Age: 66.0
Sex: F
Vaccine: PNC13, PNC13, COVID19
Symptoms: Injection site vesicles, Pharyngeal swelling, Rash papular, Swelling face
Clinical narrative: anaphylactic reaction; rash at site of the vaccine; It's now a raised rashes and beginning to blister and burnt as of skin is burnt and it's spreading down her arm is now down to her elbow/can't move her arm, its spreading, blistering and burn; swelling in the back of her throat and this face; dropped, swelling in the back of her throat and this face; trouble swallowing; It's now a raised rashes and beginning to blister and burnt as of skin is burnt and it's spreading down her arm is now down to her elbow/can't move her arm, its spreading, blistering and burn; can't move her arm; This is a spontaneous report from a contactable physician (patient). A 66-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), intramuscularly on 18Jul2021 (Batch/Lot Number: DF1307; Expiration Date: Aug2022) at the age of 66 years old, as single dose for immunization. Medical history included glaucoma, chronic lymphocytic leukaemia. Concomitant medications included brinzolamide (AZOPT) taken for an unspecified indication, start and stop date were not reported; brimonidine tartrate, timolol maleate (COMBIGAN) taken for an unspecified indication, start and stop date were not reported. The patient experienced anaphylactic reaction, rash at site of the vaccine on 18Jul2021, swelling in the back of her throat and this face on 18Jul2021, trouble swallowing on 18Jul2021, it's now a raised rashes and beginning to blister and burnt as of skin is burnt and it's spreading down her arm is now down to her elbow/can't move her arm, its spreading, blistering and burn on 18Jul2021, can't move her arm on 18Jul2021. Clinical course: the patient received vaccine on 18Jul2021, the patient had anaphylactic reaction within 30 minutes, she dropped, swelling in the back of her throat and this face, trouble swallowing, it lasted approximately 2 hours and then it resolved however her main concern was that, when she developed rash at site of the vaccine which was continuing to spread and was getting worse and it's gone significantly worse in the last 24 to 48 hours. It's now a raised rashes and beginning to blister and burnt as of skin was burnt and it's spreading down her arm was now down to her elbow. The outcome of the events anaphylactic reaction, swelling in the back of her throat and this face, trouble swallowing was recovered on 18Jul2021, of the other events was not recovered. The patient did not take anything as treatment. The patient had unspecified lab test in Jun2021 (a month before vaccination), nothing to find. All was ok. There is nothing that's match and can go as to list her diagnosis.; Sender's Comments: Based on the close temporal relationship and known drug safety profile, there is a reasonable possibility that the event anaphylactic reaction was related to PREVENAR 13.  The impact of this report on the benefit/risk profile of the Pfizer product 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.