Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site erythema, Vaccination site swelling
Clinical narrative: positive for COVID-19; Lack of drug effect; fever; body ache; headache; left arm got red on the site of injection; swollen on the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (positive for COVID-19), DRUG INEFFECTIVE (Lack of drug effect), PYREXIA (fever), MYALGIA (body ache) and HEADACHE (headache) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Autoimmune disorder NOS, Inflammation, Blood pressure abnormal and Insulin resistance. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Autoimmune disorder NOS, LISINOPRIL for Blood pressure abnormal, CELECOXIB for Inflammation, DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA) for Insulin resistance.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 16-Apr-2021, the patient experienced PYREXIA (fever), MYALGIA (body ache), HEADACHE (headache), VACCINATION SITE ERYTHEMA (left arm got red on the site of injection) and VACCINATION SITE SWELLING (swollen on the site of injection). On 03-Jan-2022, the patient experienced COVID-19 (positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. On 19-Apr-2021, PYREXIA (fever), MYALGIA (body ache) and HEADACHE (headache) had resolved. On 23-Apr-2021, VACCINATION SITE ERYTHEMA (left arm got red on the site of injection) and VACCINATION SITE SWELLING (swollen on the site of injection) had resolved. At the time of the report, COVID-19 (positive for COVID-19) outcome was unknown and DRUG INEFFECTIVE (Lack of drug effect) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2022, SARS-CoV-2 test: positive (Positive) positive.         Company comment: This Spontaneous case concerns a 36-year-old, female patient, with medical history of autoimmune disease, hypertension and insulin resistance, who experienced the unexpected, non-serious and AESI of COVID-19.  Drug ineffective was also reported in the case. The patient developed COVID-19 8 months and 19 days after receiving the second dose of mRNA-1273 vaccine. She received both doses of mRNA  1273 vaccine with an interval of 28 days between them. No further clinical information was provided for medical reviewing. The medical history of autoimmune disease, hypertension and insulin resistance remain as confounders. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This Spontaneous case concerns a 36-year-old, female patient, with medical history of autoimmune disease, hypertension and insulin resistance, who experienced the unexpected, non-serious and AESI of COVID-19.  Drug ineffective was also reported in the case. The patient developed COVID-19 8 months and 19 days after receiving the second dose of mRNA-1273 vaccine. She received both doses of mRNA  1273 vaccine with an interval of 28 days between them. No further clinical information was provided for medical reviewing. The medical history of autoimmune disease, hypertension and insulin resistance remain as confounders. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.