Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage, Vaccination site pain
Clinical narrative: Vaccination site pain; Injection site bleeding; Walking difficulty; Right side occipital stroke; Headache; Patches in scalp; lack of effect; This is a solicited report from a contactable consumer (patient) based on the information received by Pfizer from AbbVie Inc. (Mfr. Control No. 21K-163-4113290-00), Facilitated Connect. A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration (also reported as intramuscular; pending clarification) on an unspecified date (also reported as 01Apr2021-pending clarification; Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration (also reported as intramuscular-pending clarification) on an unspecified date (also reported as 01May2021-pending clarification; Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation; risankizumab (SKYRIZI), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for moderate to severe chronic plaque; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for psoriasis. The patient's medical history and concomitant medications were not reported. The patient reported events of had a right side occipital stroke and non-serious patches in scalp, lack of effect and headache with SKYRIZI (RISANKIZUMAB) and HUMIRA (ADALIMUMAB). There was no reported medical history. On Jan2021 (also reported as unknown dates), the patient experienced patches in scalp, lack of effect and headache. In Jan2021, the patient experienced had a right side occipital stroke. On an unknown date, lack of effect resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The patient reported that when she was on Humira it worked well for her and then it stopped working. It was the first medication that she tried after being diagnosed with psoriasis. She did not have any other Humira information. She had a right side occipital stroke in Jan2021 (also reported as Jan2020-pending clarification). She got a headache in between the first and second Covid-19 vaccines. She had patches in scalp, some small areas on her scalp that had not gone away. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. The patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. Primary reporter did not have the lot number information, because the packaging was discarded. On an unspecified date, the patient also experienced vaccination site pain, walking difficulty and injection site bleeding. The action taken in response to the events for Risankizumab and adalimumab was unknown. The patient recovered from lack of effect on an unspecified date, was recovering from patches in scalp, while the outcome of the other events was unknown.  Causality for SKYRIZI(RISANKIZUMAB) The reporter's causality for the event(s) of had a right side occipital stroke and headache was not provided. The reporter's causality for the event(s) of patches in scalp and lack of effect with SKYRIZI(RISANKIZUMAB) was a reasonable possibility. AbbVie's opinion is that the event of had a right side occipital stroke is not assessable. AbbVie's opinion is that there is no reasonable possibility that the events of patches in scalp, lack of effect and headache are related to SKYRIZI(RISANKIZUMAB). Causality of the events as per reporter was not reported.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of had a right side occipital stroke, patches in scalp, lack of effect and headache was not provided. AbbVie's opinion is that the event of had a right side occipital stroke is not assessable. AbbVie's opinion is that there is no reasonable possibility that the events of patches in scalp, lack of effect and headache are related to HUMIRA(ADALIMUMAB).  Causality of the events for BNT162B2 for the events vaccination site pain and headache was possible, for walking difficulty and injection site bleeding was not reported.  The reporter's assessment of the causal relationship of the events right side occipital stroke, patches in scalp, lack of effect, walking difficulty and injection site bleeding 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A contributory role of the suspect drug cannot be excluded for the reported events headache, vaccination site pain and vaccination site hemorrhage based on implied temporal association and known drug profile. Event cerebrovascular accident more likely represents an intercurrent medical condition in this 68 yo patient, and is considered unrelated to the suspect product. Drug ineffective in the context of this report appears to be referring to adalimumab, and is considered unrelated to BNT162B2. The remaining events (skin disorder and gait disturbance) are attributed to intercurrent or underlying medical conditions based on the information provided, and are considered unrelated to the suspect drug. This case will be reassessed upon receipt of additional information.