Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Carpal tunnel syndrome, Pulmonary thrombosis
Clinical narrative: BLOOD CLOT IN RIGHT LUNG; CARPEL TUNNEL; This spontaneous report received from a patient concerned a 6 decade old White female of an unknown ethnic origin. The patient's weight was 176 pounds, and height was 66 inches. The patient's concurrent conditions included: psoriatic arthritis, and other pre-existing medical conditions included: The patient had No known allergies. The patient was not pregnant at the time of vaccination. The patient was left handed. The patient received combination product guselkumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose was not reported, 1 time every 8 weeks, therapy dates were not reported for psoriatic arthritis. Product constituent parts included one press (route of admin, lot, serial number, model number, UDI number, and expiration were not reported). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) 1 in total, dose, start therapy date were not reported administered to right arm for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 6 decade old. No concomitant medications were reported.  On an unspecified date, the patient reported that she had sudden onset of nerve pain in arms and hands. She was outside working with her hands in the garden; and she experienced the worse awful pain in her right hand. She was diagnosed with carpal tunnel. That happened in April. She had surgery in her right hand; but no surgery in her left hand. Both hands/arms were still hurting and she was having to take medicine. She mentioned that that was the only problem she was having. She also mentioned that she had a blood clot a couple of years ago that happened a couple of months after her COVID shot, which she think was in her right arm. The blood clot was in her right lung. Her primary care provider did some blood work and caught it on a friday. The primary care provider recommended that she go to the emergency room, which she did. She was given some medicine, which was working for a while. She did not have to take it anymore. The patient's next dose of Tremfya (guselkumab) was on 04-SEP. The patient also reported that, that was her first regular Tremfya dose from her pharmacy. She also mentioned that she got the starter Tremfya from her doctor. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of guselkumab was not changed. The patient recovered from blood clot in right lung, and had not recovered from carpel tunnel. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230825532-covid-19 vaccine ad26.cov2.s- blood clot in right lung. The event has an unknown/unclear temporal relationship, and is labeled. There are other factors more likely to be associated with the event. Specifically: MEDICAL HISTORY. Therefore, this event is considered inconsistent with vaccine administration. 20230825532-covid-19 vaccine ad26.cov2.s- carpel tunnel. The event 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. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.  20230825532-guselkumab- blood clot in right lung. 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: MEDICAL HISTORY. Therefore, this event(s) is considered not related. 20230825532-guselkumab- carpel tunnel. 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.