Received Nov 19, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | No batch number | RA |
Hereditary angioedema attack reported as HAE attack; Site where they gave her the flu shot was swollen; Site where they gave her the flu shot was itchy; Site where they gave her the flu shot was a little sore; Itching so profusely on her ancle and knee; Left hand is puffy; Bruising on arms from itching; Intense itching and burning; This spontaneous case, initially received on 07-Nov-2025, was reported by a non health professional and concerns an elderly female patient. Concomitant medication: refer to appropriate report section, also included blood pressure and cholesterol medications. Administration of company suspect drug: On 04-Nov-2025, the patient received Influenza virus vaccine for Indication not reported, Dose regimen: not reported, route of administration: not reported, Anatomical location: Right arm, Lot number: No batch number available and would be requested upon follow up. Non-company suspect drugs: Haegarda (Complement C1 esterase inhibitor), Indication: Every 4-5 days dosing in the context of prophylaxis, HAE. The patient also received Haegarda on 07-Nov-2025, Dose regimen: not reported, route of administration: not reported, Lot number: Not reported. Adverse reactions/events and outcomes: On 06-Nov-2025, the patient experienced Itching so profusely on her ankle and knee (outcome: Unknown), Left hand is puffy (outcome: Unknown), Bruising on arms from itching (outcome: Unknown), Intense itching and burning (outcome: Unknown). On an unknown date, the patient experienced Hereditary angioedema attack reported as HAE attack (Medically Significant, outcome: Not Reported), Site where they gave her the flu shot was swollen (outcome: Recovering / Resolving), Site where they gave her the flu shot was itchy (outcome: Unknown), Site where they gave her the flu shot was a little sore (outcome: Unknown). The patient had called and stated that she used Haegarda for HAE. The patient informed that she had gone to her primary care doctor for a checkup and had received the flu shot on her right arm on Tuesday morning. The patient stated that the site where they had given her the flu shot was swollen and a little sore and itchy. The patient did not know which flu shot she had taken. The patient obtained Haegarda from pharmacy and she had taken a dose that day after experiencing severe symptoms following the flu shot. The patient stated that the previous day she had itching so profusely on her ankle and knee that she had applied hydrocortisone on it. The patient stated that that morning her hands and arms had itched so badly that she now had bruising on her arms from itching intensely. The patient informed that her left hand was puffy. The patient reported intense itching and burning. The patient stated that the itching had subsided because she had used a lot of hydrocortisone. The hydrocortisone had helped and her skin had calmed down although she had bruises now from the itching. The patient stated Haegarda worked like a charm for her and she had been on it for years. The patient stated this had not been a full-fledged outbreak; it had started with swelling at the flu shot injection site and had almost gone down. The patient did not believe her symptoms were due to Haegarda. The patient stated her symptoms were the same she got just before she had an HAE attack. The patient informed she did not take many other medications - only lisinopril, blood pressure and cholesterol medications, and Sertraline for depression. The patient stated she had last used Haegarda on Sunday or Monday and then that day due to this issue. The patient stated she had never had an issue with Haegarda. The patient stated she had trashed the bottle she had used that day but had provided the lot for another bottle that she had. Case was upgraded to serious upon company assessment of the reported event (Hereditary angioedema attack reported as HAE attack) clinical significance. Influenza virus vaccine action taken: Not Applicable Treatment medication: Hydrocortisone Reporter's assessment: The primary reporter considered the events as non-serious and causality assessment was not reported.; Reporter's Comments: Causality: Due to the spontaneous nature of the case, events are considered related for reporting purposes. Considering close anatomical proximity for vaccination site pain, vaccination site swelling and vaccination site pruritus. Considering plausible temporal relationship for events pruritus, peripheral swelling and intense burning and itching (2 days post vaccination). The event contusion is attributed to intense itching which led to bruising on arms. The event HAE attack is attributed to underlying condition of hereditary angioedema (attributed to co-suspect medication Haegarda).
Lisinopril; Sertraline; Hydrocortisone; Haegarda