Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, SARS-CoV-2 test positive
Clinical narrative: patient tested positive to COVID-19; pain in the arm of injection; achiness; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (patient tested positive to COVID-19), PAIN IN EXTREMITY (pain in the arm of injection) and PAIN (achiness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Iodine allergy. Concomitant products included AMLODIPINE, HYDROCHLOROTHIAZIDE and ACYCLOVIR [ACICLOVIR] for an unknown indication.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Nov-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm of injection) and PAIN (achiness). On 19-Apr-2022, the patient experienced SARS-COV-2 TEST POSITIVE (patient tested positive to COVID-19). On 12-Nov-2021, PAIN IN EXTREMITY (pain in the arm of injection) and PAIN (achiness) had resolved. At the time of the report, SARS-COV-2 TEST POSITIVE (patient tested positive to COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2022, SARS-CoV-2 test positive: positive (Positive) Patient tested positive for COVID-19..         No treatment medications were reported.  Company comment: This is a spontaneous case concerning a female patient of unknown age with no relevant medical history and with vaccine history of receiving first and second dose of mRNA-1273 vaccine with appropriate dosage interval of 28 days, who experienced the unexpected non-serious  event of SARS-CoV-2 test positive, the unexpected non-serious event of pain and expected non-serious event of pain in extremity (pain in the arm of injection). The events pain and pain in extremity occurred the same day with the third dose of mRNA-1273 vaccine administration with approximately 1 day duration while the event SARS-CoV-2 test positive occurred 158 days after the third dose of mRNA-1273 vaccine administration. No other information surrounding the events was reported. The outcome of the events pain and pain in extremity was reported as resolved while the event SARS-CoV-2 test positive the outcome was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-555539 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2022: Follow up received: Contained significant information Dose 1, 2 and 3 dates and batch numbers were provided.; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age with no relevant medical history and with vaccine history of receiving first and second dose of mRNA-1273 vaccine with appropriate dosage interval of 28 days, who experienced the unexpected non-serious event of SARS-CoV-2 test positive, the unexpected non-serious event of pain and expected non-serious event of pain in extremity (pain in the arm of injection). The events pain and pain in extremity occurred the same day with the third dose of mRNA-1273 vaccine administration with approximately 1 day duration while the event SARS-CoV-2 test positive occurred 158 days after the third dose of mRNA-1273 vaccine administration. No other information surrounding the events was reported. The outcome of the events pain and pain in extremity was reported as resolved while the event SARS-CoV-2 test positive the outcome was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.