Age: 44.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Paraesthesia, Pruritus, Throat tightness
Clinical narrative: Initial Report Received: 08-Jun-2018. Patient is a 44-year-old woman (race not provided) who was administered with HEPLISAV-B for hepatitis B immunization. The patient reported that she developed the non-serious events of itching all over including the soles of feet and palms of hands, flushing, needle pricking feeling in arms and back of thighs, injection site warm to touch, injection site itchy, injection site inflammation, injection site quarter-sized redness, sharp pain like bee sting in the area of the injection on the left deltoid, and drowsy from antihistamine. Relevant medical history included a previous hepatitis B vaccination (name unknown) in 2003 in which the patient received 2 doses and had a reaction of flu-like symptoms, dizziness, and ear ache. The patient reported that these reactions were worse than the current reactions reported. Allergies included some metals, nickel, and "sometimes latex". Relevant concomitant medications included Vitamin C. The patient had a titer drawn which showed no immunity.  She was required to be vaccinated for her job, and chose HEPLISAV-B. The patient received the first injection of 0.5 mL of HEPLISAV-B in the left deltoid (Lot # 1033385, expiration 11-May-2019) on 05-Jun-2018 at approximately 10:00 AM. On 06-Jun-2018, the day after having received the first injection of HEPLISAV-B, at approximately 11:00 AM, the patient was sitting at her desk when she felt a sharp pain like a bee sting in the area of the injection on the left deltoid. She began to itch all over including the soles of her feet and palms of her hands, and began to have flushing episodes. The patient left work and took an antihistamine and called her doctor, but was unable to get in to see the doctor on that day. She became drowsy from the antihistamine. On 07-Jun-2018, the patient reported that the itching continued, and she was taking the antihistamine that helped but made her drowsy. During the times when the itching subsided due to the antihistamine, the patient still felt a needle pricking feeling in her arms and the backs of her thighs, where she stated, "I seem to move most". The patient went back to the Health Department. The patient reported that the nurse said that the injection site was red and warm to the touch, and the patient reported a quarter-sized area of redness and inflammation that was itchy. The patient also saw her doctor who informed her to continue with the antihistamine. Her physician also told her to take the next HEPLISAV-B dose. The nurse verified that she administered the vaccine injection, and provided the lot number and expiration date for HEPLISAV-B. At the time of the report, the events were all ongoing. The reporters did not provide a seriousness assessment for the events. Company comment: The company assessed all events as non-serious. The events of pruritus generalized, flushing, paraesthesia, injection site warmth, injection site pruritus and somnolence are unlisted per HEPLISAV-B USPI, and the events of injection site inflammation, injection site redness and injection site pain are listed per HEPLISAV-B USPI. Sender's Comments: Company comment: The company assessed all events as non-serious. The events of pruritus generalized, flushing, paraesthesia, injection site warmth, injection site pruritus and somnolence are unlisted per HEPLISAV-B USPI, and the events of injection site inflammation, injection site redness and injection site pain are listed per HEPLISAV-B USPI.