Sex: M
Vaccine: PPV
Symptoms: Polyneuropathy, Sjogren's syndrome, Stem cell transplant, Systemic lupus erythematosus, Tooth infection
Clinical narrative: Sjogren's disease; Polyneuropathy; swollen uvula; Mass in axilla; Teeth infected; pain; Brain injury; prescribed for weight control and metabolic disorder; prescribed for weight control and metabolic disorder; Lupus; Stem cell transplant; Hemorrhage at injection site; Obstruction in artery of left foot; The patient experienced two anaphylaxis reactions; This spontaneous report has been received from a consumer via Agency and referring to a male patient of unknown age. The patient's concurrent conditions included metabolic disorder, immunodeficiency, and disability (unspecified). The information regarding the patient's concomitant therapies, historical drugs, drug reactions or allergies, or pertinent medical history was not provided.  On an unspecified date, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (strength, dosage schedule, route of administration, anatomical site, lot number, and expiration date were not reported) for prophylaxis. And on an unspecified date, the patient started therapy with semaglutide (OZEMPIC), solution for injection, at a dose of 1.34 milligram per milliliter (mg/mL) administer subcutaneously (SC) for the treatment of weight control and metabolic disorder (product prescribing issue/product used in unapproved indication).   On an unspecified date, the patient experienced brain injury which was diagnosed through a neurotransmitter test and showed a neurotransmitter deficiency and, polyneuropathy, , mass in axilla (axillary mass) that was described to be firm, constant pain (pain); additionally, the patient experienced Sjogren's disease (Sjogren's syndrome) and was unable to produce saliva which led his teeth to get infected (tooth infection) (reported as soft and worn down). It was also reported that Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) attacked the patient's throat resulting in a swollen uvula (enlarged uvula).   On an unspecified date in 2019, the patient experienced two anaphylaxis reactions (anaphylactic reaction).  On 09-DEC-2019, the patient underwent an angiography with balloon that showed and obstruction in artery of left foot (peripheral artery occlusion)  On an unspecified date in May 2020, the patient experienced hemorrhage at injection site (injection site hemorrhage) which occurred 24-48 after the medication (unspecified) was injected. Additionally, the patient underwent a Stem cell transplant fr an unspecified reason and had better cognitive ability as a result.   On an unspecified date in June 2020, the patient experienced Lupus (Systemic lupus erythematosus).  The outcome of the adverse events was unknown at the reporting time. The action taken with semaglutide (OZEMPIC) regarding the aforementioned events was reported as dose not changed.   The causal relationship between vaccination with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23), and the event swollen uvula was related. The causal relationship between vaccination with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23), and the events anaphylactic reaction, systemic lupus erythematosus, Sjogren's syndrome, stem cell transplant, brain injury, peripheral artery occlusion, polyneuropathy, axillary mass, tooth infection, pain, and injection site hemorrhage was not provided.  The causal relationship between therapy with semaglutide (OZEMPIC) and the events occurrence was not provided.   Upon internal review the events anaphylactic reaction, systemic lupus erythematosus, Sjogren's syndrome, brain injury, peripheral artery occlusion, and polyneuropathy were determined to be medically significant. Upon medical assessment the event stem cell transplant was determined to be medically significant.