Reporte zur Charge CUS245

Symptomtext

This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (feeling depressed), VACCINATION COMPLICATION (had problems) and VACCINATION SITE PAIN (Following vaccination soreness in her arm) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. CUS245) for COVID-19 prophylaxis. Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (1st dose, lot no: EN6208 ) on 04-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (2nd dose, lot no: EW0151 ) on 09-Apr-2021, PFIZER BIONTECH COVID-19 VACCINE (1st booster and Lot no: SJ5683 ) on 08-Mar-2022. On 24-Jan-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Jan-2023, the patient experienced DEPRESSED MOOD (feeling depressed), VACCINATION COMPLICATION (had problems) and VACCINATION SITE PAIN (Following vaccination soreness in her arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DEPRESSED MOOD (feeling depressed) and VACCINATION SITE PAIN (Following vaccination soreness in her arm) had resolved and VACCINATION COMPLICATION (had problems) outcome was unknown. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. In the afternoon patient started experiencing adverse events.