Sex: U
Vaccine: HEP
Symptoms: Blood pressure decreased, Chest discomfort, Ear discomfort, Extra dose administered, Hypersensitivity
Clinical narrative: Allergic Reaction; Throat tightness; Chest Tightness; Low Blood Pressure; Diffused Hives; Ears Tightness; 3 Injections Given; Initial Report Received on 08-Nov-2019  A 26-year-old female nurse (race not reported) reportedly received 3 injections of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and developed an unknown allergic reaction.   Relevant medical history and concomitant medications were not provided.   On 30-Aug-2019, the patient received the first injection of Heplisav-B (lot #, expiration date, and NDC # not reported). The vaccine was administered via a prefilled syringe.   On 30-Sep-2019, the patient received the second injection of Heplisav-B (lot #933841, expiration date, and NDC # not reported). The vaccine was administered via a prefilled syringe.   On 31-Oct-2019, the patient received the third injection of Heplisav-B (lot #399838, expiration date, and NDC # not reported). The vaccine was administered via a prefilled syringe.   On 08-Nov-2019, Dynavax received a voicemail from a nurse. The nurse reported that they had a female nurse in her 20-30s that received her first dose of HEPLISAV-B on 30-Aug-2019, that they forgot to chart. On 30-Sep-2019 and 31-Oct-2019, the patient received a second and third injection of HEPLISAV-B, respectively. The injections were administered at the left deltoid. After the third injection, while driving home, the patient started to have an allergic reaction.  She drove herself to the emergency department. The patient developed diffused hives, her throat, chest, and ears started to tighten, and she had a low blood pressure of 89/68 upon arrival to urgent care. Treatment with Epipen (epinephrine) 0.03 mg x 2, methylprednisolone shot, and Benadryl (diphenhydramine) were administered. The patient fully recovered and was released. At the time of this report, her status was stable and within normal limits.   At the time of the report, the events were considered recovered.   The reporter did not provide a serious assessment for the event.   Company comment: The company assessed the events of hypersensitivity, throat tightness, chest discomfort and hypotension as serious, and the events of urticaria, ear discomfort and extra dose administered as non-serious. Based on the temporal relationship, the events of hypersensitivity, throat tightness, chest discomfort and hypotension occurred after the third dose of Heplisav-B, a causal association between the events and Heplisav-B is possible. The events of hypersensitivity, throat tightness, chest discomfort, ear discomfort, urticaria, hypotension and extra dose administered are unlisted per Heplisav-B USPI.; Sender's Comments: The company assessed the events of hypersensitivity, throat tightness, chest discomfort and hypotension as serious, and the events of urticaria, ear discomfort and extra dose administered as non-serious. Based on the temporal relationship, the events of hypersensitivity, throat tightness, chest discomfort and hypotension occurred after the third dose of Heplisav-B, a causal association between the events and Heplisav-B is possible. The events of hypersensitivity, throat tightness, chest discomfort, ear discomfort, urticaria, hypotension and extra dose administered are unlisted per Heplisav-B USPI and IB.