Sex: F
Vaccine: PPV, PPV
Symptoms: Abdominal discomfort, Cellulitis, Erythema, Injection site swelling, Night sweats
Clinical narrative: stomach upset; overnight sweats; Redness; Arm swelling; aches; puffed up around the shot; cellulitis; This spontaneous report was received from a practice manager/administrator referring to a 69-year-old female patient. The patient's current condition included diabetes mellitus and drug hypersensitivity. The patient had drug allergies to acetaminophen, codeine and amoxicillin. The patient had received a dose of pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) at an unspecified time in the past. The patient's concomitant medications were not reported. On 21-MAY-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) a dose of 0.5 milliliter, once via intramuscular route (strength, dose, frequency, and anatomical location were unknown) with lot # S033516, and expiration date 29-JUN-2021 for prophylaxis (standard pneumococcal shot). On the same date (reported as after receiving vaccination in few hours), the patient called office reporting puffed up around shot (injection site swelling). The patient was then advised to take loratadine (CLARITIN) and use cool compress on the injection site. Later in the evening (on the same date), the patient again called and reported experiencing aches (pain), over night sweats, upset stomach (abdominal discomfort), arm swelling and redness. On an unknown date in May 2020, the patient was seen in the office with worsening symptoms and was diagnosed with cellulitis. The patient was then treated with cephalexin, moist heat to injection site, shots of ceftriaxone (ROCEPHIN) and another unspecified antibiotic. No laboratory tests or studies were performed. On 26-MAY-2020, the patient called the office to report that she was improving from the events. Practice manager/administrator had requested 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). The reporter did not mention the causality assessment between the events and suspect product. There was no product quality complaint (PQC) found.  Upon internal review the event of cellulitis was determined to be medically significant.  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; expirationdate: 29-JUN-2021; 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