Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Off label use, Product use issue, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test date 30Dec2021 covid test result Positive; covid test date 30Dec2021 covid test result Positive; Pfizer-administration date 06Apr2021, dose number 2; Moderna vaccine same date vaccine date 06Apr2021; Pfizer-administration date 06Apr2021, dose number 2; Moderna vaccine same date vaccine date 06Apr2021; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from regulatory authority.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Apr2021 (Batch/Lot number: unknown) at the age of 58 years as dose 2, single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), administered in arm right, administration date 06Apr2021 (Lot number: 066F217) as dose 3  (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Bone Spurs" (unspecified if ongoing); "Diverticulitis" (unspecified if ongoing); "adhesive tape" (unspecified if ongoing). Concomitant medication(s) included: ALBUTEROL HFA; AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]; BUDESONIDE; ALPRAZOLAM; ESCITALOPRAM; SERTRALINE; TRIAMTERENE HCTZ; PANTOPRAZOLE; METHOCARBAMOL; MONTELUKAST; KLOR-CON M20; ONDANSETRON; LISINOPRIL; MELOXICAM; OXYCODONE AND ACETAMINOPHEN; TRIAMCINOLONE; GABAPENTIN; VIT D3; VITAMIN C [ASCORBIC ACID]; FLUTICASONE; BREO ELLIPTA. Past drug history included: Cephalosporins, reaction(s): "known allergies: Cephalosporins"; Gentamicin, reaction(s): "known allergies: Gentamicin"; Erythromycin, reaction(s): "known allergies: Erythromycin"; Floroquinolones, reaction(s): "known allergies: Floroquinolones"; Asparagus, reaction(s): "known allergies: Asparagus". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8737, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 16Mar2021, when the patient was 57 years old, for Covid-19 immunization, reaction(s): "Rash on both hands". The following information was reported: OFF LABEL USE (medically significant), PRODUCT USE ISSUE (non-serious) all with onset 06Apr2021, outcome "unknown" and all described as "Pfizer-administration date 06Apr2021, dose number 2; Moderna vaccine same date vaccine date 06Apr2021"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Dec2021, outcome "unknown" and all described as "covid test date 30Dec2021 covid test result Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events vaccination failure, covid-19, off label use and product use issue with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.