Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Feeling abnormal, Paraesthesia, Peripheral swelling, Urticaria
Clinical narrative: It feels like pins are sticking into his sides and ribs and waistline and it hot to the touch.; feels like blood is fighting the whole time.; On 02Mar2021 he received his second covid vaccine, which was 4 days after Ilumya shot.; hives; Leg swelling; This is a spontaneous report from a contactable other HCP pharmacist. A male patient of an unspecified age received bnt162b2 (Pfizer COVID Vaccine, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 02Mar2021 14:00 as 2nd dose, single for covid-19 immunisation and tildrakizumab ASMN (ILUMYA), via an unspecified route of administration from 26Feb2021 to unspecified date. Medical history included psoriasis. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The concomitant medications included steroids; fluid pills started from Unspecified to stop date was Unspecified. The patient did not receive any other vaccines within four weeks prior to the vaccination. Family Medical History Relevant to AE was Not provided. The patient previously took bnt162b2 as first dose on 09Feb2021 for covid 19 immunisation and experienced Big red, warm splotches up and down sides. On an unspecified date the patient experienced, it feels like pins are sticking into his sides and ribs and waistline, it hot to the touch and feels like blood is fighting the whole time. On Apr2021, the patient experienced leg swelling. On 09Apr2021, the patient experienced hives. Reporter stated that when she talked with the patient, he told reporter that after his second COVID shot on 02Mar2021 he got a reaction. The second COVID shot was 4 days after the Ilumya shot. Patient said he got his COVID shot around 2:00pm and his reaction started about 8:00pm that night and he went dermatologist who put him on steroids for 2 weeks. Then on 09 Apr 2021, he got the second Ilumya shot. Patient told reporter that he broke out with hives again on that night and was started on steroids again for 2 weeks. Reporter stated that patient's legs began to swell really bad, so his family doctor gave him some fluid pills to help get the fluid off of his legs. Patient says that each time he takes the Ilumya shot he gets really bad hives on his side around his waistline and part of his back and he still has them right now. Patient was miserable the whole time, 24/7. It feels like pins are sticking into his sides and ribs and waistline and it hot to the touch. He had no issues with his first Ilumya shot or first covid shot but Since getting both, he was not sure if there might be some interaction. He did not have any problems until after his second COVID vaccine. No Relevant Tests were provided. Therapeutic measures were taken as a result of leg swelling (peripheral swelling). Investigation Assessment was Unknown. The outcome of the events was unknown.  Information on the lot/batch number has been requested. ; Sender's Comments: Considering a plausible temporal relationship and known product safety profile, a possible contributory role of suspect product BNT162B2 to the reported events Leg swelling, hives, Paraesthesia, feeling abnormal 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.