Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Influenza virus test, Respiratory syncytial virus test, SARS-CoV-2 test, Systemic inflammatory response syndrome
Clinical narrative: SIRS; RANDOMIZED PHASE STUDY.  This is a non-Pfizer sponsored interventional study report for protocol. Other Case identifier(s): NVSC2024US221258 (Novartis).  Case Description: Case number (manufacture number withheld), was an initial report received from an investigator on 15Nov2024 and 19Nov 2024 (combined reports) from a clinical study. This report referred to a 79-year-old male subject (center ID: withheld and subject ID: withheld) enrolled in Additon: Randomized Phase Study.  Historical conditions included testicular cancer, squamous cell of skin- dorsum right hand and right inguinal hernia. On 20Feb2023, the subject underwent transrectal ultrasound-guided biopsy. Current conditions included high cholesterol, benign prostatic hyperplasia, osteoarthritis- bilateral knees, osteoarthritis bilateral hips, urinary hesitancy, gastric reflux, bilateral hearing loss, back pain, insomnia, pain- neoplasm related, intermittent constipation, urinary retention, hot flashes, fever, thrush, hypocalcemia, septic shock, decreased appetite, adrenal insufficiency, atrial fibrillation, intermittent nausea, intermittent vomiting, hemorrhoid, left hip pain due to fracture. The subject received prophylaxis for acid reflux, constipation, hypokalemia, deep vein thrombosis (DVT), nausea, hypo magnesium (hypomagnesaemia). Concomitant medications included rosuvastatin, lactobacillus nos (CULTURELLE), omeprazole, cordyceps militaris, cyanocobalamin, krill oil, hericium erinaceus mycelium (LION'S MANE), ganoderma lucidum (REISHI MUSHROOM), curcuma longa root (TURMERIC CURCUMIN), trametes versicolor mycelium (TURKEY TAIL), colecalciferol (VITAMIN D3), macrogol 3350 (MIRALAX), bicalutamide (CASODEX), promethazine hydrochloride (PHENERGAN), temazepam (RESTORIL), zolpidem, abiraterone, fluconazole (DIFLUCAN), morphine, fentanyl, hydromorphone, paracetamol (TYLENOL), calcium gluconate, finasteride, fludrocortisone, pantoprazole, macrogol (POLYETHYLENE GLYCOL), docusate sodium/sennoside a+b (PERI-COLACE), saccharomyces boulardii (FLORASTOR), apixaban, gabapentin, dronabinol (MARINOL), magnesium sulfate, hydrocortisone, leuprorelin (LEUPROLIDE), enzalutamide, ondansetron (ZOFRAN), "preparation h- phenylephrine and pramoxine +glycerin and petroleum", bisacodyl, metoprolol, potassium, colecalciferol (CHOLECALCIFEROL), levofloxacin (LOVENOX), paracetamol (ACETAMINOPHEN), oxybutynin, olanzapine, cefepime, hydrocortisone sodium succinate, normal saline and vancomycin.  On 06Apr2023, the subject started study medication 68GA-PSMA-11 3405+KITRP+I (gallium (68ga) gozetotide) at a dose of 4.63 mCi, once/single (intravenous use) Batch/Lot Number: Unknown.  On 27Apr2023, the subject started study medication 177Lu-PSMA-617 (lutetium (177lu) vipivotide tetraxetan) solution for infusion at a dose of 194.78 mCi, once/single (intravenous use) (first dose) Batch/Lot Number: Unknown. On 20 Jul 2023, the subject received 177Lu-PSMA-617 (lutetium (177lu) vipivotide tetraxetan) at a dose of 204.03 mCi (intravenous use) (second dose), on 31Aug 2023, at a dose of 200.52 mCi (intravenous use) (third dose), on 12Oct2023, at a dose of 201.83 mCi (intravenous use) (fourth dose), on 30Nov2023, at a dose of 190.94 mCi (intravenous use) (fifth dose) and on 17Jan2024, at a dose of 197.89 mCi (intravenous use) (sixth dose) (Batch/Lot Number: Unknown).  Subject received COVID vaccine (for COVID prophylaxis) on 14Nov 2024. On 15Nov2024, 1 year, 6 months and 20 days after the first dose of the study medication 177Lu-PSMA-617 (lutetium (177lu) vipivotide tetraxetan), the subject developed SIRS (systemic inflammatory response syndrome) and was hospitalized. Reportedly, subject began experiencing acute weakness. Subject slipped out of bed and was unable to get self up and ambulate. Denied any other injury, head injury. Subject was baseline prior to vaccine. On the same day, Chest xray, flu test, RSV (respiratory syncytial virus) test and COVID test was negative. The subject was treated with vancomycin and cefepime. The action taken with 68GA-PSMA-11 and 177Lu-PSMA-617 was reported as not applicable after the subject experienced systemic inflammatory response syndrome. On 16Nov2024 (in 2 days), the subject was completely recovered from systemic inflammatory response syndrome and was discharged on the same day. The diagnosis event systemic inflammatory response syndrome was considered serious by the investigator. Additional cases for this subject were US-002147023-NVSC2023US107703, US-002147023-NVSC2023US120385, US-002147023-NVSC2024US145136, US-002147023-NVSC2024US175843, US-002147023-NVSC2024US183241 and US-002147023-NVSC2024US224143.  The causality of systemic inflammatory response syndrome with 68GA-PSMA-11 and 177Lu-PSMA-617 was reported as not suspected. Causality to any other medication or non-drug therapy was related (Pfizer Covid vaccine). Causality to the study treatment ARDT: not related, causality to the study treatment ADT: not related.  Follow up report received on 20Nov2024 and 21Nov 2024 (combined reports): Added SAE stop date and discharge date (16Nov2024), concomitant medications (casodex, acetaminophen, hydrocortisone sodium-succinate, normal saline and oxybutynin), current conditions (hot flashes and fever. Deleted concomitant medications (magic mouthwash and remeron) and changed outcome of SAE from condition unchanged to complete recovery. Follow up report received on 26Nov2024: Removed SAE (Weakness) and its details. Added SAE (SIRS) and its details and treatment medications (vancomycin and cefepime).  Follow up report received on 03Dec2024: Added brand name of suspect Covid vaccine (Pfizer). Listedness information: - 1. Product 68GA-PSMA-11 3405+KITRP+I, Event systemic inflammatory response syndrome, Causality Not Suspected Sheet Name IB Listedness Unknown. 2. Product 177Lu-PSMA-617, Event systemic inflammatory response syndrome, Causality Not Suspected Sheet Name --> IB Listedness Unknown. Novartis Comment: Considering elderly age (79 years), underlying metastatic hormone sensitive prostate cancer, current condition of septic shock as risk factors and reported causal role of COVID vaccine as alternate explanation; causality of event systemic inflammatory response syndrome with 68GA-PSMA-11 and 177Lu-PSMA-617 is assessed as not suspected.; Sender's Comments: Based on the close temporal relationship, the association between the event Systemic Inflammatory Response Syndrome (SIRS) with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.