Age: 78.0
Sex: M
Vaccine: RSV
Symptoms: Drug hypersensitivity, Pruritus, Urticaria, Urticaria thermal
Clinical narrative: an allergic reaction/clarified patient had full body hives/it did last, the presence of hives was anytime patient showered or would get warm for 3 months but on a much decreased basis; an allergic reaction to the RSV vaccine, Abrysvo; severe itching/full body hives; This is a spontaneous report received from a Nurse from medical information team.  A 78-year-old male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 06Dec2023 as dose number unknown, 240 ug/ml single (Lot number: HF5024, Expiration Date: Feb2025) at the age of 78 years, in left deltoid for immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: pfizer COVID vaccine (DOSE 5 (BOOSTER), SINGLE, NDC, lot, expiry: Thinks sees 6224, but not sure, is handwritten on vaccination card.), administration date: 29Sep2022, when the patient was 76-year-old, for COVID-19 immunization; Moderna covid-19 vaccine (DOSE 1, SINGLE), for Covid-19 Immunization; Moderna covid-19 vaccine (DOSE 2, SINGLE), for Covid-19 Immunization; Moderna covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunization; Moderna covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), for Covid-19 Immunization; Novavax covid vaccine (DOSE 6 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: ALLERGY TO VACCINE (medically significant) with onset 09Dec2023, outcome "recovering", described as "an allergic reaction to the RSV vaccine, Abrysvo"; URTICARIA (medically significant) with onset 09Dec2023, outcome "recovering", described as "an allergic reaction/clarified patient had full body hives/it did last, the presence of hives was anytime patient showered or would get warm for 3 months but on a much decreased basis"; PRURITUS (medically significant) with onset 09Dec2023, outcome "recovering", described as "severe itching/full body hives". Clinical course details: Indication also reported as "Because of age". The reporter is a retired Registered Nurse and is also the wife of the patient. The patient received the vaccine on 06Dec2023, and the reaction, full body hives, showed up 09Dec2023. Patient took Benadryl for 3 days, on the third day got in to see doctor and doctor prescribed Prednisone and another antihistamine (unknown name). Did decrease, was effective for the severe itching, severe hives. Thinks it was a 10 day course of Prednisone with decreasing dose, if not two weeks. Problem is, it did last, the presence of hives was anytime patient showered or would get warm for 3 months but on a much decreased basis. Doctor didn't need to re-prescribe, patient rode it out. Caller was tracking it, paying attention. At the end of 3 months, would say patient was relatively symptom free. Confirmed full body hives are not ongoing at this time. Patient had no respiratory component with this or wheezing or caller would have taken patient in right away. The patient has never had a reaction to a vaccine prior to this, has no food allergies. Patient has no comorbidities and no preexisting conditions. The reporter's question to Pfizer is if there was any data on allergic reactions or journal articles to review regarding Abrysvo. Concern about patient was looking at fall vaccines, patient would get a COVID vaccine and flu vaccine, stating patient has had six total COVID vaccines. Clarified the patient had four Moderna COVID vaccine doses, and then one dose of the Pfizer COVID vaccine, and then Novavax COVID vaccine. The events "an allergic reaction/clarified patient had full body hives/it did last, the presence of hives was anytime patient showered or would get warm for 3 months but on a much decreased basis", "an allergic reaction to the rsv vaccine, abrysvo" and "severe itching/full body hives" required physician office visit. Therapeutic measures were taken as a result of urticaria, allergy to vaccine, pruritus.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported event based on the known safety profile and temporal association.   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.