Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Delirium, Hypokinesia, Illness, Immunisation reaction
Clinical narrative: stayed 2 days in bed; pain; delirious; issues/problems/horrible out of body experience; became very sick; Felt flu-ish/ terrible chills/ body aches/ head hurts; could not lift her arm; This spontaneous case was reported by a patient and describes the occurrence of DELIRIUM (delirious) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient had received shingles vaccine in the past.  Concurrent medical conditions included Fibromyalgia, Drug allergy and Sickness (usually got sick easily).    In April 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2020, the patient experienced BEDRIDDEN (stayed 2 days in bed). In 2020, the patient experienced DELIRIUM (delirious) (seriousness criterion medically significant), IMMUNISATION REACTION (issues/problems/horrible out of body experience), ILLNESS (became very sick), INFLUENZA LIKE ILLNESS (Felt flu-ish/ terrible chills/ body aches/ head hurts), HYPOKINESIA (could not lift her arm) and PAIN (pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In April 2020, BEDRIDDEN (stayed 2 days in bed) had resolved. In 2020, DELIRIUM (delirious), IMMUNISATION REACTION (issues/problems/horrible out of body experience), ILLNESS (became very sick), INFLUENZA LIKE ILLNESS (Felt flu-ish/ terrible chills/ body aches/ head hurts), HYPOKINESIA (could not lift her arm) and PAIN (pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient had received a lot of concomitant medications for fibromyalgia. Following vaccination with the 1st dose of the vaccine within 3-4 hours patient experienced the following, which lasted 2 days: issues, problems, became very sick, felt flu-ish, terrible chills, could not lift her arm, pain, horrible out of body experience, not sure about fever, delirious, hurt, head hurts, body aches, stayed 2 days in bed. The patient experienced similar symptoms in the past when she received the shingles vaccine, both times for a couple of days.  Company comment: This spontaneous case concerns unspecified age female patient, with no relevant medical history, who experienced the unexpected serious (medically significant) event of delirium, which occurred unspecified days after first dose of mRNA-1273 vaccine. After 3 to 4 hours of first dose of vaccination, patient became very sick, feeling fluish, terrible chills, couldn't not lift her arm, pain, horrible out of body experience. Patient is not sure about fever, patient is delirious, hurt, head hurts, body aches and patient stayed in bed for 2 days. No further information on lab data. At the time of reporting event is recovered. The benefit-risk relationship of mRNA-1273.214 vaccine is not affected by this report   This case was linked to MOD-2022-653655, MOD-2022-653657 (Patient Link).   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns unspecified age female patient, with no relevant medical history, who experienced the unexpected serious (medically significant) event of delirium, which occurred unspecified days after first dose of mRNA-1273 vaccine. After 3 to 4 hours of first dose of vaccination, patient became very sick, feeling fluish, terrible chills, couldn't not lift her arm, pain, horrible out of body experience. Patient is not sure about fever, patient is delirious, hurt, head hurts, body aches and patient stayed in bed for 2 days. No further information on lab data. At the time of reporting event is recovered. The benefit-risk relationship of mRNA-1273.214 vaccine is not affected by this report