Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Culture urine positive, Dry eye, Erythema, Malaise, Oropharyngeal pain
Clinical narrative: Burning of her skin, like it is on fire on her arms, legs, back, neck, and face; Has been sick; sore throat; dry eyes; Redness of the left arm; Pain of the left arm; Diagnosed with a UTI; Intermittent low grade fever; Arm swelling; This case was reported by a consumer via call center representative and described the occurrence of urinary tract infection in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included urinary tract infection (was previously taking Macrobid for prevention of UTI's until June 2019,) and cold sores. Previously administered products included Macrobid. Concurrent medical conditions included arthritis. Concomitant products included sulfamethoxazole + trimethoprim (Bactrim), trimethoprim, alprazolam (Xanax), phenazopyridine hydrochloride (Pyridium), ibuprofen, tylenol #1 (nos) (Tylenol Codeine #1), magnesium, cyanocobalamin (Vitamin B12), ophthalmologicals (nos) (Eye Drops (Ingredients Unknown)) and mannose (D Mannose).   In January 2020, the patient received the 1st dose of Shingrix. In January 2020, less than 2 months after receiving Shingrix and an unknown time after starting Bactrim, Keflex, Valtrex and Macrobid, the patient experienced fever. On 24th January 2020, the patient experienced urinary tract infection. On 5th April 2020, the patient experienced swelling arm, erythema of extremities and pain in extremity. On an unknown date, the patient experienced burning skin, sickness, sore throat and eye dryness. The patient was treated with cephalexin (Keflex), valaciclovir hydrochloride (Valtrex), nitrofurantoin (Macrobid), antibiotics nos (Antibiotics Therapy (Unknown)) and nystatin. On an unknown date, the outcome of the urinary tract infection, burning skin and sore throat were not recovered/not resolved and the outcome of the fever, sickness, eye dryness, erythema of extremities and pain in extremity were unknown and the outcome of the swelling arm was recovered/resolved.   It was unknown if the reporter considered the urinary tract infection, fever, burning skin, sickness, sore throat, eye dryness, swelling arm, erythema of extremities and pain in extremity to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in mid January.      On January 24th   she was seen at a doctor visit and diagnosed with a UTI.      She states she has been placed on 5 antibiotics for the UTI and none have been successful.  She noted she hasn't completed any of the courses  of antibiotics because they weren't working.   She didn't provide any specific symptoms of UTI, other than intermittent low grade fever.    She noted  she also has burning of her skin, like it was on fire,  on her arms, legs, back, neck, and face that was worse at night when she was trying to sleep.   She was unable to provide a date of when the burning skin started.  She has been to the Emergency room twice with the UTI but hasn't stayed overnight.     She also noted she has been sick, which she described as a sore throat,  and a low grade intermittent fever.     Till the time of reporting she has the burning of her skin, the sore throat and the UTI.    She noted she has also had dry eyes, which she was using OTC eye drops for.    For 5 days, she noted she had arm swelling, redness and pain of the left arm, which was the arm of her injection.  She described the location of injection as hand width below her shoulder and on the underside/ backside of her arm.     She doesn't have documentation from the pharmacy of the vaccination route or the lot and expiration date.     She noted she has a history of cold sores in her nose and on her buttocks, she had some Valtrex for that, so she took a Valtrex 500mg today to see if it will help, she denied ever having Shingles before. She wonders if this could be shingles due to the skin burning, but denies a rash of any kind.   She was also concerned about Stephen's Johnson syndrome due to the burning of the skin and sore throat, and having been on 5 different antibiotics since 24th January2020. She noted she was placed on Macrobid intially,  500mg twice daily and took for 6 days,  it didn't improve her symptoms, so she was switched to Bactrim, twice a day, then Trimethoprim 100mg twice a day for 5 days,  it didn't work either so went to Keflex, which she also took twice a day.   Macrobid was added to Keflex initially but it didn't work, a urine culture still showed UTI.  She was placed on just on Keflex by itself, but still not working.     She wa  placed on Monoro this weekend and notes  it was a one dose drug, but not improvement still.      She has a follow up appointment with the Nurse Practitioner in the afternoon of reporting day,  on 6th March 2020, she has also been referred to Infectious Disease, but no appointment has been set up till the time of reporting.   She noted she was also seen by her physician for the sore throat and given nystatin, which helped.  She states she was told to try Xanax, pyridium,  and has also taken other vitamins and supplements that haven't helped. ER Visit Required. Reporter consented to follow up.