Age: 77.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Abnormal weight gain, Blood cholesterol, Blood cholesterol increased, Body temperature, Dementia Alzheimer's type
Clinical narrative: Pneumonia; Alzheimer was getting worsen; Fingers were getting more disfigured; Sleep apnea; Appetite had increased; Pain came back; high cholesterol; she had a cold as of 22 Dec 2022/100.3 Fever/She was coughing; Did not remember eating so had been gaining 20 lbs weight; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) and DEMENTIA ALZHEIMER'S TYPE (Alzheimer was getting worsen) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect products included non-company products UPADACITINIB (RINVOQ) for Rheumatoid arthritis and INFLUENZA VACCINE for an unknown indication.    Concurrent medical conditions included Rheumatoid arthritis.   On 29-Oct-2021, the patient started UPADACITINIB (RINVOQ) (Oral) 15 milligram once a day. On 29-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 28-Sep-2022, the patient experienced ABNORMAL WEIGHT GAIN (Did not remember eating so had been gaining 20 lbs weight). On 05-Oct-2022, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant). On 22-Dec-2022, the patient experienced NASOPHARYNGITIS (she had a cold as of 22 Dec 2022/100.3 Fever/She was coughing). On an unknown date, the patient experienced DEMENTIA ALZHEIMER'S TYPE (Alzheimer was getting worsen) (seriousness criterion medically significant), FINGER DEFORMITY (Fingers were getting more disfigured), SLEEP APNOEA SYNDROME (Sleep apnea), INCREASED APPETITE (Appetite had increased), PAIN (Pain came back) and BLOOD CHOLESTEROL INCREASED (high cholesterol). The patient was treated with DONEPEZIL HCL at a dose of 5 milligram and MEMANTINE HYDROCHLORIDE (MEMANTIN) at an unspecified dose and frequency. On 07-Oct-2022, PNEUMONIA (Pneumonia) had resolved. At the time of the report, DEMENTIA ALZHEIMER'S TYPE (Alzheimer was getting worsen), FINGER DEFORMITY (Fingers were getting more disfigured), SLEEP APNOEA SYNDROME (Sleep apnea), INCREASED APPETITE (Appetite had increased) and ABNORMAL WEIGHT GAIN (Did not remember eating so had been gaining 20 lbs weight) had not resolved and NASOPHARYNGITIS (she had a cold as of 22 Dec 2022/100.3 Fever/She was coughing), PAIN (Pain came back) and BLOOD CHOLESTEROL INCREASED (high cholesterol) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2023, Blood cholesterol: High. On an unknown date, Body temperature: 100.3. On an unknown date, Oxygen saturation: Low. On an unknown date, Weight: Gain.         Concomitant medications were not reported.  It was reported that physician had stopped therapy one week before and started up two weeks after third covid-19 booster. Patient had pain came back on the same week that she had to stop the RINVOQ getting ready for third booster. Patient had oxygen levels were low again. Patient had cold as of 22 Dec 2022. The physician had prescribed antibiotics. Patient did not eat that much, exercises for 3x work on the ultra G on the zero gravity treadmill at the rehabilitation center.  The other agency considered the causality with the cos-suspect (RINVOQ) and the events Finger deformity, Increased appetite, Alzheimer's disease, Sleep apnea, weight gain, Emotional Distress and pain as No Reasonable Possibility, with the event pneumonia and cold as Not assessable.   This case was linked to MOD-2023-723068 (Patient Link).  Company Comment: This is a spontaneous case concerning a 77-year-old female patient with a history of Rheumatoid arthritis (under treatment with upadacitinib), and having been vaccinated with influenza vaccine on the same day of COVID-19 vaccination, who experienced the serious (due to medically significant and hospitalization) event of pneumonia, and the serious (due to medically significant) event of dementia Alzheimer's type. Event Pneumonia occurred approximately 6 days after a dose of Moderna COVID-19 vaccine, Bivalent (original and omicron BA.4/BA.5), received as the fifth dose of COVID-19 vaccination schedule. Event dementia Alzheimer's type occurred on an unknown date. Patient also experienced other non-serious events. It was reported that Emergency room physician thought that it may had triggered the pneumonia. Physician had stopped therapy one week before and started up two weeks after third covid-19 booster. She had pain came back on the same week that she had to stop the upadacitinib getting ready for third booster. Her oxygen levels were low again and 6 days after fifth dose, she got another pneumonia which resolved on 2 days later. Three months after fifth dose, her husband started getting sick, and she had a cold. She was coughing and had fever. The physician prescribed antibiotics. She did not eat that much. She had mood swings. She got upset but because of her short-term memory and forgets soon. Causality of event pneumonia was assessed as not related due to lack of biological plausibility plus other medical conditions. 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. The mentioned medical history remains as a confounder. Upadacitinib and Influenza vaccine were considered as co-suspect drugs. The benefit-risk relationship of Moderna COVID-19 vaccine, Bivalent (original and omicron BA.4/BA.5) is not affected by this report.; Sender's Comments: Company Comment: This is a spontaneous case concerning a 77-year-old female patient with a history of Rheumatoid arthritis (under treatment with upadacitinib), and having been vaccinated with influenza vaccine on the same day of COVID-19 vaccination, who experienced the serious (due to medically significant and hospitalization) event of pneumonia, and the serious (due to medically significant) event of dementia Alzheimer's type. Event Pneumonia occurred approximately 6 days after a dose of Moderna COVID-19 vaccine, Bivalent (original and omicron BA.4/BA.5), received as the fifth dose of COVID-19 vaccination schedule. Event dementia Alzheimer's type occurred on an unknown date. Patient also experienced other non-serious events. It was reported that Emergency room physician thought that it may had triggered the pneumonia. Physician had stopped therapy one week before and started up two weeks after third covid-19 booster. She had pain came back on the same week that she had to stop the upadacitinib getting ready for third booster. Her oxygen levels were low again and 6 days after fifth dose, she got another pneumonia which resolved on 2 days later. Three months after fifth dose, her husband started getting sick, and she had a cold. She was coughing and had fever. The physician prescribed antibiotics. She did not eat that much. She had mood swings. She got upset but because of her short-term memory and forgets soon. Causality of event pneumonia was assessed as not related due to lack of biological plausibility plus other medical conditions. 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. The mentioned medical history remains as a confounder. Upadacitinib and Influenza vaccine were considered as co-suspect drugs. The benefit-risk relationship of Moderna COVID-19 vaccine, Bivalent (original and omicron BA.4/BA.5) is not affected by this report.