Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Anaphylactic reaction, Anxiety, COVID-19, Diabetes mellitus, Respiratory distress
Clinical narrative: Diabetes mellitus; anaphylaxis/ anaphylactic reaction; Respiratory distress; Anxiety; covid; This serious case was reported by a consumer via other manufacturer and described the occurrence of diabetes mellitus in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included BNT162b2 for prophylaxis.   The patient's past medical history included anaphylactic reaction. Previously administered products included Bnt162b2 with an associated reaction of anaphylactic reaction (received 1st dose on an unknown date for Covid-19 immunization) and Covid -19 vaccine with an associated reaction of adverse reaction (received 1 primary series and 2 booster shots of COVID-19 Vaccine on an unknown date). Concurrent medical conditions included rubber sensitivity (anaphylactic reaction), autoimmune disorder (autoimmune disease, unspecified if ongoing) and latex allergy (unspecified if ongoing). Concomitant products included INFLUENZA VACCINE and PNEUMOCOCCAL VACCINE.   On an unknown date, the patient received Shingrix and the 2nd dose of BNT162b2. On an unknown date, an unknown time after receiving Shingrix, the patient experienced diabetes mellitus (Verbatim: Diabetes mellitus) (serious criteria GSK medically significant and other: serious as per reporter), anaphylactic reaction (Verbatim: anaphylaxis/ anaphylactic reaction) (serious criteria GSK medically significant and other: serious as per reporter), respiratory distress (Verbatim: Respiratory distress) (serious criteria GSK medically significant), anxiety (Verbatim: Anxiety) (serious criteria other: serious as per reporter) and covid-19 (Verbatim: covid). The patient was treated with famotidine (Pepcid), calcium carbonate (Antacid), epinephrine (Epipen), cetirizine and salbutamol (Albuterol). The outcome of the diabetes mellitus, anaphylactic reaction and anxiety were unknown and the outcome of the respiratory distress and covid-19 were not reported.   It was unknown if the reporter considered the diabetes mellitus, anaphylactic reaction, respiratory distress, anxiety and covid-19 to be related to Shingrix.     The company considered the diabetes mellitus, anaphylactic reaction, respiratory distress and anxiety to be unrelated to Shingrix. It was unknown if the company considered the covid-19 to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-OCT-2024 The patient self-reported this case. The reporter reported that a patient received BNT162b2 (BNT162B2), as dose 2, single for covid-19 immunization and varicella zoster vaccine rge (cho) (Shingrix) fir immunization. The patient received previously 1st dose of BNT162b2 and had a reaction but handled and able to do all 3/anaphylaxis. The patient experienced anaphylactic reaction, diabetes mellitus and anxiety. Therapeutic measures were taken as a result of anaphylactic reaction. The patient had 1 primary series and 2 booster shots of COVID-19 Vaccine and wanted to know if the 4th booster the liquid on the vial from Pfizer did not have latex on the vial because she had some immune issues and she took the Shingrix vaccine and experienced anaphylaxis and was on steroids.  The patient wanted to know if this was safe for her to take the 4th booster shot from Pfizer. Caller (patient) clarified details provided by the transfer agent. She stated that was little complicated and that was the reason she had an Immunologist. She had the flu shot and pneumonia vaccine and was fine and then the Shingrix she had instant anaphylaxis and pharmacist said was too quick to be anaphylaxis.  Ultimately, she was able to discern and very carefully and both Shingrix and the reconstituted vial had latex and liquid had latex in the vial. The FDA (food drug and administration) had warned her and that was the issue and prepared her. She was anything but antivaccine.  Her immunologist came up with an allergy action plan, she called Pfizer and Moderna and the answer she got from both was that vial tops were latex base, but liquid might or might not have latex in the liquid. The health department would not give her either vaccine.  The pharmacist was willing to circumvent this. Her immunologist wrote her allergy action plan and started on steroids and on Pepcid.  She would be with a senior pharmacist to take her blood pressure and do 30 minutes of observation and have her EpiPen. After doing successfully, she had a reaction but handled and able to do all, she was able to take 4th but that was different. She wanted to make an inquiry.  The latex top she knows but need to know if risk for having a reaction and should not be taking steroids if not necessary and might compromise the vaccine and have the steroid does she take another dose of old one or wait for the new COVID-19 Vaccine.  The patient declined report as she had an appointment and not prepared for a safety report. Step 1 in order for her to break them apart. If in fact needed to this works so well to take with or without the flu shot as she knew some people were receiving the vaccines together. Her immunologist said to take separate. Patient had a very dear friend who had a latex allergy and was a hospital pharmacist and was a teaching immunologist, her experience had a latex allergy and getting an answer and avoid and should not have to take and was latex safe inside and out and be sad if forced to take steroids.  She was already dealing with immune issues and why stress her body out. She trusts Pfizer.  She needs an answer and leads her take to steroids that were not necessary.  Food drug and administration trained her from prior events and did not want to have an event and at same time if could not get a clear answer should not have to take. She was an ally. She just had a Latex Allergy awareness week and pressing to get vaccination, and this was the issue. She had to work hand in hand. Caller asked if Pfizer covid-19 booster, the new one, had latex in it. The reporter had the 3 original vaccines and booster, the new have not had the new one.  Nobody would give that to patient, health department and pharmacist would not give that to patient because had interpolation for vaccines, she had me in succession with that together, she had flu then pneumonia vaccine, then had the Shingrix vaccine and the final step was having the covid vaccine. They have had carefully tracked those vials, the vial of vaccine and the reconstituting vial, both were labelled latex safe. Upon further investigation, the liquid inside, part that was injected to, had latex in it, immediately put into anaphylaxis. The reporter when got the inquiry they got a response, yes, the caps were latex safe however they could not guarantee that the liquid inside or the reconstituting vial liquid might have a latex in it. Allergy reaction plan, take course of steroids, with antacid, take it before during and after, have an EpiPen.  Told her if she would go fine with the first shot (covid vaccine) then she could go all three, did had a reaction, but it was a very controlled reaction.  The patient was able to have all three, she had a choice to take it, she was taking cetirizine and Pepcid. The patient should not take steroids unless necessary, because she had already immune issues, did not want to compound and make the vaccine less effective or omicron reaction worst by taking more steroids. The hospital pharmacist friend with latex allergy made understands her allergy.  She knew that the top of the vial was supposedly latex free but based on her experience with Shingrix vaccine, that was not the case.  Hospital pharmacist who gave birth as well, had more serious immune issues than did, going to get her flu shot on the day of reporting, had not started taking the course of steroid, cetirizine and Pepcid. The reaction they have was not from the medicine it was from the latex. The patient said, pharmacist of a generic company, albuterol (could not remember the manufacturer) had latex in it, the colorant did have latex. Was sent to hospital. They accidentally gave her albuterol due to respiratory distress with covid and was treated at home and found out other products with latex on it and zolpinex was on it. Patient did not consider it an adverse reaction just a controlled event, normally treated with antiallergics and corticosteroid. Caller had the Pfizer covid-19 vaccine Biontech haven't had the other ones that were available. She needs to get allergen information because its Oct already. She has allergies and autoimmune issues. She was aware that the vaccine might contain latex. She experienced a mild reaction after her first and second shots and developed diabetes. She took Pepcid, Cetirizine, and used an Epipen, and also experienced anxiety. It was unknown if the reporter considered the diabetes mellitus, anaphylactic reaction, respiratory distress, anxiety and covid-19 to be related to BNT162b2.; Sender's Comments: Diabetes mellitus  Respiratory distress Anxiety are unlisted events which are considered unrelated to GSK vaccine Shingrix.  Anaphylactic reaction is a listed event which, due to the following criteria (h/o anaphylactic reaction and concomitant BNT162b2) is considered unrelated to GSK  vaccine Shingrix.