Age: 57.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Injection site pain, Rash vesicular, Suspected COVID-19
Clinical narrative: Hurt bad until switched to citrate free pen; COVID-19; COVID-19; Rash that got filled with liquid COVID vaccine; 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): 22K-163-4311957-00 (AbbVie).  A 58 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Dec2021 (Batch/Lot number: unknown) at the age of 57 years as dose 3 (booster), single, intramuscular, administration date 10Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 20Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at single (unk (citrate free)) for psoriasis, psoriatic arthropathy, rheumatoid arthritis. Relevant medical history included: "Cigarette smoker" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 10Jan2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 10Jan2022, outcome "recovered" (2022) and all described as "COVID-19"; INJECTION SITE PAIN (non-serious), outcome "recovered", described as "Hurt bad until switched to citrate free pen"; RASH VESICULAR (non-serious) with onset 20Mar2021, outcome "recovered", described as "Rash that got filled with liquid COVID vaccine". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of suspected covid-19, injection site pain, rash vesicular with prednisone.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of when started HUMIRA it used to hurt bad until switched to citrate free pen, rash that got filled with liquid with covid vaccine, COVID-19 with HUMIRA(ADALIMUMAB) was no reasonable possibility.  Causality for Pfizer biontech COVID-19: The reporter causality for the events "Rash that got filled with liquid COVID vaccine" was reported as possible, for "Hurt bad until switched to citrate free pen", COVID-19 Pfizer biontech COVID-19 were not reported.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective(LOE) and  cannot be ruled out. Event "Hurt bad until switched to citrate free pen' is assessed unrelated to suspect vaccine BNT162B2, since its possibly related to concomitant drug humira.   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.