Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Feeling abnormal, Gait disturbance, Hypertension, Insomnia
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (My feet started to get swollen,my toes started to swell up like water,The sole would start to get hard and then it would transform into water ,my right index finger was swollen.I can't have pressure there because it is very painful/angioderma), INSOMNIA (I couldn't sleep), TACHYCARDIA (Tachycardia,my blood pressure blew up), FEELING ABNORMAL (I felt weird/I also felt weird like my feet were going to burn) and JOINT SWELLING (My joints started to get swollen) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included METFORMIN and LOSARTAN for an unknown indication. On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, the patient experienced INSOMNIA (I couldn't sleep) and TACHYCARDIA (Tachycardia,my blood pressure blew up). On 05-Aug-2021, the patient experienced FEELING ABNORMAL (I felt weird/I also felt weird like my feet were going to burn), HYPERTENSION (Blood pressure blew up) and NERVOUSNESS (Thought it was due to nervousness of the vaccine). In August 2021, the patient experienced PERIPHERAL SWELLING (My feet started to get swollen,my toes started to swell up like water,The sole would start to get hard and then it would transform into water ,my right index finger was swollen.I can't have pressure there because it is very painful/angioderma), JOINT SWELLING (My joints started to get swollen), BURNING SENSATION (I also felt weird like my feet were going to burn/I couldn't ware closed), PAIN IN EXTREMITY (I can't have pressure in feet because it is very painful.) and PAIN IN EXTREMITY (I also had pain in my right knee /I also had it in my right index finger). On an unknown date, the patient experienced GAIT DISTURBANCE (I couldn't walk for a week), PRODUCT DOSE OMISSION ISSUE (More than 35 days for administration of second dose) and INTENTIONAL PRODUCT USE ISSUE (Intentional deviation from dosage regimen). The patient was treated with MONTELUKAST for Adverse event, at a dose of 10 mg once a day and LEVOCETIRIZINE DIHYDROCHLORIDE for Adverse event, at a dose of 5 UNK, qd. At the time of the report, PERIPHERAL SWELLING (My feet started to get swollen,my toes started to swell up like water,The sole would start to get hard and then it would transform into water ,my right index finger was swollen.I can't have pressure there because it is very painful/angioderma) had not resolved, INSOMNIA (I couldn't sleep), TACHYCARDIA (Tachycardia,my blood pressure blew up), FEELING ABNORMAL (I felt weird/I also felt weird like my feet were going to burn), JOINT SWELLING (My joints started to get swollen), GAIT DISTURBANCE (I couldn't walk for a week), HYPERTENSION (Blood pressure blew up), NERVOUSNESS (Thought it was due to nervousness of the vaccine), BURNING SENSATION (I also felt weird like my feet were going to burn/I couldn't ware closed) and PAIN IN EXTREMITY (I can't have pressure in feet because it is very painful.) outcome was unknown and PAIN IN EXTREMITY (I also had pain in my right knee /I also had it in my right index finger), PRODUCT DOSE OMISSION ISSUE (More than 35 days for administration of second dose) and INTENTIONAL PRODUCT USE ISSUE (Intentional deviation from dosage regimen) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient was scheduled for second dose on 01 Sep 2021, but patient didn't go. The patient contacted primary doctor through phone and as per doctor's advice patient visited chiropologist on 10 Aug 2021, but it didn't help. On On 31 Aug 2021, patient went to see an allergist for the first time and then second time were on 15 Sep 2021. Patient had an analysis to dismiss it was not a hereditary condition, and to check that a particular protein was not involved. Everything came back negative. Patient was diagnosed with angioedema. Patient had an edema in the feet, like water comes out of them. On 20 Sep 2021, patient tried walking for 10 minutes. With her right foot she could walk, as it is better. However, with left foot it had edema again when woke up.  Patient booked appointment with primary doctor on 19 Oct 2021 to check the results of the studies.; Sender's Comments: This case concerns a 57-year-old, female patient with a relevant  medical history of DM and HTN (based on con meds), who experienced the unexpected non-serious events of insomnia, tachycardia, feeling abnormal, burning sensation,  joint swelling, pain in the extremity, peripheral swelling, gait disturbance and Intentional deviation from dosage regimen. The events occurred gradually from next day after receiving the first dose of Moderna mRNA vaccine. The rechallenge is not applicable as the patient skipped the second dose intentionally. The reporter did not provide the causality assessment. The medical history of DM and HTN and its complications remains as confounders for some of the events. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.