Age: 66.0
Sex: F
Vaccine: PNC20
Symptoms: Asthenia, Blood creatine phosphokinase increased, Full blood count normal, Gait inability, Haemoglobin normal
Clinical narrative: Weakness/bilateral or lower extremity weakness; bilateral or lower extremity weakness; inability to walk; acute onset of emesis; basic metabolic panel remarkable for hyperglycemia, hypercalcemia; basic metabolic panel remarkable for hyperglycemia, hypercalcemia; Creatine kinase level Elevated at 478; This is a spontaneous report received from a contactable reporter (Pharmacist).  A 66-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 30Jun2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years for immunisation. The patient's relevant medical history included: "COPD", "Major depression", "Borderline personality disorder", "Anxiety", and "chronic low back pain", all unspecified if ongoing. Concomitant medication(s) included: ALENDRONATE; ATORVASTATIN; CLONAZEPAM taken for anxiety; DULOXETINE; ERGOCALCIFEROL; FLUOXETINE; GABAPENTIN; LEVOTHYROXINE; MIRTAZAPINE; OMEPRAZOLE; OXYBUTYNIN; CELECOXIB. The following information was reported: BLOOD CREATINE PHOSPHOKINASE INCREASED (non-serious) with onset 2022, described as "Creatine kinase level Elevated at 478"; HYPERGLYCAEMIA and HYPERCALCAEMIA, both non-serious with onset 2022, and described as "basic metabolic panel remarkable for hyperglycemia, hypercalcemia"; ASTHENIA (hospitalization) with onset Jul2022, 36 hrs after the suspect product administration, described as "Weakness/bilateral or lower extremity weakness"; VOMITING (non-serious) with onset Jul2022, 36 hrs after the suspect product administration, described as "acute onset of emesis"; MUSCULAR WEAKNESS (hospitalization) with onset Jul2022, 36 hrs after the suspect product administration, described as "bilateral or lower extremity weakness"; GAIT INABILITY (non-serious) with onset Jul2022, 36 hrs after the suspect product administration, described as "inability to walk". The outcome of all the events was unknown. The patient was hospitalized for asthenia, muscular weakness (start date: 02Jul2022). The clinical course was reported as follows: The pharmacist was calling from a hospital. The patient presented to the hospital with acute onset of emesis, bilateral or lower extremity weakness with inability to walk, 36 hours after receiving her Prevnar 20 vaccine at an outside clinic. The patient had the blood work done. Her basic metabolic panel was remarkable for hyperglycemia, hypercalcemia, and her creatine kinase level was elevated at 478 and her CBC demonstrated a normal white blood count and hemoglobin.Any treatment for the weakness included patient being hospitalized, given supportive care. The patient presented to the hospital on 02Jul2022 and she is still hospitalized now. The patient underwent the following laboratory tests and procedures: Creatine kinase level: (2022) Elevated at 478; blood work: (2022) Unknown results; CBC: (2022) Normal white blood count and hemoglobin; hemoglobin: (2022) normal; basic metabolic panel: (2022) remarkable for hyperglycemia, hypercalcemia; white blood count: (2022) normal. Therapeutic measures were taken as a result of asthenia, muscular weakness.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently provided, Weakness/bilateral or lower extremity weakness are more likely attributed to ATORVASTATIN unrelated to PREVNAR 20 use.  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