Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Skin discolouration, Therapy non-responder, X-ray
Clinical narrative: HURTS TO WALK AND CAN NOT WALK LONG DISTANCE; PROBLEM IN HIS HIP; CAN NOT PRACTICE EXERCISE; CHANGED QUALITY OF LIFE; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; INFLAMMATION; LEFT FOOT DARKER IN COLOR; LEFT FOOT AND HAND PAIN; STRANGE SWOLLEN WITH NO REASON IN LEFT HAND WITH THE FINGERS AND VISIBLY LEFT FOOT BY THE END OF THE MIDDLE AREA OF TOES; This spontaneous report received from a patient concerned a 49 year old male. The patient's height, and weight were not reported. The patient's past medical history included under weight, and concurrent conditions included hypertension, non-alcohol user, and non smoker, and other pre-existing medical conditions included patient had no known allergies and patient eats very health, no arthritis, no rheumatoid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: unknown) dose was not reported, 1 total, administered on 22-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 14-APR-2021, patient had a strange swollen with no reason in his left hand with the fingers. On 28-APR-2021, the same side foot started to be swollen. His left foot (by the end of the middle area of toes) was swollen with the same pattern that happen to the hand as well. It was visibly swollen, and darker in color. The color subsided but the pain is still there. He was using cold ice and Epson salt bath. By the end of Apr-2021 it caused an alarm for him so he contacted primary care physician who ordered blood work which did not find anything. Then primary care physician referred him to see orthopedic. So between May and June, he saw two orthopedics in May-2021, the first orthopedic gave him prednisone tablets. Patient complained a week later and insisted on getting steroid injection. So the first orthopedic gave him 3 shots in both hand and foot because he was complaining of a lot of pain. The second orthopedic gave him one shot only in the foot. The first orthopedic ordered X-Ray in MAY-2021 for both hand and foot which came well, no broken bones. Also he ordered Magnetic resonance imaging(MRI) in Jun-2021 which showed inflammation so patient got cortisone 2 shots in hand and about 3 or 4 in the foot to reduce the swelling. There was a little improvement but a week later, the pain comes back so the Epson water and cortisone injection did not help. It was hurting to walk. He cannot wear close shoes. The doctor said that it was too constrictive and ordered him to wear an orthopedic open shoes which was higher in the left side than the normal shoes and asked him to stay out of his foot and it was very complicated for patient. So the doctor order a knee scoter for him but it was not comfortable so patient bought a wheelchair. He started to use crutches because he had problem in his hip as a consequence of the unbalanced it was after wearing the high orthopedic shoes in the left side. Patient cannot walk long distance and cannot practice exercise. All of that changed his quality of life. On Jun-2021, his primary care physician ordered spike protein antibody test which came negative(confirmed immunological vaccine failure). A month ago, around Jul-2021, the doctor ordered to test for Covid-19 which came negative. Also the doctor ordered again same spike protein antibody test which came again negative.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from left foot darker in color, was recovering from strange swollen with no reason in left hand with the fingers and visibly left foot by the end of the middle area of toes, had not recovered from left foot and hand pain, and the outcome of inflammation, hurts to walk and can not walk long distance, problem in his hip, can not practice exercise, confirmed immunological vaccine failure and changed quality of life was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210851513-covid-19 vaccine ad26.cov2.s- Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive 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 20210851513- Covid-19 vaccine ad26.cov2.s- Strange swollen with no reason in left hand with the fingers and visibly left foot by the end of the middle area of toes, left foot darker in color, inflammation, hurts to walk and cannot walk long distance, problem in his hip, cannot practice exercise, changed quality of life. This event(s) is considered unassessable. 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). 20210851513- Covid-19 vaccine ad26.cov2.s- Left foot and hand pain. This event(s) is labeled and is therefore considered potentially related.