Age: 100.0
Sex: F
Vaccine: COVID19-2
Symptoms: Investigation, Wheezing
Clinical narrative: wheezing; fatigue; loss of appetite; The first bivalent booster was given on 18Jan2023, and then was given another dose 3 days later; Patient received 2 of the Moderna COVID Vaccines for her primary series; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  An 100-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Jan2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 100 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2, BNT162b2 omi ba.4-5 (Bivalent gray cap booster , Dose 3), administration date: 18Jan2023, when the patient was 100-year-old, for COVID-19 immunization; Moderna covid vaccine (primary series, Dose 1), for COVID-19 immunization; Moderna covid vaccine (primary series, Dose 2), for COVID-19 immunization.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 25Jan2023, outcome "unknown", described as "Patient received 2 of the Moderna COVID Vaccines for her primary series"; INCORRECT DOSE ADMINISTERED (non-serious) with onset 25Jan2023, outcome "unknown", described as "The first bivalent booster was given on 18Jan2023, and then was given another dose 3 days later"; FATIGUE (non-serious) with onset 26Jan2023, outcome "not recovered"; DECREASED APPETITE (non-serious) with onset 26Jan2023, outcome "not recovered", described as "loss of appetite"; WHEEZING (non-serious) with onset 26Jan2023, outcome "not recovered". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Given a dose of the bivalent booster on 18Jan2023, and then a week later she was inadvertently given another bivalent booster. Right now she is experiencing wheezing and fatigue. Reporter seriousness for given a dose of the bivalent booster on 18Jan2023, and then a week later she was inadvertently given another bivalent booster was not Serious. The patient other condition was reported as yes. Other Products was reported as no. Caller also stated that the patient was also experiencing a loss of appetite, but has no neurological deficits. The family was concerned because this patient was a very active vibrant person, but after this last dose of the Pfizer COVID-19 Bivalent vaccine, she has completely become somebody different. She received the 1st dose of the Pfizer COVID-19 Bivalent vaccine while in the hospital after breaking her hip. She was transferred to the withheld facility on 23Jan2023. Caller states that this was not acutely medically significant, but may hamper the patient's withheld. Because she was now wheezing, the doctor was going to order some albuterol nebulizer treatments. Patient received 2 of the Moderna COVID-19 Vaccines for her primary series, but she doesn't have any product information to provide, including the date/Lot/NDC/Expiry. Caller did not have any product information to provide for the Pfizer COVID-19 Bivalent booster the patient received on 18Jan2023. States that she could look up all this information, but she has other patients that are waiting on her, so she doesn't have time. Vaccine Administered at Facility was reported as no. Any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) and Family Medical History Relevant to Adverse Events (AEs) was reported as none.   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.