Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Aged parent, Extra dose administered, Gait disturbance, Grip strength decreased, Speech disorder
Clinical narrative: stumbling with her words/can't talk; not able to walk, or hold a phone in her hand; not able to walk, or hold a phone in her hand; she seemed to have aged a lot; 8 vaccines total and also that her mother received both primary series and boosters at the same time; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SPEECH DISORDER (stumbling with her words/can't talk), GAIT DISTURBANCE (not able to walk, or hold a phone in her hand) and GRIP STRENGTH DECREASED (not able to walk, or hold a phone in her hand) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 001M21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Dementia. Concurrent medical conditions included Cancer.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced SPEECH DISORDER (stumbling with her words/can't talk) (seriousness criteria disability and medically significant), GAIT DISTURBANCE (not able to walk, or hold a phone in her hand) (seriousness criteria disability and medically significant), GRIP STRENGTH DECREASED (not able to walk, or hold a phone in her hand) (seriousness criterion disability), AGED PARENT (she seemed to have aged a lot) and EXTRA DOSE ADMINISTERED (8 vaccines total and also that her mother received both primary series and boosters at the same time). At the time of the report, SPEECH DISORDER (stumbling with her words/can't talk) had not resolved and GAIT DISTURBANCE (not able to walk, or hold a phone in her hand), GRIP STRENGTH DECREASED (not able to walk, or hold a phone in her hand), AGED PARENT (she seemed to have aged a lot) and EXTRA DOSE ADMINISTERED (8 vaccines total and also that her mother received both primary series and boosters at the same time) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The patient received 1st dose on 27-Jan-2021 with lot number 027L02A, 2nd dose on 25 Feb 2021 with lot number 031m20a, 1st booster dose on 01 Nov 2021 with lot number 014F21A, 2nd booster dose on 15 Apr 2022 with unknown lot number. Around in Nov 2022, she started stumbling with her words. Also stated she seemed to have aged a lot. This progressed very quickly. She was not able to talk, walk or hold a phone in her hand.  Concomitant medication not reported.  Treatment medication not reported.   Company Comment This spontaneous case concerns a 69-years-old-female patient, with  medical history of cancer and dementia who experienced the  unexpected seriousness criterion medically significant and disability events  of  speech disorder, gait disturbance; the  unexpected seriousness criterion medically significant event of grip strength decreases; and the unexpected events of extra dose administrated and aged parent unknown days after a  dose of  mRNA- 1273 bivalent vaccine. The patient received several Covid-19 vaccines before the mentioned one. The medical history is a confounder for the events. The benefit-risk relationship of mRNA-1273 bivalent vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.