Age: 55.0
Sex: F
Vaccine: PNC13, PPV, VARZOS
Symptoms: Injection site warmth, Mobility decreased, Product administered at inappropriate site, Pyrexia, Urticaria
Clinical narrative: skin is discolored in that area darker, like a light bruise; Light bruise; was sick for a bit; Injection site was extremely swollen and larger/ about the size of the palm of hand/ raised up quite a bit; It was extremely hot; It was extremely red; chills; Fever was over 101; tired; mostly bedridden; 5 hard nodules under skin; I could get up and go run and errand; welt was about 3 by 4 inches; Vaccine administered at inappropriate site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   Previously administered products included COVID VACCINE with an associated reaction of vomiting (1st or 2nd Covid shot had a really bad reaction for a week- was throwing up). Concurrent medical conditions included asthma, hypothyroidism and allergy (that was stuffy all the time). Concomitant products included COVID-19 VACCINE (COVID VACCINE).   On 31st May 2022 13:15, the patient received the 1st dose of Shingrix (intramuscular) and PNEUMONIA VACCINE. On 31st May 2022 13:15, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. On 1st June 2022, the patient experienced injection site swelling, injection site warmth, injection site erythema, chills and fever. In June 2022, the patient experienced injection site nodule, injection site urticaria, tiredness, bedridden and mobility decreased. On an unknown date, the patient experienced injection site discoloration, injection site bruising and sickness. On 5th June 2022, the outcome of the fever was recovered/resolved. On 30th June 2022, the outcome of the injection site warmth was recovered/resolved. On an unknown date, the outcome of the injection site swelling was recovering/resolving and the outcome of the injection site erythema, injection site urticaria, sickness, mobility decreased and vaccine administered at inappropriate site were unknown and the outcome of the injection site discoloration, injection site nodule and injection site bruising were not recovered/not resolved and the outcome of the chills, tiredness and bedridden were recovered/resolved.   The reporter considered the injection site swelling, injection site warmth, injection site erythema, injection site discoloration, injection site nodule, injection site bruising, injection site urticaria, chills, fever, tiredness, bedridden, sickness and mobility decreased to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-AUG-2022 Reporter's Comments: The reporter was the patient. The reporter stated that she had Shingrix shot around 1:15 in the afternoon on her left deltoid and an unspecified pneumonia shot at the same time in the right arm. (The Shingrix shot was given lower on the left arm that the 4th COVID booster which was given 2 days prior). The reporter noted that at the time of the Shingrix injection the left arm had no reaction, no red spot or anything. The reporter stated that she does not had the lot number of the Shingrix administered but it was given at her primary care doctor's office and she provided contact information for that office. The reporter stated that she was calling the GlaxoSmithKline response center reporting that she had an "good adverse reaction" to the Shingrix shot and wanted advice regarding whether or not she should receive the second Shingrix shot. The reporter indicated that the next morning, the left arm, at the spot where the Shingrix shot was given, was extremely swollen and larger. It was about the size of the palm of her hand. It was extremely hot and red and raised up quite a bit (not quite as thick as her thumb) but it was raised up. The reporter stated that by then she was also having chills and a fever. "Fever was over 101 and that lasted from the morning of June 1st through sometime in the early hours of June 5th and fever broke. So it was 101, on June 4th that night, it was 102.1 so the patient had the fever, chills, just tired, mostly bedridden. The reporter stated that she did had one spell where she could get up and go run and errand. She had a fever for those days. The reporter stated that the area stayed hot and red and by June 6th the swollen area had gone down a little bit but the welt was about 3 by 4 inches, still hot but the hard, red part of it by that point was just 2 by 2 inches, but it was still hot and red but she did not had a fever anymore or any other symptoms besides the site area. The reporter stated that, one month later, June 30, the area was no longer hot but she had about 5 hard nodules under her skin. Even on the day of reporting, the skin upon carefully looking, was discolored in that area, darker (especially after a shower) like a light discoloration like a light bruise. So she knew that her body did not like getting the shot. The reporter summarized by saying she was sick for a bit. The reporter consented to follow up. In June 2022, less than a month after receiving Shingrix, the patient experienced tiredness, bedridden and injection site nodule. In June 2022, less than a month after receiving PNEUMONIA VACCINE, the patient experienced tiredness, bedridden. In June 2022, less than a week after receiving Shingrix, the patient experienced Injection site urticaria, Mobility decreased. In June 2022, less than a week after receiving PNEUMONIA VACCINE, the patient experienced Mobility decreased. In 2022, less than 3 months after receiving Shingrix, the patient experienced injection site discoloration, and sickness, injection site bruising. In 2022, less than 3 months after receiving PNEUMONIA VACCINE, the patient experienced sickness. On 1st June 2022, 1 day after receiving Shingrix, the patient experienced injection site swelling, injection site warmth, injection site erythema, chills and fever. On 1st June 2022, 1 day after receiving PNEUMONIA VACCINE, the patient experienced chills and fever. It was unknown if the reporter considered the chills, fever, tiredness, sickness, mobility decreased and bedridden to be related to PNEUMONIA VACCINE. Additional Supportive Information: The COVID booster shot (4th dose) was reported as patient medical history, however, it was coded as concomitant currently as it was reported as "two days before Shingrix shot- no red spot on the left arm after that shot".