Sex: U
Vaccine: HEP
Symptoms: Dyspnoea, Electrocardiogram, Laboratory test, Palpitations
Clinical narrative: Shortness of Breath; Racing Heart; Initial Report  Received on 19-Jun-2019, 20-Jun-2019 (non-significant), and 21-Jun-2019   A regional business director from Dynavax reported that the safety and compliance manager and the office assistant for risk management for the county office reported that patient, a 26 year-old female patient (race not provided), received the second injection of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and developed "shortness of breath and a racing heart."   Relevant medical history was not reported.   Concomitant medications were not reported.   On 08-May-2019, the patient received the first injection of HEPLISAV-B in  the left deltoid (lot # 1036463, expiration date 28-Jul-2019, NDC # unknown). The vaccine was administered by a medical assistant.   On 18-Jun-2019 in the morning at an unspecified time, the patient received the second injection of HEPLISAV-B at the left deltoid via a vial (lot #103643, expiration date 28-Jul-2019, NDC # unknown). The vaccine was administered by a certified medical assistant. The injection was administered at the occupational health provider for County. It was unknown who the prescribing physician was at the time of this report. At approximately 11:30 a.m., the office assistant for risk management for the county office received notification from the patient's supervisor stating that the patient was having shortness of breath and her heart was racing. According to the emergency room documentation, the safety and compliance manager for the county office was on hand when the patient arrived at the emergency room at 3:30 p.m. The patient was treated by a physician. The patient was monitored, an electrocardiogram (EKG) was performed, lab work was done, and Benadryl (diphenhydramine) was administered (unknown route). The patient was released the same day with instructions to continue with oral Benadryl (diphenhydramine) for symptoms. The episode resolved according to the safety and compliance manager and the office assistant for risk management for the county office, who spoke with the patient in the afternoon on this date.   On 19-Jun-2019, the regional business director at Dynavax reported that the above event was reported to him on this date and that he would have the person call back. On this date, the patient was able to return to work. The safety and compliance manager of the county office did not have information regarding the prescribing physician information. The safety and compliance manager of the county office stated that he was awaiting the records from Medical office and would email when available.   At the time of this report, the events were considered recovered.    The reporter did not provide a seriousness assessment for this event.   Company comment: The company assessed the events of "shortness of breath and a racing heart" as non-serious. As only limited information has been obtained to date, a cause and effect relationship between HEPLISAV-B and the reported events cannot be assessed. The events of "shortness of breath and a racing heart" are unlisted per HEPLISAV-B USPI.; Sender's Comments: The company assessed the events of "shortness of breath and a racing heart" as non-serious. As only limited information has been obtained to date, a cause and effect relationship between HEPLISAV-B and the reported events cannot be assessed. The events of "shortness of breath and a racing heart" are unlisted per HEPLISAV-B USPI.