Age: 78.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Blood sodium, Blood sodium decreased, COVID-19, Drug ineffective, Psoriasis
Clinical narrative: Plaque psoriasis on hands; Loss of potassium; Loss of sodium; Loss of elctrolyte; Weakness due to Covid; Weakness due to Covid; Weakness due to Covid; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4518506-00.  A 79-year-old male patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Batch/Lot number: unknown), on 20Nov2021 as dose 2, single (Batch/Lot number: unknown) and on 20Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 78 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at 40mg/0.4ml, citrate free (single dose pen), subcutaneous for psoriasis. The patient's relevant medical history included: "Plaque psoriasis on hands" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 17Oct2022, outcome "recovered" (22Oct2022) and all described as "Weakness due to Covid"; ASTHENIA (non-serious) with onset 22Oct2022, outcome "unknown", described as "Weakness due to Covid"; PSORIASIS (non-serious), outcome "recovered", described as "Plaque psoriasis on hands"; BLOOD POTASSIUM DECREASED (non-serious), outcome "unknown", described as "Loss of potassium"; BLOOD SODIUM DECREASED (non-serious), outcome "unknown", described as "Loss of sodium"; BLOOD ELECTROLYTES DECREASED (non-serious), outcome "unknown", described as "Loss of elctrolyte". The patient underwent the following laboratory tests and procedures: Blood electrolytes: (unspecified date) Loss; Blood potassium: (unspecified date) Loss; Blood sodium: (unspecified date) Loss; SARS-CoV-2 test: (17Oct2022) Positive; (19Oct2022) Positive; (21Oct2022) Positive; (22Oct2022) Negative. The action taken for adalimumab was unknown.  The reporter considered "weakness due to covid", "plaque psoriasis on hands", "loss of potassium", "loss of sodium" and "loss of elctrolyte" related to BNT162b2.  Causalities: The reporter's causality for the event(s) of Loss of potassium, Loss of electrolytes, Loss of sodium, Plaque psoriasis on hands, Weakness due to Covid onset 17Oct2022 and Weakness due to Covid onset 22Oct2022 with Adalimumab Solution for Injection was Not Provided and with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Reasonable Possibility.  Opinion was that the causality for the event(s) of Loss of potassium, Loss of electrolytes, Loss of sodium, Plaque psoriasis on hands, Weakness due to Covid onset 17Oct2022 and Weakness due to Covid onset 22Oct2022 with Adalimumab Solution for Injection and with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided.  Assessment Results: HUMIRA 40MG/0.4ML: Events (Plaque psoriasis, Potassium low, Blood electrolytes decreased, Sodium low, COVID-19, Weakness) by Regulatory Authority was not reported.  Pfizer BioNTech COVID-19 vaccine: Events (Potassium low, Blood electrolytes decreased, Sodium low, Plaque psoriasis, COVID-19 and Weakness) by Regulatory Authority method was possible.  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 known drug safety profile, there is reasonable possibility of causal association between the events Drug ineffective, covid-19, Psoriasis, Blood sodium decreased, Blood potassium decreased, Blood electrolytes decreased, and Asthenia and BNT162B2