Age: 46.0
Sex: F
Vaccine: PNC20
Symptoms: Peripheral swelling, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: painful/hard to touch; Lethargy; Lethargy was reported as worsened.; Dizziness; Itchy at site; her left arm became swollen; she noted a red circle from 4 inches from her shoulder to her elbow/Red Circle, growing, painful, hard to touch; the circle grew 1 inch since saturday; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A 46-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 16Sep2022 as dose 1, single (Lot number: FW2328, Expiration Date: 31Aug2023) at the age of 46 years, in left deltoid for immunisation. The patient's relevant medical history included: "Penicillin allergy" (unspecified if ongoing), notes: patient has a documented penicillin allergy. There were no concomitant medications. Vaccination history included: pneumococcal polysaccharide 23 vaccine (patient had received doses of the Pneumococcal Polysaccharide 23 vaccine on 23Sep2020 and 29Apr2013), administration date: 29Apr2013; pneumococcal polysaccharide 23 vaccine (patient had received doses of the Pneumococcal Polysaccharide 23 vaccine on 23Sep2020 and 29Apr2013), administration date: 23Sep2020. The following information was reported: VACCINATION SITE PRURITUS (medically significant) with onset Sep2022, outcome "unknown", described as "Itchy at site"; PERIPHERAL SWELLING (medically significant) with onset Sep2022, outcome "unknown", described as "her left arm became swollen"; ERYTHEMA (medically significant) with onset Sep2022, outcome "unknown", described as "she noted a red circle from 4 inches from her shoulder to her elbow/Red Circle, growing, painful, hard to touch"; CONDITION AGGRAVATED (medically significant) with onset Sep2022, outcome "unknown", described as "the circle grew 1 inch since saturday"; DIZZINESS (medically significant) with onset 17Sep2022, outcome "unknown"; ARTHRALGIA (medically significant), outcome "unknown", described as "painful/hard to touch"; LETHARGY (medically significant), outcome "not recovered"; CONDITION AGGRAVATED (medically significant), outcome "not recovered", described as "Lethargy was reported as worsened.". The events "her left arm became swollen", "she noted a red circle from 4 inches from her shoulder to her elbow/red circle, growing, painful, hard to touch", "the circle grew 1 inch since saturday", "painful/hard to touch", "itchy at site", "dizziness", "lethargy" and "lethargy was reported as worsened." required physician office visit.  Clinical course: Caller was a nurse reporting an adverse event for a patient. Calling on behalf of a 46 yr old female patient who is reporting an adverse event with this product. Patient was administered this product on Friday16Sep2022 and within 24 hrs. of receiving the injection in her left deltoid, her left arm became swollen, and she noted a red circle from 4 inches from her shoulder to her elbow. Describes area as painful, red, hard to touch and reports the circle grew 1 inch since Saturday. Patient reports itchiness at the site and gradual worsening of lethargy and dizziness since Saturday. Patient is being sent to urgent care for evaluation. This was the patient's first dose of the Prevnar 20 vaccine per the caller; caller also states that the patient had received doses of the Pneumococcal Polysaccharide 23 vaccine on 23Sep2020 and 29Apr2013. The patient denied any adverse reactions related to any other vaccines. Caller states that she may not have a comprehensive list of the patient vaccine as the patient may have received vaccines at other facilities that the caller is unaware of. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) and additional vaccines administered on same date of the Pfizer Suspect were reported as None. AE(s) requires a visit to Emergency Room was No and Physician Office was Yes. Caller stated that the patient was going to go to the Emergency Room, but the patient pharmacist advised the patient not to. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s), AE(s) following prior vaccinations and Relevant Tests were reported as None.; Sender's Comments: Based on the information available, the causal relationship between the reported events and suspect drug PREVNAR 20 cannot be excluded. 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.