Age: 69.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Decreased appetite, Drug ineffective, Incorrect dose administered, Injection site haemorrhage
Clinical narrative: COVID; Injection site bleeding; Wrong injection technique; Inappropriate dose of drug administered; Appetite absent; COVID; This is a Spontaneous report based on the information received by Pfizer (Mfr. Control No.: 21K-163-4065749-00). A contactable consumer(patient) reported for himself. A 69-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number: not reported) via an intramuscularly administered on 17Feb2021 as DOSE 2, SINGLE (age at vaccination: 69 years-old) for COVID-19 immunisation. adalimumab (HUMIRA, Solution for injection, in pre-filled pen, Lot number: not reported) via subcutaneously from Jan2021 and ongoing, at 40 mg, cyclic (40 mg,1 in 2 wk) for plaque psoriasis. Medical history included tobacco use (stopped 2007) from an unknown date to 2007, anxiety from an unknown date and unknown if ongoing, anxiety, high blood pressure, high cholesterol level, alcohol use: social drinker, seasonal allergy, allergy to grass, plaque psoriasis all from an unknown date and unknown if ongoing, COVID-19 from 28Dec2020 to an unknown date on 27Dec2020, the patient experienced nasal congestion and no appetite. On 28Dec2020, the patient experienced covid/delta type of covid virus. In Jan2021, the covid/delta type of covid virus, nasal congestion and no appetite resolved, nasal congestion from 27Dec2020 to an unknown date, no appetite from 27Dec2020 to an unknown date. Concomitant medications included lisinopril 5 mg, once a day oral taken for high blood pressure, start and stop date were not reported; metoprolol succinate (TOPROL XL) 75 mg, once a day oral taken for high blood pressure, start and stop date were not reported; hydrochlorothiazide 12.5 mg, once a day taken for high blood pressure, start and stop date were not reported; fenofibrate 145 mg, once a day taken for high cholesterol level, start and stop date were not reported; omeprazole (PRILOSEC [OMEPRAZOLE]) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid, ascorbic acid (ASPIRIN COMPOUND [ACETYLSALICYLIC ACID;ASCORBIC ACID]) taken for high blood pressure, start and stop date were not reported; bupropion hydrochloride (WELLBUTRIN) 300 mg, once a day taken for anxiety, start and stop date were not reported.  The patient previously took humira 40mg/0.4 ml for plaque psoriasis at Least 10 years ago - 14Dec2020, bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot number: not reported) via an intramuscularly on 28Jan2021 as DOSE 1, SINGLE (age at vaccination: 69 years-old) for COVID-19 immunisation. On an unspecified date Aug2021, the patient experienced COVID-19. On 10Aug, had appetite absent, reoccurred no appetite. On an unspecified date, had injection site bleeding. 0n 31Aug2021, had wrong injection technique, inappropriate dose of drug administered. It was reported that COVID/delta type of COVID virus, nasal congestion, no appetite, COVID, reoccurred no appetite, injection site bleeding and did not pinched skin and placed pen/pushed plum button/heard a soft click and barely receive needle stick/lifted pen up and perceived unsuccessful injection with HUMIRA 40mg/0.4ml (ADALIMUMAB). On 31Aug2021, the patient experienced did not pinched skin and placed pen/pushed plum button/heard a soft click and barely receive needle stick/lifted pen up and perceived unsuccessful injection. It was unknown if patient was enrolled in a COVID-19 Vaccine trial. The patient was treated with prednisone, Z-PAK and Ibuprofen. The patient underwent lab tests and procedures which included Covid rapid test resulted as unknown results on an unspecified date Aug2021, Covid swab test resulted as unknown results on 28Dec2020 and unknown results on an unspecified date Aug2021. The clinical outcome of the event COVID-19 was recovering and the events injection site bleeding, wrong injection technique on an unspecified date Aug2021 was recovered and the events wrong injection technique, inappropriate dose of drug administered on 31Aug2021 was recovered. Causality for humira 40MG/0.4ML (ADALIMUMAB): The reporters causality for the event(s) of COVID/delta type of COVID virus, nasal congestion, no appetite, reoccurred no appetite and injection site bleeding with HUMIRA 40mg/0.4ml (ADALIMUMAB) was no reasonable possibility. The reporters causality for the event(s) of COVID, did not pinched skin and placed pen/pushed plum button/heard a soft click and barely receive needle stick/lifted pen up and perceived unsuccessful injection onset 31Aug2021 and did not pinched skin and placed pen/pushed plum button/heard a soft click and barely receive needle stick/lifted pen up and perceived unsuccessful injection onset 31 Aug 2021 was not provided. The reporters causality for the events COVID-19, nasal congestion, and appetite absent was not related, COVID-19, wrong injection process, inappropriate dose of drug administered was not reported, appetite absent, injection site bleeding was not related. The causality as per reporter COVID-19, nasal congestion, appetite absent, COVID-19, wrong injection technique, inappropriate dose of drug administered, appetite absent, injection site bleeding was possible.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Drug Ineffective and COVID-19 and the suspect drug bnt162b2. The causal association between the event Decreased appetite and the suspect drug bnt162b2 cannot be excluded as it is also an event which might have occurred due to co suspect HUMIRA. Events Wrong injection technique and Incorrect dose administered are Unrelated to bnt162b2 and are events associated with co suspect HUMIRA.