Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: COVID-19, Chills, Drug ineffective, Fatigue, Hypersensitivity
Clinical narrative: test was positive for COVID; test was positive for COVID; tired; chills; Arms Heavy; Interchange of vaccine products; symptoms like allergies; This is a spontaneous report received from contactable reporter(s) (Physician and Other HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Sep2022 as dose 6 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 25Sep2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CARDIZEM [DILTIAZEM] (ongoing); LOSARTIN (ongoing); CALCIUM WITH VITAMIN D 3, Multivitamin with Iron, Probiotic. The following information was reported: HYPERSENSITIVITY (non-serious) with onset 2022, outcome "unknown", described as "symptoms like allergies"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 25Sep2022, outcome "unknown"; LIMB DISCOMFORT (non-serious) with onset 26Sep2022, outcome "unknown", described as "Arms Heavy"; CHILLS (non-serious) with onset 26Sep2022, outcome "unknown"; FATIGUE (non-serious) with onset 01Oct2022, outcome "unknown", described as "tired"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Oct2022, outcome "unknown" and all described as "test was positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Oct2022) Positive, notes: Binax tests. Therapeutic measures were taken as a result of limb discomfort, chills.  Clinical information: Reported as, She also received the flu vaccine at the same appointment. The day after receiving that dose she felt both of her arms were heavy. She took ibuprofen and felt fine until that evening when she had chills. She had also experienced chills with some of her previous Moderna vaccines. She then had "symptoms like allergies" for the next few days. She felt tired this weekend and took a test on Sunday (02Oct2022). Her test was positive for COVID-19. Another one of her colleagues also tested positive for COVID-19, though she received the Pfizer bivalent booster. Patient continued taking her Cardizem and Losartin. Patient stopped taking of her supplements Including (calcium with vitamin D a multivitamin with iron band a probiotic).   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.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective, covid-19 and interchange of vaccine products and BNT162B2.