Age: 60.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Pain, Unevaluable event, Urinary incontinence
Clinical narrative: LOOSING 9 UNITS OF BLOOD / EXCESSIVE BLEEDING; BLOOD MIXED WITH HIS OWN FECES; UNCONTROLLED BOWEL MOVEMENTS; LOST CONTROL WITH  HIS BLADDER; IRREGULAR APPETITE; SHORTNESS OF BREATH; CONGESTION; BODY ACHES; OCCASIONAL COUGH; OCCASIONAL CHILLS; WEAKNESS; TOTALLY EXHAUSTED / FATIGUE; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient concerned a 66-year-old male of an unspecified race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) 1 in total, dose was not reported, administered on 29-APR-2021 on left arm for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 7 decade old. No concomitant medications were reported. The patient received Non-company suspect vaccine included: influenza vaccine (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on DEC-2022 (3 months ago) for prophylactic vaccination. On an unspecified date in 2021 (reported as 5 weeks after shot) the patient experienced adverse effects loosing 9 units of blood/excessive bleeding, irregular appetite (Dose number in series 1). He had uncontrolled bowel movements, prone in hospital bed for 3 days with his blood mixed with his own feces and lost control with his bladder (Dose number in series 1). The patient was treated with some plasma. He survived it. He said those are residual effects from loosing of 9 units of blood or side effect from vaccine. On an unspecified date, he reported further symptoms of shortness of breath, fatigue, congestion, body aches, no diarrhea, no nausea, occasional chills occasional cough (Dose number in series 1). He never lost sense of taste or smell, no sore throat. He knew his symptoms and enough about his body, residual symptoms had to be connected in some way. His body had not righted itself in 2 years. He was still facing with shortness of breath, fatigue and weakness. The patient reported that he had still ongoing symptoms (Dose number in series 2). The patient additionally received booster dose of Pfizer BioNTech Covid-19 vaccine (Dose number in series 2), (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 17-FEB-2022 for covid-19 prophylaxis which was associated with revaccination covid-19 vaccine (dose number in series 2). On 13-MAR-2023, he experienced an adverse symptom (Dose number in series 2). He walked 2 miles home, and when he got home, all day he was totally exhausted (Dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s, tozinameran, and influenza vaccine was not applicable. The patient had not recovered from loosing 9 units of blood / excessive bleeding, uncontrolled bowel movements, blood mixed with his own feces, lost control with his bladder, totally exhausted / fatigue, shortness of breath, congestion, body aches, occasional chills, occasional cough, weakness, and irregular appetite, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20230336631-loosing 9 units of blood / excessive bleeding, uncontrolled bowel movements, blood mixed with his own feces, lost control with his bladder, irregular appetite,. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.