Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Therapy non-responder, Urinary incontinence, Vision blurred
Clinical narrative: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; LUMP ON MIDDLE LEFT FINGER (PATHOLOGICALLY CONFIRMED AS GIANT CELL TUMOR); BLURRED VISION; BLADDER SPASMS; PROBLEM WALKING; URINARY INCONTINENCE; SEVERE BACK PAIN; FEELING WORSE; NECK PAIN; BLOOD PRESSURE ELEVATED; TINGLING IN HANDS/FEET; FEVER OF 102; This spontaneous report received from a patient concerned a 52 year old female. Initial information was processed along with the additional information received on 18-Jan-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy, seasonal allergies, abstains from alcohol, non smoker, immune thrombocytopenic purpura, and multiple sclerosis. Patient did not report any history of drug use or illicit drug abuse. The patient was previously treated with rituximab for multiple sclerosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) (dose number in series: 1), administered 1 in total on 25-AUG-2021 for prophylactic vaccination. Concomitant medications included ocrelizumab for multiple sclerosis.  On 25-AUG-2021, the patient experienced blurred vision, bladder spasms, problem walking, urinary incontinence, severe back pain, worse feeling, neck pain, blood pressure elevated, tingling in hands/feet, and fever of 102. Laboratory data included: Blood pressure (NR: not provided) 179/93 mmHg, and Body temperature (NR: not provided) 102 F. On 26-AUG-2021, around 02:00-03:00 AM the patient noticed lump on middle left finger (pathologically confirmed as giant cell tumor). On 28-AUG-2021, Laboratory data included: Blood pressure (NR: not provided) 179/84 mmHg.  On 29-AUG-2021, patient went to the Emergency room for severe back pain. She also went to Urgent care regarding the lump on her finger because she was concerned about clots. The doctor told her that the lump was an inflammatory reaction to the vaccine. The blood work was performed to assess her platelet count as she was having a history of ITP (Immune thrombocytopenic purpura) dating back to 2001-2002 which has been in remission since 2018 when she started therapy for her multiple sclerosis which put her platelet back to normal. On 11-NOV-2021, Laboratory data included: Antibody test (NR: not provided) absence of antibodies.  On 17-DEC-2021, the lump on her finger was surgically removed as Pathology determined that the lump was diagnosed as giant cell tumor.  On an unspecified date, the patient experienced confirmed immunological vaccine failure. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Not reported, and MRI (Magnetic resonance imaging) (NR: not provided) to make sure the vaccine did not cause new lesions. Treatment medications (dates unspecified) included: baclofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever of 102, recovered with sequelae from lump on middle left finger (pathologically confirmed as giant cell tumor) on 17-DEC-2021, and the outcome of blurred vision, bladder spasms, problem walking, urinary incontinence, tingling in hands/feet, confirmed immunological vaccine failure, severe back pain, neck pain, feeling worse and blood pressure elevated was not reported. This report was serious (Other Medically Important Condition).  This report was associated with product quality complaint number: 90000212679.; Sender's Comments: V0: 20220132815-JANSSEN 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. 20220132815-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Giant cell tumor. This event(s) is considered not related. The event(s) shows an incompatible temporal relationship.