Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Clostridium test positive, Cough, Diarrhoea, Fatigue, Groin pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of diarrhea, clostridium difficile in a 66-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis and Amoxicillin + Clavulanic Acid unknown for sore throat and lymphadenopathy cervical. On 12th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 26th April 2018, the patient started Amoxicillin + Clavulanic Acid at an unknown dose and frequency. On 12th April 2018, not applicable after receiving SHINGRIX and Amoxicillin + Clavulanic Acid and unknown after receiving SHINGRIX, the patient experienced incomplete course of vaccination. On 14th April 2018, the patient experienced influenza-like symptoms, lymph node pain, axillary pain, groin pain, pain, cough, fatigue, weakness, chest pain, headache, runny nose, fever and chills. On 26th April 2018, the patient experienced sore throat and lymphadenopathy cervical. On 8th May 2018, the patient experienced diarrhea, clostridium difficile (serious criteria GSK medically significant). The patient was treated with metronidazole and vancomycin. The action taken with Amoxicillin + Clavulanic Acid was unknown. On 26th April 2018, the outcome of the fatigue, weakness and chest pain were recovered/resolved. On 18th October 2018, the outcome of the diarrhea, clostridium difficile was recovered/resolved. On an unknown date, the outcome of the influenza-like symptoms, lymph node pain, axillary pain, groin pain, pain, cough, headache, runny nose, fever, chills, sore throat and lymphadenopathy cervical were recovered/resolved and the outcome of the incomplete course of vaccination was unknown. It was unknown if the reporter considered the diarrhea, clostridium difficile, influenza-like symptoms, lymph node pain, axillary pain, groin pain, pain, cough, fatigue, weakness, chest pain, headache, runny nose, fever, chills, sore throat and lymphadenopathy cervical to be related to SHINGRIX. It was unknown if the reporter considered the diarrhea, clostridium difficile to be related to Amoxicillin + Clavulanic Acid. Additional details were provided as follows: The patient had her first SHINGRIX vaccine at on 12th April 2018 at 17:00 and around 14th April 2018, she started having flu like symptoms, sharp jabbing pains in her lymph area, pain under arm and groins, aches, cough, fatigue, weakness, chest pain, headache, runny nose, slight fever, chills. All these symptoms were lasted 7 to 10 days except fatigue, weakness and chest pain that didn't go away until April 26th. On 26th April 2018, she developed a sore throat and swollen neck glands. She went to the physician and he gave her amoxicillin/clavulanate, which she took until 2nd May 2018. When the patient finished her antibiotic treatment, she believed that the antibiotic wiped out her good bacteria and around 8th May 2018, she started developing a bad diarrhea which was diagnosed as being c difficile diarrhea. She was given metronidazole. However, she tested positive for c difficile diarrhea again on 6th June 2018. She was put on Vancomycin on 3rd August 2018. She did well again. On 4th September 2018, the patient tested positive for c difficile diarrhea and was put on DIFICID. On 18th October 2018, the patient had finally recovered from c difficile diarrhea. The patient said that it was been more than six months since she had the first SHINGRIX vaccine which led to incomplete course of vaccination.