Sex: F
Vaccine: VARZOS
Symptoms: Chills, Circadian rhythm sleep disorder, Headache, Heat stroke, Injection site discomfort
Clinical narrative: This case was reported by a consumer and described the occurrence of sunstroke in a adult female patient who received SHINGRIX (batch number 539A2, expiry date 30th March 2020) and (batch number X3M27, expiry date 29th August 2020). The patient's past medical history included injection site reaction (after previous unknown vaccinations). On 26th February 2018, the patient received SHINGRIX (intramuscular). On an unknown  date, the dose was an unknown dose. In February 2018, several hours after receiving SHINGRIX, the patient experienced headache, shivering, leg pain, fever, jet lag and injection site discomfort. On 26th February 2018, the patient experienced sunstroke (serious criteria GSK medically significant). On 27th February 2018, the patient experienced sickness. The patient was treated with paracetamol and ADVIL. On 27th February 2018, the outcome of the leg pain was recovered/resolved. On 27th August 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the sunstroke, jet lag and injection site discomfort were unknown and the outcome of the headache, shivering and sickness were recovering/resolving. The reporter considered the sunstroke, headache, shivering, leg pain, fever, jet lag, sickness and injection site discomfort to be probably related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient never reacted to vaccines so thought she was likely to be one of those who do not react. So the patient did not expect to. The patient received the vaccine in the afternoon. Which was administered by a pharmacist, so no other healthcare professional was involved. In terms of administration, the patient reported that, the vaccine was properly reconstituted and injected as she watched. So there were no administration errors. Until midnight, there were no issues when the patient woke up shivering with a headache and aching legs. The patient thought she had a low grade fever but no thermometer to measure it. The patient took paracetamol and managed to get back to sleep (jet lag also a factor). The patient woke up 3 hours later, but still with a headache and felt a bit sick. The patient took more paracetamol and managed to eat and felt better. Later, fever was resolved and could function but the patient was definitely still under the weather and took 2 ADVILS. Overall, the patient would describe the feeling like sunstroke and as she was in the sun and cycled to the pharmacy. The patient did not burn so she assumed it was not sunstroke. But the patient thought it might be sunstroke. The patient thought the aching legs was because she cycled quite a long way and thus muscular but when she woke up it was gone so she thought it was not the result of the cycling. The patient stated that, she had no injection site issues. She could feel she had the injection and if someone punched her it would be uncomfortable but not enough for the patient to report it as it was not worse than the injection site reaction she had with other vaccines. The patient reported that, it was not serious and she was not 100 percent sure if it was related to the vaccine but it probably was.