Sex: F
Vaccine: COVID19, UNK
Symptoms: Ear discomfort, Hypoacusis, Rash, Skin papilloma, Unevaluable event
Clinical narrative: Partial hearing loss; Rash aggravated; Ear feels clogged; Warts; Unevaluable event; FACILITATED COLLECT  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-163-4202609-00 (Agency). A 55 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) as citrate free for crohn's disease. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOACUSIS (medically significant), outcome "not recovered", described as "Partial hearing loss"; RASH (medically significant), outcome "not recovered", described as "Rash aggravated"; EAR DISCOMFORT (medically significant), outcome "unknown", described as "Ear feels clogged"; SKIN PAPILLOMA (medically significant), outcome "unknown", described as "Warts"; UNEVALUABLE EVENT (medically significant), outcome "unknown", described as "Unevaluable event". The action taken for adalimumab was unknown.  It was reported that an adult female with events of 25 percent loss of hearing in right high from covid-vaccine and non-serious skin rash/outbreaks of about 20 to 30, had a plugged ear after second Pfizer vaccination, warts on arms and legs and source in nerve bed with Humira (adalimumab). there was no reported medical history.  On unknown dates, the patient experienced 25 percent loss of hearing in right high from covid-vaccine, skin rash/outbreaks of about 20 to 30, had a plugged ear after second Pfizer vaccination, warts on arms and legs and source in nerve bed. Pfizer BioNTech covid-19 vaccine (tozinameran) was also considered suspect. The patient immediately had a plugged ear 24 hours after second Pfizer vaccination. she had 25 percent loss of hearing in right high from covid vaccine. source in nerve. she had warts on arms and legs and outbreaks of about 20 to 30. It was unknown if patient was enrolled in a covid-19 vaccine trial. on unknown date, patient received first dose covid-19 vaccine manufactured by Pfizer/BioNTech. on unknown date patient received second dose covid-19 vaccine manufactured by Pfizer/BioNTech.   Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the event(s) of 25 percent loss of hearing in right high from covid-vaccine, skin rash/outbreaks of about 20 to 30, had a plugged ear after second Pfizer vaccination, warts on arms and legs and source in nerve bed was not provided. Agency's opinion is that there is no reasonable possibility that the events of 25 percent loss of hearing in right high from covid-vaccine, had a plugged ear after second Pfizer vaccination and source in nerve bed are related to Humira(adalimumab). Agency's opinion is that the events of skin rash/outbreaks of about 20 to 30 and warts on arms and legs are not assessable.  Drug: HUMIRA(Solution for injection in pre-filled pen)(ADALIMUMAB) Causality 1) Partial hearing loss (10050564) (Hypoacusis) Causality as per reporter (Drug/Vaccine): Not Reported Causality as per Mfr.(Drug/Vaccine): No reasonable possibility 2) Rash aggravated (10048332) (Rash) Causality as per reporter (Drug/Vaccine): Not Reported Causality as per Mfr.(Drug/Vaccine): Not assessable 3) Ear feels clogged (10014008) (Ear discomfort) Causality as per reporter (Drug/Vaccine): Not Reported Causality as per Mfr.(Drug/Vaccine): No reasonable possibility 4) Warts (10047828) (Skin papilloma) Causality as per reporter (Drug/Vaccine): Not Reported Causality as per Mfr.(Drug/Vaccine): Not assessable 5) Unevaluable event (10062355) (Unevaluable event) Causality as per reporter (Drug/Vaccine): Not Reported Causality as per Mfr.(Drug/Vaccine): No reasonable possibility Drug: PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN),UNKNOWN,UNKNOWN Causality 1) Partial hearing loss (10050564) (Hypoacusis (10048865)) Causality as per reporter (Drug/Vaccine): Possible 2) Rash aggravated (10048332) (Rash (10037844)) Causality as per reporter (Drug/Vaccine): Not Reported 3) Ear feels clogged (10014008) (Ear discomfort (10052137) Causality as per reporter (Drug/Vaccine): Possible 4) Warts (10047828) (Skin papilloma (10040907) Causality as per reporter (Drug/Vaccine): Not Reported 5) Unevaluable event (10062355) (Unevaluable event (10062355) Causality as per reporter (Drug/Vaccine): Not Reported  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 in the case report, a possible causal association between the events and suspect drug BNT162B2 cannot be 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.