Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Off label use, Pain, Paraesthesia
Clinical narrative: body ache; fatigue; tingling fingers; injection site remains red swollen warm painful; injection site remains red swollen warm painful; injection site remains red swollen warm painful; injection site remains red swollen warm painful; periodic itching at site; swelling in right axillary; large hard area red painful x3 days; off label use; booster; This is a spontaneous report from a contactable nurse (patient). A 54-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiry date not reported), intramuscular, administered in Arm Right on 12Oct2021 (age at vaccination was 54 years) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. Medical history included asthma, gastrooesophageal reflux disease, gluten sensitivity (gluten intolerance), and allergy to arthropod sting (anaphylaxis bee stings). The patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a nursing home/ senior living facility. The patient was not diagnosed with COVID-19 prior to vaccination. Since post vaccination, the patient has been tested for COVID-19. Concomitant medication included influenza vaccine (FLU VACCINE VII) taken for an unspecified indication from 07Oct2021 to 07Oct2021. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot numbers and expiry dates not reported), on 19Jan2021 as dose 2, single and on 23Dec2020 as dose 1, single; both given via intramuscular route, left leg, at the age of 53 years, for COVID-19 immunization. The patient experienced large hard area red painful x3 days on 12Oct2021 with outcome of recovering, swelling in right axillary on 16Oct2021 with outcome of recovering, body ache on 17Oct2021 with outcome of recovering, fatigue on 17Oct2021 with outcome of recovering, tingling fingers on 17Oct2021 with outcome of recovering, injection site remains red swollen warm painful on 17Oct2021 with outcome of recovering, periodic itching at site on 17Oct2021 with outcome of recovering; off label use and booster on 12Oct2021 with outcome of unknown.  The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 14Oct2021 Nasal Swab. Therapeutic measures were taken as a result of vaccination site swelling. No therapeutic measure was taken for the other events. The event large hard area red painful x3 days was reported as serious, medically significant, while the rest of the events were reported as non-serious.  Lot number for the vaccine was not provided and will be requested during follow-up.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the serious event Skin reaction and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.