Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: loss of smell; tested positive for Covid-19; injection site was inflamed, itchy, bumpy for 2 days; the injection site was inflamed and bumpy for 2 days; Inflammation in the vaccine area with irritation and almost unbearable itchy feeling; Vaccination site was red and bruised, about 2inches in diameter, which was raised and painful; Body ache; injection site was also painful; Shortness of breath; worsening of asthma; Sore throat; fever of 100.6F; Headache; sore arm; redness at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), OROPHARYNGEAL PAIN (Sore throat), DYSPNOEA (Shortness of breath), COVID-19 (tested positive for Covid-19) and ASTHMA (worsening of asthma) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma (mild asthma, started in 2004).   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm), VACCINATION SITE ERYTHEMA (redness at the site of injection) and HEADACHE (Headache). On 14-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and PYREXIA (fever of 100.6F). On 17-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath) and ASTHMA (worsening of asthma). On 19-Jan-2021, the patient experienced VACCINATION SITE INFLAMMATION (the injection site was inflamed and bumpy for 2 days), VACCINATION SITE IRRITATION (Inflammation in the vaccine area with irritation and almost unbearable itchy feeling), VACCINATION SITE BRUISING (Vaccination site was red and bruised, about 2inches in diameter, which was raised and painful), VACCINATION SITE PRURITUS (injection site was inflamed, itchy, bumpy for 2 days), MYALGIA (Body ache) and VACCINATION SITE PAIN (injection site was also painful). On 21-Jan-2021, the patient experienced COVID-19 (tested positive for Covid-19). On 23-Jan-2021, the patient experienced ANOSMIA (loss of smell). On 21-Jan-2021, VACCINATION SITE INFLAMMATION (the injection site was inflamed and bumpy for 2 days), VACCINATION SITE IRRITATION (Inflammation in the vaccine area with irritation and almost unbearable itchy feeling) and VACCINATION SITE PRURITUS (injection site was inflamed, itchy, bumpy for 2 days) had resolved. On 28-Jan-2021, ASTHMA (worsening of asthma) and ANOSMIA (loss of smell) had resolved. On 29-Jan-2021, COVID-19 (tested positive for Covid-19) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm), OROPHARYNGEAL PAIN (Sore throat), DYSPNOEA (Shortness of breath), VACCINATION SITE ERYTHEMA (redness at the site of injection), PYREXIA (fever of 100.6F) and HEADACHE (Headache) had not resolved and VACCINATION SITE BRUISING (Vaccination site was red and bruised, about 2inches in diameter, which was raised and painful), MYALGIA (Body ache) and VACCINATION SITE PAIN (injection site was also painful) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Body temperature: 100.6 (High) fever of 100.6 F. On 21-Jan-2021, SARS-CoV-2 test: positive (Positive) positive for Covid-19. On 29-Jan-2021, SARS-CoV-2 test: negative (Negative) Negative PCR test results.         No Concomitant medication information not provided. No treatment information was provided. Patient is undergoing physical therapy for the back ache currently (April 2021)   This case was linked to MOD-2021-078653 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: Follow up received on 25-JAN-2021, additional events added to the report. On 27-Jan-2021: Follow up was received on 27-JAN-2021. The report contains and no new information added. On 13-Apr-2021: Follow up was received on 13-APR-2021, via ADR reporting form. Patient demographics, additional events and outcome of the events, reporter causality were updated. On 21-Jul-2021: Significant FU received on 21-Jul-2021: Patient details updated