Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersomnia, Knee deformity, Movement disorder, Pain
Clinical narrative: confusion; short term memory loss; Shortness of breath; tingling of hands and feet; Knee sensitive to light; Body ache; Rash on cheeks and forehead; Joint pain in left hand, and thumb, knees, ankles, hips, shoulders, lower back; Extreme fatigue; Intermittent headache; all of the side effects from the first symptoms with the second shot aside from the nausea and; has been sleeping 12-14 hours since the second shot; her right hand and left ankle is swollen; tongue is swollen; cannot get up; This spontaneous case was reported by a consumer and describes the occurrence of SYMPTOM RECURRENCE (all of the side effects from the first symptoms with the second shot aside from the nausea and), HYPERSOMNIA (has been sleeping 12-14 hours since the second shot), PERIPHERAL SWELLING (her right hand and left ankle is swollen), SWOLLEN TONGUE (tongue is swollen) and MOVEMENT DISORDER (cannot get up) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN from 01-Jan-2010 to an unknown date, ESTRADIOL (DIVIGEL) from 01-Jan-2010 to an unknown date and ATORVASTATIN from 01-Jan-2010 to an unknown date for an unknown indication.   On 12-Mar-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021 at 12:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced SYMPTOM RECURRENCE (all of the side effects from the first symptoms with the second shot aside from the nausea and), HYPERSOMNIA (has been sleeping 12-14 hours since the second shot), PERIPHERAL SWELLING (her right hand and left ankle is swollen), SWOLLEN TONGUE (tongue is swollen) and MOVEMENT DISORDER (cannot get up). On an unknown date, the patient experienced CONFUSIONAL STATE (confusion), AMNESIA (short term memory loss), DYSPNOEA (Shortness of breath), PARAESTHESIA (tingling of hands and feet), KNEE DEFORMITY (Knee sensitive to light), PAIN (Body ache), RASH (Rash on cheeks and forehead), ARTHRALGIA (Joint pain in left hand, and thumb, knees, ankles, hips, shoulders, lower back), FATIGUE (Extreme fatigue) and HEADACHE (Intermittent headache). At the time of the report, SYMPTOM RECURRENCE (all of the side effects from the first symptoms with the second shot aside from the nausea and), HYPERSOMNIA (has been sleeping 12-14 hours since the second shot), PERIPHERAL SWELLING (her right hand and left ankle is swollen), SWOLLEN TONGUE (tongue is swollen), MOVEMENT DISORDER (cannot get up), CONFUSIONAL STATE (confusion), AMNESIA (short term memory loss), DYSPNOEA (Shortness of breath), KNEE DEFORMITY (Knee sensitive to light), PAIN (Body ache), RASH (Rash on cheeks and forehead), ARTHRALGIA (Joint pain in left hand, and thumb, knees, ankles, hips, shoulders, lower back), FATIGUE (Extreme fatigue) and HEADACHE (Intermittent headache) outcome was unknown and PARAESTHESIA (tingling of hands and feet) had not resolved. Not Provided          Patient mentioned insomnia due to body and muscle ache.   Treatment for the events was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-080450 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Concomitant medications, new events, race, ethnicity, height, weight were added.; 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 US-MODERNATX, INC.-MOD-2021-080450:1st dose case