Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Erythema, Hypokinesia, Incorrect route of product administration
Clinical narrative: Not sure if she missed the muscle and it went in the tissue or if an adverse event; 2 inches by 3 inches red whelp on right arm at injection site; Chest redness to lymph nodes near right arm pit/The two nodes that were removed on right were also red and raised; Chest redness to lymph nodes near right arm pit/The two nodes that were removed on right were also red and raised; Fever; nausea; couldn't make it to the toilet to urinate/could hardly move; weakness; feeling ill; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Feb2022 10:30 (Lot number: FK9895) at the age of 77 years as dose 2, 0.3 ml, single for covid-19 immunisation. Relevant medical history included: "Mastectomy" (unspecified if ongoing), notes: Mastectomy, Right side 09Dec2021, Left side 30 years ago; "Emergency Appendectomy", start date: 01Jul2021 (unspecified if ongoing), notes: Emergency Appendectomy, Start date: 01Jul2021. There were no concomitant medications. Vaccination history included: Bnt162b2 (Lot Number: FJ1614, Expiry Date: unknown, Route, Anatomical Location: injection, right arm, No. of Previous Doses: 1, Date: 01Feb2022), administration date: 01Feb2022, for COVID-19 immunization, reaction(s): "didn't feel so good". The following information was reported: PYREXIA (medically significant) with onset 23Feb2022 02:00, outcome "recovered" (24Feb2022), described as "Fever"; MALAISE (disability) with onset 22Feb2022, outcome "recovered" (24Feb2022), described as "feeling ill"; LYMPHADENOPATHY (medically significant), ERYTHEMA (medically significant) all with onset 24Feb2022, outcome "unknown" and all described as "Chest redness to lymph nodes near right arm pit/The two nodes that were removed on right were also red and raised"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Not sure if she missed the muscle and it went in the tissue or if an adverse event"; ASTHENIA (non-serious) with onset 22Feb2022 18:00, outcome "recovered" (24Feb2022), described as "weakness"; NAUSEA (non-serious) with onset 23Feb2022 02:00, outcome "recovered" (23Feb2022 18:00), described as "nausea"; HYPOKINESIA (non-serious) with onset 23Feb2022, outcome "recovered" (23Feb2022), described as "couldn't make it to the toilet to urinate/could hardly move"; INFUSION SITE ERYTHEMA (non-serious) with onset 24Feb2022, outcome "recovered" (02Mar2022), described as "2 inches by 3 inches red whelp on right arm at injection site". The patient underwent the following laboratory tests and procedures: body temperature: 101. Therapeutic measures were taken as a result of pyrexia, lymphadenopathy, erythema, infusion site erythema.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   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.