTHEMA (Right arm was red) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Aug-2021, X-ray: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had spine condition which doesn't let her to put the hands in front of her body when she felled. Patient reported that the arm redness and swelling lasted until 3-4 days ago before reporting. Patient fell out of sofa on 06 Aug and found by neighbor on 08 Aug and was carried to hospital for 10 hours.  Patient had a Brain scan, but the results were unknown. Patient was treated with Pills for diarrhea and blue liquid for diarrhea. Kneecap replacement surgery, shoulder surgery, and a cataracts surgery scheduled before was postponed due to the symptoms experienced after second dose of vaccination.   This case was linked to MOD-2021-297455 (Patient Link).