Report #2879568

Overview

Sex

Male

Age

Age unknown

State

—

Recovered

Recovered

Vaccinated

—

Onset

—

Days to onset

—

Hospital days

—

Symptoms (1)

Symptom narrative

Anaphylactic reaction; This is a spontaneous report received from a Pharmacist from a sales representative. A male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "recovered". It was unknown if therapeutic measures were taken as a result of anaphylactic reaction. Clinical course: The patient reported to the pharmacist that he had an anaphylactic reaction to a previous pneumococcal conjugate vaccine. Based on history, pharmacist thinks it may have been PCV13 but is unsure. The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event anaphylactic reaction and the suspect drug PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN). 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.