Age: 82.0
Sex: M
Vaccine: PPV
Symptoms: Incoherent, Injected limb mobility decreased, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a the patient's wife and refers to an approximately 72 year old male patient. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. On an unspecified date in December 2008, the patient was vaccinated with pneumococcal vaccine (manufacturer unknown) (strength, dose, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis. On an unspecified date in December 2008, the patient experienced mild sore arm (Pain in extremity). On an unknown date, the patient experienced blood pressure abnormal and was placed under an unspecified medication, gastrooesophageal reflux disease (GERD) and was placed under therapy with esomeprazole sodium (NEXIUM). He also experienced and unspecified hospitalization (reported as "a few years ago") (adverse event) and a low blood count (full blood count decreased). On 20-OCT-2018, (reported as "on Saturday morning"), the patient was vaccinated with PNEUMOVAX 23 one injection in his right arm, on the recommendation of the physician (strength, route of administration, lot number and expiration date were not reported). On the same day, three hours after vaccination, the patient developed swelling that grew 6 inches long from the top of his arm to his elbow(peripheral swelling), it looked like a ping-pong ball under his skin at the injection site (injection site nodule) and injection site pain. On 21-OCT-2018, (reported as "on Sunday"), the patient developed extreme lethargy and a fever that went up to 102.5 degrees Fahrenheit (pyrexia) and began vomiting. The reporter said she gave the patient acetaminophen (TYLENOL) and ibuprofen but was only able to get his fever down to 99 or 100 degrees fahrenheit. He could not move his right arm because of the extreme swelling (administration site movement impairment), became confused (confusional state) and was not coherent (incoherent). The reporter called 911 which rushed the patient to the hospital and put him on intravenous (IV) fluids and IV acetaminophen (TYLENOL) and he immediately began to improve.  On an unspecified date in October 2018, (reported as "while hospitalized"), the patient received unspecified IV Magnesium after blood tests revealed a deficiency (magnesium deficiency). It was stated that unspecified tests were performed, however, the results were not reported. On 24-OCT-2018, (reported as "just got home today"), the patient was discharged. The outcome of the patient's gastrooesophageal reflux disease, blood pressure abnormal was reported as not recovered, the outcome of adverse event was not reported and the outcome of pain in extremity and full blood count decreased was reported as recovered. The outcome of the patient's peripheral swelling, injection site nodule, injection site pain, magnesium deficiency, confusional state, administration site movement impairment, incoherent, pyrexia, vomiting and lethargy was reported as recovering as it was stated that the patient was doing much better but still had mild injection site pain and swelling. The reporter did not assess the causal relationship between therapy with pneumococcal vaccine and PNEUMOVAX 23 and the aforementioned events.