Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, COVID-19, Dizziness, Fatigue, Fungal skin infection
Clinical narrative: The Patient experienced Covid Virus; Dizziness; Yeast infections occasionally under bra line or axilla; Pain all over; severe fatigue; headache; was in bed for three days; Describe reaction:  COVID-19 (COVID-19)- Recovering/resolving Dizziness (Dizziness)- Unknown Yeast infection of the skin (Fungal skin infection)-Recovering/resolving General body pain (Pain)- Unknown  Solicited report from a consumer of an adult female with events of COVID VIRUS and non-serious DIZZINESS, YEAST INFECTIONS OCCASIONALLY UNDER BRA LINE OR AXILLA and PAIN ALL OVER with HUMIRA (ADALIMUMAB). The patient had a relevant medical history of DIZZINESS.  On unknown dates, the patient experienced covid virus, dizziness, yeast infections occasionally under bra line or axilla and pain all over. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect.   The patient had spots still under clothes. Shaving or a bra cannot be worn by her. So much more improved and area on back 90 clear. She had Covid virus and was hospitalized. Prior to starting Humira dizziness still occasionally while on Humira. Then had severe fatigue, headache, pain all over and was in bed for three days.  It was unknown if patient was enrolled in a COVID 19 Vaccine Trial. On 09Dec2021 patient received first dose COVID 19 Vaccine manufactured by Pfizer/BioNTech.  Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the event(s) of COVID VIRUS, DIZZINESS, YEAST INFECTIONS OCCASIONALLY UNDER BRA LINE OR AXILLA and PAIN ALL OVER was not provided. AbbVie's opinion is that there is no reasonable possibility that the events of COVID VIRUS, DIZZINESS and PAIN ALL OVER are related to HUMIRA(ADALIMUMAB). AbbVie's opinion is that the event of YEAST INFECTIONS OCCASIONALLY UNDER BRA LINE OR AXILLA is not assessable.  Suspect drugs: Humira Therapy dates: Unknown  Product-Reaction level: Seq.No.: 1 Drug: HUMIRA  Causality: Covid-19(Covid-19) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not reported Causality as per Mfr (Drug/Vaccine):No reasonable possibility Dechallenge: N/A  Dizziness(Dizziness) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not reported Causality as per Mfr (Drug/Vaccine):No reasonable possibility Dechallenge: N/A  Yeast infection of the skin (Fungal skin infection) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not reported Causality as per Mfr (Drug/Vaccine):Not assesable Dechallenge: N/A  General body pain (Pain) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not reported Causality as per Mfr (Drug/Vaccine):No reasonable possibility Dechallenge: N/A  Pfizer Biontech COVID-19 Vaccine(Tozinameran) (Tozinameran), Unknown Daily Dose: (1 in 1 Once)  Seq.No.: 2 Drug: Pfizer Biontech COVID-19 Vaccine(Tozinameran)(Tozinameran), Unknown,  Causality: Covid-19(Covid-19) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Probable Dechallenge: N/A  Dizziness(Dizziness) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not reported Dechallenge: N/A  Yeast infection of the skin (Fungal skin infection) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Not reported Dechallenge: N/A  General body pain (Pain) Action(s) taken with drug: Unknown Causality as per reporter (Drug/Vaccine): Probable Dechallenge: N/A  Did event abate after stopping drug? NA  Concomitant drugs and dates of administration: Not reported; Sender's Comments: Based on the  information in the case report, a possible causal relationship 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.