Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Chills, Hypoaesthesia, Hypoaesthesia oral, Injection site haematoma
Clinical narrative: the left side of her neck and tonger were starting to feel numb; the left side of her neck and tonger were starting to feel numb; is was hot and painful to touch; is was hot and painful to touch; believes that she suffered from a systemic inflammatory reaction to PNEUMOVAX 23; developed a large knot; body aches; developed a large knot, which patient believes is a hematoma at injection site / palm size knot, firm area in the deltoid region of patient's left arm; chills; arm soreness at injection site / painful to touch; a temperature of 102F; This spontaneous report was received from a nurse and refers to a female patient of unknown age. The patient's historical drugs included clarithromycin (BIAXIN), H1N1 flu vaccine and ibuprofenum. Her concurrent conditions included drug reactions/allergies to latex, clarithromycin (BIAXIN), H1N1 flu vaccine and ibuprofenum (caused urticaria). The patient's medical history included heart disease, gestational diabetes mellitus (DM) and urticaria. No information regarding the patient's concomitant therapies was provided.   On 28-SEP-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter, lot # T020638, expiration date 26-FEB-2022, intramuscularly in the left deltoid for indication of vaccination and influenza virus split virion 3v vaccine inactivated (FLUARIX) 0.5 milliliter, lot # AJ3AC, expiration date 30-JUN-2021 (route of administration and indication were not reported). On the same day(reported also as 24 hours after administration - conflicting information), the patient experienced arm soreness at injection site, developed a large knot, which patient believed was a hematoma at injection site, along with chills, body aches, and a temperature of 102 Fahrenheit degrees and the patient believed that she suffered from a systemic inflammatory reaction to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). It was reported that the patient started experiencing adverse events a week after administration because initially the patient disregarded symptoms due to the possibility of being common adverse reactions (conflicting information). The patient sought medical attention and visited the emergency room on 03-OCT-2020 due to the symptoms and was prescribed cephalexin (KEFLEX) and ceftriaxone sodium (ROCEPHIN) for the symptoms. The patient was also personally taking acetaminophen (TYLENOL). On 06-OCT-2020, the patient called and reported that the left side of her neck and tongue had started to feel numb. She also reported that it was not an anaphylactic feeling. The provider changed the patient's prescription of cephalexin (KEFLEX) to clindamycin. The computed tomography (CT) scan was recommended but the patient wanted to come to provider's office to have them look at it. On an unknown date in October 2020, the patient's arm was evaluated by the another provider, who found a palm size knot, firm area in the deltoid region of patient's left arm. The provider reported that it was hot and painful to touch. The ultrasound was performed, checking for abscess versus hematoma but there was no result. On 07-OCT-2020, the patient saw a general surgeon to drain the knot located in the patient's arm but it was impossible to perform. The adverse events were not a cancer events and no overdose occurred. On 22-OCT-2020, the patient's called and reported that she was feeling slightly better, the knot was still large and that it was still painful but not as bad as initially. The outcome of the events was reported as recovering/resolving.   The reporter considered systemic inflammatory reaction to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23). The causality assessment between the other events and the suspect therapy was not provided.  Upon internal review, the event of systemic inflammatory reaction was determined to be medically significant. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T020638; expirationdate: 26-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent