Sex: F
Vaccine: VARZOS
Symptoms: Lip exfoliation, Local reaction, Loss of personal independence in daily activities, Oral discomfort, Oral mucosal blistering
Clinical narrative: Itchy Rash; Burning/lips burning/Lips were burning/sides of mouth were burning; Mouth Blisters; feeling sunburned/ear burning; Rash across chest/on shoulders/on arm/on back/on face/on earlobe; lips rash; rash on external genitalia; genitalia burning; blisters on tip of tongue/blister on underneath tongue; Lips were peeling; side of mouth were cracking; difficulty in brushing; Redness on her arm; Swelling on arm; Sore Arm; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (thrice). Previously administered products included Beta-blocker. Concurrent medical conditions included drug allergy (allergy to an unspecified beta blocker).   On 20th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 21st August 2019, 1 days after receiving Shingrix, the patient experienced erythema of extremities, swelling arm and pain in arm. On an unknown date, the patient experienced itchy rash, oral discomfort, blistering of mouth, burning sensation skin, rash, rash lips, genital rash, genital burning, tongue blistering, peeling lips, cracked lips and activities of daily living impaired. The patient was treated with benadryl (nos) (Benadryl). On 3rd September 2019, the outcome of the erythema of extremities, swelling arm and pain in arm were recovered/resolved. On an unknown date, the outcome of the itchy rash was recovering/resolving and the outcome of the oral discomfort and blistering of mouth were recovered/resolved and the outcome of the burning sensation skin, rash, rash lips, genital rash, genital burning, tongue blistering, peeling lips, cracked lips and activities of daily living impaired were unknown.   It was unknown if the reporter considered the erythema of extremities, swelling arm, pain in arm, itchy rash, oral discomfort, blistering of mouth, burning sensation skin, rash, rash lips, genital rash, genital burning, tongue blistering, peeling lips, cracked lips and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her right arm, and the following day having redness, swelling and soreness on her arm.  The redness described as being as wide as a softball as far as area, but not raised as high as a softball. Local reactions reported to have lasted approximately 2 weeks.  The patient had itchy rash developed that comes and then goes away following oral Benadryl 50mg that is taking throughout the day.  The rash has appeared across chest, shoulders, arm, back, lips, earlobes, external genitalia, and face.  The caller still has bouts of recurrent rash that was suppressed following oral Benadryl.  The caller reported lips, earlobes and genitalia as burning or feeling sunburned, and caller also reports blisters in mouth on the tip of tongue and underneath tongue.  The lips were burning and peeling and the sides of mouth were cracking and burning.  The caller describes difficulty in brushing teeth due to burning sensitivity in mouth from toothpaste.  The burning sensations and oral blisters resolved in approximately 1 week. The reporter consented to follow up. In the mix of events, the caller reports discovering an allergy to an unspecified beta blocker that has at the time of reporting been stopped and switched to a different therapy. The caller unsure if side effects are from Shingrix vaccine or something else.  The caller inquires if she should receive 2nd dose.Referred to health care professional.  The caller has appointment tomorrow with her dermatologist about ongoing rash. There is discrepancy between the outcome reported in the structured field of system (recovered) for redness, swelling and soreness on her arm and the outcome reported in the source document (recovered with sequel); outcome for itchy rash in the structured field of system (recovering) while in source document it is reported as fatal.