Received Aug 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC13 | PNEUMO (PREVNAR13) | PFIZER\WYETH | 3 | — | — |
shortness of breath; low heart rate; This is a spontaneous report received from an Other HCP. Other Case identifier(s): 02842711 (Merck). An infant patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in Jul2020 as dose 3, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "immunocompromised with immunodeficiency" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Prevnar 13 (DOSE 1, SINGLE), administration date: 2019, for Immunization; Prevnar 13 (DOSE 2, SINGLE), administration date: Jan2020, for Immunization. The following information was reported: HEART RATE DECREASED (life-threatening, medically significant) with onset 2020, outcome "unknown", described as "low heart rate"; DYSPNOEA (life-threatening, medically significant) with onset 2020, outcome "unknown", described as "shortness of breath". The patient underwent the following laboratory tests and procedures: Heart rate: (2020) low. Clinical course: HCP called and stated a patient had received PREVNAR 20 shortness of breath, low heart rate, and the "almost called code blue" and had it in 2020, and the patient was a child and still growing, now looking to see if they could receive pneumovax23. Had 1 dose in 2019, and then 2 doses in Jan2020 and Jul2020. Patient had PREVNAR 20 at a different clinic. Patient received those doses at 1 year old or less. Patient was immunocompromised with immunodeficiency and asthma. Reporter was asking what ingredients are in PNEUMOVAX23. 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: As there is limited and conflicting information in the case provided, the causal association between the events dyspnoea, and heart rate decreased; and the suspect drug PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN) 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 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.
Medical History/Concurrent Conditions: Immunodeficiency; Infantile asthma
Test Date: 2020; Test Name: heart rate; Result Unstructured Data: Test Result:low