Age: 57.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fatigue, Intentional product misuse, Polymerase chain reaction
Clinical narrative: Intentional drug misuse; Tiredness; Asymptomatic COVID-19; Asymptomatic COVID-19; This is a solicited report based on the information received by Pfizer (Mfr. Control No.: 21K-163-4096259-00).   A contactable consumer (patient) reported that a 57-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose intramuscularly on 27Feb2021 (Batch/Lot number was not reported) at age of 57 years old as a single dose, 2nd dose intramuscularly on 20Mar2021 (Batch/Lot number was not reported) at age of 57 years old as a single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for Non-infectious intermediate, posterior and panuveitis. Medical history included Exposure to COVID-19. The patient's concomitant medications were not reported. The patient experienced asymptomatic covid-19 in 2021, intentional drug misuse and tiredness, both in Jul2021. The patient underwent lab tests and procedures which included antibody test: had covid in 2021, IGG spike semi-quantitative antibody testing: unknown results, came back as though he never had the COVID on 28Aug2021, blood test: had covid in 2021, PCR: had covid in 2021. The action taken in response to the events for adalimumab was unknown. The outcome of the event Asymptomatic COVID-19 was not recovered, Intentional drug misuse and tiredness, both was recovered in 2021.   Solicited report from a consumer of a 57 year old male with events of Cornea transplant and non-serious exposed to covid from a family member, gave self a dose, medication spilled out on leg/took another injection same day as didnot believed received any medication from the first pen/next day experienced extreme tiredness and covid but no symptoms ever occurred with Humira (ADALIMUMAB). There was no reported medical history. In 2021, the patient experienced exposed to covid from a family member and covid but no symptoms ever occurred. In Jul2021, the patient experienced gave self a dose, medication spilled out on leg/took another injection same day as did not believed received any medication from the first pen/next day experienced extreme tiredness and gave self a dose, medication spilled out on leg/took another injection same day as did not believed received any medication from the first pen/next day experienced extreme tiredness. On 16Sep2021, the patient experienced cornea transplant. In 2021, the gave self a dose, medication spilled out on leg/took another injection same day as did not believed received any medication from the first pen/next day experienced extreme tiredness resolved. Pfizer biontech covid-19 vaccine (Tozinameran) was also considered suspect. In Jul2021, the patient gave himself a dose and the medication spilled out on to his leg. He took another injection the very same day because he did not believe he received any medication from the first pen. Next day he experienced some extreme tiredness that he was not familiar with and then thought to himself might be he did get some of the first dose and now have too much in his system. Next day he felt his energy came back up. On 29Jul2021, there was first attempt of cornea transplant surgery but as he was aware he had been exposed to COVID from a family member and once his surgeon became aware she decided not to do the surgery because she was unaware if he really had COVID or not. He had no COVID symptoms. Polymer chain reaction and antibodies test were completed which blood test revealed he had COVID at one point though no symptoms ever occurred. On 28Aug2021, he received a IGG Spike semi-quantitative antibody testing and it came back as though he never had the COVID vaccination. The physician then told him he needed to get the third COVID-19 shot immediately and got it on 28Aug2021, the same day he became aware of this information. On 16Sep2021, he had a cornea transplant and the surgery went well and he was recovering. It was unknown if he was enrolled in a COVID-19 Vaccine Trial. On 27Feb2021, he received first dose of COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 20Mar2021, he received second dose of COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 28Aug2021, he received third shot of COVID-19 Vaccine manufactured by Pfizer/BioNTech.   Causality for Humira(Adalimumab): The reporter's causality for the event(s) of cornea transplant, exposed to covid from a family member, gave self a dose, medication spilled out on leg/took another injection same day as did not believed received any medication from the first pen/next day experienced extreme tiredness onset in Jul2021 and covid but no symptoms ever occurred was not provided. The reporter's causality for the event(s) of gave self a dose, medication spilled out on leg/took another injection same day as did not believed received any medication from the first pen/next day experienced extreme tiredness onset in Jul2021 and gave self a dose, medication spilled out on leg/took another injection same day as did not believed received any medication from the first pen/next day experienced extreme tiredness onset in Jul2021 with Humira(Adalimumab) was a reasonable possibility.   Database opinion is that there is no reasonable possibility that the events of cornea transplant, exposed to covid from a family member, gave self a dose, medication spilled out on leg/took another injection same day as did not believed received any medication from the first pen/next day experienced extreme tiredness onset in Jul2021, gave self a dose, medication spilled out on leg/took another injection same day as did not believed received any medication from the first pen/next day experienced extreme tiredness onset in Jul2021 and covid but no symptoms ever occurred are related to humira(adalimumab). Database opinion is that there is a reasonable possibility that the event of gave self a dose, medication spilled out on leg/took another injection same day as did not believed received any medication from the first pen/next day experienced extreme tiredness onset in Jul2021 is related to humira(adalimumab).   The reporter's assessment of the causal relationship of all events with the suspect product (BNT162B2) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for BNT162B2 was not provided and will be requested during follow-up.; Sender's Comments: Considering a temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported events Asymptomatic covid 19, Drug ineffective and Fatigue cannot be completely excluded. Based on available information , event Intentional drug misuse is unrelated to BNT16B2.