Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Pruritus, Urticaria
Clinical narrative: Pfizer Bivalent booster: hives everywhere; Pfizer Bivalent booster: Itching; Event: Pfizer Bivalent booster: hives everywhere was reported as worsened/Itching was reported as worsened; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 34-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 34 years intramuscular, in right deltoid for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: moderna (Dose: 1, Had Moderna vaccine for his first two Covid doses , Moderna was intramuscular), administration date: 04Jan2021, when the patient was 33-year-old, for Covid-19 immunization; moderna (Dose: 2, Had Moderna vaccine for his first two Covid doses , Moderna was intramuscular), administration date: 01Feb2021, when the patient was 33-year-old, for Covid-19 immunization; BNT162b2 (DOSE 3 (INITIAL PFIZER DOSE), SINGLE, Batch/lot number: FJ1620, unknown dose intramuscularly one shot right deltoid , First time was after he got his booster was on 26Nov2021, Time the Vaccination Was Given: 0900, first time he had hives they lasted two weeks., Put some Benadryl the first time he had hives), administration date: 26Nov2021, when the patient was 33-year-old, for Covid-19 immunization, reaction(s): "Pfizer Covid vaccine: hives everywhere", "Had Moderna on 04Jan2021 and the second Moderna on 01Feb2021", "Had Moderna on 04Jan2021 and the second Moderna on 01Feb2021"; flu shot (Had flu shot on the same date as the Pfizer Covid vaccine. Manufacturer, dosage and formulation not provided.), administration date: 26Nov2021, when the patient was 33-year-old, for immunisation. The following information was reported: CONDITION AGGRAVATED (disability) with onset 2022, outcome "not recovered", described as "Event: Pfizer Bivalent booster: hives everywhere was reported as worsened/Itching was reported as worsened"; PRURITUS (disability) with onset 25Sep2022, 3 days after the suspect product(s) administration, outcome "not recovered", described as "Pfizer Bivalent booster: Itching"; URTICARIA (disability) with onset 25Sep2022, 6 days 15 hrs after the suspect product(s) administration, outcome "not recovered", described as "Pfizer Bivalent booster: hives everywhere". Therapeutic measures were taken as a result of urticaria, pruritus, condition aggravated.  Clinical course: Caller stated that he had the Covid vaccine and had delayed reactions and hives to it everyday. Hives were everywhere. Was after both doses. First time was after he got his booster was on 26Nov2021. Couple of weeks after he had hives thought nothing of it and they went away after a couple of days. Had the Pfizer Bivalent booster and noticed hives about couple of days after which had lasted a month to today. Was still having daily hives everyday. Had the Pfizer Bivalent booster on Sep2022. Had Moderna vaccine for his first two Covid doses in Jan2021 and then 28 days later. Manufacturer of Moderna was Moderna. Moderna was intramuscular. Moderna was a mix for reconstitution. Dose for Moderna was unknown. Had Moderna on 04Jan2021 and the second Moderna on 01Feb2021. Clarified delayed reactions as the reactions were not immediate; was not like he walked out and had hives the same day but that it took about a week before the hives showed up. Had flu shot on the same date as the Pfizer Covid vaccine. Manufacturer, dosage and formulation not provided. Wanted advice, to know if they had heard reports from other people and know what to do. Wanted to know if people recommended to do other treatments or therapies. Hives are lasting a lot longer. Is not even sure what to do with them. Later clarified that the first time he had hives they lasted two weeks. Now he is walking around itching and with hives all day. Treatment reported as put some Benadryl the first time he had hives. Had Pepcid and put on Benadryl the second time he had hives. The patient did not receive any other vaccines within four weeks prior to the vaccination. Family medical history relevant to ae(s) were reported as none. Relevant tests were reported as none.; Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events Urticaria, Interchange of vaccine products, Condition aggravated, Pruritus and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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.