Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Anxiety, Asthenia, Herpes zoster, Hypersensitivity, Injection site pain
Clinical narrative: ichy/ 6 raised, red areas that are small and very itchy./ 6 small, red, raised very itchy bumps/rash; possible hypersensitivity reaction; 5 to 6 inch area of rash/ one, small reddish, raised spot on upper chest/left shoulder area; shingles/ Possible Shingles; 5 to 6 inch area of rash/ one, small reddish, raised spot on upper chest/left shoulder area; sore and a little swollen injection area on left deltoid; injection site pain/ injection area was sore; not feel as energized; anxiety; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included rash (was located right across the right area of her abdomen in March 2018). Previously administered products included zostavax with an associated reaction of herpes zoster (received in March 2018 a year before.) and antivirals (treated with antivirals at that time for outbreak.).   On 17th June 2019, the patient received Shingrix (intramuscular). In June 2018, less than a month after receiving Shingrix, the patient experienced anxiety. On 18th June 2019, the patient experienced injection site swelling, injection site pain and energy decreased. On 24th June 2019, the patient experienced shingles, raised rash, hypersensitivity reaction and red rash. On 25th June 2019, the patient experienced itchy rash. On an unknown date, the outcome of the injection site swelling and injection site pain were recovered/resolved and the outcome of the shingles, anxiety and hypersensitivity reaction were unknown and the outcome of the raised rash, itchy rash and red rash were recovering/resolving and the outcome of the energy decreased was resolved with sequelae.   It was unknown if the reporter considered the injection site swelling, injection site pain, shingles, raised rash, itchy rash, anxiety, energy decreased, hypersensitivity reaction and red rash to be related to Shingrix.  Additional details were provided as follows: The patient reported that she had a previous outbreak of shingles in March 2018 that kept her out of work for 6 to 8 weeks and was very painful. she was treated with antivirals at that time. this outbreak was after a zostavax injection years ago.  her rash in march 2018 was located right across the right area of her abdomen. the rash she has now does resemble the rash she had in March 2018. The patient got a shingrix injection on left deltoid and and the next day, as expected, the injection area was sore and a little swollen and she also did not feel as energized as usual. She reported that before bed on 24th June 2019, she noticed one small, reddish, raised spot on her upper chest/shoulder area that she thought was a mosquito bite. On 25th June 2019, In morning she woke up with a 5 to 6 inch rash across the left side of her upper chest adjacent to where she got the injection. She stated there are about 6 raised, red areas that are small and very itchy. she does not know if she is having a hypersensitivity reaction or a shingles rash. The caller reported anxiety as a result of the symptoms that we documented in the original report. She also voiced concern that the symptoms she was having may be Shingles and that why she was anxious. Since there was mention of possible Shingles after receiving the vaccine there also an AE for Lack of effect. The route of administration and dosage were not asked for during the call. she will go back to clinic today on 26th June 2019. she took some pictures with her phone. The patient informed she will get a letter from safety and may provide additional information in the future.