Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Cataract, Chills, Dehydration, Discomfort
Clinical narrative: BLOOD CLOT; CATARACTS; DISCOMFORT IN LOWER EXTREMITY; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; CHILLS; ACHES AND PAINS; DEHYDRATION; DISCOMFORT; This spontaneous report received from a patient concerned a 6 decade old male. The patient's weight was 180 pounds, and height was 73 inches. The patient's concurrent conditions included: pre-diabetic, enlarged prostate, glaucoma, penicillin allergy, alcohol user (occasional), and smoker (occasional), and other pre-existing medical conditions included: The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported 1 total, for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 6 decade old. Concomitant medications included finasteride for enlarged prostate, bimatoprost (lumigan) for glaucoma, dorzolamide for glaucoma. On an unspecified date, the patient felt some discomfort in lower extremity and he went to the emergency room where a blood clot was discovered (dose number in series 1). It was reported that, the clot occurred subsequent to receipt of the Janssen covid-19 vaccine. The patient related that the blood clot was "possibly" related to the Janssen covid-19 vaccine, but the doctor never could figure out why. On an unspecified date in 2020, the patient had started treatment with rivaroxaban (Xarelto) 20 mg daily, orally, for prevention of a deep vein thrombosis, prevention of pulmonary embolism and blood clots which he experienced at some point between 2020 and 2022. On an unspecified date, he experienced cataracts for which he had recently underwent cataract surgery and on the day of reporting he had visual impairments which he had attributed to his recent cataract surgery (dose number in series 1). The patient additionally received booster dose of non-company suspect vaccine Pfizer Biontech covid-19 vaccine (tozinameran) (dose number in series 2) (form of admin, route of admin, and batch number were not reported, expiry: unknown), dose, start therapy date were not reported for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 2). On 12-JAN-2023, the patient experienced aches and pains, discomfort, chills, and he described that all symptoms started suddenly in the afternoon and thought it might be something like dehydration (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable. The patient had not recovered from chills, discomfort, aches and pains, and dehydration, and the outcome of blood clot, discomfort in lower extremity, cataracts and revaccination with different covid-19 vaccine was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20230131372.; Sender's Comments: V0:20230127730- Blood clot.  The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There are other factors more likely to be associated with the event. Specifically: MEDICAL HISTORY. Therefore, this event is considered inconsistent with vaccine administration.  V0:20230127730- Cataract. The event 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. Specifically: MEDICAL HISTORY. Therefore, this event is considered inconsistent with vaccine administration.