Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal discomfort, Herpes zoster, Hypersensitivity, Incomplete course of vaccination, Malaise
Clinical narrative: isolated spots on body associated with nerve pain; isolated spots on body associated with Sensitivity; isolated spots on body associated with itching; outbreak as appearing as measles physically; shingles recurrence would occur/ outbreak; first dose Shingrix September 30, 2019; Sore arm; isolated spots on body associated with Sensitivity; feeling sick; Runny nose; Body aches; digestive/ gastrointestinal upset; Fever; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had recurrent shingles prior to Shingrix vaccination reoccurs approximately 1 to 2 times a year.).   On 30th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On 1st October 2019, 1 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm, feeling unwell, runny nose, general body pain, gastrointestinal upset and fever. In October 2019, the patient experienced hypersensitivity. On an unknown date, the patient experienced nerve pain, rash, pruritus, measles-like rash, shingles and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm, feeling unwell, runny nose, general body pain, gastrointestinal upset and fever were recovered/resolved and the outcome of the nerve pain, rash, pruritus, measles-like rash, hypersensitivity and shingles were recovering/resolving and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pain in arm, feeling unwell, runny nose, general body pain, gastrointestinal upset, fever, nerve pain, rash, pruritus, measles-like rash, hypersensitivity and shingles to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in the left arm. The reporter stated that after vaccination, on following day the patient had sore arm and feeling sick described as runny nose, fever, digestive or gastrointestinal upset, and body aches for approximately 1 to 2 days. The reporter reported that, approximately 1 to 2 months after receiving Shingrix, the patient reported recurrent minor outbreaks that came and gone consisting of isolated spots on body associated with nerve pain, itching, and sensitivity. The minor outbreak reoccurred twice and on the day of reporting there was no reports of an outbreak. The patient reported that, shingles recurrence would occur if extremely stressed out around mid-back on rib cage and described outbreak as appearing as measles physically but not truly measles. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. This case has been linked with US2020133254, reported by same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2020133254: