Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Immunisation, Off label use, Rash
Clinical narrative: off label use; Booster; rash all over; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history included: "Pre-diabetic" (unspecified if ongoing), notes: Pre-diabetic. Concomitant medication(s) included: ELIQUIS; METOPROLOL; POTASSIUM CHLORIDE. Vaccination history included: BNT162b2 (Dose 1 single, Lot#: FL9263), administration date: 20Feb2021, when the patient was 65-year-old, for COVID-19 Immunization; BNT162b2 (Dose 2 single, Date of Vaccination: 19Mar2021), administration date: 19Mar2021, when the patient was 65-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot#: Consumer stated, "That one is, FF288."), administration date: 26Sep2021, when the patient was 65-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Lot#: FM0698), administration date: 30Mar2022, when the patient was 66-year-old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 07Sep2022, outcome "unknown", described as "Booster"; OFF LABEL USE (non-serious) with onset 07Sep2022, outcome "unknown"; RASH (non-serious) with onset 07Sep2022, outcome "unknown", described as "rash all over". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of rash.  Additional information: The patient was also the reporter. COVID Vaccine was a Bivalent Pfizer product. Consumer stated that, "the patient need to report a rash that have got after getting the vaccine couple of weeks ago". When paraphrased the concern, Consumer stated that, "Yeah, patient got the vaccine on 07Sep22 (7Sep2022) and started getting a rash from it". Consumer was informed about the role of Pfizer Drug Safety. The fifth one (Pfizer COVID Vaccine Bivalent). Prior Vaccinations (Within 4 weeks): Consumer stated, that "No" medical Conditions and patient was pre diabetic and do take blood thinners for heart." Name of blood thinner medications was "Its a Eliquis, the blood thinner". Patient take Regular Medications like vitamins, Potassium Chloride (1 tablet a day 20 mEq), Metoprolol (1 tablet daily 25 milligrams)." Patient had lab test from his doctor they just did about few weeks ago before getting this shot. Just blood work, general lab work that had done. It was for, they were checking diabetes, checking TSH, cholesterol test, a general checkup.". Consumer stated that he has not taken any treatment for Rash anymore. It does not itch him, patient don't think that it was itching him, right now anyway. Patient was just calling to see if they can tell him how long does it supposed to last or anything. Consumer was told about the role of Pfizer Medical Information. Consumer stated that Route of administration and dosage of vaccine that he doesn't know what it is. It was the 5th shot which patient was supposed to get. Patient don't know what the dosage was, standard dose or whatever supposed to get on the 5th shot." Patient demographics: Consumer stated that, patient really need that for this, and he don't see what that was all going to do with it.