Sex: M
Vaccine: PPV, UNK
Symptoms: Chills, Headache, Injection site swelling, Tremor
Clinical narrative: After receiving vaccination, 36 hours later, patient called office reporting shaking, chills, headache, right deltoid swollen where dose administered; After receiving vaccination, 36 hours later, patient called office reporting shaking, chills, headache, right deltoid swollen where dose administered; After receiving vaccination, 36 hours later, patient called office reporting shaking, chills, headache, right deltoid swollen where dose administered; After receiving vaccination, 36 hours later, patient called office reporting shaking, chills, headache, right deltoid swollen where dose administered; This spontaneous report was received from a practice manager/administrator referring to a 66 year old male patient with hyperlipidaemia, hypertension, gastrooesophageal reflux disease (GERD) and seasonal allergies. Concomitant therapies included atorvastatin calcium(LIPITOR), and other unspecified medications. The patient had received a dose of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) at an unspecified time in the past.  On 21-MAY-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) a dose of 0.5 milliliter, intramuscular route (strength, dose, frequency, and anatomical location were unknown) with lot # S033516, and expiration date 29-JUN-2021 for prophylaxis.    After receiving vaccination on, 36 hours later, patient called the office to report that he experienced shaking (tremor), chills, headache, and right deltoid swollen(injection site swelling) where the dose was administered. Subsequently, 48 hours from vaccination, patient was recovering with instructions to apply ice and heat to injection site and take Ibuprofen as needed. No laboratory tests or studies were performed.   Practice manager/administrator had request a lot check. Upon advising of time frame for lot check, the reporter stated request was time sensitive and needs information earlier than 60 days. Additionally, stated unspecified medical director had remaining pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) doses (16 doses) with this lot on hold along with other lots until information comes available for this lot check. Office had other boxes of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23): carton of 10 (Lot #:T007790, expiration date 03-DEC-2021) and another box 10 (Lot #: S009945, expiration date 10-AUG-2020).     At the time of the report, the outcome of tremor, injection site swelling, headache and chills was reported as resolving. The reporter did not mention the causality assessment between the events and  pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccination.  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. ; devicelotnumber: S033516; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; 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-009507513-2006USA000886: