Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Condition aggravated, Diarrhoea, Dyspnoea, Feeling abnormal
Clinical narrative: shingles outbreak; back hurt; back / burned; was uncomfortable; itched; it hurt to breathe; Diarrhea; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included gastrointestinal infection (infection a few years back- lost some of the lining of her colon- colon is now delicate), alzheimer's disease (Family History) (to sister), shingles (first outbreak when she was in high school, another outbreak 2 years after receiving shingles vaccine), ophthalmic herpes zoster (on an unknown date 2020 one shingle above her right eye causing her eye to be bulged and sore.), bulging eyes, sore eye and influenza (the 1970s when the patient had the flu). Previously administered products included Shingrix with an associated reaction of ophthalmic herpes zoster (1st dose received on 11th March 2021 refer case US2021AMR160131), shingles with an associated reaction of herpes zoster (about 2 years after receiving shingles she developed shingles) and COMPAZINE with an associated reaction of feeling abnormal (her body is wacky with the way it sometimes responds to medications). Concurrent medical conditions included arthritis (left arm), bursitis (left arm), blood pressure high, thyroid disorder and constipation. Concomitant products included COVID-19 VACCINE (COVID 19 VACCINE), COVID-19 VACCINE (COVID 19 VACCINE) and macrogol (Miralax).   On 21st June 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 9th July 2021, 18 days after receiving Shingrix, the patient experienced shingles, back pain, burn of unspecified degree of back (any part), feeling unwell, pruritus, difficulty breathing and diarrhea. On 11th July 2021, the outcome of the shingles was recovered/resolved. In July 2021, the outcome of the diarrhea was recovered/resolved. On an unknown date, the outcome of the back pain, burn of unspecified degree of back (any part), feeling unwell, pruritus and difficulty breathing were unknown.   The reporter considered the shingles and diarrhea to be related to Shingrix. It was unknown if the reporter considered the back pain, burn of unspecified degree of back (any part), feeling unwell, pruritus and difficulty breathing to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The patient received 2nd dose of Shingles shots in intramuscularly the right deltoid. On 9th July 2021, Patient experienced back started to hurt patient thought she pulled a muscle but then her back hurt, burned, was uncomfortable, itched and it hurt to breathe and also had diarrhea. The patient indicated that this was a shingles outbreak. On 11th July 2021, at night shingles outbreak has resolved. The diarrhea side effect went on all weekend (then resolved). The patient was taking Miralax (with apple juice) for the prevention of constipation taken everyday. The patient said everything was coming out so she had to decrease her Miralax to every other day instead of every day The patient stated that one time in the 1970's when she had the flu she received a shot of COMPAZINE and it didn't work for her. She had a backwards reaction to the Compazine because her body was wacky. The patient had her first shingles outbreak when she was in high school. The patient received the (live) shingles shot (Zostavax) but about 2 years after the shot she developed of shingles on her back from her shoulder to her waist. The reporter asked if the patient reported this (vaccine failure) to the manufacture (Merck) she said no but that she did reported it to her doctor who indicated he would report it.  The patient had 1st Shingrix shot in right deltoid. The patient did not have the lot number or expiration date for the Shingrix shots but did provide the phone number for the pharmacy where they were administered.  In 2020, the patient got one shingle above her right eye causing her eye to be bulged and sore. The patient had provided her eye doctor's contact information because the eye doctor had information regarding prescription medication she received to treat the condition. The patient said, after the second Covid shot the eye started acting up again. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR160131:Same reporter