Age: 81.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Pain in extremity, Product administered at inappropriate site, Ultrasound scan normal
Clinical narrative: She sometimes couldn't sleep because of the arm pain; Swollen bicep muscle; The vaccine may have been given in the bicep muscle and not up higher where it normally should be; Soreness in the arm; malaise; swelling in the area where she received the shingrix shot\lump in arm; It was red and painful; It was red and painful; she couldn't hardly move her arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included denosumab (Prolia) for osteoporosis.   Previously administered products included Prolia with an associated reaction of pain.   On 1st August 2019, the patient received the 1st dose of Shingrix. On 12th August 2019, the patient started Prolia (subcutaneous) at an unknown dose and frequency. On 1st August 2019, less than a day after receiving Shingrix, the patient experienced pain in arm, malaise and vaccine administered at inappropriate site. In August 2019, the patient experienced extensive swelling of vaccinated limb, injection site pain, injection site erythema and injected limb mobility decreased. On an unknown date, the patient experienced difficulty sleeping and muscle swelling. On 2nd August 2019, the outcome of the pain in arm and malaise were recovered/resolved. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site erythema and injected limb mobility decreased were recovering/resolving and the outcome of the difficulty sleeping, muscle swelling and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the pain in arm, malaise, extensive swelling of vaccinated limb, injection site pain, injection site erythema, injected limb mobility decreased, difficulty sleeping and muscle swelling to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the patient experienced soreness in the arm and malaise for about a day and then it resolved. On  12th October 2019, the patient went into receive her 14th dose of Prolia, which she did in the left arm also but in the subcutaneous tissue on the back upper side of her left arm.  The patient developed swelling in the area where she received the shingrix shot, it was red and painful.  The patient noted it was so swollen she looked like a football player.  it was down to the elbow. The patient returned to her Endocrinologist where she received the Prolia on 8/19, because that was the last shot and it was so far after the Shingrix shot. An MRI and ultrasound of her arm were done to rule out blood clot and ruptured muscle.  The patient was told Prolia shot wouldn't cause that reaction and she was referred to a bone doctor.  Blood tests were also performed and negative along with the Ultrasound and MRI.   The patient saw the bone doctor on 30th August 2019,  she states she could not hardly move her arm to dress herself and the pain was worse. The patient noted she sometimes could not sleep because of the arm pain. The patient also noted lump in the arm. The bone doctor showed her on the MRI that she had a very swollen bicep muscle. The patient was concerned when she saw the MRI film as she believes the vaccine may have been given in the bicep muscle and not up higher where it normally should be, which led to vaccine administered at inappropriate site. The patient believes it was given on the front of the arm, in the middle between her shoulder and elbow. The patient noted the Prolia was given to the back of the arm but appeared a little higher than normal.  The patient noted she had improved significantly,  she still had difficulty holding her arm up and out but the pain is about 95 percent better.   The patient stated the bone doctor has her doing arm exercises and recommended she receive the shingrix second shot in her right arm, which she stated she would not do. The patient states she would not be able to go that lone with her dominant arm in pain or with decreased mobility. The patient plans to discuss the second shot with her  Endocrinologist and her primary care physician. The reporter consented to follow up.      Lab Comments: on an unknown date MRI, ultrasound and blood test was done