Age: 49.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Hepatic enzyme abnormal, Hepatitis B antibody negative, Herpes zoster, Inappropriate schedule of product administration, Injection site induration
Clinical narrative: She reports inflammation on T-12 of her spine; Persistent migraine and headaches; She was healthy and is now deteriorating; Pain symptoms of lupus; Hepatitis B antibody negative; Patient reports abnormal liver enzymes requiring surgery; Recent 25 pound weight loss; Right upper quadrant pain persisted; Confirmed Bell's Palsy of the 7th cranial nerve; After the second injection, she developed a horrible earache, pain on the left side, and a burning sensation of the left side of her throat; First dose 02 Jan 2015, second dose 10 Feb 2015 (more than 1 month); The vaccine may have activated shingles; Her vision was horrible; She had sores on the inside of her mouth on the left side/She cannot eat food on the left side of her mouth; She had rash on the left side of her face; She was feverish; Developed a rash on her left arm; The area at the injection site of her left arm was hard like a rock after the first injection; This spontaneous report was received from a female patient of unknown age concerning to herself. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On 02-JAN-2015 (discrepant information, also reported as four years ago), the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (lot # J013394, expiration date reported as 25-OCT-2016, but upon internal review stablished as 25-AUG-2016), (strength, route of administration not provided) in the left arm. On an unspecified date, she had a test that showed that she did not have hepatitis B antibodies. On an unspecified date in 2015, after the first dose, the patient stated that she was feverish (pyrexia), developed a rash in the left arm, and that the injection site area was "hard like a rock" (injection site induration).  On 10-FEB-2015, the patient was vaccinated with the second dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) (lot # K010535, expiration date: 27-AUG-2016). On approximately 12-FEB-2015 (reported as by the second day after the vaccine injection, inappropriate schedule of product administration), the patient developed a horrible earache (ear pain), pain on the left side of her face, and a burning sensation on the left side of her throat (throat irritation). She called her primary care physician (PCP) and received unspecified ear drops, but it did not work, as she continued with the pain. She also continued experiencing pain in her left eye and jaw and continued feverish. On 13-FEB-2015, the patient was at her home and she her left eye was dry and uncomfortable, and the left side of her nose and mouth was "droopy". On 14-FEB-2015, she stated that she had a pain on the left side of her face that looked like she had a stroke, but she took her blood pressure to rule it out; besides, her speech was "funny" (speech disorder); therefore, the physician advise her to go to the emergency room, but she did not do it. Instead, she saw the physician on 15-FEB-2015 (also reported as Monday), and she was performed a computed tomography (CT) scan and a magnetic resonance imaging (MRI) that confirmed Bell's Palsy of the 7th cranial nerve, also, this was confirmed by her eye doctor, one to two weeks after second dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB). She also stated that she wore a patch on her left eye for six months because she could not close her eye or blink (corneal reflex decreased). Moreover, she stated that her vision was horrible (visual impairment). Patient said that her eye doctor stated that the vaccine might have activated shingles (herpes zoster). Also, she had sores on the left side inside of her mouth (stomatitis), as well as rash on the left side of her face, and that she could not eat food on the left side of her mouth.  The patient saw an ear, nose and throat (ENT) and an unspecified specialist that confirmed Bell's palsy. As treatment for this event, she had received two surgeries from a plastic surgeon to help close her eye and to blink, onabotulinumtoxinA (BOTOX) injections every 3 months to help with the spasms of her face, and acupuncture. In addition, she was performed an unspecified test "with cables attached to her head" which showed that the right side of her face reacted normally but the nerves on the left side did not react like if they were dead. On an unspecified date in May 2015 (reported as 3 months after second dose of vaccine), she received consultation by ENT and was told that Bell's Palsy damage would be for life. Even though she went to physical therapy and helped with facial spasms on the left side of her face, eventually was stopped due to lack of improvement.   On an unspecified date in 2018, the patient underwent a procedure (also reported as surgery) for abnormal liver enzymes, and a recent 25 pound weight loss. Even though and ultrasound showed that everything was normal with her liver, the pain in her right upper quadrant (abdominal pain upper persisted). On an unspecified date, she was evaluated for "rheumatoid" due to pain symptoms of Lupus, but she was not diagnosed with lupus, for which she was taking unspecified medication and steroids. She also reported to take hydroxychloroquine (PLAQUENIL) for unspecified reason.  On an unspecified date, the patient was diagnosed with inflammation on thoracic (T)12 of her spine for which she had received unspecified epidural injections and for the left side of her face to alleviate pain and spasms. Moreover, she had persistent migraine headaches treated with erenumab (AIMOVIG) monthly, and the patient stated that after this events, her health was deteriorating and it was horrible.   The reporter considered shingles to be related to Hepatitis B Vaccine (Recombinant)(RECOMBIVAX HB). The causality assessment between the remaining events and the vaccine were not reported.  The reporter considered Bell's Palsy as a disability event. Upon internal review, Bell's Palsy was determined to be medically significant.