Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Productive cough, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received SHINGRIX (batch number 4492P, expiry date April 2019) for prophylaxis. Previously experienced adverse reactions included low density lipoprotein cholesterol (started in 2014) and anterior ischemic optic neuropathy (started in 2014). Previously administered products included BREO ELLIPTA with an associated reaction of optic ischemic neuropathy (the patient started the therapy somewhere before 2014, refer case US2018105435). Concurrent medical conditions included bronchitis (prior to BREO ELLIPTA therapy). Concomitant products included diazepam, NEURONTIN, Aspirin, PLAVIX, PREVACID, WELLBUTRIN, Acetaminophen, prazosin and REPATHA. On 9th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 9th June 2018, 3 hrs after receiving SHINGRIX, the patient experienced injection site pain, fever and shivering. On 10th June 2018, the patient experienced injected limb mobility decreased, loss of energy, productive cough, general body pain and feeling unwell. The patient was treated with ZITHROMAX. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the injected limb mobility decreased, fever and shivering were recovered/resolved and the outcome of the loss of energy, productive cough and general body pain were not recovered/not resolved and the outcome of the feeling unwell was unknown. The reporter considered the injection site pain, injected limb mobility decreased, fever, shivering, loss of energy, productive cough, general body pain and feeling unwell to be related to SHINGRIX. Additional information was reported as follows: The patient took PROAIR as a concomitant medication. It was guessed at the time of reporting that BREO ELLIPTA was ordered to help the patient's breathing and to keep her lungs clear. After vaccination with SHINGRIX, arm pain was described to be at the site of injection and was so severe she was unable to lift up that arm. On the date of vaccination, Saturday, about 11 pm in the night, the patient experienced fever and shivering. The patient's fever was reported to be 100.6 degrees. The patient's pulmonologist had provided her previously with a ZITHROMYCIN antibiotic which she had on hand to use if needed as directed preventatively for bronchitis. The patient had decided to start the ZITHROMYCIN antibiotic last night before the date of reporting, because of the symptom of coughing up green mucus. As a results of administration of ZITHROMYCIN antibiotics, on the date of reporting, the green mucus had changed to yellow in color. At the time of reporting, the patient was still feeling generally unwell described as not having any energy. Because the patient had an insurance change she was not able to visit her pulmonologist due to cost and so did not make an appointment for the recent symptoms of cough with mucus. She was referred to her healthcare provider to report all symptoms before the call ended. The patient has denied permission to contact her physician. The reporter was called back, who said that she had not had bronchitis since starting BREO ELLIPTA therapy but her that the recent pulmonologist liked to stay ahead of any bronchitis and ordered the antibiotic proactively to use as needed in case she would have any bronchitis symptoms. This case was linked with case US2018105435 (case for BREO ELLIPTA therapy), reported by the same reporter for the same patient.