Age: 78.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Interchange of vaccine products, Off label use, Product use issue, Vaccination site pain, Wrong product administered
Clinical narrative: arm is still sore where got Pfizer shot; received Monovalent instead of Bivalent; 4th dose Moderna COVID-19 ...5th dose says Pfizer; Flu Shot - 20Oct2022; Flu Shot - 20Oct2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 78-year-old female patient received BNT162b2 (BNT162B2), on 20Oct2022 as dose 5 (booster), single (Lot number: FR2587) at the age of 78 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 4v (FLUAD QUAD), on 20Oct2022 as dose number unknown, single (Lot number: 346360), in right arm for immunisation. The patient didn't receive BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5). The patient's relevant medical history included: "rash" (unspecified if ongoing), notes: rash on her leg prior to the Pfizer Vaccine.; "edema" (unspecified if ongoing), notes: edema on her leg but was prior to the Pfizer Vaccine. Concomitant medication(s) included: AMLODIPINE; OMEPRAZOLE; VALACYCLOVIR [VALACICLOVIR]; PAROXETINE; LEVOTHYROXINE; ATORVASTATIN; CALCIUM; VITAMIN D NOS. Vaccination history included: moderna (Dose: 1, Lot number: 014M20A, Route of Administration: Intramuscular), administration date: 26Feb2021, when the patient was 77-year-old, for COVID-19 Immunization; moderna (Dose: 2, Lot number: 047A21A, Route of Administration: Intramuscular), administration date: 26Mar2021, when the patient was 77-year-old, for COVID-19 Immunization; moderna (Dose: 3, Lot number: 048C21A, Route of Administration: Intramuscular), administration date: 05Nov2021, when the patient was 77-year-old, for COVID-19 Immunization; moderna (Dose: 4, Lot number: 057M21A, Route of Administration: Intramuscular), administration date: 25Apr2022, when the patient was 78-year-old, for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 20Oct2022, outcome "unknown", described as "4th dose Moderna COVID-19 ...5th dose says Pfizer"; OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 20Oct2022, outcome "unknown" and all described as "Flu Shot - 20Oct2022"; WRONG PRODUCT ADMINISTERED (non-serious) with onset 20Oct2022, outcome "unknown", described as "received Monovalent instead of Bivalent"; VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "arm is still sore where got Pfizer shot". Additional information: Patient was also taking multivitamins. Caller is calling about the COVID-19 Vaccine Booster Monovalent and Bivalent. The place where his wife got the booster for latest booster was supposed to get Bivalent and was given Monovalent. Place called a couple days ago and wanted to let her know. He is trying to find out what this means and the place was very vague. Place said to call doctor and doctor said didn't know. The reason he is calling instead of his wife is because she has a lot of health problems and this is difficult for her. Just got the booster 20Oct2022. Patient stated arm is still sore where got Pfizer shot.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.