Age: 64.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site vesicles, Malaise
Clinical narrative: Shingles or Herpes; blisters; rash/rash on chest; bumps; itching/itching on chest; having sharp, shooting/jabbing pains on her chest; tenderness in her chest near her sternum; itching at the injection site; having sharp, shooting/jabbing pains at the injection site; rash, and itching, mainly on her chest, but also at the injection site; blisters at the injection site; bumps at the injection site; vertigo; light headedness; received Shingrix and flu vaccine both in right arm on he same day; did not feel well; achy; was in a bed lot; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis.   The patient's past medical history included herpes zoster (had in past).   On 28-SEP-2023, the patient received the 1st dose of Shingrix (right arm) and the 1st dose of Flu vaccine (intramuscular, right arm). In SEP-2023, an unknown time after receiving Shingrix and Flu vaccine, the patient experienced feeling unwell (Verbatim: did not feel well), pain (Verbatim: achy) and bedridden (Verbatim: was in a bed lot). On 28-SEP-2023, the patient experienced wrong technique in drug usage process (Verbatim: received Shingrix and flu vaccine both in right arm on he same day). On 30-SEP-2023, the patient experienced vertigo (Verbatim: vertigo) and light headedness (Verbatim: light headedness). On 08-OCT-2023, the patient experienced shingles (Verbatim: Shingles or Herpes). In OCT-2023, the patient experienced injection site itching (Verbatim: itching at the injection site), injection site pain (Verbatim: having sharp, shooting/jabbing pains at the injection site), injection site rash (Verbatim: rash, and itching, mainly on her chest, but also at the injection site), injection site blisters (Verbatim: blisters at the injection site), injection site swelling (Verbatim: bumps at the injection site), blister (Verbatim: blisters), rash (Verbatim: rash/rash on chest), mass (Verbatim: bumps), pruritus (Verbatim: itching/itching on chest), chest pain (Verbatim: having sharp, shooting/jabbing pains on her chest) and chest tenderness (Verbatim: tenderness in her chest near her sternum).The patient was treated with valaciclovir hydrochloride (Valacyclovir Hydrochloride), hydrocortisone and ibuprofen. On 03-OCT-2023, the outcome of the vertigo and light headedness were resolved (duration 3 days). The outcome of the injection site itching, injection site blisters, injection site swelling, blister, rash, mass, pruritus and chest pain were not resolved and the outcome of the injection site pain, injection site rash, shingles and bedridden were not reported and the outcome of the chest tenderness was resolving and the outcome of the feeling unwell and pain were resolved and the outcome of the wrong technique in drug usage process was unknown.   It was unknown if the reporter considered the injection site itching, injection site pain, injection site rash, injection site blisters, injection site swelling, shingles, blister, rash, mass, pruritus, chest pain, chest tenderness, vertigo, light headedness, feeling unwell, pain and bedridden to be related to Shingrix and Flu vaccine.  It was unknown if the company considered the injection site itching, injection site pain, injection site rash, injection site blisters, injection site swelling, shingles, blister, rash, mass, pruritus, chest pain, chest tenderness, vertigo, light headedness, feeling unwell, pain and bedridden to be related to Shingrix and Flu vaccine.   Additional Information: GSK Receipt Date: 10-OCT-2023 The case was reported by the patient. The reporter reported that she received Shingrix (only confirmed by paperwork that said Shingrix, no lot/expiry, NDC available) in her right arm and a Flu Vaccine (unknown product as paperwork said that Influenza PF - Fluarix, Flulaval, Fluzone Pres Free 0.5ml Quadrivalent) at the same time in the same right arm, which led to wrong technique in drug usage process.  The next day, on 29th September 2023, the patient reported she was achy and did not feel well, which lasted 4 to 5 days. Th starting on 30th September 2023, the patient reported that having light headedness and vertigo, that came and went for 3 days, until 3rd October 2023 and that she did not feel well all week and was in bed a lot.  The patient reported that 5 days after receiving the 2 vaccines, around 4th October 2023 to 5th October 2023, she experienced tenderness in her chest near her sternum, that went on for 3 days but was getting better.  The patient reported that that 8th October 2023, she started having sharp, shooting/jabbing pains, rash, and itching, mainly on her chest but also at the injection site, accompanied by bumps and almost blisters. The patient reported that she still had the bumps, itching and blisters on her chest and at the injection site at the time of reporting.  The patient did contact a virtual doctor on 8th October 2023 that diagnosed her with either Shingles or Herpes and prescribed Valacyclovir HCL 1gm tablets (unknown manufacturer information) to be taken Three times a day for 7 days, and she took her 1st dose on 8th October 2023.  The patient was also using over the counter Hydrocortisone 1 percent Cream (unknown product information) topically for the itching.  The patient also reported that she took over the counter Ibuprofen 200 mg (unknown product information) - 1 tablet every 5 hours, for a total of 5 doses for the pain. The patient reported she has had shingles in the past (pre-existing Shingrix or the unknown flu vaccine). The reporter did not consent to follow-up.