Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Middle insomnia, Muscle spasms, Nuclear magnetic resonance imaging, Oedema, Oedema peripheral
Clinical narrative: elephantitis; Charlie Horses/cramping in the toes/muscle cramps; Swelling in her legs/swelling/edema (feet to legs); Numbness in her legs; heaviness in her legs/ feel like they weigh 300 pounds each; ability to walk affected; venous congested; non-pitting edema; edema (feet to legs); This case was reported by a consumer via call center representative and described the occurrence of elephantiasis in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included weight loss. The patient had a Family History of pancreatic cancer (Father died of pancreatic cancer). Previously administered products included ciprofloxacin (experienced after taking the antibiotic cipro where it caused them not to be able to walk) and Zostavax (prior injection with Zostavax live shingles injection). Concomitant products included Hepatitis A vaccine.   On 2nd July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced elephantiasis (serious criteria GSK medically significant), charley horse, swelling of legs, numbness in leg, heaviness in leg, walking difficulty, hyperemia, edema and leg edema. The patient was treated with cefixime (Flexeril (Cefixime)), potassium nos (Potassium Supplements), magnesium (Magnesium Supplements) and cyanocobalamin (Vitamin B12 Supplement). On an unknown date, the outcome of the elephantiasis, charley horse, swelling of legs, numbness in leg, heaviness in leg, walking difficulty, hyperemia, edema and leg edema were recovering/resolving.   The reporter considered the elephantiasis, charley horse, swelling of legs, numbness in leg, heaviness in leg, walking difficulty, hyperemia, edema and leg edema to be possibly related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The patient received Shingrix in her arm/deltoid but she did not remember if it was her left or right arm. The patient also did not remember if the vaccine was received subcutaneously or intramuscularly. Last week before the date of reporting, the patient received Hepatitis A vaccine at the same pharmacy where she received Shingrix but the leg swelling was already present when she received Shingrix. The patient did not knew the brand name of the Hepatitis A vaccine. It was reported that, after receiving vaccine, till the time of reporting, the patient experienced Charlie horses that woke her up at night and she also experienced cramp in the toes.  It was reported that prior to receiving Shingrix, the patient lost weight but at the time of reporting the patient experienced swelling, numbness and heaviness in her legs which affected her ability to walk. The swelling was from her feet to her legs.  The patient mentioned the word elephantitis, but she said that her doctor called it something else which she could not remember what something that sounded like venous congested. The neurologist said it was non-pitting edema.  It was reported that, her legs felt like they weigh 300 pounds each. She said that the neurologist said it was not water. She elevated her feet at night. On 19th August 2019 (Monday), the patient would undergo an MRI. The reactions the patient experienced (leg cramps, legs going numb) were similar to something in the past that she (and her parents) experienced after receiving antibiotic Cipro where it caused them unable to walk.  The patient was not sure if Shingrix caused all of her symptoms but believed that it might be related because she could not think of anything else that she had changed.  The patient received potassium, magnesium, and B12 supplements for muscle cramps. The patient was also prescribed Flexeril for the muscle spasms. The reporter consented to follow up.