Age: 41.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Rash, Vaccination site swelling, Vertigo
Clinical narrative: Allergic edema; Hearing loss; swelling at injection site after covid vaccination; vertigo; swelling of hand; high blood pressure; rash on legs; This is a solicited report FACILITATED COLLECT based on the information received by Pfizer from biopharmaceutical company  (MFR Control No. # 21K-163-3802407-00) from a non-contactable consumer (patient)  A 41-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 single intramuscular on 04Mar2021 (Batch/Lot number was not reported) at age of 41 years for covid-19 immunisation; adalimumab (HUMIRA), via subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 40 mg (40 mg,1 in 7 D) for ankylosing spondylitis  .  Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication(s) included omalizumab (XOLAIR) taken for an unspecified indication, start and stop date were not reported.  The patient experienced hearing loss (medically significant) on Mar2021 with outcome of not recovered , swelling at injection site after covid vaccination (non-serious) on Mar2021 with outcome of recovering , vertigo (non-serious) on Mar2021 with outcome of not recovered , swelling of hand (non-serious) on Mar2021 with outcome of recovering , high blood pressure (non-serious) on Mar2021 with outcome of recovering , rash on legs (non-serious) on Mar2021 with outcome of unknown , allergy caused eye to swell (coded as allergic oedema) (non-serious) on an unspecified date with outcome of recovering.  The patient underwent lab tests and procedures which included blood pressure measurement: blood pressure measurement: high   on 2021  . The clinical course was reported as follows: The patient had a relevant medical history of asthma.On an unknown date, the patient experienced allergy caused eye to swell. In March 2021, the patient experienced hearing loss, swelling at injection site after Covid vaccination, vertigo, swelling of hand, high blood pressure and rash on legs. Pfizer BioNTech Covid-19 vaccine was also considered suspect.It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 04Mar2021, patient received first dose COVID-19 Vaccine manufactured by Pfizer. On 04Mar2021, after taking Covid vaccine patient had swelling at the injection site, high blood pressure, hand swelling, rash on legs, hearing loss and vertigo. He had an allergy that caused eye to swell.The action taken with Humira was unknown  The reporter stated that there is no reasonable possibility that the events are related to HUMIRA .While for Pfizer Biontech Covid-19 Vaccine reporter's causality was reported as probable for Hearing loss and vertigo and unknown for the other events. AbbVie's causality for all events vs Humira was reported as follows: No reasonable possibility  The reporter's assessment of the causal relationship of all the events except for hearing loss and vertigo with the Pfizer 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; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events deafness, vaccination site swelling, vertigo, peripheral swelling, hypertension, rash, and allergic edema and the suspect drugs.  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.