Sex: F
Vaccine: PNC20
Symptoms: Allergy test, Angioedema, Peripheral swelling, Urticaria
Clinical narrative: Angioneurotic edema; Hives over my body; Swelling on my feet; This is a spontaneous report received from a Nurse from medical information team.  A 67-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "strep throat" (unspecified if ongoing); "terrible hives" (unspecified if ongoing); "rheumatic fever" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: ANGIOEDEMA (medically significant), outcome "unknown", described as "Angioneurotic edema"; URTICARIA (non-serious), outcome "not recovered", described as "Hives over my body"; PERIPHERAL SWELLING (non-serious), outcome "not recovered", described as "Swelling on my feet". The events "angioneurotic edema", "hives over my body" and "swelling on my feet" required physician office visit. The patient underwent the following laboratory tests and procedures: Allergy test: unknown results. Therapeutic measures were taken as a result of urticaria, peripheral swelling. Clinical courses is as follows: Reporter is a nurse and also the patient and got the Prevnar 20 about a month ago and 10 days(it also was reported as about 8 or 9 days) later broke out in hives all over her body.  She took Benadryl for it but eventually went to see an allergist who did some testing(all kinds of, possible allergies) and also noticed her foot swelling.  The allergist put her on Zyrtec but as soon as she doesn't take it, the hives return. The patient wondered if it was a reaction to the Prevnar 20.  When she was little, she got strep throat and broke out in terrible hives and eventually got rheumatic fever.  She has never gotten hives from anything again and wonders if she had the reaction and it's due to the vaccine because of her reaction to having had strep in the past. The patient checked the website and they did list on there, one of the side effects that has been experienced is Angioneurotic edema, which is one of the things the allergist had mentioned to her it could be and a question that she had was, she knew it supposed to help with the Strepto-pneumoniae illness preventing that and she just was not sure as a child, she had severe hives when she had Strep and got rheumatic fever.   The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: The event angioedema is conservatively assessed as related to the suspect drug PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN) based on close temporal association but consider also possible contributory effects from medical history of the patient like past history of urticaria/hives and/or concomitant medications. 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.