Age: 77.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Limb mass, Mass, Pruritus, Therapeutic product effect decreased
Clinical narrative: Lack of drug effect; Drug effect decreased; Itching; Diarrhea; Breast lump; Shoulder lump; Mass/Shoulder lump; Imbalance hormonal/hormone imbalance; Diarrhea recurrent; Abdominal pain; This is a solicited report based on the information received by Pfizer from regulatory authority. (MFR Control No. #21K-163-3990057-00). A contactable consumer (patient) reported that a 77-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on 26Feb2021 (lot number and expiry date not reported) and second dose on 27Mar2021 (lot number and expiry date not reported), both via intramuscular at single dose for COVID-19 immunization; adalimumab (HUMIRA), subcutaneous from 2017 to an unspecified date then from an unspecified date and ongoing, both via subcutaneous at 40mg, weekly (40 mg, 1 in 1 wk) for arthritis and Crohn's disease. Medical history included lactose intolerant, allergic to hazelnuts, allergic to penicillin (could not recall the type of allergic reactions); grass allergy, cats allergy, mildew allergy, weeds allergy, all manifested by stuffy nose and runny nose; eggs allergy manifested by diarrhea, anemia, antidiarrhea, cholesterol, high blood pressure, Crohn's disease, supplementation; smoking and drinking alcohol which started when he was a teenager. Patient stopped smoking in 1981. Concomitant medication included ascorbic acid, cyanocobalamin, folic acid, iron (FERROUS FORTE) for anaemia; loperamide as antidiarrhea; ezetimibe for cholesterol; amlodipine for high blood pressure; rosuvastatin for cholesterol; vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) for supplementation; vitamin b12 nos (VITAMIN B 12 [VITAMIN B12 NOS]) for supplementation; progesterone (PROSTAGEN); mesalazine (PENTASA) for Crohn's disease. The patient previously took Iron Dextran, amoxicillin, clavulinic acid (AUGMENTIN), propylene glycol, and amoxicillin and experienced allergy (could not reccall the type of allergic reactions). The patient experienced lack of drug effect, drug effect decreased, itching, diarrhea on an unspecified date; diarrhea recurrent and abdominal pain on 26Feb2021; imbalance hormonal/hormonal imbalance, breast lump, shoulder lump and mass on Jun2021. The action taken in response to the events for adalimumab was dose not changed. The patient had not recovered from drug effect decreased, imbalance hormonal, breast lump and shoulder lump; recovering from itching; recovered from diarrhea on an unspecified date, recovered from diarrhea recurrent and abdominal pain on Mar2021. Outcome of lack of drug effect was unknown.   Causality between the events and BNT162b2 was reported as: not related for itching, diarrhea, breast lump and mass. Probable for abdominal pain and imbalance hormonal. Probable and not assessable for diarrhea recurrent. Not reported for drug effect decreased and lack of drug effect. Causality between the events and Humira was reported as: not assessable for itching, diarrhea, imbalance hormonal, breast lump, and mass. Not related with abdominal pain. Not related and not assessable for diarrhea recurrent. Not reported for drug effect decreased and lack of drug effect.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: A causal association between BNT162B2 and the reported events drug effect decreased, lack of drug effect, abdominal pain, imbalance hormonal, and diarrhea recurrent cannot be excluded based on a compatible temporal relation. The rest of the events are likely due to underlying medical conditions or are intercurrent and are unrelated to suspect product 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 RAs, Ethics Committees, and Investigators, as appropriate.