Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Felt very tired the next day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 90-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Arthritic knees" (unspecified if ongoing), notes: Has arthritic knees not she does not have good bones.; "Does not have good bones" (unspecified if ongoing), notes: Has arthritic knees not she does not have good bones. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunization, reaction(s): "Felt very tired the next day". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Felt very tired the next day".  Additional information: A caller has about the Pfizer Bivalent vaccine. She saw on the fact sheet that the Pfizer bivalent vaccine is not FDA approved. She wants to know why it was not FDA approved. She also wants to know what were the differences of the Pfizer bivalent vaccine with the first three doses of vaccines. She had not taken the bivalent vaccine and wants to know if there would be any reactions. Caller stated she has received 4 shots of COVID 19 vaccines at the moment. She referred to the Bivalent gray cap vaccine as her potential third booster. Do the Bivalent vaccine have some sort of extra adjunct material to make it stronger? or why was it called bivalent. Caller also asked if there was something different in this new vaccine compared to the first three doses that she received. Caller mentioned that she was already in her appointment to receive a dose of the new Bivalent gray cap vaccine, but when she read the vaccine was not FDA approved, and the term "bivalent", she decided not to receive the dose. Caller mentioned she was 90 years old and had arthritic knees not she did not have good bones. She asked if she could be irritated by receiving the 4th dose with the bivalent. She also mentioned that with her previous doses she felt very tired the next day, and asked, what was going on with the fatigue. She asked if she could be fatigue with the new bivalent. She mentioned that it was concerning, but that probably apart from being more tired that she has been with the previous vaccination, caller suspects she will not suffer from anything unusual, and that she will make an appointment to receive the vaccine. Caller asked about the ingredients of the Bivalent vaccine and for the function of the polyethylene glycol. Form: Gray cap, Original/Omicron BA.4/BA.5 (Bivalent), greater than or equal to 12 years- 15/15 mcg per dos. She asked if she could be irritated by receiving the 4th dose with the bivalent. Caller mentioned that with her previous doses she felt very tired the next day, and asked, what was going on with the fatigue. She asked if she could be fatigue with the new bivalent.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.