Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Fatigue; Delirious; Issues/problems/horrible out of body experience; Becoming very sick; Feeling flu-ish; Couldn't lift her arm; Pain/hurt; Staying 3 days in bed; Terrible chills; Head hurts; Body aches/muscle hurt; 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 (Spikevax) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.  Patient did not test positive for COVID-19 or diagnosed with it. Previously administered products included for Product used for unknown indication: Shingles (Similar symptoms when received shingles vaccine, both times for a couple of days.), Shingles (Similar symptoms when received shingles vaccine and both times for a couple of days.). Past adverse reactions to the above products included Adverse reaction with Shingles and Shingles. Concurrent medical conditions included Fibromyalgia (A lot of the symptoms patient experienced were a lot like fibromyalgia symptoms, chills fatigue muscle hurt.), Drug allergy (Compazine), Drug allergy (Mesalamine) and Drug allergy (Statin drugs).  On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced DELIRIUM (Delirious) (seriousness criterion medically significant), IMMUNISATION REACTION (Issues/problems/horrible out of body experience), ILLNESS (Becoming very sick), INFLUENZA LIKE ILLNESS (Feeling flu-ish), HYPOKINESIA (Couldn't lift her arm), PAIN (Pain/hurt), BEDRIDDEN (Staying 3 days in bed), CHILLS (Terrible chills), HEADACHE (Head hurts), MYALGIA (Body aches/muscle hurt) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DELIRIUM (Delirious), IMMUNISATION REACTION (Issues/problems/horrible out of body experience), ILLNESS (Becoming very sick), INFLUENZA LIKE ILLNESS (Feeling flu-ish), HYPOKINESIA (Couldn't lift her arm), PAIN (Pain/hurt), BEDRIDDEN (Staying 3 days in bed), CHILLS (Terrible chills), HEADACHE (Head hurts), MYALGIA (Body aches/muscle hurt) and FATIGUE (Fatigue) had resolved.  Concomitant medications included fibromyalgia medications. Patient experienced events within 4 hours after vaccination. The events patient had  were same patient experienced after first dose but worse. Patient was not sure about fever. Patient stated that patient usually gets sick easily. Patient sought medical care, went for office visit.  Company Comment: This spontaneous case concerns a female patient of an unknown age, with relevant medical history of Fibromyalgia, who experienced the unexpected serious (medically significant) event of Delirium, the unexpected events of Immunisation reaction, Illness, Influenza like illness, Hypokinesia, Pain, and Bedridden, and the expected events of Chills, Headache, Myalgia and Fatigue. The events occurred on an unknown date after receiving the second dose of mRNA-1273 Vaccine. Treatment information was not provided. The outcome of the events was reported as resolved. The patient's medical history of Fibromyalgia remains as a confounder for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.  This case was linked to MOD-2022-653602, MOD-2022-653657 (Patient Link).  Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a female patient of an unknown age, with relevant medical history of Fibromyalgia, who experienced the unexpected serious (medically significant) event of Delirium, the unexpected events of Immunisation reaction, Illness, Influenza like illness, Hypokinesia, Pain, and Bedridden, and the expected events of Chills, Headache, Myalgia and Fatigue. The events occurred on an unknown date after receiving the second dose of mRNA-1273 Vaccine. Treatment information was not provided. The outcome of the events was reported as resolved. The patient's medical history of Fibromyalgia remains as a confounder for the occurrence of the events. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.