Age: 67.0
Sex: F
Vaccine: PPV, UNK
Symptoms: Erythema, Feeling hot, Headache, Injection site erythema, Injection site swelling
Clinical narrative: Patient reported soreness; The patient reported some redness and soreness/ the patient stopped by to show the pharmacist her arm and the swelling/redness was to the right of the injection site near the inner arm and armpit on the left side; The patient reported some redness and soreness/ the patient stopped by to show the pharmacist her arm and the swelling/redness was to the right of the injection site near the inner arm and armpit on the left side; The patient also developed headache, nausea, felt warm/possible fever and did not sleep well that evening; The patient also developed headache, nausea, felt warm/possible fever and did not sleep well that evening; The patient also developed headache, nausea, felt warm/possible fever and did not sleep well that evening; The patient also developed headache, nausea, felt warm/possible fever and did not sleep well that evening; This spontaneous report was received from a pharmacist referring to a 67-year-old female patient. The patient's pertinent concurrent conditions included high cholesterol and hypertension. The patient's concomitant medication included unspecified cholesterol medication, unspecified blood pressure medication and sertraline hydrochloride(ZOLOFT). The patient had previous drug reaction/ allergies to penicillin and cephalosporin. On 01-DEC-2018, the patient received pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13).  On 14-FEB-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscular injection in the left arm for "over  65 recommended vaccination schedule" (concentration, number of administered dose, vaccination scheme frequency were not reported; lot number S029916 has been verified to be a valid, expiration date reported and validated as 12-JUN-2021).     Beginning the evening of 14-FEB-2020, the patient experienced some redness and soreness (pain). The swelling and redness was to the right of the injection site near the inner arm and armpit on the left side (injection site swelling and injection site erythema). Throughout the night the patient also developed headache, nausea, felt warm, possible fever (pyrexia) and did not sleep well (poor quality sleep) that evening. On 15-FEB-2020, the patient stopped by to show the pharmacist her arm and the pharmacist recommended ibuprofen or acetaminophen (TYLENOL) and ice to the area 20 minutes on and 20 minutes off (conflicting information also was reported that the patient did not seek medical attention). On 18-FEB-2020, the pharmacist followed up with the patient and she was improving. On 26-FEB-2020 (reported as last week), the reporter saw the patient and seemed back to her normal activities. No laboratory diagnostic or studies were performed for the patient.  As the reporter stated that the patient had the worse reaction of injection site swelling and injection site erythema to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), therefore the causality was being considered as related.  The causality assessment between therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the events poor quality sleep, pyrexia, nausea, headache and pain was not reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S029916; expirationdate: 12-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent