Age: 64.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fall, Gait disturbance, Head injury, Loss of consciousness, Malaise
Clinical narrative: Neck pain; Fall; Passed out; Head injury; Wound bleeding; Walking difficulty; Feeling unwell; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out), HEAD INJURY (Head injury), WOUND HAEMORRHAGE (Wound bleeding), GAIT DISTURBANCE (Walking difficulty), FALL (Fall) and NECK PAIN (Neck pain) in a 64-year-old male 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 IBRUTINIB (IMBRUVICA) tablet for Chronic lymphoid leukemia.    Concurrent medical conditions included Chronic lymphoid leukemia.   On 03-Jul-2021, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram once a day. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Dec-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criteria hospitalization and medically significant), HEAD INJURY (Head injury) (seriousness criterion hospitalization), WOUND HAEMORRHAGE (Wound bleeding) (seriousness criterion hospitalization), FALL (Fall) (seriousness criterion hospitalization) and MALAISE (Feeling unwell). In December 2021, the patient experienced GAIT DISTURBANCE (Walking difficulty) (seriousness criterion hospitalization). On an unknown date, the patient experienced NECK PAIN (Neck pain) (seriousness criterion hospitalization). In December 2021, LOSS OF CONSCIOUSNESS (Passed out) had resolved. At the time of the report, HEAD INJURY (Head injury) and WOUND HAEMORRHAGE (Wound bleeding) was resolving, GAIT DISTURBANCE (Walking difficulty) and FALL (Fall) had not resolved, NECK PAIN (Neck pain) had resolved and MALAISE (Feeling unwell) outcome was unknown. Not Provided          The patient was not feeling well after the booster shot and was later found past out on bathroom floor and with a cut on above left eye that required seven stitches. The patient was in the hospital after his fall. Patient was not walking well and was bleeding from a cut over left eye. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medication information was reported. No treatment medication information was reported.  For the event fall, stop date was reported as Dec-2021 though outcome is not recovered.  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.  Company  Comment: This is a Spontaneous case reported by a consumer, concerning a 64-year-old male patient, with relevant medical condition of chronic lymphoid leukemia, who experienced the unexpected and serious (due to hospitalization and medically significant) event of Loss of consciousness, and the unexpected and serious (due to hospitalization) events of Gait disturbance, Wound haemorrhage, Fall and Neck pain, which occurred the same day after the third dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Ibrutinib for chronic lymphoid leukemia. Patient started not feeling well after vaccine, and he was later found past out on his bathroom floor, and with a cut on above his left eye that bled and required 7 stitches. He needed hospitalization. He was not walking well and he experienced neck pain. No information disclosed about diagnostic tests performed or treatments received. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jan-2022: Significant follow up appended  : Event updated; Sender's Comments: This is a Spontaneous case reported by a consumer, concerning a 64-year-old male patient, with relevant medical condition of chronic lymphoid leukemia, who experienced the unexpected and serious (due to hospitalization and medically significant) event of Loss of consciousness, and the unexpected and serious (due to hospitalization) events of Gait disturbance, Wound haemorrhage, Fall and Neck pain, which occurred the same day after the third dose of mRNA-1273 vaccine. Co-suspect product includes non-company product Ibrutinib for chronic lymphoid leukemia. Patient started not feeling well after vaccine, and he was later found past out on his bathroom floor, and with a cut on above his left eye that bled and required 7 stitches. He needed hospitalization. He was not walking well and he experienced neck pain. No information disclosed about diagnostic tests performed or treatments received. The benefit-risk relationship of mRNA-1273 vaccine, is not affected by this report.