Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Off label use, Peripheral swelling, Vaccination site erythema, Vaccination site mass
Clinical narrative: injection site became itchy, hard and hot.  Upon look at in the mirror it appears red as well.; injection site became itchy, hard and hot.  Upon look at in the mirror it appears red as well.; injection site became itchy, hard and hot.  Upon look at in the mirror it appears red as well.; injection site became itchy, hard and hot.  Upon look at in the mirror it appears red as well.; off label use; booster; Red/swelling arm; This is a spontaneous report from a contactable pharmacist (patient). A 59-year-old (non-pregnant) female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0175) via intramuscular route, administered in arm left on 17Sep2021 09:15 (at the age of 59-year-old) at dose 3 (booster), single for covid-19 immunisation. Medical history included MCTD (on immunotherapy), hyperlipidemia and patient had allergies to Bactrim, Antihistamine. Concomitant medications were not reported. No covid prior vaccination, no covid tested post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. The patient historical drugs included Prednisone 5mg QD, Mycophenolate 1000mg, BID, Nifedipine XL 30mg, QD, Cetrizine 10mg QD, Atorvastatin 40mg QD, Cyclobenzaprine 10mg, HS, Calcium, QD, Budesonide/Form 160/4.5mcg inhaler QD. Patient previously received first dose of bnt162b2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EH9899) via intramuscular route, administered in arm right on 29Dec2020 16:00 (at the age of 59-year-old) at dose 1, single for covid-19 immunisation and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL3247) via intramuscular route, administered in arm right on 19Jan2021 16:00 (at the age of 59-year-old) at dose 2, single for covid-19 immunisation. On 19Sep2021 20:00 the patient experienced injection site became itchy, hard and hot. Upon look at in the mirror it appears red as well and on an unspecified date in on 2021 red/swelling arm. Reported Event: About 2.5 days after receiving the vaccine, injection site became itchy, hard and hot. Upon look at in the mirror it appears red as well. The patient did not require the initiation of new medication or other treatment or procedure. Patient did not receive treatment for the adverse events. Information on organ involvement: Generalized prickle sensation: Yes, Localized injection site urticaria: Yes. Just around injection site red hard hot 2 diameter. Do you consider the Pfizer product had a causal effect to the adverse event. Yes. Outcome of the events injection site became itchy, hard and hot. Upon look at in the mirror it appears red as well and red/swelling arm was resolved on an unspecified date in 2021.  Follow-Up (13Oct2021): Follow-up attempts are completed. No further information is expected.