Sex: M
Vaccine: COVID19
Symptoms: Blindness unilateral, Blood test, Depressed mood, Discomfort, Gait disturbance
Clinical narrative: This spontaneous report received from a patient via other manufacturer concerned an adult male of unspecified race and ethnicity. The patient's weight was 278 pounds, and height was 186 centimeters. The patient's concurrent conditions included: non alcoholic, no tobacco user, penicillin allergy, tetracycline allergy and rheumatoid arthritis. The patient was previously treated with tetracycline. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported, expiry: unknown) dose was not reported, 1 total administered on an unspecified date in 2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included nimesulide, trazodone and and promex. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported, expiry: unknown) dose was not reported, 1 time every 2 weeks, on an unspecified date in 2021 for moderate to severe rheumatoid arthritis. On an unspecified date, the patient experienced unqualified visual loss one eye/lost sight in right eye, iritis with eye disorder/issues with eye, prostatic disorder/prostate issues, red blood count increased/elevated red blood count, difficulty in walking which he reported was not new, white blood cell count increased/elevated white blood count, feeling down, Covid-19 vaccine issue of pain in arm/sore arm, pain/could not sit for more than about hour, began to hurt and discomfort/discomfort when sitting. In 2021, patient had Covid-19 with lingering cough (suspected Covid-19 infection) and had suspected clinical vaccination failure. Laboratory data (dates unspecified) included: Blood test Unknown, Red blood cell count elevated, and White blood cell count elevated. On unspecified date suspected Covid-19 infection resolved. It was unknown if the patient was enrolled in Covid-19 clinical trial. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported for events unqualified visual loss one eye/lost sight in right eye, iritis, suspected clinical vaccination failure, prostatic disorder/prostate issues, red blood cell count increased/elevated red blood count, white blood cell count increased/elevated white blood count, pain/could not sit for more than about hour, began to hurt and discomfort/discomfort when sitting and adalimumab dosage maintained for events difficulty in walking, feeling down, suspected Covid-19 infection, and pain in arm/sore arm. The patient recovered from and suspected Covid-19 infection, was recovering from difficulty in walking, and the outcome of unqualified visual loss one eye/lost sight in right eye, iritis, suspected clinical vaccination failure, prostatic disorder/prostate issues, red blood count increased/elevated red blood count, white blood cell count increased/elevated white blood count, feeling down, pain in arm/sore arm, pain/could not sit for more than about hour, began to hurt and discomfort/discomfort when sitting was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20220615751-COVID-19 VACCINE AD26.COV2.S-UNQUALIFIED VISUAL LOSS ONE EYE/LOST SIGHT IN RIGHT EYE, IRITIS. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20220615751-COVID-19 VACCINE AD26.COV2.S-SUSPECTED CLINICAL VACCINATION FAILURE. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.