Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: COVID-19; COVID-19; sore arm with all three doses; Nausea; Rash; Headache; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4042085-00 (Agency).  A 60 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Feb2021 (Batch/Lot number: unknown) at the age of 58 years as dose 2, single and intramuscular, administration date 20Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (cf) for rheumatoid arthritis. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm with all three doses"; NAUSEA (non-serious), outcome "recovered", described as "Nausea"; RASH (non-serious), outcome "recovered", described as "Rash"; HEADACHE (non-serious), outcome "recovered", described as "Headache". The action taken for adalimumab was dosage permanently withdrawn. Reporter with events of non-serious after Pfizer vaccination and had sore arm with all three doses, nausea, rash, headache and covid-19 with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced After Pfizer vaccination and had sore arm with all three doses, nausea, rash, headache and covid-19. On unknown dates, nausea, rash and headache resolved. Pfizer Biontech covid-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 17Feb2022, received updates to event information, reporter opinion of causality, suspect drug information and narrative description. The events of After Pfizer vaccination and had sore arm with all three doses' and covid-19 were added. Reporter's causality for the events had sore arm with all three doses and COVID-19 was no reasonable possibility and for the events nausea, rash and headache with Humira(adalimumab) was a reasonable possibility. Reporter's causality for the event pain in extremity was Probable and for the events of nausea, rash, COVID-19 and headache with BNT162B2 was Not Reported.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided there is a reasonable possibility of causal association between the events pain in extremity, nausea, rash, headache with the suspect product bnt162b2. However, based on the current available limited information in the case provided, the causal association between the events Vaccination failure, COVID-19 and the use of suspect product BNT162B2 cannot be fully 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.