Received Mar 19, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
burning sensation; erythema; facial and periorbital swelling; facial and periorbital swelling; Literature Report. This literature report was received from the authors of a published literature article, titled as stated above, and refers to a 45 -year-old female patient. The patient's concurrent condition included migraines. The patient's concomitant medication included Onabotulinumtoxin A. The patient's past medications were not reported. On an unknown date, the patient was vaccinated with first Hepatitis B Vaccine (Recombinant) (manufacturer unknown) and on an unspecified date in November 2024, received the second dose, both for prophylaxis (strengths, specific dosages, routes of administration, anatomical sites of application, lot numbers and expiration dates were not provided) On an unspecified date in 2024 (reported as one week after the second dose of Hepatitis B Vaccine (Recombinant) (manufacturer unknown)), she developed facial (Swelling face) and periorbital swelling, erythema and burning sensation for several days that improved with cold compress applications. Over the span of one month, she had two similar exacerbations. She denied systemic symptoms and other allergic diseases including hives. The clustering of symptoms following vaccination and higher-dose onabotulinumtoxin A exposure suggest a vaccine-induced immune modulation, stimulating a type IV hypersensitivity response at prior injection sites which ultimately resolved (recovered). The causal relationship between the event and suspect therapy was considered to be related, as the author stated: exposure suggest a vaccine-induced immune modulation. A copy of the published article is attached as further documentation of the patient's experience.
Migraine
OnabotulinumtoxinA