Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Adverse reaction, Anuria, Cellulitis, Full blood count, Ill-defined disorder
Clinical narrative: severe reaction; her whole body system ultimately shut down; er blood count was all over the chart; she came close to dying; it started out looking like it was cellulitis but went through her body/infectious disease; Lethargic; her urine was off; it started out looking like it was cellulitis; This spontaneous report has been received from a 72 year old female patient reporting on herself. The patient's concurrent conditions included hypertension, drug hypersensitivity, hypersensitivity, and allergy to arthropod sting. Her medical history included sepsis, and 2 hip arthroplasties. Historical drugs included sulfamethoxazole, trimethoprim (BACTRIM), unspecified flu vaccine, and unspecified antibiotic. Her concomitant medications included lisinopril (Manufacturer unknown), unspecified flu vaccine, and an unspecified vaginal tablet.     On 09-OCT-2019, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # S018140, expiration date not reported but upon internal validation established as 02-MAR-2021) for prophylaxis, strength, and route of administration were not reported. At the same time, the patient was also vaccinated with a shot of unspecified flu vaccine in the same arm.   On the same date, after vaccination the patient experienced a severe reaction (vaccination complication), she stated that her whole body system ultimately shut down (ill-defined disorder), her blood count was all over the chart (full blood count increased), and she was close to dying (near death experience). She also stated, that it started out looking like it was cellulitis, but went through her body (cellulitis/sepsis), she was very sick, lethargic, and her urine was off (Anuria). She reported that she was working with an infectious disease. Due to this, she sought medical attention, and she stated that she ended up in the hospital for 3 days (unspecified dates). The patient was treated with intravenous (IV) antibiotics. On an unknown date in January 2020, the patient recovered from the adverse events.    She reported that the doctor and "they" had determined that it was in fact the  pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccine that had caused her reaction. Moreover, she stated that she had always the flu shot every year, but since she had the "13 vaccine", they wanted her to go ahead and get the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), reported as (23 vaccine).     The reporter considered the adverse events to be life threatening.   Upon internal review the patient's anuria, sepsis, and near death experience were considered 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: S018140; expirationdate: 02-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability