Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Illness, Inappropriate schedule of product administration, Lacrimation increased, Lymphadenopathy
Clinical narrative: dispensing error/physician didn't specify patient wanted prefilled syringe; Patient Had Mild Symptoms; Tears Came To Eyes; Fatigue; mental exhaustion; Sickness; Weight loss; General body pain; Swollen lymph nodes; Psoriatic arthritis aggravated; first dose 04Apr2021, second dose 18Apr2021; 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, US-ABBVIE-4179597.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 18Apr2021 as dose 2, 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. Vaccination history included: BNT162b2 (First dose, Route of administration:Intramuscular), administration date: 04Apr2021, when the patient was 44-year-old, for Covid-19 Immunization, reaction(s): "tears came to eyes", "Swollen lymph nodes", "General body pain", "Psoriatic arthritis aggravated", "Sickness", "mental exhaustion", "dispensing error/physician didn't specify patient wanted prefilled syringe", "Patient Had Mild Symptoms".  The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 18Apr2021, outcome "unknown", described as "first dose 04Apr2021, second dose 18Apr2021"; 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"; VACCINATION COMPLICATION (non-serious), outcome "unknown", described as "Patient Had Mild Symptoms"; LACRIMATION INCREASED (non-serious), outcome "unknown", described as "Tears Came To Eyes"; FATIGUE (non-serious), outcome "unknown"; 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", "first dose 04apr2021, second dose 18apr2021", "dispensing error/physician didn't specify patient wanted prefilled syringe", "patient had mild symptoms", "tears came to eyes", "fatigue", "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's assessment of the causal relationship of the events [Vaccination complication, Product prescribing error, Lacrimation increased, Fatigue] with Humira was not reported. The reporter's assessment of the causal relationship of the events [Vaccination complication, Fatigue] with suspect BNT162B2 was possible and events [Product prescribing error, Lacrimation increased] with suspect BNT162B2 was not reported.  Additional information: Causality for Humira(adalimumab): Solicited report from 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. Pfizer BioNtech Covid-19 vaccine (tozinameran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial. Concomitant drugs and dates of administration (Exclude those used to treat event): Concomitant Drugs Not Reported. Other relevant history: Not reported. Amendment to data received on 25Feb2022 with changes to event information and narrative description. Version one was created to correct the event verbatim for fall as fatigue and product dispensing error as drug dosage form prescribing error. 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. Causalities: The reporter's causality and company's opinion for the event(s) of Whenever eats anything with sugar gave a psoriatic arthritis flare up/Symptoms of psoriatic arthritis, lose weight, mental exhaustion and sick with Adalimumab Solution for Injection and Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided. Primary reporter did not have the lot number information, because the packaging was discarded. Assessment Results: HUMIRA 40MG/0.4ML and Pfizer BioNTech COVID-19 vaccine -Weight loss, Psoriatic arthritis aggravated, Sickness, Mental exhaustion, Non-Health Care Professional, Global Introspection, Not Reported. Pfizer BioNTech COVID-19 vaccine/ HUMIRA 40MG/0.4ML -Sickness, Market Authorization Holder (MAH).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported Information: Updated Onset date of event "Inappropriate schedule of vaccine administered " as product administration date: 18Apr2021.  Follow-up (04Apr2022): This is a follow-up solicited report from a Study (MARKETING PROGRAM NAME NOT AVAILABLE) based on information received by Pfizer from company, MFR Control No. 22K-163-4294840-00). A contactable 44-year Male consumer (patient) reported for himself that:  Updated Information: Events are added, De-challenge and action taken are updated for Humira, Causality updated for events.  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 company (Mfr Control No: US-ABBVIE-4179597). A contactable consumer (patient) reported that: Updated information included: new events (mental exhaustion, sickness and psoriatic arthritis aggravated, Weight loss, General body pain and Swollen lymph nodes) and clinical information.; 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.