Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pruritus, Rash erythematous, Scar, Skin burning sensation
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of malaise in a 74-year-old female patient who received SHINGRIX. The patient's past medical history included shingles (might be multiple times 15 to 20 years before reporting date. This case required hospitalization and IV acyclovir. Other cases since then but milder in presentation.) and eye operation. Previously administered products included ZOSTAVAX (received when it came out 10-15 years before the reporting date). Concurrent medical conditions included drug allergy. Concomitant products included amlodipine, Aspirin, CLARITIN and metoprolol. On 29th March 2018 16:19, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, less than a month after receiving SHINGRIX, the patient experienced malaise. On 27th April 2018, the patient experienced erythematous rash, shingles and blister. On 30th April 2018, the patient experienced scar. On an unknown date, the patient experienced scar. On an unknown date, the patient experienced burning skin, tiredness, chills, influenza-like symptoms and pruritus. The patient was treated with VALTREX. In April 2018, the outcome of the shingles and blister were recovered/resolved. On an unknown date, the outcome of the malaise, erythematous rash and chills were recovering/resolving and the outcome of the burning skin was recovered/resolved and the outcome of the tiredness was not recovered/not resolved and the outcome of the influenza-like symptoms, pruritus and scar were unknown. The reporter considered the malaise, erythematous rash, burning skin, tiredness, shingles, chills and blister to be possibly related to SHINGRIX. It was unknown if the reporter considered the influenza-like symptoms, pruritus and scar to be related to SHINGRIX. Additional details were provided as follows: The patient was a retired GSK employee. The patient stated that she had cases of shingles in the past, mostly on her face, so she had VALTREX on hand to take. She noted she had had a mild case of shingles a couple of weeks before getting SHINGRIX vaccine, and had informed the pharmacist about that before got the vaccine. The patient stated that she got her 1st dose of SHINGRIX in the left deltoid around holiday. The patient stated that she just was not feeling well during the week before and was contributing that to the weather, but then that Friday the rash appeared. The patient reported that 29 days after receiving the SHINGRIX, she experienced shingles rash, very definitive red rash with blisters in clusters. It was under her right breast and above her waist and around to her back side and on her stomach. The patient also experienced chills and general malaise. The patient experienced burning, itching, and flu like symptoms, prior to rash. The patient began taking VALTREX last Friday morning, taking 1 gram three times daily and the rash improved. She stated her doctor was not always convinced for previous episodes what she had was shingles, but noted this case was more severe than those other episodes, but not as severe as the one she was hospitalized for 15 to 20 years before reporting date. The patient stated that her doctor was not aware of this episode, she did report it back to the pharmacist. The patient stated the rash was gone and at the date of reporting she can only see evidence there was a rash present, like a little scarring. The patient was still tired and the other symptoms are improving as well. She believed it was not just a coincidence of these events to her shingles episode. She was referred to her physician as she was given information from her pharmacist to wait 5 months from a shingles episode before getting booster and to see if she was advised to get the booster. She was made aware that she was not fully protected without the booster. The patient reported that she called another GSK employee about reaction but did not believe it was being reported by that employee. The patient had not spoken to healthcare professional (HCP), so declined HCP with this call. Authorization form would be received.