Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dementia Alzheimer's type, Influenza like illness, Vomiting
Clinical narrative: Alzheimer's disease; Flu like symptoms; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA ALZHEIMER'S TYPE (ALZHEIMER'S DISEASE) in a 64-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 ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.  No Medical History information was reported.  On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 14-Jan-2022, the patient experienced INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS) and VOMITING (THROWING UP FROM COVID BOOSTER/VOMITING). On an unknown date, the patient experienced DEMENTIA ALZHEIMER'S TYPE (ALZHEIMER'S DISEASE) (seriousness criterion medically significant). At the time of the report, DEMENTIA ALZHEIMER'S TYPE (ALZHEIMER'S DISEASE) outcome was unknown and INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS) and VOMITING (THROWING UP FROM COVID BOOSTER/VOMITING) had not resolved.     This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  It was unknown if patient was enrolled in a COVID-19 Vaccine trial.  No concomitant product use was reported.  The patient received all doses of moderna vaccine one in once. Humira (Adalimumab) was citrate free.  No treatment information was provided.  The reporter's causality for the event of throwing up from covid booster/vomiting with Humira (Adalimumab) was no reasonable possibility. The reporter's causality with Humira (Adalimumab) for the events of flu like symptoms and alzheimer's disease was not provided.  Company comment. This spontaneous case concerns a 64  year - old female patient, in treatment with co  suspect product Adalimumab for Rheumatoid arthritis, who received three doses of mRNA-1273 vaccine and experienced the serious medically significant unexpected event of Dementia Alzheimer's type. Onset date was not reported; hence latency and temporal association cannot be properly assessed. No further clinical information was available for medical reviewing. Patient´s age is a confounding factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.  Sender's Comments: This spontaneous case concerns a 64  year - old female patient, in treatment with co  suspect product Adalimumab for Rheumatoid arthritis, who received three doses of mRNA-1273 vaccine and experienced the serious medically significant unexpected event of Dementia Alzheimer's type. Onset date was not reported; hence latency and temporal association cannot be properly assessed. No further clinical information was available for medical reviewing. Patient´s age is a confounding factor. The benefit-risk relationship of mRNA-1273 is not affected by this report.