Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Haemoglobin decreased, Head injury, Headache, Inappropriate schedule of product administration, Loss of consciousness
Clinical narrative: Head injury; scalp lacerations; felt dizzy and next remembers waking up on the floor in blood; felt dizzy; received 2nd dose of shingrix late; headache; body aches; MYALGIA; This case was reported by a physician and described the occurrence of head injury in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included transient ischemic attack. Previously administered products included Shingrix (1st dose received on 10th September 2019). Concurrent medical conditions included anxiety, back pain, osteoporosis, sciatica, raynaud's syndrome, tension headache, constipation, hypercholesterolemia, hypertension, presbyopia, macular degeneration and drug allergy (in 2017).   On 10th August 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 10th August 2020, less than a day after receiving Shingrix, the patient experienced headache, general body pain, myalgia and drug dose administration interval too long. On 11th August 2020, the patient experienced head injury (serious criteria hospitalization), scalp laceration (serious criteria hospitalization), loss of consciousness (serious criteria GSK medically significant) and dizziness. The patient was treated with DTPa (Reduced antigen) (Tdap Vaccine). On 10th August 2020, the outcome of the myalgia was recovered/resolved. On 11th August 2020, the outcome of the headache was recovered/resolved. On 20th August 2020, the outcome of the head injury and scalp laceration were recovered/resolved. On an unknown date, the outcome of the loss of consciousness, general body pain, dizziness and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the head injury, scalp laceration, loss of consciousness, headache, general body pain, myalgia and dizziness to be related to Shingrix.  Additional details were reported as follows: On 11th August 2020, the following lab test were performed: Alanine aminotransferase result was 16 u/L, Aspartate aminotransferase result was 19 u/L, Blood alkaline phosphatase result was 140 u/L, Blood calcium result was 8.9 mg/dL, Blood chloride result was 106 mmol/L, Blood creatinine result was 1.25 mg/dL, Blood glucose result was 178 mg/dL, Blood potassium result was 3.7 mmol/L, Blood sodium result was 136 mmol/L, Blood urea result was 28 mg/dL, Carbon dioxide result was 22 mmol/L, Computerized tomogram head result was (without IV contrast) not provided, Electrocardiogram result was within normal limits, Haematocrit result was 36.7 percent, Haemoglobin result was 11.8 g/dL, Platelet count result was 194 k/mcl, Protein total result was 7.4 g/dL and White blood cell count result was 10.32 k/mcl. On 10th August 2020, the patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule and reported a headache and body aches. On the (early) morning of 11th August 2020, the headache worsened and when patient got out of bed to get OTC medication, she felt dizzy and next remembers waking up on the floor in blood and on the same day the patient went to emergency room, after the head injury and lacerations on scalp and was under observation. On 11th August 2020, the patient was treated with Tdap Vaccine for head injury and 2 scalp lacerations. On 13th August 2020, the patient was discharged. For tolerance of study drug refer case US2020214008.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020214008:same reporter