Reporte zur Charge 002BNA

Symptomtext

Her 2nd dose was scheduled for 4Jun2021 but she coudnt get it; hallucinations; appetite was off; bowel movements were off; feeling weak; strong sense of smell; This spontaneous case was reported by a patient and describes the occurrence of HALLUCINATION (hallucinations), DECREASED APPETITE (appetite was off), BOWEL MOVEMENT IRREGULARITY (bowel movements were off), ASTHENIA (feeling weak) and PAROSMIA (strong sense of smell) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002BNA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. Concomitant products included HYDROCHLOROTHIAZIDE and LISINOPRIL for Hypertension, FAMOTIDINE and EZETIMIBE for an unknown indication. On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced HALLUCINATION (hallucinations), DECREASED APPETITE (appetite was off), BOWEL MOVEMENT IRREGULARITY (bowel movements were off), ASTHENIA (feeling weak) and PAROSMIA (strong sense of smell). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Her 2nd dose was scheduled for 4Jun2021 but she coudnt get it). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HALLUCINATION (hallucinations) had resolved and DECREASED APPETITE (appetite was off), BOWEL MOVEMENT IRREGULARITY (bowel movements were off), ASTHENIA (feeling weak), PAROSMIA (strong sense of smell) and PRODUCT DOSE OMISSION ISSUE (Her 2nd dose was scheduled for 4Jun2021 but she coudnt get it) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. Patient's second dose was scheduled at 4Jun2021 but still its pending Company Comment Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.