Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Headache, Myalgia, Peripheral swelling
Clinical narrative: Swelling in his left arm; Lack of drug effect; Patient caught COVID-19 (had fatigue, congestion in his head, cough, sneeze, had moderate symptoms, lost taste and smell); Headache; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Lack of drug effect), PERIPHERAL SWELLING (Swelling in his left arm), HEADACHE (Headache), MYALGIA (Body aches) and COVID-19 (Patient caught COVID-19 (had fatigue, congestion in his head, cough, sneeze, had moderate symptoms, lost taste and smell)) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jun-2021, the patient experienced HEADACHE (Headache) and MYALGIA (Body aches). On 05-Dec-2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). 05-Dec-2021, the patient experienced COVID-19 (Patient caught COVID-19 (had fatigue, congestion in his head, cough, sneeze, had moderate symptoms, lost taste and smell)). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling in his left arm). At the time of the report, DRUG INEFFECTIVE (Lack of drug effect), PERIPHERAL SWELLING (Swelling in his left arm), HEADACHE (Headache) and MYALGIA (Body aches) outcome was unknown and COVID-19 (Patient caught COVID-19 (had fatigue, congestion in his head, cough, sneeze, had moderate symptoms, lost taste and smell)) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.         No treatment medication was reported by reporter.  Company Comment: This spontaneous case concerns a 65-year-old, male patient with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19 and drug ineffective was considered as an additional event, and other associated unexpected and expected, non-serious events after administration of the second dose of the Moderna mRNA-1273 vaccine. The patient experienced mild headache and body aches 1 day after vaccine administration. These were accompanied by some swelling in his left arm. Treatment information was not provided. The outcomes of these events were unknown at the time of the report. Approximately 5 months after administration of the second dose of the Moderna mRNA-1273 vaccine, the patient had a positive COVID-19 test result. He had moderate COVID-19 symptoms of fatigue, congestion in his head, cough and sneezing. These were accompanied by lost of taste and smell. Treatment information was not provided. However, after a 10-day quarantine, the patient felt better and regained his sense of taste and smell. The event COVID-19 was resolving at the time of the report. The patient's age remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-458763 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jan-2022: follow-up received and contains No new information. Sender's Comments: This spontaneous case concerns a 65-year-old, male patient with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19 and drug ineffective was considered as an additional event, and other associated unexpected and expected, non-serious events after administration of the second dose of the Moderna mRNA-1273 vaccine. The patient experienced mild headache and body aches 1 day after vaccine administration. These were accompanied by some swelling in his left arm. Treatment information was not provided. The outcomes of these events were unknown at the time of the report. Approximately 5 months after administration of the second dose of the Moderna mRNA-1273 vaccine, the patient had a positive COVID-19 test result. He had moderate COVID-19 symptoms of fatigue, congestion in his head, cough and sneezing. These were accompanied by lost of taste and smell. Treatment information was not provided. However, after a 10-day quarantine, the patient felt better and regained his sense of taste and smell. The event COVID-19 was resolving at the time of the report. The patient's age remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.