Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Illness, Lymphadenopathy, Mental fatigue
Clinical narrative: Psoriatic arthritis aggravated; Knocked patient on his butt; Hit a nerve; Uncomfortable; mental exhaustion; Sickness; Weight loss; General body pain; Swollen lymph nodes; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. Other Case identifier(s): 22K-163-4294840-00, US-ABBVIE-4179597.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 18Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at 1 DF single (unk (citrate free, 1 df=40 mg/0.4 ml)), subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Route of admin: Intramuscular), administration date: 04Apr2021, when the patient was 44-year-old, for Covid-19 immunization, reaction(s): "Dispensing error/physician didn't specify patient wanted prefilled syringe", "Tears came to eyes", "Patient had mild symptoms"; BNT162b2 (Dose 1, Route of admin: Intramuscular), administration date: 04Apr2021, when the patient was 44-year-old, for COVID-19 immunization, reaction(s): "mental exhaustion", "Sickness", "Psoriatic arthritis aggravated", "Weight loss", "General body pain", "Swollen lymph nodes"; BNT162b2 (Dose 2, Route of admin: Intramuscular), administration date: 18Apr2021, when the patient was 44-year-old, for Covid-19 immunization, reaction(s): "Dispensing error/physician didn't specify patient wanted prefilled syringe", "Tears came to eyes", "Patient had mild symptoms", "First dose 04Apr2021, second dose 18Apr2021"; BNT162b2 (Dose 2, Route of admin: Intramuscular), administration date: 18Apr2021, when the patient was 44-year-old, for COVID-19 immunization, reaction(s): "mental exhaustion", "Sickness", "Psoriatic arthritis aggravated", "Weight loss", "General body pain", "Swollen lymph nodes". The following information was reported: PSORIATIC ARTHROPATHY (medically significant), outcome "unknown", described as "Psoriatic arthritis aggravated"; FATIGUE (non-serious), outcome "unknown", described as "Knocked patient on his butt"; NERVE INJURY (non-serious), outcome "unknown", described as "Hit a nerve"; DISCOMFORT (non-serious), outcome "unknown", described as "Uncomfortable"; MENTAL FATIGUE (non-serious), outcome "unknown", described as "mental exhaustion"; ILLNESS (non-serious), outcome "unknown", described as "Sickness"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "Weight loss"; PAIN (non-serious), outcome "unknown", described as "General body pain"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph nodes". The patient underwent the following laboratory tests and procedures: Weight: loss. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "psoriatic arthritis aggravated", "hit a nerve", "uncomfortable", "mental exhaustion", "sickness", "weight loss", "general body pain" and "swollen lymph nodes" with the suspect product(s) 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 reporter considered "knocked patient on his butt" related to BNT162b2.  Clinical course: Solicited report by a consumer of an adult male with events of non-serious covid-19 vaccinations side effects. on unknown dates, the patient experienced third shot knocked patient on his butt, did an injection and thought hit a nerve, broke the chart of uncomfortable and was given pen and it was awful with humira (adalimumab). Pfizer biontech covid-19 vaccine (tozinameran) was also considered suspect. it was unknown if patient was enrolled in a covid-19 vaccine trial. Did event abate after stopping drug? : NA. Concomitant Drugs Not Reported. Other Relevant History: Not reported. causality for humira (adalimumab)the reporter and ampampampampaposs causality for the event(s) of covid-19 vaccinations side effectsthird shot knocked patient on his butt, did an injection and thought hit a nerve, broke the chart of uncomfortable and was given pen and it was awful was not provided. Solicited report by a consumer of an adult male with events of non-serious COVID-19 Vaccinations side effects /first and second shots patient had mild symptoms, dispensing error/ physician didn't specify patient wanted prefilled syringe, tears came to eyes, COVID-19 Vaccinations side effects/Third shot knocked patient on his butt, did an injection and thought hit a nerve, broke the chart of uncomfortable and was given pen and it was awful with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced COVID-19 Vaccinations side effects /first and second shots patient had mild symptoms, dispensing error/ physician didn't specify patient wanted prefilled syringe, tears came to eyes, COVID-19 Vaccinations side effects/Third shot knocked patient on his butt, did an injection and thought hit a nerve, broke the chart of uncomfortable and was given pen and it was awful. Pfizer BioNTech COVID-19 Vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. Upon follow-up on 05Dec2022, solicited report by a consumer of an adult male with events of and non-serious sick, whenever eats anything with sugar gave a psoriatic arthritis flare up/Symptoms of psoriatic arthritis, lose weight, mental exhaustion, body aches, and swollen lymph nodes with Adalimumab Solution for Injection, Single Dose Pen. There was no reported medical history. On unknown date(s), the patient experienced swollen lymph nodes, body aches, mental exhaustion, lose weight, whenever eats anything with sugar gave a psoriatic arthritis flare up/Symptoms of psoriatic arthritis, sick. Moderna COVID-19 vaccine, Pfizer BioNTech COVID-19 vaccine were also considered suspect.  Causality: Fall (Fall) Causality as per reporter (Drug/Vaccine): Possible. Nerve injury (Nerve injury), Causality as per reporter (Drug/Vaccine): Not Applicable. Discomfort (Discomfort), Causality as per reporter (Drug/Vaccine): Not Applicable.  Causality for Humira (Adalimumab) The reporter's causality for the event(s) of COVID-19 Vaccinations side effects /first and second shots patient had mild symptoms, dispensing error/ physician didn't specify patient wanted prefilled syringe, tears came to eyes, COVID-19 Vaccinations side effects/Third shot knocked patient on his butt, did an injection and thought hit a nerve, broke the chart of uncomfortable and was given pen and it was awful was not provided. Change History  Amendment to data received on 25Feb2022 with changes to event information and narrative description. Version one was created to correct the LLT for fall as fatigue and product dispensing error as drug dosage form prescribing error.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (04Apr2022): This is a follow up solicited report from a Non-Interventional Study (Program ID not available) based on information received by Pfizer from Agency, (manufacturer control number: 22K-163-4294840-00). A contactable male consumer (patient) reported for himself that: new information added includes department and email for reporter slider#02, 1st and 2nd dose as historical vaccine, indication and dose description for 3rd dose, formulation for Humira, Patient Route of Administration for 3rd dose of BNT162B2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [05Dec2022], this case now contains serious adverse reaction(s). Information processed together  Follow-up (05Dec2022): This is a solicited follow-up report based on the information received by Pfizer from Agency(Mfr Control No: US-ABBVIE-4179597). A contactable consumer (patient) reported. Updated information included: New reporter added. Historical vaccine reaction. Dosage regimen: Humira [Dose, unit, dose description]. New AEs [mental exhaustion, Sickness and Psoriatic arthritis aggravated, Weight loss, General body pain and Swollen lymph nodes] and clinical information added.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely 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.