Age: 72.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Off label use, Product use issue, Rash, Wrong technique in product usage process
Clinical narrative: rash; Flu vaccine administered date: 14Sep2022; Flu vaccine administered date: 14Sep2022; The injection may not have penetrated the skin, Two injection were given in the same area, my arm felt wet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Sep2022 as dose 5 (booster), single (Lot number: GJ2524, Expiration Date: 29Nov2022) at the age of 72 years for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), on 14Sep2022 as dose number unknown, single (Batch/Lot number: unknown) intramuscular, in arm for immunisation. The patient's relevant medical history included: "Absence seizures", start date: 1969 (ongoing), notes: Absence seizures; "Essential tremor", start date: 2000 (ongoing); "low thyroid", start date: 1924 (ongoing), notes: low thyroid; "seizure" (ongoing); "tremor" (ongoing), notes: Onset date: 2000 plus or minus; "thyroid" (ongoing); "Hashimotos" (unspecified if ongoing), notes: Hashimotos (thyroid), Onset Date Not less than 1972, Pertinent Details: Surgery 1972; "Surgery", start date: 1972 (unspecified if ongoing); "Multiple surgeries" (unspecified if ongoing), notes: Onset Date 1990s plus, Multiple surgeries; "Dupuytens Contracture Hands" (ongoing), notes: Pertinent Details: Multiple surgeries, Onset Date 1990s plus; "Epilepsy", start date: 1968 (ongoing). Concomitant medication(s) included: LAMOTRIGINE oral taken for seizure (ongoing); PROPRANOLOL oral taken for tremor (ongoing); SYNTHROID oral taken for thyroid disorder (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Anatomical site of injection: arm, Route of administration: intramuscular, Batch/lot number: Pfizer EN6205), administration date: 04Mar2021, when the patient was 70-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE, Anatomical site of injection: arm, Route of administration: intramuscular, Batch/lot number: Pfizer EP6955), administration date: 01Apr2021, when the patient was 71-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Anatomical site of injection: arm, Route of administration: intramuscular, Batch/lot number: Pfizer FH8020), administration date: 18Oct2021, when the patient was 71-year-old, for COVID-19 immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Anatomical site of injection: arm, Route of administration: intramuscular, Batch/lot number: Pfizer FK9893), administration date: 25Apr2022, when the patient was 72-year-old, for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 14Sep2022, outcome "unknown" and all described as "Flu vaccine administered date: 14Sep2022"; WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious) with onset 14Sep2022, outcome "unknown", described as "The injection may not have penetrated the skin, Two injection were given in the same area, my arm felt wet"; RASH (non-serious), outcome "unknown".  Additional information: Upon Follow-up (16Mar2023) it was reported that Booster dose (other) Recommended age GJ2524 14Sep2022- May not actually have penetrated skin. The injection may not have penetrated the skin. Two injections were given in the same area. Patient's arm felt wet and a rash subsequently appeared. She didn't know if it was the booster or the flu vaccine. She commented at that time with no response. The error noticed and intercepted before the product was supplied to the patient was not applicable. Inadvertent human error was the factor considered to be responsible for the medication error. The patient did not experience any adverse event (s) as a consequence of the error. The only complication is that patient did contract COVID after having received my booster. If she did get one. The injection may not have penetrated the skin.  Follow-up (01Mar2023): Follow-up attempts are completed. No further information is expected.  Follow-up (16Mar2023): This is a spontaneous follow up report received from a contactable consumer. This 72-year-old female consumer (patient) reported in response to non-HCP letter sent via follow-up letter in a cross-referenced case which included that: Updated information: Reporter and patient information updated, RMH Epilepsy, Hashimotos, Dupuytrens contracture hands, surgery (multiple surgery) were added, New events (The injection may not have penetrated the skin, two injection were given in the same area, my arm felt wet and rash) were added, Lot number for dose 3 updated in notes field from AT8020 to FH8020 and additional information added.