Sex: M
Vaccine: COVID19, RSV
Symptoms: Balance disorder, Blood thyroid stimulating hormone, Computerised tomogram limb, Contusion, Dementia
Clinical narrative: Injury to right shoulder (rotator cuff); He has a dislocated right index finger; Injury to right forehead; Injury to  both knees and general bruises; bruises; Fall; Balance issues; Dementia/Feel quite confused (brain fog); This spontaneous case was reported by a non-healthcare professional and describes the occurrence of DEMENTIA (Dementia/Feel quite confused (brain fog)) and FALL (Fall) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030949) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product RSV vaccine prot. subunit PreF 2v (Abrysvo) for Respiratory syncytial virus immunisation.    The patient's past medical history included Coronary artery bypass graft (Cardiac catheterization due to Coronary artery disease) in 1985. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine on 12-Nov-2021 and Moderna COVID-19 vaccine on 08-Apr-2022; for Product used for unknown indication: Pfizer BioNTech COVID-19 vaccine and bivalent (original and omicron BA.4/5) on 01-Nov-2022. Past adverse reactions to the above products included No adverse effect with Moderna COVID-19 vaccine and Moderna COVID-19 vaccine; and No adverse event with Pfizer BioNTech COVID-19 vaccine and bivalent (original and omicron BA.4/5). Family history included Cataract (Mother had cataract), Dementia (Mother and maternal uncle had dementia), Glaucoma (Mother had glaucoma), Coronary artery disease (Father and brother had Coronary artery disease), Diabetes mellitus (First brother had diabetes mellitus) and Interstitial lung disease (Second brother had interstitial lung disease). Concurrent medical conditions included Benign prostatic hyperplasia (stable on Proscar) since 07-Jul-2010, Hypertension (Well controlled on medication) since 07-Jul-2010, Nephrolithiasis (on Allopurinol for prevention) since 08-Jun-2016, Hyperlipidemia and Coronary artery disease (undergone Cardiac catheterization due to Coronary artery disease) since 1990. Concomitant products included Finasteride (Proscar) from 02-Apr-2013 to an unknown date for BPH, Acetylsalicylic acid (Aspirin) from 20-Jan-2016 to an unknown date for Coronary artery disease, Atorvastatin calcium (Lipitor) from 02-Apr-2013 to an unknown date for Hyperlipidemia, Atenolol from 02-Apr-2013 to an unknown date and Losartan potassium (Losartan) from 02-Apr-2013 to an unknown date for Hypertension, Allopurinol from 02-Apr-2013 to an unknown date for Nephrolithiasis.   On 09-Nov-2023 at 1:22 PM, the patient received dose of RSV vaccine prot. subunit PreF 2v (Abrysvo) (Intramuscular use) .5 milliliter. On 09-Nov-2023 at 1:26 PM, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) .5 milliliter. On 09-Nov-2023, the patient experienced DEMENTIA (Dementia/Feel quite confused (brain fog)) (seriousness criterion medically significant) and BALANCE DISORDER (Balance issues). On 27-Feb-2024, the patient experienced FALL (Fall) (seriousness criterion medically significant). On an unknown date, the patient experienced LIMB INJURY (Injury to right shoulder (rotator cuff)), JOINT DISLOCATION (He has a dislocated right index finger), HEAD INJURY (Injury to right forehead), JOINT INJURY (Injury to  both knees and general bruises) and CONTUSION (bruises). The patient was treated with Physical therapy for Balance disorder. At the time of the report, DEMENTIA (Dementia/Feel quite confused (brain fog)) and BALANCE DISORDER (Balance issues) had not resolved and FALL (Fall), LIMB INJURY (Injury to right shoulder (rotator cuff)), JOINT DISLOCATION (He has a dislocated right index finger), HEAD INJURY (Injury to right forehead), JOINT INJURY (Injury to  both knees and general bruises) and CONTUSION (bruises) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Mar-2024, Vitamin B12 (213-816 picogram per millilitre): 702 picogram per millilitre. On 07-Mar-2024, Blood thyroid stimulating hormone: Result:1.08, unit: Mc 10/ml (Reference range : 0.35 to 4.94). On 09-Mar-2024, Magnetic resonance imaging head: small vessel ischemic changes in white matter with diffuse atrophy changes with ex vacuo ventricular prominence. On 11-Mar-2024, Computerised tomogram limb: CT Knee - report indicated acute vertical nondisplaced fracture of lateral patella.   It was reported that the patient fell several times, and patient was unsteady on his feet. Patient had difficulty with composing thoughts, had much trouble with thought like numbers, making balance check book/having memory issues and patient felt difficult to make business decisions. Patient had trouble with numbers and found it troublesome to find words at times. It was reported that dementia was prolonged for the patient, and patient was unable to drive. Patient received physical therapy as treatment for balance concerns. Patient was evaluated for dementia and patient might need treatment. Patient fell on 27-Feb-2024 and patient was taken to emergency room. Due to fall, the patient had a dislocated right index finger and also had injury to right forehead, right shoulder (rotator cuff), both knees and general bruises and pain that was connected to these injuries. Patient has undergone several x-rays and CT scans. Patient felt pain due to injury.  Company comment: Causality for event fall was assessed as not related due to nature of the event and causality for events limb injury, joint dislocation, head injury, contusion and joint injury was assessed as not related in the context of the fall. Concurrent conditions of hypertension and dyslipidemia remain as contributory risk factors for the event dementia while co-administration of RSV vaccine the same day the product was given remains as a confounder. The benefit-risk relationship of product is not affected by this report.