Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: International normalised ratio, Retinal haemorrhage, Retinal vein thrombosis, Retinogram
Clinical narrative: RETINAL HEMORRHAGE; RETINAL VEIN WAS OCCLUDED, LEFT EYE HAD A CLOT; This spontaneous report received from a patient concerned a 75 year old male. The patient's weight was 145 pounds, and height was not reported. The patient's past medical history included: heart valve infection which ended with a surgery, and concurrent conditions included: penicillin allergy (severe reaction), non-alcohol user, non-smoker, type 2 diabetes (Type 2 diabetes controlled), pacemaker, and heart condition. The patient had no drug abuse or illicit drug usage. The patient was HCP (health care professional). The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 205A21A and expiry: unknown) dose was not reported, 1 total, administered on left deltoid on 24-MAY-2021 for prophylactic vaccination. It was unspecified whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (Dose number in series 1). The patient received additional booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822811 and expiry: unknown) dose was not reported, 1 total, administered on left deltoid on 15-NOV-2021 for prophylactic vaccination. Concomitant medications included metoprolol for heart condition, metformin for type 2 diabetes, and warfarin sodium. On 05-MAR-2022, 3.5 months after receiving the booster dose (Dose number in series 2), the patient lost vision of the left eye (Dose number in series 2), it was diagnosed by an ophthalmologist and the retinal vein was occluded (Dose number in series 2), left eye had a clot (Dose number in series 2) and also hemorrhage in the retina (Dose number in series 2) as a result of the clot. The patient suddenly lost vision when he never had a problem with his vision before. An ophthalmologist diagnosed the case, then referred him to a retinal specialist. On 05-MAR-2022, laboratory data included: Retinal photography which revealed blood clot of left retinal vein. The patient was started on medication Eylea (aflibercept) which was injected into his eye monthly. The patient received first dose on 05-MAR-2022. On the same day, before the first injection, the first episode of vision loss occurred. It came back in about an hour on its own. Then while being diagnosed, the patient lost his vision again for half an hour, so the ophthalmologist decided to refer him to the retinal specialists. 2 weeks after the diagnosis, patient had a follow up with a physician who saw nothing, there was no sign of arterial stroke. The patient received second dose of Eylea on 02-APR-2022 and 4 days after the second shot, he lost his vision again for about an hour. The patient got his vision back later and never lost his vision since then, but he felt nervous it might happen again given that it happened three and half months after booster dose. The patient received third dose of Eylea on 05-MAY-2022. The fourth dose was scheduled on 18-JUN-2022. On an unspecified date Laboratory data (dates unspecified) included: INR (NR: not provided) INR in therapeutic range. The patient felt improvement in his condition with the injections, the retinal vein was totally patent. On the day of reporting, the patient stated that the clot and hemorrhage had entirely gone. The patient wondered if it was associated with the vaccine and if it was linked 3.5 and now 6 months later. The patient was referring mainly to the booster shot when reporting his adverse event and the timing of the adverse event in relation to the booster shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from retinal hemorrhage, and retinal vein was occluded, left eye had a clot. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220513993.; Sender's Comments: V0: 20220515062-covid-19 vaccine ad26.cov2.s -retinal hemorrhage, and retinal vein was occluded, left eye had a clot.. The event(s) 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(s). Therefore, this event(s) is considered unassessable.