Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Balance disorder, Blood test, Fatigue, Gait disturbance
Clinical narrative: wobbly/Wobbly after 2nd dose; he felt fatigue/Fatigue after 2nd dose; Back pain after 2nd dose/Back pain; Can no longer bend over to put on socks after 2nd dose/Can no longer bend over to put on socks; Gait problem  after 2nd dose; Balance problem  after 2nd dose/Body was out of balance  after 2nd dose; Waking up at night after 2nd dose/Waking up at night; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Gait problem after 2nd dose), BALANCE DISORDER (Balance problem after 2nd dose/Body was out of balance after 2nd dose), SLEEP DISORDER (Waking up at night after 2nd dose/Waking up at night), TREMOR (wobbly/Wobbly after 2nd dose), BACK PAIN (Back pain after 2nd dose/Back pain), MOBILITY DECREASED (Can no longer bend over to put on socks after 2nd dose/Can no longer bend over to put on socks) and FATIGUE (he felt fatigue/Fatigue after 2nd dose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced TREMOR (wobbly/Wobbly after 2nd dose) (seriousness criterion hospitalization) and FATIGUE (he felt fatigue/Fatigue after 2nd dose) (seriousness criterion hospitalization). In February 2021, the patient experienced GAIT DISTURBANCE (Gait problem  after 2nd dose) (seriousness criterion hospitalization), BALANCE DISORDER (Balance problem  after 2nd dose/Body was out of balance  after 2nd dose) (seriousness criterion hospitalization), SLEEP DISORDER (Waking up at night after 2nd dose/Waking up at night) (seriousness criterion hospitalization), BACK PAIN (Back pain after 2nd dose/Back pain) (seriousness criterion hospitalization) and MOBILITY DECREASED (Can no longer bend over to put on socks after 2nd dose/Can no longer bend over to put on socks) (seriousness criterion hospitalization). The patient was hospitalized on sometime in February 2021 due to BALANCE DISORDER and GAIT DISTURBANCE. At the time of the report, GAIT DISTURBANCE (Gait problem  after 2nd dose), BALANCE DISORDER (Balance problem  after 2nd dose/Body was out of balance  after 2nd dose), SLEEP DISORDER (Waking up at night after 2nd dose/Waking up at night), TREMOR (wobbly/Wobbly after 2nd dose), BACK PAIN (Back pain after 2nd dose/Back pain), MOBILITY DECREASED (Can no longer bend over to put on socks after 2nd dose/Can no longer bend over to put on socks) and FATIGUE (he felt fatigue/Fatigue after 2nd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood test: normal (normal) normal. In February 2021, Scan brain: normal (normal) normal. In February 2021, Whole body scan: normal (normal) normal.         It was reported patient was on Antidepressant after vaccination but name was not reported. No relevant concomitant medication was reported. Treatment information was not reported.  the events were considered serious, with seriousness criteria "Hospitalization", as there is no mention on which of the symptoms motivated the hospitalization and there is no definitive diagnosis to explain the symptoms.  Company Comment: This case concerns a 74-year-old, male patient with a history of diabetes, who experienced the unexpected serious events of tremor, fatigue, gait disturbance, balance disorder, sleep disorder, back pain  and mobility decreased. The events tremor and fatigue occurred approximately two days after the second dose of Spikevax, gait disturbance, balance disorder, sleep disorder, back pain  and mobility decreased occurred after the second dose of Spikevax, at an unspecified date. The rechallenge was not applicable as the events happened after the second dose and no additional dosing will be given. The medical history of diabetes remains a confounder for gait disturbance and balance disorder. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 74-year-old, male patient with a history of diabetes, who experienced the unexpected serious events of tremor, fatigue, gait disturbance, balance disorder, sleep disorder, back pain  and mobility decreased. The events tremor and fatigue occurred approximately two days after the second dose of Spikevax, gait disturbance, balance disorder, sleep disorder, back pain  and mobility decreased occurred after the second dose of Spikevax, at an unspecified date. The rechallenge was not applicable as the events happened after the second dose and no additional dosing will be given. The medical history of diabetes remains a confounder for gait disturbance and balance disorder. The benefit-risk relationship of Spikevax is not affected by this report.