Age: 64.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, UNK
Symptoms: Head injury, Loss of consciousness, Malaise, Neck pain, Wound haemorrhage
Clinical narrative: PASSED OUT; INJURY IN THE HEAD; NECK PAIN; CUT ON THE LEFT EYE; HEADING BLEEDING; NOT FEELING WELL; FELL; PASSED OUT AND HIT HEAD AND HAD BLEEDING FROM CUT OVER LEFT EYE; NOT WALKING WELL; This solicited report received from a consumer via MC-2018-191: Program by a Business partner (AbbVie Inc, US-ABBVIE-21K-163-4207665-00) on 21-DEC-2021 and concerned a 64 year old male. The patient's weight was 93.07 kilograms, and height was 179 centimeters. The patient's past medical history included: hip surgery, foot surgery, femur fracture, fracture repair, fracture repair, and bone operation, and concurrent conditions included: non-smoker, abstains from alcohol, and white blood cell count increased, and other pre-existing medical conditions included: The patient had no known allergies. The patient was treated with ibrutinib (tablet, oral, batch number: 1151796, expiry: FEB-2024) 420 mg, 1 time every 1 day, from 31-JUL-2021 for chronic lymphoid leukemia.  The patient received first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on 24-APR-2021 for covid-19 vaccination. Drug start and last period was 257 days. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  It was unknown if the patient experienced any adverse event after vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received second dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on an unspecified date in 2021 for  an unspecified indication. Drug start and last period was 257 days. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  It was unknown if the patient experienced any adverse event after vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2). The patient received additional non-company suspect vaccine included: mrna 1273 (dose number in series 3) (form of admin unknown, intramuscular, batch number: unknown, expiry: unknown ) dose was not reported, administered on 14-DEC-2021 for covid-19 vaccination. Drug start and end period was 1 days. Concomitant medications included ezetimibe for blood cholesterol abnormal, rosuvastatin for blood pressure high, lisinopril for high cholesterol, and metoprolol for high cholesterol. On an unspecified date in DEC-2021, the patient experienced not walking well (Dose number in series 3). On 14-DEC-2021, after receiving booster shot, the patient was not feeling well and was later found unconscious in his bathroom floor with head injury and a cut on his left eye that required seven stitches. He was bleeding from a cut over his left eye after his fall. (Events with dose number in series 3). On 15-DEC-2021, the patient was hospitalized for nine days for injury in head and passed out. He was experienced neck pain while in hospital (dose number in series 3). He had unknown blood work done and had physical therapy during his hospitalization. The action taken with covid-19 vaccine ad26.cov2.s, and covid-19 vaccine ad26.cov2.s was not applicable; dose of ibrutinib was not changed; and action taken with mrna 1273 was not reported. The patient recovered from passed out on 16-DEC-2021, injury in the head, and cut on the left eye on 29-DEC-2021, passed out and hit head and had bleeding from cut over left eye, fell, and heading bleeding on 15-DEC-2021, not feeling well on 23-DEC-2021, and neck pain, and had not recovered from not walking well. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and passed out, injury in the head, passed out and hit head and had bleeding from cut over left eye, not walking well, not feeling well, fell, neck pain, cut on the left eye, heading bleeding, passed out, injury in the head, passed out and hit head and had bleeding from cut over left eye, not walking well, not feeling well, fell, neck pain, cut on the left eye, and heading bleeding as related, between covid-19 vaccine ad26.cov2.s, and passed out, injury in the head, passed out and hit head and had bleeding from cut over left eye, not walking well, not feeling well, fell, neck pain, cut on the left eye, heading bleeding, passed out, injury in the head, passed out and hit head and had bleeding from cut over left eye, not walking well, not feeling well, fell, neck pain, cut on the left eye, and heading bleeding as related; and between ibrutinib, and passed out, injury in the head, passed out and hit head and had bleeding from cut over left eye, not feeling well, fell, cut on the left eye, and heading bleeding as not related. The reporter did not provide a causality assessment between ibrutinib, and not walking well, and neck pain; and between mrna 1273, and passed out, injury in the head, passed out and hit head and had bleeding from cut over left eye, not walking well, not feeling well, fell, neck pain, cut on the left eye, and heading bleeding. Company causality between ibrutinib, and not walking well, and neck pain was not related. This report was serious (Hospitalization Caused / Prolonged, Life Threatening and Medically Important Condition). This case is a duplicate of 20220208893.  Additional information was received from consumer via MC-2018-191: Program by a Business partner (AbbVie Inc, ABBVIE-21K-163-4207665-00) on 02-FEB-2022. The following information was updated and incorporated into the case narrative: patient height, weight, medical history, event cut on the left eye and heading bleeding added, information regarding vaccine (Jansssen and Moderna) added.  It was determined that [20220208893] was a duplicate of this case. All relevant information regarding this case will be submitted under.