Age: 71.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain in extremity, Pyrexia, Rash, Ultrasound scan normal
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of allergic reaction in a 71-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date 28th April 2020) and (batch number ZX3YA, expiry date 28th April 2020). The patient's past medical history included retinal detachment, ulcerative colitis, chronic renal impairment (stage 2), coronary artery disease (coronary atherosclerosis), cholelithiasis, back pain and colitis. Previously administered products included Sulfa with an associated reaction of rash (received Sulfa in 1998, did not still have the reaction from 1998 but, avoided sulfa drugs at the time of reporting), Hydrocodone-Acetaminophen with an associated reaction of nightmare (received on 25th August 2014), Hydrocodone-Acetaminophen with an associated reaction of hallucination (received on 25th August 2014) and Omeprazole with an associated reaction of diarrhoea (received on 20th January 2015). Concurrent medical conditions included hypertension and phlebitis lower limb (phlebitis in left leg below knee in 2007). On 29th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 30th March 2018, 1 days after receiving SHINGRIX, the patient experienced allergic reaction, nausea, fever, tiredness, pain in thigh, walking difficulty and adverse reaction. On 8th April 2018, the patient experienced rash. On 9th April 2018, the patient experienced eyelids pruritus. The patient was treated with ADVIL, TYLENOL and BENADRYL. On 30th March 2018, the outcome of the nausea was recovered/resolved. On 31st March 2018, the outcome of the pain in thigh and walking difficulty were recovered/resolved. On 11th April 2018, the outcome of the rash and eyelids pruritus were recovered/resolved. In April 2018, the outcome of the allergic reaction and adverse reaction were recovered/resolved. On an unknown date, the outcome of the fever and tiredness were recovered/resolved. It was unknown if the reporter considered the allergic reaction, nausea, fever, tiredness, pain in thigh, walking difficulty, rash, eyelids pruritus and adverse reaction to be related to SHINGRIX. Additional details were reported as follows: The patient's medical history or current illness had no other acute illnesses. On 3rd March 2018, the patients ultrasound scan revealed no left lower extremity deep vein thrombosis (DVT) was identified (normal). On the day of vaccination, the patient okay. The next day (Friday), she woke up with nausea and a slight fever (body temperature 98.8 measured orally). The nausea lasted for one hour. The patient was tired and lay down for a nap in the afternoon. When she woke up, she had stabbing pains in her left thigh and leg. She had difficulty walking due to the pain. The patient went to the emergency room. At the hospital, to rule out a blood clot, an ultrasound was performed. Two TYLENOL were given at the hospital which helped her pain. The patient went home and took two ADVIL - PMs prior going to bed. On 31 March 2018, she woke up with no leg pain. She had no symptoms until the following weekend. Ten days after receiving SHINGRIX (Sunday), the patient woke up with a rash on her face. She still had rash on her face on Monday. Eleven days after receiving SHINGRIX, the patient's eyelids were itchy. She took BENADRYL in the evening and also on 10th April 2018 evening (Tuesday). All the symptoms were resolved as of 11th April 2018 (Wednesday). The patient's doctor recommended patient not to get the 2nd dose of SHINGRIX vaccination. The medication was noted as an allergy on patient's medical record.