Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster, Incorrect dose administered, Interchange of vaccine products, Off label use, Product use issue
Clinical narrative: I got shingles on my trunk area on the right side; off label; Product use for unapproved combination; Inappropriate dose of vaccine administered; Interchange of vaccine products; The initial case was missing the following minimum criteria: invalid as info not qualifying for AE reporting - Medical Information. Upon receipt of follow-up information on (18Sep2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s). The reporter is the patient.  A 69-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Lot number: 346334, Expiration Date: 13Apr2023) at the age of 69 years, in right arm for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 08Sep2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna coviD-19 vaccine (First shot: LOT#: 018B21A; , Administration date: 26Mar2021, All four Moderna is left arm), administration date: 26Mar2021, when the patient was 68-year-old, for COVID-19 immunization; moderna coviD-19 vaccine (Second shot: LOT#: 036B21A; Administration date: 23Apr2021, All four Moderna is left arm), administration date: 23Apr2021, when the patient was 68-year-old, for COVID-19 immunization; Moderna covid-19 vaccine (Booster (first): LOT#: 056M2A, All four Moderna is left arm), for COVID-19 immunization; Moderna covid-19 vaccine (two boosters I have Moderna, Moderna is left arm), for COVID-19 immunization. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 08Sep2022, outcome "unknown", described as "Inappropriate dose of vaccine administered"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 08Sep2022, outcome "unknown"; PRODUCT USE ISSUE (non-serious) with onset 08Sep2022, outcome "unknown", described as "Product use for unapproved combination"; OFF LABEL USE (non-serious) with onset 08Sep2022, outcome "unknown", described as "off label"; HERPES ZOSTER (non-serious) with onset 14Sep2022, outcome "unknown", described as "I got shingles on my trunk area on the right side". Therapeutic measures were taken as a result of herpes zoster.  Additional information: It was stated that, "Well on 08Sep she went to a market and the pharmacy department offering the latest Covid vaccine, one with the original in the omicron for BA4/A5. So, she got that vaccine on the 08Sep and almost a week later probably around the 14Sep she got shingles on her trunk area on the right side, and she went online just to see if any cases reported after receiving you know the Pfizer vaccine, Covid vaccine and getting shingles and getting apparently this was the site it was, she forgot which site it was. But they have some cases of shingles after receiving the Pfizer vaccine. she just wants to alert you that she was one of those cases now. I don't know if you want me to add to your studies." When paraphrased concern: Patient stated, "Right I did go online and there have been reported cases directly linked to it. I just did let you know I did get shingles." Follow up: Patient stated, "Yes. I do let you know that my first two vaccine and two boosters I have Moderna." LOT# (Covid-19 vaccine bivalent): Patient stated, "346334" (captured as provided over call). LOT# (Moderna Covid-19 vaccine): Patient stated, "I thought you can't interchange them, right? Well, I was anxious to get it because my husband I have to take care of my husband. I just wanted to get the vaccine as soon as possible." She reported that, first shot: LOT#: 018B21A; Administration date: 26Mar2021; Second shot: LOT#: 036B21A; Administration date: 23Apr2021; Booster (first): LOT#: 056M2A. Anatomical site of vaccine administration: Patient stated, "All four Moderna is left arm and Pfizer was the right arm. "Treatment: Patient stated, "No. Just over the counter Benadryl, Hydrocortisone and anti-itch cream."