Sex: M
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: immunisation reaction; This is a spontaneous report received from a Consumer or other non HCP from License Party. Other Case identifier(s): 2023SA309940 (Sanofi), AE-016224 (BioNTech SE).  A 77-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; dupilumab (DUPIXENT), first regimen since 17Apr2023) at 600 mg 1x/day (600mg 1x (once)) and second regimen since 11Dec2023 (ongoing) (Lot number: 3F242A, Expiration Date: 30Apr2025) at 300 mg (300 mg qow (every other week)), all subcutaneous for dermatitis atopic. The patient's relevant medical history included: "rash" (ongoing), notes: At the time of the event, the patient had ongoing rash and skin lesion; "skin lesion" (ongoing), notes: At the time of the event, the patient had ongoing rash and skin lesion. Concomitant medication(s) included: CLARITIN [LORATADINE]. The following information was reported: IMMUNISATION REACTION (non-serious) with onset 2023, outcome "recovering". The action taken for dupilumab was dosage not changed. Therapeutic measures were taken as a result of immunisation reaction. Additional information: On 17Apr2023, patient started taking dupilumab solution for injection (strength: 300 mg/2ml) at a loading dose of 600mg 1x (once) followed by a maintenance dose of 300 mg QOW) (every other week) since 2023 subcutaneously for atopic dermatitis delivered via Dupixent single dose prefilled pen First lime product used: No. On an unknown date. the patient started taking Covid-19 vaccine (Formulation, dose, strength route, frequency,) for prophylactic vaccination. Patient had a reaction last week to his dupilumab injection. he spoke with his Dermatologist who believed it was cellulitis (event onset Oct2023 latency 7 month approximately). He started a new statin medication (name unspecified) that could had some He still had a rash and lesions and was waiting for dupilumab to cleat that up. His hair was falling Off his legs (Alopecia) (event onset 2023 unknown latency), Legs were swollen (Peripheral swelling) (feeling hot) red (Erythemal, warm (Skin warm) (event onset 2023 unknown latency). His heart rate had a:so dropped (Hear rate decreased) (even: onset 2023 unknown latency), He had a reaction to the covid vaccine  recently as well (immunization reaction) (event onset 2023 unknown latency). The provider advised to take Claritin and Benadryl and did not give antibiotic. was advised  may had been due the covid vaccine hence they did not give the antibiotic. Currently everything was getting back to normal. Patient was having reaction with the injections On their 1st time, when he got it  in the office, 600 mg, he did not had a reaction. When he did self-inject at home. the very first me, the injection swelled up, and it was warm, swelled up to 7-8 inches (injection site swelling) (event onset 2023 and latency unknown), Patient took Benadryl From that point on, every injection since then, they lake Benadryl after, much sooner, but still swelled up and still arm (injection site warmth) (even: onset 2023 and  latency unknown). it had gotten much better from 7-8 inches down to 2 inches swelling. He was not really noticing any difference taking the dupilumab (drug ineffective) (event Onset 2023 and  latency unknown). after 2 and half months. his doctor added light and al that point. he noticed that the crustiness slowed down (scab) (event onset and latency unknown), as well as the stinging itch now (pruritus) (even: onset and latency unknown), seemed be subsiding withing the last few days. Patient had his injection given today. Some of the medication drained down his leg once it was done (accidental exposure to product) (exposure via skin contact) (Onset date: 11Dec2023 and Latency: months 24 days) (batch number: 3F242A, expiry date on 30Apr2025). After confirming the lot number, patient checked his injections and found out that all the 4 pens that he had used and placed in the sharps container had the same lot number and expiration date. Patient explained that  What happened with his injection was that it looked like it either dripped out and a couple of drops didn't make into his leg. He said that he put 'he cove back on and placed the pens in the sharp continent so he  wouldn't get poked he try to retrieve Patient stated that if this happen again. he would know next time to hold on to the pen. Patient mentioned that he was not used to using the pen. He said he was told to squeeze his leg and then now he was being told that was not squeeze his leg before injections because that was only for kids. said he injected [he held it on, heard the clicks. then waited and waited, but when he  pulled it out, something was dripping on his leg. He said that il seemed like left a streak on his leg and crystalized. patient said that was just a few drops that leaked out or dripped out. The patient stated that the  product was no longer for return since he had no way of knowing which of the he on Monday 11Dec2023. It was unknown if the patient experienced any additional symptoms/events. was unknown if there were lab data/results available. Patient sent message of bilateral lower leg redness (injection site rash) (unknown Onset and latency). one leg was Where he injected dupilumab. Doctor believed to be hives (injection site urticaria) (unknown onset and latency) and unrelated cleared with Benadryl. Patient stated that it sometimes painful When he gives himself his injections with the pre-filled pens (injection site pain, unknown onset date), Wishes there were smaller needles. Also stated first injection gave him a 7" red circle around injection site (injection site erythema, onset date, If Sep2023 and latency, 4 months 29 days). He took Benadryl and was fine, No further information reported. In the follow-up version patient slated he wish they were al because they hurt to self-inject. Patient also stated he aways had a flare up near the injection site (dermatitis atopic) (Onset date and latency - unknown) but he took Benadryl and the rash go away. Patient stated during his last injection May2024 that his pen did not click when injected. when he took it out all of the medication spilled. Patient did not experience any additional symptoms/event. Patient staled. during last injection on 29May2024 his pen did not click When he injected, When he took it out, all of  the medication spilled. The patient repotted about 5 weeks ago, he "jerked" when the injection was in his skin A hen he removed the injection, the medication leaked Out. NO additional information available.  Reporter causality: Not Reported for dermatitis atopic, injection site warmth, scab, pruritus, injection site swelling. accidental exposure to product, exposure via skin contact, injection site urticaria, related for  injection site pain, injection site erythema, injection site rash; Unassessable for rest of the events.   Company causality: Reportable for injection site warmth. injection site swelling, injection site pain, injection site erythema, injection site urticaria, injection site rash and not reportable for rest of the events.   Company Comment: Company comment follow-up dated on 10Sep2024. New follow up information received does not change he previous assessment of this case and is not considered as medically relevant. This case involved 77 years old male patient who had cellulitis while being treated with dupilumab. Based on the limned information provided regarding this case, causal role of the company suspect product can be out. However, lack of information of patient's past medication and relevant medical history preclude comprehensive case assessment, The case will be re-assessed based on follow-up information would be received. Company comment follow-up dated 15Dec2023, New follow up information received does not change the previous assessment of this case and is no: considered as medically relevant.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.