Received Mar 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | LJ5284 | OT / LA |
Fluid building around her heart goes hand with breathing; Coughing; Difficulty breathing; face numbness; This is a spontaneous report received from a Pharmacist. A 67-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 10Feb2025 as dose number unknown, 0.5 ml, single (Lot number: LJ5284) at the age of 66 years intramuscular, in left deltoid for immunisation; budesonide, formoterol fumarate (SYMBICORT) at 2 DF 2x/day (2 df, 2x/day (2 puffs twice a day)) for respiratory disorder. The patient's relevant medical history included: "COPD" (ongoing); "Blood pressure high" (unspecified if ongoing); "Cholesterol" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "chest pain" (unspecified if ongoing); "circulation around heart" (unspecified if ongoing); "wheezing" (unspecified if ongoing); "mild heart failure" (ongoing), notes: pre-existing condition with her heart, like heart failure. Concomitant medication(s) included: LOSARTAN oral taken for hypertension (ongoing); ROSUVASTATIN oral taken for blood cholesterol increased; EZETIMIBE oral taken for blood cholesterol abnormal (ongoing); ISOSORBIDE MONONITRATE oral taken for cardiovascular disorder, chest pain (ongoing); ALBUTEROL HFA taken for wheezing (ongoing). The patient also took other concomitant therapy which included "eye drops" (as reported). The following information was reported: DYSPNOEA (disability) with onset 11Feb2025, outcome "recovering", described as "Difficulty breathing"; HYPOAESTHESIA (medically significant) with onset 11Feb2025, outcome "recovering", described as "face numbness"; PERICARDIAL EFFUSION (medically significant), outcome "unknown", described as "Fluid building around her heart goes hand with breathing"; COUGH (non-serious), outcome "unknown", described as "Coughing". The events "difficulty breathing", "face numbness" and "fluid building around her heart goes hand with breathing" required physician office visit. The action taken for budesonide, formoterol fumarate was dosage reduced. Therapeutic measures were taken as a result of dyspnoea, hypoaesthesia, pleural effusion. Clinical course: The reporter has a patient that is a medication therapy management patient. It was recommended for the patient to be immunized. She confirmed she did not give it, and the patient got it at the doctor's office. The patient reported some concerning side effects. Clarified events as the patient has had difficulty breathing. She has a pre-existing condition with her heart, like heart failure. She has a fluid feeling around her heart. She also experienced face numbness. Difficulty Breathing: Fluid building around her heart goes hand with breathing (as reported). She saw the doctor about it on 20Feb2025 and had course of Prednisone and Azithromycin Z Pack. She also was given a cough suppressant, Benzonatate 100mg. She also experienced coughing. She added, she takes Symbicort inhaler for breathing anyways. However, normally she takes 2 puffs twice a day. On her own she has cut from taking 2 puffs twice a day to 1 puff twice a day. When she did this her breathing and facial numbness got better. She wanted to see if this is something that has been reported in the past, related, or documented previously. Relatedness of vaccine to events Dyspnoea, Hypoaesthesia and Cough was reported as Unknown (Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection).; Sender's Comments: The events dyspnoea, and hypoaesthesia are conservatively assessed as related to the suspect drug PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN) based on plausible temporal association but consider also possible contributory effects from medical history of the patient and/or concomitant medications. As there is limited information in the case provided, the causal association between the event pleural effusion and the suspect drug 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.
COPD; Heart failure (pre-existing condition with her heart, like heart failure)
Medical History/Concurrent Conditions: Blood cholesterol abnormal; Blood pressure high; Chest pain; High cholesterol; Unspecified circulatory system disorder; Wheezing
LOSARTAN; ROSUVASTATIN; EZETIMIBE; ISOSORBIDE MONONITRATE; ALBUTEROL HFA; SYMBICORT