Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Missed 2nd dose. 1st shot in June 2020; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in June 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that he/she missed reminder to get 2nd Shingrix shot within 6 months, which led to incomplete course of administration. The patient further stated it was now at the time of reporting one and a half years gap and wanted to know if he/se should get the 2nd dose or start over. The patient was wondering if there was a view at Shingrix site as doctors seemed confused as per the patient because of such a long gap. The patient was notified that any information they were provided was not intended as medical advice, for medical advice he/she should refer them to his/her healthcare provider as their primary resource for patient care. The patient was disconnected twice, it was the 3rd time he/she had been there, was bumped off twice during transfer to shingrix specialist. The patient was advised- individual medical guidance for patients should be provided by medical professionals and was not something GlaxoSmithKline provides to patients. The FDA (Food and Drug Administration) approved dosing schedule for Shingrix was the first dose at month 0, followed by a second dose 2-6 months after the first dose. The Centers for Disease Control (CDC) had provided guidance that if it had been more than 6 months since a patient received the first dose, they should get the second dose as soon as possible; patients do not need to restart the vaccine series. However, the efficacy of alternative dosing regimens had not been evaluated. Data regarding the safety of alternative regimens were limited. Individuals might remain at risk for herpes zoster during a longer than recommended interval between doses 1 and 2. The patients were advised that they consult with their healthcare provider about this guidance and their individual situation. The patient stated that he/she just needed to see if there was general guidance as the gap had been long, he/she had seen the Centers for Disease Control (CDC) guidelines but imagined they meant a few months late. The patient was informed that Shingrix was administered as a 2-dose series. The FDA approved schedule did not include a booster dose of Shingrix or a repeat of the series. The patient stated he/she will figure out with the doctor and it was just that he/she was aware this was a good vaccine and wanted to be sure he/she was covered. The patient was provided with the link for the package insert. The reporter denied consent to follow up.