Age: 56.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site warmth, Insomnia, Myalgia, Pain
Clinical narrative: vaccinated for shingles and still got them; Suspected vaccination failure/vaccinated for shingles and still got them; She cannot lower her arm without severe pain; Injection site pain; Injection site area of her arm is seriously red; Injection site area of her arm is seriously hard; Injection site area of her arm is seriously swollen/local swelling; Injection site area of her arm is seriously hot; Headache; Fever (greater than 100.5 F); Shivers; Aching joints; Upset stomach; Tiredness; Trouble sleeping/cannot sleeping; Muscle pain; arm pit area. It is painful/ She cannot lower her arm without severe pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number N2E73, expiry date 19th March 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 2nd February 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 1st dose of Shingrix. In February 2020, less than a week after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injected limb mobility decreased, injection site pain, injection site erythema, injection site induration, injection site swelling, injection site warmth, headache, fever, shivers, joint pain, upset stomach, tiredness, difficulty sleeping, muscle pain and pain. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with non-drug therapy (Ice Pack (No Medication)), paracetamol (Tylenol) and ibuprofen (Advil). On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the injected limb mobility decreased, injection site erythema, injection site induration, injection site swelling, injection site warmth and pain were not recovered/not resolved and the outcome of the injection site pain, headache, fever, shivers, joint pain, upset stomach, tiredness, difficulty sleeping and muscle pain were recovering/resolving.   It was unknown if the reporter considered the vaccination failure, injected limb mobility decreased, injection site pain, injection site erythema, injection site induration, injection site swelling, injection site warmth, shingles, headache, fever, shivers, joint pain, upset stomach, tiredness, difficulty sleeping, muscle pain and pain to be related to Shingrix. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     Additional Information: GSK receipt date: 27-June-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had been vaccinated for the shingles and still got them. On 3rd February 2020, the patient reported that, one day before (yesterday), she received 2nd dose of Shingrix in left arm and less than a day after vaccination, developed headache, fever (greater than 100.5F), shivers, aching joints, upset stomach, tiredness and pain at the injection site.  The patient stated that she could not sleep last night. On 5th February 2020, the patient called to provide additional details. The muscle and joint pain had reduced but she now had severe swelling in her left arm pit.  The swelling was the size of a burger and it was located toward the forward half of the arm pit area and was painful.  She could not lower her arm without sever pain.  She could not sleep and had been constantly icing it and taking Tylenol and advil but the medications had not reduced the pain or swelling.  The injection site area of her arm was seriously swollen, red, hot and hard. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. Note: As per latest update, the present case was kept valid with Suspected vaccination failure and all the non- serious event. The case US2020019109 was deleted and all future correspondence would be added in the present case which stands as case of record for this patient.