Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cataract, Mycobacterium tuberculosis complex test, Paraesthesia oral
Clinical narrative: tingling needles in chin and in bottom of front teeth; Cataract aggravated; This is a solicited report based on the information received by a regulatory authority. The consumer reported 2 reports for same patient and different doses, this is the first of 2 reports. A contactable consumer (patient) reported that a 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular on 25Jun2021 at age of 65 years old (Batch/Lot Number: EV00196) as DOSE 1, SINGLE for COVID-19 Vaccination; risankizumab (SKYRIZI, Solution for injection in pre-filled syringe, strength:75mg), subcutaneous from Jul2020 (Batch/Lot number was not reported) and ongoing, at 150 mg, (1 in 12 wk) for moderate to severe chronic plaque psoriasis.  Medical history included appendix removal from Jan1973, left shoulder surgery from 2015, cataract in both eyes from Mar2020 (in spring time), abstains from alcohol, moderate to severe chronic plaque psoriasis, acid reflux, hormone level abnormal and non-tobacco user, all unknown information reported for ongoing. In Jul2020, the patient's last tuberculosis test was and resulted to normal. Other relevant history: No known allergies. The cataract in both eyes of the patient originally started in spring time of 2020 before Skyrizi. Concomitant medications included pantoprazole taken for acid reflux, start and stop date were not reported; estradiol taken for hormone level abnormal, start and stop date were not reported. The patient experienced cataract aggravated in Jun2021 and tingling needles in chin and in bottom of front teeth on 25Jun2021. In Jun2021, the patient experienced worsened cataract on right eye. On 25Jun2021, the patient experienced tingling needles in chin and bottom of front teeth. PFIZER BIONTECH COVID-19 VACCINE (Tozinameran) was also considered suspect. She did not have any managements and treatments done for the side effects of Covid 19 vaccines. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The patient underwent lab tests and procedures which included mycobacterium tuberculosis complex test: normal in Jul2020. The action taken in response to the events for risankizumab was dose not changed. The outcome of event was not recovered without treatment given.  Causality with Risankizumab as per reporter for event cataract aggravated was not reported, for event tingling mouth Paraesthesia oral was not related. Causality with PFIZER BIONTECH COVID-19 VACCINE (Tozinameran) as per reporter for event cataract aggravated was not reported, for event tingling mouth paraesthesia oral was probable. The reporter's causality for the events of worsened cataract on right eye, tingling needles in chin and bottom of front teeth with Skyriz (Risankizumab) was no reasonable possibility. Withheld opinion is that there was no reasonable possibility that the events of worsened cataract on right eye, numbness in both wrists, thumbs and index fingers and tingling needles in chin and bottom of front teeth are related to Skyrizi (Risankizumab).   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events Paresthesia oral and Cataract which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available.,Linked Report(s) : US-PFIZER INC-202101098266 same reporter/patient/product, different dose/event.