Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain upper, Anxiety, Asthenia, Back pain
Clinical narrative: legs were swollen; difficulty breathing; chest pain; rash / on both ankles that spread up to thighs and to the middle of the spine and hips.; loss of appetite; felt like she was going to pass out; weakness; sick on stomach; diarrhea; cramping in stomach; soreness in both arms and shoulders/leg pain; back pain; fever of 101 degrees; being tired; felt drunk like; pain around the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included esomeprazole magnesium (Nexium) and simvastatin.   On 10th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 10th September 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On 11th September 2020, the patient experienced feeling drunk and tiredness. On 12th September 2020, the patient experienced impending doom, weakness, stomach discomfort, diarrhea, stomach cramps, pain in extremity, back pain and fever. On 13th September 2020, the patient experienced rash and appetite lost. On 16th September 2020, the patient experienced swelling of legs, difficulty breathing and chest pain. The patient was treated with paracetamol (Tylenol) and prednisone. Shingrix was discontinued. On 17th September 2020, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the injection site pain, feeling drunk, impending doom, weakness, pain in extremity, back pain, difficulty breathing and chest pain were recovered/resolved and the outcome of the tiredness was recovering/resolving and the outcome of the stomach discomfort, diarrhea, stomach cramps, rash, appetite lost and swelling of legs were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, feeling drunk, impending doom, tiredness, weakness, stomach discomfort, diarrhea, stomach cramps, pain in extremity, back pain, fever, appetite lost, swelling of legs, difficulty breathing and chest pain to be related to Shingrix. The reporter considered the rash to be related to Shingrix.  Additional details were reported as follows: The patient concomitant drugs are Nexium and Simvastain. The patient received 1st dose of Shingrix vaccine in the right arm and less than a day pain around the injection site which began in the evening after being vaccinate and had resolved. The patient reported, 1 day after vaccination felt drunk like she had been given a sedative and this has resolved and being tired and this was still ongoing till the time of reporting. The patient reported, 2 days after vaccination that had weakness and felt like she was going to pass out, soreness in both arms and shoulder and back pain and these had resolved till the time of reporting, but felt sick on stomach, diarrhea and cramping in stomach are still ongoing till the time of reporting. The patient reported fever 101 degree on 2 day after vaccination and was treated with Tylenol and got resolved on 17th September 2020. On 3 days after vaccination reported rash on both ankles that spread up to thighs and to the middle of the spin and hips. The patient reported used Aveeno lotion and bath with baking soda but these did not help and made the rash worse. The patient reported went to the physician on 15th September 2020 and was given a steroid cream for the rash but rash continued to get worse. On 16th September 2020, the patient reported leg pain both legs and went back to physician and was given Prednisone and got resolved till the time of reporting. The patient said still has rash up to both thighs but it was better till the time of reporting. The patient said that both physician said that the rash was not shingles but a reaction form the vaccine. The both legs were swollen and this was still ongoing currently around the ankles. The patient found difficulty in breathing for which she got an inhaler to use as well as chest pain and both of these had resolved till the time of reporting. The patient reported her physician told her not to get the 2nd dose of Shingrix based on these events. The reporter consented to follow up.