Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness, Interchange of vaccine products, Malaise, Multiple sclerosis, Viral infection
Clinical narrative: Suspect Drug(s): Pfizer BioNTech COVID-19 vaccine/ Suspect Drug(s): Moderna COVID-19 vaccine; Multiple Sclerosis; Sick; Not felt well due to another virus/Contracted virus; Not felt well due to another virus/Contracted virus; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-4159748.  A 42-year-old female patient received BNT162b2 (BNT162B2), on 10Apr2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 41 years intramuscular for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), (Batch/Lot number: unknown), subcutaneous for psoriasis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Suspect Drug(s): Pfizer BioNTech COVID-19 vaccine/ Suspect Drug(s): Moderna COVID-19 vaccine"; MULTIPLE SCLEROSIS (medically significant), outcome "recovering"; ILLNESS (non-serious), outcome "unknown", described as "Sick"; VIRAL INFECTION (non-serious), outcome "recovering", MALAISE (non-serious), outcome "unknown" and all described as "Not felt well due to another virus/Contracted virus". The action taken for risankizumab was unknown. Therapeutic measures were taken as a result of multiple sclerosis.  Clinical course: The patient experienced not felt well due to another virus/contracted virus, not felt well due to another virus/contracted virus, sick, multiple sclerosis. Pfizer BioNTech COVID-19 vaccine, Moderna COVID-19 vaccine were also considered suspect. It was unknown if patient was enrolled in COVID-19-Vaccine Trial. The patient had multiple sclerosis. She took Ocrevus and was somewhat unclear as to whether she should be taking both that and the skyrizi but seemed to get different answers from different physicians. The Skyrizi had basically been the magic drug for her psoriasis and she was just like the commercials. She had the first covid vaccine Moderna which made her sick for about three days and had not any after that. She was not feeling well due to another virus that was going around. Treatment Drugs: The patient was treated with Ocrevus. Causalities: The reporters causality for the event(s) of contracted virus, multiple sclerosis, not felt well due to another virus unknown onset, sick with risankizumab solution for injection was not provided. The reporters causality for the event(s) of with risankizumab solution for injection was not provided. The reporters causality for the event(s) of with moderna covid-19 vaccine (elasomeran) was not provided. The reporters causality for the event(s) of with moderna covid-19 vaccine (elasomeran) was not provided. The reporters causality for the event(s) of with moderna covid-19 vaccine (elasomeran) was not provided. The reporters causality for the event(s) of sick with moderna covid-19 vaccine (elasomeran) was reasonable possibility. The reporters causality for the event(s) of with risankizumab solution for injection was not provided. The reporters causality for the event(s) of with risankizumab solution for injection was not provided. The reporters causality for the event(s) of with pfizer biontech covid-19 vaccine (tozinameran) was reasonable possibility. The reporters causality for the event(s) of with pfizer biontech covid-19 vaccine (tozinameran) was reasonable possibility. The reporters causality for the event(s) of with pfizer biontech covid-19 vaccine (tozinameran) was reasonable possibility. The reporters causality for the event(s) of with pfizer biontech covid-19 vaccine (tozinameran) was reasonable possibility. Company opinion was that the causality for the event(s) of with risankizumab solution for injection was not provided. Company opinion was that the causality for the event(s) of with moderna covid-19 vaccine (elasomeran) was not provided. Company opinion was that the causality for the event(s) of with moderna covid-19 vaccine (elasomeran) was not provided. Company opinion was that the causality for the event(s) of with moderna covid-19 vaccine (elasomeran) was not provided. Company opinion was that the causality for the event(s) of with moderna covid-19 vaccine (elasomeran) was not provided. Company opinion was that the causality for the event(s) of with risankizumab solution for injection was not provided. Company opinion was that the causality for the event(s) of with risankizumab solution for injection was not provided. Company opinion was that the causality for the event(s) of with pfizer biontech covid-19 vaccine (tozinameran) was not provided. Company opinion was that the causality for the event(s) of with pfizer biontech covid-19 vaccine (tozinameran) was not provided. Company opinion was that the causality for the event(s) of with pfizer biontech covid-19 vaccine (tozinamer was not provided. Company opinion was that the causality for the event(s) of with pfizer biontech covid-19 vaccine (tozinameran) was not provided. Company opinion was that the causality for the event(s) of with risankizumab solution for injection was not provided. Assessment Results: Skyrizi - Multiple sclerosis, non-health care professional, global introspection, not reported. Skyrizi - Unwell, Market Authorization Holder (MAH). Skyrizi - Unwell, non-health care professional, global introspection, not reported. Moderna COVID-19 vaccine - Multiple sclerosis, market authorization holder (MAH). Moderna COVID-19 vaccine - Multiple sclerosis, non-health care professional, global introspection, not reported. Moderna COVID-19 vaccine - Viral infection, market authorization holder (MAH). Moderna COVID-19 vaccine - Viral infection, non-health care professional, global introspection, not reported. Moderna COVID-19 vaccine - Unwell, market authorization holder (MAH). Moderna COVID-19 vaccine - Unwell, Non-health care professional, global introspection, not reported. Moderna COVID-19 vaccine - sickness, market authorization holder (MAH). Moderna COVID-19 vaccine - sickness, non-health care professional, global introspection, possible. Skyrizi - Viral infection, market authorization holder (MAH). Skyrizi - Viral infection, non-health care professional, global introspection, not Reported. Skyrizi - Sickness, market authorization holder (MAH). Skyrizi - Sickness, Non-health care professional, global introspection, not reported. Pfizer BioNTech COVID-19 vaccine - Multiple sclerosis, market authorization Holder (MAH). Pfizer BioNTech COVID-19 vaccine - multiple sclerosis, non-health care professional, global introspection, possible. Pfizer BioNTech COVID-19 vaccine - viral infection, market authorization Holder (MAH). Pfizer BioNTech COVID-19 vaccine - Viral infection, non-health care professional, global introspection, possible. Pfizer BioNTech COVID-19 vaccine - Unwell, market authorization holder (MAH). Pfizer BioNTech COVID-19 vaccine - Unwell, non-health care professional, global introspection, possible. Pfizer BioNTech COVID-19 vaccine - Sickness, market authorization holder (MAH). Pfizer BioNTech COVID-19 vaccine - Sickness, Non-health care professional, global introspection, Possible. Skyrizi - Multiple sclerosis, market authorization holder (MAH).  The reporter considered "suspect drug(s): pfizer biontech covid-19 vaccine/ suspect drug(s): moderna covid-19 vaccine", "multiple sclerosis", "sick" and "not felt well due to another virus/contracted virus" related to BNT162b2.The reporter's assessment of the causal relationship of "suspect drug(s): pfizer biontech covid-19 vaccine/ suspect drug(s): moderna covid-19 vaccine" 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information available, the causal association between the events INTERCHANGE OF VACCINE PRODUCTS, Multiple sclerosis, Ilness, Malaise, Viral infection and suspect drug BNT162b2 cannot be excluded. the case will be reassessed once new information becomes available. 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 RAs, Ethics Committees, and Investigators, as appropriate.