Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal distension, Chills, Cold sweat, Diarrhoea, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site induration in a 56-year-old female patient who received SHINGRIX. Concurrent medical conditions included shingles (first occurrence 2012-nine since reoccurrences all prior to the SHINGRIX vaccination). Concomitant products included KLOR-CON, Losartan, XYZAL and ibuprofen. On 2nd February 2018, the patient received SHINGRIX. On 2nd February 2018, 4 hrs after receiving SHINGRIX, the patient experienced injection site induration, injection site erythema, injection site pain, injection site warmth, general body pain, headache, generalized muscle aches, abdominal bloating and wrong vaccine administered. On 3rd February 2018, the patient experienced lethargy, diarrhea, chills, cold sweat and bedridden. On 4th February 2018, the outcome of the lethargy, chills and cold sweat were recovered/resolved. In February 2018, the outcome of the diarrhea was recovered/resolved. On an unknown date, the outcome of the injection site induration, injection site erythema, injection site pain and injection site warmth were not recovered/not resolved and the outcome of the general body pain, headache, generalized muscle aches, bedridden and wrong vaccine administered were unknown and the outcome of the abdominal bloating was recovering/resolving. The reporter considered the injection site induration, injection site erythema, injection site pain and injection site warmth to be related to SHINGRIX. It was unknown if the reporter considered the lethargy, diarrhea, chills, cold sweat, general body pain, headache, generalized muscle aches, abdominal bloating and bedridden to be related to SHINGRIX. Additional details were reported as follows: The patient's physician had ordered her to be vaccinated with the other shingles vaccine she recently discussed the SHINGRIX product with her pharmacist after reading an article. Because it did not require a prescription and was covered by her insurance and because her local pharmacist told her that he had received the SHINGRIX product already in stock and was trained on administering the product, she decided to go ahead and had him administer the SHINGRIX intramuscularly into her upper left arm on Friday about 1 pm lunchtime. The patient was vaccinated with the SHINGRIX vaccine instead of the other shingles vaccine ordered on a prescription from her physician. After being vaccinated with SHINGRIX, the area at the injection site became swollen, red and painful. There was now a hardened bump two inches wide at the injection site described to still be hot, tender, and painful. Several hours after vaccination, the generalized muscle pain was described as being very sore over all the body, bloating of her belly starting in the late evening on Friday. On Saturday morning, 1 day after vaccination, the patient was so lethargic upon awakening that she was mostly unable to get out of bed on Saturday and Sunday, excepting when she had to get up from bed and ambulate to the restroom due to the bad diarrhea which started on Saturday. Her lethargy had resolved by Sunday morning, and the diarrhea was now resolved with the belly bloating's currently resolving. One day after vaccination, the chills and cold sweats which started morning had resolved by Sunday evening. By late afternoon on Friday, several hours after vaccination, the patient felt like she was getting a headache and took OTC ibuprofen about 10 pm that night. The headache has continued and she woke up at 3:30 am that morning needing to take more OTC ibuprofen for the terrible headache. The patient was scheduled to see her physician on Thursday 8th February 2018. The reporter granted permission to be contacted by letter to her P.O. Box and that the pharmacist may be contacted as well. The reporter said the pharmacist was the responsible physician. The reporter assumed she got the standard 0.5 mL dose but did not know certainly. It was unknown if the pharmacist contacted patient's physician authorization to dispense SHINGRIX instead of the other product ordered prior to the administration.