Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Nausea, Pyrexia, Rash
Clinical narrative: shingles; rash described as a few spots on her chest; blotchy rash; Facial Rash/ itchy rash on face; Flu-like Symptoms; fever; Constipation; joint pain; nausea; redness at injection site; bruising at injection site; tenderness at injection site; injection site warmth; ibjection site swelling; Injection site hard; injection site itchy; injection site rash; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 14th June 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema, injection site bruising, injection site tenderness, injection site warmth, injection site swelling, injection site induration, injection site itching and injection site rash. On 15th June 2019, the patient experienced influenza-like symptoms, fever, constipation, generalized joint pain and nausea. On 18th June 2019, the patient experienced shingles, rash, blotchy rash and itchy rash. The patient was treated with ibuprofen, polyethylene glycol (Miralax), loratadine (Claritine) and non-drug therapy (Cold Compress). On 16th June 2019, the outcome of the influenza-like symptoms, fever, generalized joint pain and nausea were recovered/resolved. On 17th June 2019, the outcome of the constipation was recovered/resolved. On an unknown date, the outcome of the shingles, blotchy rash and itchy rash were unknown and the outcome of the injection site erythema, injection site bruising, injection site tenderness, injection site warmth, injection site swelling, injection site induration, injection site itching, injection site rash and rash were recovering/resolving.   It was unknown if the reporter considered the shingles, injection site erythema, injection site bruising, injection site tenderness, injection site warmth, injection site swelling, injection site induration, injection site itching, injection site rash, influenza-like symptoms, fever, rash, constipation, generalized joint pain, nausea, blotchy rash and itchy rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her right arm around 4:30 to 5:00 pm. The injection site rash described as swollen 3 to 3 and half inch's circular area, bruising in the middle of that area, redness, itchy, hard like a baseball, warm to touch, extremely tender to touch, and painful. On the day of reporting injection sire reaction decreased to roughly 2 inches in diameter, itchiness, redness, pain, swelling and tenderness are getting better. The patient reported flu like symptoms including running a fever, generalized joint pain, and nausea all relieved. Constipation also reported and relieved. In the morning of day of reporting the patient woke up with slightly itchy, blotchy rash on face near left temple and left eye. The patient also reported rash described as a few spots on her chest more localized to the left side leading her to go to an immediate care facility. The reporter gave consent to follow up. The patient was being sicker and was told to take Claritin and ibuprofen.  The patient also started taking Miralax to relieve constipation. Immediate care facility concerned rash on face might be shingles rash and caller to take off work for a few days. There is a discrepancy with respect to the outcome of the event constipation. In source document, the outcome is reported as recovered/ resolved with sequale for all the symptoms, however as per narrative description it is recovered/resolved. The outcome of all the symptoms retains as per the narrative description.