Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Herpes zoster
Clinical narrative: COVID 19; COVID 19; Shingles outbreak/red mark on the eyebrow quickly spread to forehead/spreadall over face; MARKETING PROGRAM NAME NOT AVALIBLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-22K-163-4434552-00.  A 43-year-old female patient received BNT162b2 (BNT162B2), on 01Mar2021 as Dose 1,SINGLE  (Batch/Lot number: unknown) and on 01Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 43 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Batch/Lot number: unknown) at 40 mg (40 mg ( citrate free)), subcutaneous and second regimen (Batch/Lot number: unknown) at 40 mg (40 mg ( citrate free)), intramuscular for psoriasis. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19"; HERPES ZOSTER (non-serious), outcome "unknown", described as "Shingles outbreak/red mark on the eyebrow quickly spread to forehead/spreadall over face". The action taken for adalimumab was unknown.  The reporter considered "covid 19" and "shingles outbreak/red mark on the eyebrow quickly spread to forehead/spreadall over face" related to BNT162b2.  Clinical course:Event Description: Solicited report by a consumer of an adult female with events of and non-serious Shingles outbreak/red mark on the Reaction Information: Describe reactions (S) (including relevant tests/lab data): eyebrow quickly spread to forehead/spread all over face, and covid 19 with Adalimumab Solution for Injection, Single-Dose Pen. There was no reported medical history. On unknown date(s), the patient experienced covid 19, Shingles outbreak/red mark on the eyebrow quickly spread to forehead/spread all over face. Pfizer BioNTech COVID-19 vaccine was also considered suspect. It was unknown if patient was enrolled in COVID-19-Vaccine Trial. Causalities: The reporter's causality for the event(s) of Shingles outbreak/red mark on the eyebrow quickly spread to forehead/spread all over face and covid 19 with Adalimumab Solution for Injection was Reasonable Possibility. The reporter's causality for the event(s) of Shingles outbreak/red mark on the eyebrow quickly spread to forehead/spread all over face and covid 19 with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility. opinion was that the causality for the event(s) of Shingles outbreak/red mark on the eyebrow quickly spread to forehead/spread all over face and covid 19 with Adalimumab Solution for Injection was Not Provided. opinion was that the causality for the event(s) of Shingles outbreak/red mark on the eyebrow quickly spread to forehead/spread all over face and covid 19 with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.