Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Extra dose administered, Furuncle, Mass, Off label use
Clinical narrative: On 28Aug2021, patient received third dose COVID-19 Vaccine; On 28Aug2021, patient received third dose COVID-19 Vaccine; Boil under armpit / Multiple Boils under right armpit; irritated/lump that had the same size with a ping pong ball; Skin irritation; This is a solicited report based on the information received by Pfizer from Regulatory Authority (Mfr. Control No.:21K-163-4067790-00) via a contactable consumer (patient).  A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular on 19Mar2021 (Batch/Lot number was not reported) (at the age of 62 years old) as single dose, and dose 3 intramuscular on 28Aug2021 (Batch/Lot number was not reported) (at the age of 63 years old) as booster dose, single for Covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from 2017 (Batch/Lot number was not reported) to Jul2021, at 40 mg (1 in 2 wk.), then subcutaneous from 09Sep2021 (Batch/Lot number was not reported), at 40 mg (1 in 2 wk.) for moderate to severe rheumatoid arthritis and ankylosing spondylitis. Medical history included alcohol use: beer, occasionally (Started 1979), and no tobacco use. The first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was administered on 26Feb2021 (Batch/Lot number was not reported) (at the age of 62 years old) intramuscular as single dose for Covid-19 immunisation. Concomitant medications included lisinopril taken for high blood pressure; carvedilol taken for high blood pressure on; atorvastatin taken for high cholesterol; pantoprazole taken for acid reflux; all start and stop date were not reported. In Jun2021, the patient experienced boil under armpit/multiple boils under right armpit, irritated/lump that had the same size with a ping pong ball, and skin irritation. The patient first noticed that there was something bothering him in between his right armpit and was irritating. He noticed it became a lump that had the same size with a ping pong ball. He had it checked and physician said those were multiple boils under his right armpit. He was off of Humira 30 days before the removal of boils. His physician ran a Covid antibody test (Jul2021) and it came back negative. In Jul2021, the patient's boils under the armpit and lump had been removed at physician office. He was taking unspecified oral antibiotics for 10 days as part of his post-operative medication. In Jul2021, he was afraid to get infected on the surgical site after the procedure and just suspended taking Humira as of 13Sep2021 even if the physician reassured him that there was no need to do that. In Jul2021, the multiple boils under right armpit and irritated/lump that had the same size with a ping pong ball resolved. On 28Aug2021, patient received third dose Covid-19 vaccine. Humira antibody test in Aug2021: (unknown result) there were lacking and no anti Adalimumab antibodies. Outcome of the events was recovered in Jul2021.  The reporter's causality for the event(s) of Boil under armpit with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of Covid Antibody test came negative was not provided. Regulatory Authority opinion is that there is a reasonable possibility that the event of Boil under armpit is related to HUMIRA(ADALIMUMAB). RA's opinion is that there is no reasonable possibility that the event of Covid Antibody test came negative is related to HUMIRA (ADALIMUMAB).  The reporter's causality for all adverse events with suspect product BNT162B2 was not reported at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts were possible, information about lot/batch number cannot be obtained. No further information was expected.  Amendment: This follow-up report is being submitted to amend previously reported information: updated company causality for events Furuncle and SARS-CoV-2 antibody test negative with regard to Pfizer suspect product.  Follow-up (17Sep2021): New information received by Pfizer from Pfizer from Regulatory Authority (Mfr. Control No.:21K-163-4067790-00) via the same contactable consumer (patient) includes: concomitant medications, new events (irritated/lump that had the same size with a ping pong ball, and skin irritation), reaction data (event onset date and event outcome), and lab data.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely 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.