Age: 81.0
Sex: F
Vaccine: COVID19-2, VARZOS
Symptoms: Chest discomfort, Dementia, Headache, Herpes zoster, Musculoskeletal discomfort
Clinical narrative: his wife might have dementia; Shingles; she mentioned that everything hurts/Pain; Cold; Chest was heavy; Bad shoulder; didn´t sleep at all; Headache; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEMENTIA (his wife might have dementia) in an 81-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS764SB) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) for an unknown indication.    No Medical History information was reported.   On 02-Aug-2023, the patient received sixth 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 VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) (unknown route) 1 dosage form. On 02-Aug-2023, the patient experienced HERPES ZOSTER (Shingles), PAIN (she mentioned that everything hurts/Pain), NASOPHARYNGITIS (Cold), CHEST DISCOMFORT (Chest was heavy), MUSCULOSKELETAL DISCOMFORT (Bad shoulder), SLEEP DISORDER (didn´t sleep at all) and HEADACHE (Headache). On an unknown date, the patient experienced DEMENTIA (his wife might have dementia) (seriousness criterion medically significant). At the time of the report, DEMENTIA (his wife might have dementia), HERPES ZOSTER (Shingles), PAIN (she mentioned that everything hurts/Pain), NASOPHARYNGITIS (Cold), CHEST DISCOMFORT (Chest was heavy), MUSCULOSKELETAL DISCOMFORT (Bad shoulder), SLEEP DISORDER (didn´t sleep at all) and HEADACHE (Headache) outcome was unknown.            No concomitant medication was reported. It was reported that the patient also had a bad night, with similar side effects with that of the husband. The reporter(patient's husband) mentions that the patient might have demencia (it is not diagnosed yet), and the patient mentioned that everything hurts. The reporter mentions a few times that the reporter believes that this was because of the Shingles vaccine, because it hurt, but the Moderna vaccine they didn´t feel it. It was the shingles shot the one that hurt them. No treatment medication was reported. Company Comment: This is a spontaneous case concerning an 81-year-old female patient with history of receiving varicella zoster vaccine on the same day of receiving Moderna vaccine, who experienced the serious (due to medically significant) unexpected, event of Dementia, which occurred on an unknown date, and was reported in the context of receiving sixth dose of mRNA-1273 Bivalent .222 (original and omicron BA.4/BA.5). Patient also experienced other non-serious events on the same day of receiving both vaccines. Event dementia was assessed as not related due to lack of biological plausibility. Patient´s age could be a confounder for event Dementia. Varicella zoster vaccine was considered as a co-suspect drug. The benefit-risk relationship of mRNA-1273 Bivalent .222 (original and omicron BA.4/BA.5) is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-735488 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735488:Husband's case