Age: 88.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Pruritus, Tremor, Vaccination site pain, Vaccination site swelling
Clinical narrative: can't walk like I used to, I fear that I may fall; neuropathy; out of breath; I itch and the scratching is horrible; shaking; coughing; confused; hear out of one ear; I see out of one eye; I've been sick ever since, and has been progressing; I'm not sleeping properly, I have pain all over; my memory is not the same; I'm loosing my hair, I had thick hair; My veins and my body is not the same, I look creepy; I've been feeling rough after the shot and it's progressing; My bones, my flesh it hurts to touch; I have pain all over; fatigue; muscle pain; I didn't realize at the time that when the shot was given to me but the arm hurts all the time; the area where I got the shot (right arm) was swollen; This spontaneous case was reported by a patient and describes the occurrence of GAIT DISTURBANCE (can't walk like I used to, I fear that I may fall) and NEUROPATHY PERIPHERAL (neuropathy) in an 88-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient had no prior diagnosis of covid.  Concurrent medical conditions included Blood pressure fluctuation, Allergy and Thyroid disorder. Concomitant products included MONTELUKAST for Allergy, NIFEDIPINE for Blood pressure, LEVOTHYROXINE SODIUM (LEVOXYL) for Thyroid disorder, ESTRADIOL BENZOATE (ESTRADIOL [ESTRADIOL BENZOATE]) for an unknown indication.    On 14-Dec-2022, the patient received fourth 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 GAIT DISTURBANCE (can't walk like I used to, I fear that I may fall) (seriousness criterion medically significant), NEUROPATHY PERIPHERAL (neuropathy) (seriousness criterion medically significant), DYSPNOEA (out of breath), PRURITUS (I itch and the scratching is horrible), TREMOR (shaking), COUGH (coughing), CONFUSIONAL STATE (confused), HYPOACUSIS (hear out of one ear), VISUAL IMPAIRMENT (I see out of one eye), ILLNESS (I've been sick ever since, and has been progressing), INSOMNIA (I'm not sleeping properly, I have pain all over), MEMORY IMPAIRMENT (my memory is not the same), ALOPECIA (I'm loosing my hair, I had thick hair), VEIN DISORDER (My veins and my body is not the same, I look creepy), FEELING ABNORMAL (I've been feeling rough after the shot and it's progressing), BONE PAIN (My bones, my flesh it hurts to touch), PAIN (I have pain all over), FATIGUE (fatigue), MYALGIA (muscle pain), VACCINATION SITE PAIN (I didn't realize at the time that when the shot was given to me but the arm hurts all the time) and VACCINATION SITE SWELLING (the area where I got the shot (right arm) was swollen). At the time of the report, GAIT DISTURBANCE (can't walk like I used to, I fear that I may fall), NEUROPATHY PERIPHERAL (neuropathy), DYSPNOEA (out of breath), PRURITUS (I itch and the scratching is horrible), TREMOR (shaking), COUGH (coughing), CONFUSIONAL STATE (confused), HYPOACUSIS (hear out of one ear), FATIGUE (fatigue), MYALGIA (muscle pain) and VACCINATION SITE PAIN (I didn't realize at the time that when the shot was given to me but the arm hurts all the time) had not resolved and VISUAL IMPAIRMENT (I see out of one eye), ILLNESS (I've been sick ever since, and has been progressing), INSOMNIA (I'm not sleeping properly, I have pain all over), MEMORY IMPAIRMENT (my memory is not the same), ALOPECIA (I'm loosing my hair, I had thick hair), VEIN DISORDER (My veins and my body is not the same, I look creepy), FEELING ABNORMAL (I've been feeling rough after the shot and it's progressing), BONE PAIN (My bones, my flesh it hurts to touch), PAIN (I have pain all over) and VACCINATION SITE SWELLING (the area where I got the shot (right arm) was swollen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Results of Blood work work were fine..     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 previous COVID-19 vaccination: 1st dose on 09-Mar-2021 (Lot 207B21A) and 2nd dose on  06-Apr-2021 (Lot 23H22A) and 3rd doe on 17-Jan-2022 (Lot 007W21-2A).  On 9-Feb-2023, patient had an appointment and expressed how she was feeling but hasn't seen him since as he was moving at the time, but was back on 09-May-2023.  No treatment medications were reported. Company comment This spontaneous case concerns an 88-year-old female patient with medical history of thyroid disorder, who experienced the serious, medically significant, unexpected events of neuropathy peripheral and gait disturbance. The events onset date was not provided, thus, exact latency between vaccination and onset of the event could not be assessed. The patient received the fourth dose of mRNA-1273.222 (BA.4/BA.5). It was reported that the patient could take care of herself before and did her house work, but now she could not help herself. She had muscle pain, fatigue, couldn't walk like she used to, she fear that she may fall, she was itching and the scratching was horrible. She was shaking, had neuropathy, was not sleeping properly, had pain all over. She got out of breath fast and started coughing. She was confused, her memory was not the same, she was losing hair, had bone pain, was seeing out of one eye and hearing out of one year. No further clinical information was provided for medical review. The medical history of thyroid disorder could be a confounder for the non-serious events of alopecia, tremor, visual impairment, confusional state and neuropathy peripheral. The patient's advanced age could be a contributor factor for alopecia, tremor, visual impairment, confusional state, memory impairment, gait disturbance. The benefit-risk relationship of mRNA-1273.222 (BA.4/BA.5) is not affected by this report.