Age: 76.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Poor quality sleep, Pruritus, Rash, Skin test negative, Umbilical hernia
Clinical narrative: not sleeping well; tingling in his arm; light headed; PVC's associated with regular heart rate; chest Pain; epigastric skin spongiotic dermatitis; 2nd hernia at his naval; his belly was swollen; elevated blood sugar,; blood pressure is out of line.; itching; welts/hives; Rash in late January 2023 all over his body, including his chest, back and arms; Patient reports he did not receive the 2nd dose of Shingrix; This serious case was reported by a consumer via call center representative and described the occurrence of generalized rash in a 76-year-old male patient who received Herpes zoster (Shingrix) (batch number 252JX, expiry date 14-SEP-2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and prednisone for product used for unknown indication.   The patient's past medical history included hernia, colon cancer (had colon cancer in 2013), premature ventricular contractions (had a heart condition in 2015 with PVC's (pre existing Shingrix)) and heart disorder. Concurrent medical conditions included pollen allergy. Concomitant products included fexofenadine hydrochloride (Allegra).   On 30-DEC-2022, the patient received the 1st dose of Shingrix (left deltoid). On an unknown date, the patient did not receive the 2nd dose of Shingrix and prednisone. In JAN-2023, less than a month after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced generalized rash (Verbatim: Rash in late January 2023 all over his body, including his chest, back and arms) (serious criteria hospitalization). In FEB-2023, the patient experienced generalized pruritus (Verbatim: itching) (serious criteria hospitalization) and generalized urticaria (Verbatim: welts/hives) (serious criteria hospitalization). On an unknown date, the patient experienced poor sleep (Verbatim: not sleeping well) (serious criteria hospitalization), tingling of extremity (Verbatim: tingling in his arm) (serious criteria hospitalization), light headedness (Verbatim: light headed) (serious criteria hospitalization), premature ventricular contractions (Verbatim: PVC's associated with regular heart rate) (serious criteria hospitalization), chest pain (Verbatim: chest Pain) (serious criteria hospitalization), spongiotic dermatitis (Verbatim: epigastric skin spongiotic dermatitis) (serious criteria hospitalization), umbilical hernia (Verbatim: 2nd hernia at his naval) (serious criteria hospitalization), swollen abdomen (Verbatim: his belly was swollen) (serious criteria hospitalization), blood sugar increased (Verbatim: elevated blood sugar,) (serious criteria hospitalization), increased blood pressure (Verbatim: blood pressure is out of line.) (serious criteria hospitalization) and incomplete course of vaccination (Verbatim: Patient reports he did not receive the 2nd dose of Shingrix). The patient was treated with methylprednisolone, loratadine, lisinopril, carvedilol and spironolactone. The action taken with prednisone was unknown. The outcome of the generalized rash, spongiotic dermatitis and generalized urticaria were not resolved and the outcome of the poor sleep, tingling of extremity, light headedness, premature ventricular contractions, chest pain, generalized pruritus, umbilical hernia, blood sugar increased, increased blood pressure and incomplete course of vaccination were unknown and the outcome of the swollen abdomen was not reported.   It was unknown if the reporter considered the generalized rash, spongiotic dermatitis, generalized pruritus, generalized urticaria, umbilical hernia and swollen abdomen to be related to Shingrix. The reporter considered the poor sleep, tingling of extremity, light headedness, premature ventricular contractions, chest pain, blood sugar increased and increased blood pressure to be unrelated to Shingrix.     It was unknown if the company considered the generalized rash, spongiotic dermatitis, generalized pruritus, generalized urticaria, umbilical hernia and swollen abdomen to be related to Shingrix. The company considered the poor sleep, tingling of extremity, light headedness, premature ventricular contractions, chest pain, blood sugar increased and increased blood pressure to be unrelated to Shingrix.   Additional Information: GSK receipt date: 11-Aug-2023 The patient received 1st dose of Shingrix and developed a rash in late January 2023 all over his body, including his chest, back and arms.  He received a rash skin test (unknown test or date received) from his allergist, that was not positive to any skin allergy.  Patient went to his PCP 28 February 2023 and received a shot of methylprednisone 80mg injection times 2 doses (this is what he said the drug name was).  Patient went back to his allergist (no date provided) and was put on Prednisone (unknown strength) to take 30 tablets over 12 days.  While taking the prednisone taper, the patient experienced side effects of: not sleeping well, elevated blood pressure, tingling in his arm (unknown which arm), premature ventricular contractions associated with regular heart rate, light headed, concern of elevated blood sugar and chest pain.  Patient was told these were adverse events related to the Prednisone by his Allergist.  Patient was told to follow up with his cardiologist for the PVC's if his symptoms worsened. Patient also saw a dermatologist (no date provided) that did a biopsy which was diagnosed as epigastric skin spongiotic dermatitis. Since February 2023 the patient reports itching and welts off and on all over his body, including his chest and back. Patient has received a diagnosis of Hives (unknown date provided for diagnosis) which are all over his body. Patient had been in and out of the emergency room 5 times since February 2023, with one resulting in an overnight stay in the hospital, 24 July 2023 to 25 July 2023, and he had a heart monitor on.  Patient reported that his blood pressure would go up and down, and he monitors at home, and went to the emergency room if his blood pressure was out of line. While in the hospital, the patient reports a CT scan was done of his hernia from his incision for his colon cancer surgery in 2013 (preexisting Shingrix), and a 2nd hernia at his naval was observed at the same previous incision site, and his belly was swollen. The patient reported that he took Allegra when tree pollen was high (unknown date and not sure if preexisting Shingrix). The patient reports he did not receive the 2nd dose of Shingrix and it had been more than 6 months since the first dose. Till the date of reporting the patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up with HCP.