Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hallucination, Product dose omission issue, Vaccination site erythema, Vaccination site pain
Clinical narrative: Severe hallucination; Feeling very strange; The vaccination site looked very red and painful; The vaccination site looked very red and painful; she didn't receive her 2nd dose because of the experience she had after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Severe hallucination) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Diarrhea (she suffers from severe diarrhea for 10 days or so due to the antibiotics.). Concurrent medical conditions included Acute sinusitis (She suffers from acute sinus infections 10 months out of the year). Concomitant products included AMOXICILLIN for Acute sinusitis.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HALLUCINATION (Severe hallucination) (seriousness criteria hospitalization and medically significant), FEELING ABNORMAL (Feeling very strange), VACCINATION SITE ERYTHEMA (The vaccination site looked very red and painful), VACCINATION SITE PAIN (The vaccination site looked very red and painful) and PRODUCT DOSE OMISSION ISSUE (she didn't receive her 2nd dose because of the experience she had after the 1st dose). The patient was hospitalized for 2 days due to HALLUCINATION. At the time of the report, HALLUCINATION (Severe hallucination), FEELING ABNORMAL (Feeling very strange), VACCINATION SITE ERYTHEMA (The vaccination site looked very red and painful) and VACCINATION SITE PAIN (The vaccination site looked very red and painful) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (she didn't receive her 2nd dose because of the experience she had after the 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received her 1st dose with the Moderna COVID-19 vaccine about 8 months or so ago.  The patient had just turned 65 yesterday (04-Jan-2022).  The patient was deadly afraid that she was unprotected in any way. The sinus infection got better, but she suffered from severe diarrhea for 10 days or so due to the antibiotics. So her immune system was pretty weak, which added to her fear.  No treatment medication details was provided.  Company Comment: This case of Product dose omission issue concerns a 65-year-old female patient, with no relevant medical history, who experienced the unexpected events of Hallucination and Feeling abnormal, and the expected events of Vaccination site erythema and Vaccination site pain. The events occurred on an unknown date after receiving the first dose of mRNA-1273 Vaccine which resulted in hospitalization. At the time of the report the outcome of the events was resolved. The rechallenge is not applicable as the events occurred after the first dose and no information about second dose is available. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This case of Product dose omission issue concerns a 65-year-old female patient, with no relevant medical history, who experienced the unexpected events of Hallucination and Feeling abnormal, and the expected events of Vaccination site erythema and Vaccination site pain. The events occurred on an unknown date after receiving the first dose of mRNA-1273 Vaccine which resulted in hospitalization. At the time of the report the outcome of the events was resolved. The rechallenge is not applicable as the events occurred after the first dose and no information about second dose is available. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.