Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Bronchitis, Candida infection, Illness, Immunodeficiency, Inappropriate schedule of product administration
Clinical narrative: weakened immune system; On 05Apr2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer BioNTech. On 26Jun2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer BioNTech.; sick; bronchitis; strep throat; sore throat; thrush; 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-163-4168711-00.  A 46 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 26Jun2021 (Batch/Lot number: unknown) at the age of 46 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriasis, rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), administration date: 05Apr2021, when the patient was 46 years old, for Covid-19 Immunization. The following information was reported: IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "weakened immune system"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "On 05Apr2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer BioNTech. On 26Jun2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer BioNTech."; ILLNESS (non-serious), outcome "unknown", described as "sick"; BRONCHITIS (non-serious) with onset Nov2021, outcome "unknown", described as "bronchitis"; PHARYNGITIS STREPTOCOCCAL (non-serious) with onset Jul2021, outcome "unknown", described as "strep throat"; CANDIDA INFECTION (non-serious) with onset 2021, outcome "unknown", described as "thrush"; OROPHARYNGEAL PAIN (non-serious) with onset Jun2021, outcome "unknown", described as "sore throat". The reporter's assessment of the causal relationship of the events of sick, weakened immune system, bronchitis, strep throat, thrush and sore throat was not provided with suspect product (Bnt162b2). The reporter's causality for the event(s) of sick with humira(adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of weakened immune system, bronchitis, strep throat, thrush and sore throat was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Immunodeficiency, Illness, Bronchitis, Pharyngitis streptococcal, Candida infection, and Oro-pharyngeal pain and BNT162B2.  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.