Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Muscular weakness, Pain, Skin warm, Swelling
Clinical narrative: the patient developed redness, warmth, pain, swelling and weakness in the unspecified arm injected; the patient developed redness, warmth, pain, swelling and weakness in the unspecified arm injected; the patient developed redness, warmth, pain, swelling and weakness in the unspecified arm injected; the patient developed redness, warmth, pain, swelling and weakness in the unspecified arm injected; the patient developed redness, warmth, pain, swelling and weakness in the unspecified arm injected; This spontaneous report was received from a registered nurse referring to a 23-year-old female patient. The patient's concurrent conditions included ulcerative colitis, she was immunocompromised and her medical history included drug reaction to SULFA (unspecified). The patient's concomitant medications included vedolizumab (ENTYVIO). This report concerns 1 patient and 1 combination product.  On 30-JUN-2020, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) pre-filled syringe by intramuscular route of administration in an unspecified arm, lot number T007790 and expiration date 03-DEC-2021 (specific anatomical location of administration was not reported) for prophylaxis, as the patient was immunosuppressed.  On the same day, within an hour of the administration, the patient developed redness, warmth, pain, swelling and weakness in the unspecified injected arm. She sought medical attention and was prescribed an ice, acetaminophen (TYLENOL) and an unspecified antihistamine. A routine blood work was performed on the same day and the result was normal.   The nurse was concerned about using the reported lot of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for other patients, as this was the second patient who developed similar symptoms a few days after the first patient. The nurse reported that there were no such experiences in the past. The nurse asked for the lot check to be done as soon as possible and she did not want to use pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) until the lot check was done.   At the reporting time, the patient was recovering from the events with the prescribed treatment.   The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events was not reported.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: T007790; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; operatorofdevice: Health Care Professional; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2007USA001323: