Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Anaphylactic reaction, Feeling abnormal, Incorrect route of drug administration, Malaise, Pharyngeal oedema
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of Stevens Johnson syndrome in a 55-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included hypertension (the patient was currently taking blood pressure medicines, it might be amlodipine). Concomitant products included amlodipine. In May 2018, the patient received SHINGRIX (subcutaneous) .5 ml. In May 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On 19th June 2018, the patient experienced weird feeling (serious criteria other: as per reporter). On 20th June 2018, the patient experienced jaw movements disturbance (serious criteria other: as per reporter). On an unknown date, the patient experienced Stevens Johnson syndrome (serious criteria GSK medically significant and other: as per reporter), anaphylaxis (serious criteria GSK medically significant and other: as per reporter), facial swelling (serious criteria other: as per reporter), felt ill (serious criteria other: as per reporter) and throat swelling (serious criteria other: as per reporter). The patient was treated with Antibiotics (Brand Names Not Known) and BENADRYL. On an unknown date, the outcome of the Stevens Johnson syndrome, anaphylaxis, facial swelling, weird feeling and jaw movements disturbance were not recovered/not resolved and the outcome of the felt ill was recovered/resolved and the outcome of the throat swelling and intramuscular formulation administered by other route were unknown. The reporter considered the Stevens Johnson syndrome, anaphylaxis, facial swelling, weird feeling, jaw movements disturbance, felt ill and throat swelling to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient's wife. The healthcare professional called to ask about her husband. The healthcare professional reported that one day after receiving the SHINGRIX vaccine, unsure of date, sometime at the end of May, the patient felt ill. Seven days after receiving, SHINGRIX the patient developed anaphylaxis (symptoms were facial and throat swelling, not diagnosed with anaphylaxis) and he was treated at the hospital with antibiotics as they suspected strep throat due to facial and throat swelling. Eight days after receiving the SHINGRIX, the patient still had facial and throat swelling and he went back to hospital, they prescribed steroids, still suspected strep throat. On 9th day, the patient was still not felt well and called hospital, they said go to the emergency room for facial and throat swelling. An emergency room was continued with strep suspicion and continued with steroids. The patient was called to emergency room and later said that strep was ruled out and told patient that he had Stephen Johnson's Syndrome. Several days, after receiving SHINGRIX, the patient experienced Stephen Johnson's Syndrome. The healthcare professional stated, several weeks, after receiving SHINGRIX, the patient felt funny on the day before reporting. Several weeks, after receiving SHINGRIX, on the day of reporting the patient had cheek swelling and decreased range of motion (ROM) in jaw, the patient took BENADRYL and went to the hospital and was seen. The patient sent home without intervention. Once home he took more BENADRYL and was sleeping. It was told by hospital that SHINGRIX was given wrong by nurse friends. The patient received SHINGRIX via subcutaneous route and should have been intramuscular, which led to inappropriate route of vaccination. The hospital did not provide any details when the reporter asked them about it and they told this was not because of the vaccine. The healthcare professional did not have vaccine or administration details and stated that they did not report this adverse event as they did not felt it was related to the vaccine.