Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal weight gain, Blood cholesterol, Blood cholesterol increased, Dementia Alzheimer's type, Finger deformity
Clinical narrative: double pneumonia; alzheimer was getting worsen/did not remember eating so had been gaining 20 lbs weight; fingers were getting more disfigured; appetite had increased; Sleep apnea; high cholesterol; She was gained 20 lbs; Cold; This spontaneous case was reported by a patient and describes the occurrence of DEMENTIA ALZHEIMER'S TYPE (alzheimer was getting worsen/did not remember eating so had been gaining 20 lbs weight) and PNEUMONIA (double pneumonia) in a 77-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.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to Severe).   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient started UPADACITINIB (RINVOQ) (Oral) 15 milligram every other day. On 13-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Dec-2021, the patient experienced NASOPHARYNGITIS (Cold). On 03-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PNEUMONIA (double pneumonia) (seriousness criteria hospitalization and medically significant). On 28-Sep-2022, the patient experienced ABNORMAL WEIGHT GAIN (She was gained 20 lbs). On 11-Jan-2023, the patient experienced BLOOD CHOLESTEROL INCREASED (high cholesterol). On an unknown date, the patient experienced DEMENTIA ALZHEIMER'S TYPE (alzheimer was getting worsen/did not remember eating so had been gaining 20 lbs weight) (seriousness criterion medically significant), FINGER DEFORMITY (fingers were getting more disfigured), INCREASED APPETITE (appetite had increased) and SLEEP APNOEA SYNDROME (Sleep apnea). The patient was hospitalized from 03-Aug-2022 to 11-Aug-2022 due to PNEUMONIA. The patient was treated with MEMANTINE at a dose of 20 milligram; DONEPEZIL HYDROCHLORIDE for Memory loss, at a dose of 5 milligram and Physical therapy for Pneumonia. On 11-Aug-2022, PNEUMONIA (double pneumonia) had resolved. At the time of the report, DEMENTIA ALZHEIMER'S TYPE (alzheimer was getting worsen/did not remember eating so had been gaining 20 lbs weight), ABNORMAL WEIGHT GAIN (She was gained 20 lbs), FINGER DEFORMITY (fingers were getting more disfigured), INCREASED APPETITE (appetite had increased) and SLEEP APNOEA SYNDROME (Sleep apnea) had not resolved and NASOPHARYNGITIS (Cold) and BLOOD CHOLESTEROL INCREASED (high cholesterol) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Sep-2022, Weight: She was gained 20 lbs. On 11-Jan-2023, Blood cholesterol: High. On an unknown date, Oxygen saturation: low.         Concomitant medication of the patient was not reported.  MPID of Moderna COVID-19 vaccine was reported as 4782590.  The patient had appetite increased but not sure if it was because she was getting back to normal eating or because of her Alzheimer to where she forgot that she ate little bit ago and asking for more food in short time later and had been gaining weight. Nurse practitioner at neurology clinic gave her the memory test and it was two points less than last time. The patient was still getting physical therapy. Her Alzheimer was getting worsen. Emergency room physician thought that it may had triggered the pneumonia. Physician had stopped therapy one week before and start up two weeks after third COVID-19 booster.  The reporter's causality for the event(s) of double pneumonia and high cholesterol with Moderna COVID-19 vaccine (Elasomeran) was not provided. The reporter's causality for the event(s) of alzheimer was getting worsen/did not remember eating so had been gaining 20 lbs weight, appetite had increased, cold, fingers were getting more disfigured and sleep apnea with Moderna COVID-19 vaccine (Elasomeran) was reasonable possibility. Company's opinion was that the causality for the event(s) of cold, double pneumonia and high cholesterol with Upadacitinib was not assessable. Cpmapany's opinion was that the causality for the event(s) of alzheimer was getting worsen/did not remember eating so had been gaining 20 lbs weight, appetite had increased, fingers were getting more disfigured and sleep apnea with Upadacitinib was no reasonable possibility.  Company's Alternative Etiology for of alzheimer was getting worsen/did not remember eating so had been gaining 20 lbs weight with Upadacitinib: Most likely related to consequence of increased appetite and most likely related to increased risk from age.   Company's Alternative Etiology for Pain came back with Upadacitinib: Most likely related to underlying Rheumatoid arthritis confounded by interruption of Rinvoq therapy.   Company's Alternative Etiology for sleep apnea with Upadacitinib: Most likely possibly related to concurrent weight gain in an elderly patient. Company's Alternative Etiology for appetite had increased with Upadacitinib: Most likely related to Alzheimer's disease and patient forgetting about meal taken before.   Company's Alternative Etiology for upset but because of short term memory with Upadacitinib: More likely related to psychiatric burden associated with concurrent Alzheimer's disease, age and underlying rheumatoid arthritis.  This case was linked to MOD-2023-723113 (Patient Link).  Company Comment: This is a spontaneous case concerning a 77  year  old female patient, under treatment with Upadacitinib for Rheumatoid arthritis, who experienced the unexpected serious (due to medically significant and hospitalization) event of pneumonia, and the serious (due to medically significant) event of dementia Alzheimer's type. The patient experienced pneumonia, described as bilateral pneumonia, approximately three month from the second booster dose of mRNA  1273 original COVID  19 vaccine, received as the fourth dose of her COVID-19 vaccination schedule. She was hospitalized for 9 days, and the outcome was recovered. The event dementia Alzheimer's type occurred on an unknown date, it was described as "Alzheimer was getting worsen", and the outcome was not recovered. It was mentioned that at the neurology clinic "the memory test was two points less than last time" (no dates reported). She was taking Memantine 20 milligram, and the nurse prescribed Donepezil Hydrochloride 5 milligram. Causality of event pneumonia was assessed as not related due to lack of biological plausibility, temporal relationship, and other possible medical explanation. Causality of event dementia was assessed as not related due to alternative explanation. Causality of non-serious event finger deformity was assessed as not related due to alternative explanation (medical history of Rheumatoid arthritis). Causality of non-serious event nasopharyngitis was assessed as not related due to alternative explanation and temporal relationship. Causality of blood cholesterol increased was assessed as not related other possible medical explanation and temporal relationship. Patient´s age and mentioned medical history remains as a confounder for the events. Upadacitinib was considered as co-suspect drug. The benefit-risk relationship of mRNA  1273 original vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 77  year  old female patient, under treatment with Upadacitinib for Rheumatoid arthritis, who experienced the unexpected serious (due to medically significant and hospitalization) event of pneumonia, and the serious (due to medically significant) event of dementia Alzheimer's type. The patient experienced pneumonia, described as bilateral pneumonia, approximately three month from the second booster dose of mRNA  1273 original COVID  19 vaccine, received as the fourth dose of her COVID-19 vaccination schedule. She was hospitalized for 9 days, and the outcome was recovered. The event dementia Alzheimer's type occurred on an unknown date, it was described as "Alzheimer was getting worsen", and the outcome was not recovered. It was mentioned that at the neurology clinic "the memory test was two points less than last time" (no dates reported). She was taking Memantine 20 milligram, and the nurse prescribed Donepezil Hydrochloride 5 milligram. Causality of event pneumonia was assessed as not related due to lack of biological plausibility, temporal relationship, and other possible medical explanation. Causality of event dementia was assessed as not related due to alternative explanation. Causality of non-serious event finger deformity was assessed as not related due to alternative explanation (medical history of Rheumatoid arthritis). Causality of non-serious event nasopharyngitis was assessed as not related due to alternative explanation and temporal relationship. Causality of blood cholesterol increased was assessed as not related other possible medical explanation and temporal relationship. Patient´s age and mentioned medical history remains as a confounder for the events. Upadacitinib was considered as co-suspect drug. The benefit-risk relationship of mRNA  1273 original vaccine is not affected by this report.