Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Lacrimation increased, Lymphadenopathy, Mental fatigue, Pain
Clinical narrative: Psoriatic arthritis aggravated; dispensing error/physician didn't specify patient wanted prefilled syringe; tears came to eyes; Patient Had Mild Symptoms; Swollen lymph nodes; General body pain; Sickness; mental exhaustion; lose weight; 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-163-4294840-00, ABBVIE-4179597.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2021 as dose 1, 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 (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. The following information was reported: PSORIATIC ARTHROPATHY (medically significant), outcome "unknown", described as "Psoriatic arthritis aggravated"; PRODUCT PRESCRIBING ERROR (non-serious), outcome "unknown", described as "dispensing error/physician didn't specify patient wanted prefilled syringe"; LACRIMATION INCREASED (non-serious), outcome "unknown", described as "tears came to eyes"; VACCINATION COMPLICATION (non-serious), outcome "unknown", described as "Patient Had Mild Symptoms"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph nodes"; PAIN (non-serious), outcome "unknown", described as "General body pain"; ILLNESS (non-serious), outcome "unknown", described as "Sickness"; MENTAL FATIGUE (non-serious), outcome "unknown", described as "mental exhaustion"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "lose weight". 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", "tears came to eyes", "swollen lymph nodes", "general body pain", "sickness", "mental exhaustion" and "lose weight" 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 "patient had mild symptoms" related to BNT162b2.  Additional information: 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. 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. On unknown date, 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.   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 (MARKETING PROGRAM NAME NOT AVAILABLE) based on information received by Pfizer. A contactable 45-year-old male consumer (patient) reported for himself that: Updated information include: New event Vaccination complication added. Recoded event product dispensing error as drug dosage form prescribing error. Additional information added. Narrative updated.  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. A contactable consumer (patient) reported that: Updated information included: Reporter details were updated, Humira Dosage Regimens (dose, unit, dose description) added, Event information (new event 'Mental exhaustion', 'Sickness', 'Psoriatic arthritis aggravated', 'Weight loss', 'General body pain', 'Swollen lymph nodes') added and clinical information was updated  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 available information and close temporal association, a possible causal relationship cannot be excluded between the suspect vaccine BNT162b2 and the reported events 'psoriatic arthropathy', 'product prescribing error', 'Mental fatigue', 'Sickness', 'Psoriatic arthritis aggravated', 'Weight decreased', 'pain', 'illness', 'lymphadenopathy', 'vaccination complication', 'lacrimation increased'. 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.