Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue
Clinical narrative: Stomach started cramping; fatigue; mild chills; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Covid vaccine (received 1st, 2nd and 3rd shot on an unknown date).   On 18th January 2022, the patient received the 1st dose of Shingrix. On 19th January 2022, 1 days after receiving Shingrix, the patient experienced fatigue and chills. On 23rd January 2022, the patient experienced stomach cramps. On 25th January 2022, the outcome of the fatigue, chills and stomach cramps were recovered/resolved.   It was unknown if the reporter considered the fatigue, chills and stomach cramps to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The reporter enquired about the ingredients for shingrix and further stated, he/she could not find them anywhere on the website. The reporter was informed, Shingrix was supplied as a vial of powder with an accompanying liquid vial of an adjuvant. These two vials were mixed together prior to administration. The powder was made up of a purified protein antigen found on the surface of the inactive varicella zoster virus (the virus that causes shingles). The adjuvant contains lipids, plant extract and a saline solution. Shingrix (Zoster Vaccine Recombinant, Adjuvanted) was a sterile suspension for Intramuscular injection. The vaccine was supplied as a vial of lyophilized recombinant varicella zoster virus surface glycoprotein E (gE) antigen component, which must be reconstituted at the time of use with the accompanying vial of AS01B  djuvantsuspension component. The lyophilized gE antigen component is presented in the form of a sterile white powder. The AS01B adjuvant suspension component is an opalescent, colorless to pale brownish liquid supplied in vials. The gE antigen is obtained by culturing genetically engineered Hamster Ovary cells, which carry a truncated gE gene, in media containing amino acids, with no albumin, antibiotics, or animal-derived proteins. The gE protein is purified by several chromatographic steps, formulated with excipients, filled into vials, and lyophilized. The adjuvant suspension component is AS01B which is composed of 3-O-desacyl-4- monophosphoryl lipid A (MPL) from Salmonella minnesota and QS-21, a saponin purified from plant extract Quillaja saponaria Molina, combined in a liposomal formulation. The liposomes are composed of dioleoyl phosphatidylcholine (DOPC) and cholesterol in phosphate-buffered saline solution containing disodium phosphate anhydrous, potassium dihydrogen phosphate, sodium chloride, and water for injection. After reconstitution, each 0.5-mL dose is formulated to contain 50 mcg of the recombinant gE antigen, 50 mcg of MPL, and 50 mcg of QS-21. Each dose also contains 20 mg of sucrose (as stabilizer), 4.385 mg of sodium chloride, 1 mg of DOPC, 0.54 mg of potassium dihydrogen phosphate, 0.25 mg of cholesterol, 0.160 mg of sodium dihydrogen phosphate dihydrate, 0.15 mg of disodium phosphate anhydrous, 0.116 mg of dipotassium phosphate, and 0.08 mg of polysorbate 80. After reconstitution, SHINGRIX was a sterile, opalescent, colorless to pale brownish liquid. Shingrix does not contain preservatives. Each dose may also contain residual amounts of host cell proteins (greater than or equal to 3.0 percent) and DNA (greater than or equal to 2.1 picograms) from the manufacturing process. The vial stoppers are not made with natural rubber latex. The reporter was provided with the link for the package insert. The patient got the first dose of Shingrix on 18th January 2022 and about 24 hours later had quite a bit of fatigue, mild chills. The patient slept it off and had no problem, later on late Sunday night the patients stomach started cramping and then chills started. The patient stated all of that lasted until the morning of reporting day. The patient wanted to know if it could be second delayed reaction to the vaccine. The patient was informed, individual responses could vary, but the local and general adverse reactions (pain, redness, swelling at the injection site, myalgia, fatigue, headache, shivering, fever and GI symptoms) were seen with Shingrix in the two clinical studies in adults 50 and 70 years of age had a median duration of 2 to 3 days, some patients might continue to experience reactions beyond 3 days. The patient just wondered if her experience was considered normal, or if not typical, possible. The patient wanted to know for the second dose, if there was any sweet spot in timing, she knew its 2-6 months, but wanted to know if 2 months was considered the optimal time for a good result. The patient was advised, in clinical trials the median duration of side effects reported was 2 to 3 days and there was no preferred time to get the second shot. However, it might be a good idea for a patient to get it as soon as possible within the 2-6 month timeframe, so they do not forget to get their second shot. Also some patients might want the reassurance of knowing the series was complete by getting the second dose at the 2 month mark versus waiting longer. The patient stated she got it listed in her calendar for two months. The patient further wanted to know If a fourth covid vaccine (patient had Pfizer all 3) was recommended around the time of her second shingrix, were there any recommendations to hold off on one for a period of time. The patient stated that issue wasn't addressed, it was addressed in FAQs but she had heard anecdotal stories about that issue. The patient was advised that patients should consult with their healthcare provider regarding questions about administering Shingrix and a COVID-19 vaccine at the same time and that there were no available data on the co-administration of GSK vaccines and a COVID-19 vaccine. The patient was advised to refer the CDC.