Age: 37.0
Sex: F
Vaccine: COVID19, FLUC3
Symptoms: Off label use, Product administered at inappropriate site, Product use issue, Vaccination site erythema, Vaccination site mass
Clinical narrative: off label use; Shot was not given in proper placement in arm; was given much lower in AM; Other vaccine same date vaccine date 26Sep2021; Baseball sized, red, raised, painful, itchy welt at injection site; Baseball sized, red, raised, painful, itchy welt at injection site; Baseball sized, red, raised, painful, itchy welt at injection site; Baseball sized, red, raised, painful, itchy welt at injection site; Baseball sized, red, raised, painful, itchy welt at injection site; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Sep2021 13:30 (Batch/Lot number: unknown) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUADRIVALENT), administered in arm left, administration date 26Sep2021 (Batch/Lot number: unknown) as dose number unknown, single. The patient's relevant medical history was not reported. Concomitant medication(s) included: CALCIUM. Past drug history included: Ceclor, reaction(s): "Known allergies: Ceclor", notes: Known allergies: Ceclor. Vaccination history included: Bnt162b2 (Previous dose product: COVID 19, Previous dose brand: Pfizer, Previous dose lot number: EL3248, Previous dose administration date: 13Jan2021 , Prev dose dose number: 2), administration date: 13Jan2021, when the patient was 37 years old, for Covid-19 Immunization; Bnt162b2 (Previous dose product: COVID 19, Previous dose brand: Pfizer, Previous dose lot number: EK5730, Previous dose administration date: 19Nov2020, Previous dose number: 1), administration date: 19Nov2020, when the patient was 37 years old, for Covid-19 Immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE PAIN (non-serious), VACCINATION SITE REACTION (non-serious), VACCINATION SITE MASS (non-serious) all with onset 26Sep2021, outcome "recovered" and all described as "Baseball sized, red, raised, painful, itchy welt at injection site"; OFF LABEL USE (non-serious) with onset 26Sep2021 13:30, outcome "unknown", described as "off label use"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 26Sep2021 13:30, outcome "recovered", described as "Shot was not given in proper placement in arm; was given much lower in AM"; PRODUCT USE ISSUE (non-serious) with onset 26Sep2021 13:30, outcome "recovered", described as "Other vaccine same date vaccine date 26Sep2021". The events "baseball sized, red, raised, painful, itchy welt at injection site", "baseball sized, red, raised, painful, itchy welt at injection site", "baseball sized, red, raised, painful, itchy welt at injection site", "baseball sized, red, raised, painful, itchy welt at injection site", "baseball sized, red, raised, painful, itchy welt at injection site", "shot was not given in proper placement in arm; was given much lower in am" and "other vaccine same date vaccine date 26sep2021" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site pruritus, vaccination site pain, vaccination site reaction, vaccination site mass.  Additional information: Facility type vaccine was Pharmacy or Drug Store. Patient received other vaccine in four weeks. Other medications received in two weeks was multivitamin. Shot was not given in proper placement in arm. was given much lower in AM. Patient was not tested covid prior vaccination. Patient was not tested covid post vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.