Reporte zur Charge 004F21N

Symptomtext

little bit of soreness at the injection site; fatigue; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE PAIN (little bit of soreness at the injection site) and FATIGUE (fatigue) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) (batch nos. 004F21N and 05A22A) for COVID-19 prophylaxis. Previously administered products included for Product used for unknown indication: flu shot. Past adverse reactions to the above products included No adverse event with flu shot. Concurrent medical conditions included Chronic lung disease and Polyneuropathy. On 09-Nov-2021, the patient received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 03-Jun-2022, received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (little bit of soreness at the injection site) and FATIGUE (fatigue). At the time of the report, INJECTION SITE PAIN (little bit of soreness at the injection site) and FATIGUE (fatigue) had resolved. For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments. No concomitant and treatment medication were reported. Patient tolerated all shots well and has not gotten sick. Patient had a little bit of soreness at the injection site and fatigue with all of the doses. Events lasted about 1.5 days before resolving with each dose. Patient had taken another 4 doses of the Moderna COVID-19 vaccine as on 24FEB2021 with lot number 006M20A, 26MAR2021with lot number 026A21A, 28NOV2022 with lot number 016H22A and Last dose of unknown date or lot number. This case was linked to MOD-2023-749422 (Patient Link).