Age: 83.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Off label use
Clinical narrative: Dose 5 of COMIRNATY; Dose 5 of COMIRNATY; got the Bivalent shot before the recommended 2 month interval; really sick; Tired; Lethargic; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team, Program ID.  An 83-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), 0.3 ml single (Batch/Lot number: unknown) at the age of 83 years intramuscular for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 4, SINGLE at pharmacy; NDC No: 80777-027310), administration date: 01Aug2022, when the patient was 83-year-old, for COVID-19 immunization; Covid-19 vaccine (Dose 1), for COVID-19 immunization; Moderna covid-19 vaccine (Dose 2), for COVID-19 immunization; Moderna covid-19 vaccine (Dose 3), for COVID-19 immunization. The following information was reported: LETHARGY (non-serious) with onset 2022, outcome "unknown", described as "Lethargic"; FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "Tired"; ILLNESS (non-serious) with onset 2022, outcome "unknown", described as "really sick"; OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 15Sep2022, outcome "unknown" and all described as "Dose 5 of COMIRNATY"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 15Sep2022, outcome "unknown", described as "got the Bivalent shot before the recommended 2 month interval". Therapeutic measures were not taken as a result of off label use, immunisation, illness, fatigue, lethargy.  Additional information: Caller states that she told her father to go to (withheld) specifically get the flu and Pneumonia shot, he was instead encouraged to get the flu and Pfizer bivalent shot instead as it was being pushed at the moment. His father agreed and got the Pfizer COVID-19 bivalent shot. Caller then states that his last Pfizer COVID-19 shot was given to him on August 1st at pharmacy, which would mean that he got the Bivalent shot before the recommended 2 month interval. Caller was asking if we have any data for these kinds of situations. He said he wanted 3 shots and pharmacy said they could do two at time and he was old and listened to what they say. Caller said her mom gave him a fake paper so he wouldn't get lost. He mother has the original with the date. The pharmacy wrote on the original and patient did not see on the copy and caller said usually the insurance will block and they billed the insurance and the insurance did not block and was less than 2 months. Her father said he was glad he did not get all 3 shots because he got really sick and was lethargic and tired and she told him he got to soon. She said he should have got pneumonia. Asking because of older people and just pushing things. Wanted to see if there were other people trying and if they were safe.  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.