Age: 66.0
Sex: F
Vaccine: COVID19, FLUX, COVID19
Symptoms: Headache, Injected limb mobility decreased, Injection site pain, Joint range of motion decreased, Lethargy
Clinical narrative: sleep pattern incr to 12+ hours subsided after 1 week; initial site pain became severe, c/n lift arm/no relief of mobility issues makes dressing difficult, lifting or weight bearing w/arm; site pain became severe; malaise; dizziness; headache; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (malaise), HEADACHE (headache), DIZZINESS (dizziness), SLEEP DISORDER (sleep pattern incr to 12+ hours subsided after 1 week) and VACCINATION SITE MOVEMENT IMPAIRMENT (initial site pain became severe, c/n lift arm/no relief of mobility issues makes dressing difficult, lifting or weight bearing w/arm) in a 66-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 203G234) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (INFLUENZA) for an unknown indication.    Previously administered products included for Product used for unknown indication: INFLUENZA and Pfizer. Past adverse reactions to the above products included Vaccination adverse reaction with INFLUENZA and Pfizer. Concurrent medical conditions included Anxiety and Blood pressure high (mild increased BP). Concomitant products included BUPROPION and ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, AMLODIPINE for Blood pressure high.   On 31-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form and dose of INFLUENZA VACCINE (INFLUENZA) (unknown route) 1 dosage form. On 31-Oct-2023, the patient experienced MALAISE (malaise), HEADACHE (headache) and DIZZINESS (dizziness). On an unknown date, the patient experienced SLEEP DISORDER (sleep pattern incr to 12+ hours subsided after 1 week), VACCINATION SITE MOVEMENT IMPAIRMENT (initial site pain became severe, c/n lift arm/no relief of mobility issues makes dressing difficult, lifting or weight bearing w/arm) and VACCINATION SITE PAIN (site pain became severe). The patient was treated with IBUPROFEN (ANADVIL) for Vaccination site pain, at a dose of 500 milligram every four hours; IBUPROFEN (ANADVIL) for Vaccination site pain, at a dose of 500 milligram as required; PARACETAMOL (ACETAMINOPHEN) for Vaccination site pain, at a dose of 500 milligram every four hours and PARACETAMOL (ACETAMINOPHEN) for Vaccination site pain, at a dose of 500 milligram as required. At the time of the report, MALAISE (malaise), HEADACHE (headache), DIZZINESS (dizziness), VACCINATION SITE MOVEMENT IMPAIRMENT (initial site pain became severe, c/n lift arm/no relief of mobility issues makes dressing difficult, lifting or weight bearing w/arm) and VACCINATION SITE PAIN (site pain became severe) had not resolved and SLEEP DISORDER (sleep pattern incr to 12+ hours subsided after 1 week) had resolved.            Patient experienced site pain which became severe, could not lift arm, pain had continued over 1 month post injection and had begun to migrate down arm to elbow. No relief of mobility issues made dressing difficult, lifting or weight bearing with arm.  Patient also received high does flu shot at same time in same arm (left) and had a similar reaction/adverse event a few years ago with Pfizer and flu combo.  Treatment medications included Advil/Acetaminophen 2 or 3 500 mg every 4 hours initially, continued as need for 1 month post injection at least 1 or 2 daily especially overnight when arm pain awakens her.