Sex: F
Vaccine: COVID19
Symptoms: Blindness, Feeling abnormal, Magnetic resonance imaging head, Vaccination complication
Clinical narrative: This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (Not Provided). The reporter is the patient. A 14 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 10Feb2022 (Batch/Lot number: unknown) as dose 3 (booster), single for Covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from 01Nov2021 (Batch/Lot number: unknown) to 10Jan2022 at 40 mg (unknown (40 mg,1 in 2 wk.)) for juvenile idiopathic arthritis. Relevant medical history included: "Migraine", start date: 2019 (unspecified if ongoing); "Depression", start date: 2020 (unspecified if ongoing); "Juvenile Idiopathic Arthritis" (unspecified if ongoing); "Gastritis" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Attention Deficit" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE (ongoing); NEURONTIN (ongoing); FOLIC ACID (ongoing). Vaccination history included: Bnt162b2 (1st dose, Route: Intramuscular), administration date: 21Jun2021, for COVID-19 immunization; Bnt162b2 (2nd dose, Route: Intramuscular), administration date: 14Jul2021, for COVID-19 immunization. The following information was reported: FEELING ABNORMAL (hospitalization) with onset 14Feb2022, outcome "not recovered", described as "Feeling dazed"; VACCINATION COMPLICATION (hospitalization) with onset 12Feb2022, outcome "recovered" (Feb2022), described as "Vaccination adverse reaction"; BLINDNESS (medically significant) with onset 14Feb2022, outcome "recovered" (14Feb2022), described as "Vision loss". The patient was hospitalized for feeling abnormal, vaccination complication (start date: 15Feb2022). The patient underwent the following laboratory tests and procedures: magnetic resonance imaging head: (17Feb2022) unknown result. The action taken for adalimumab was dosage permanently withdrawn on 10Jan2022.Clinical information: The reporter's causality for the event(s) of dazed and vision loss with Humira 40mg/0.4ml (adalimumab) was no reasonable possibility. The reporter's causality for the event(s) of reaction to Covid-19 vaccine was not provided. Regulatory Authority opinion is that there is no reasonable possibility that the events of dazed, vision loss and reaction to Covid-19 vaccine are related to Humira 40mg/0.4ml (adalimumab). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Based on limited information in the case , a possible causal association between All the reported events Feeling abnormal, Vaccination complication, Blindness,   and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.