Received Sep 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | 1 | Y011819 | IM / RA |
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Y011819 | OT / RA |
DEATH; PLASMAPHERESIS; ENDOTRACHEAL INTUBATION; INTENSIVE CARE; HEADACHE; PARAESTHESIA ORAL; GAIT INABILITY; FALL; BACK PAIN; PAIN IN EXTREMITY; GUILLAIN-BARRE SYNDROME; HYPOAESTHESIA; RESPIRATORY DISTRESS; IMMUNOGLOBULIN THERAPY; Information has been received from Food And Drug Administration Agency (FDA) via Vaccine Adverse Events Reporting System (VAERS) (VAERS # 2849138-1) on 04-Aug-2025. This spontaneous report was referring to a 61-year-old female patient. The patient's surgical history included cholecystectomy. The patient's medical problems also included Obstructive sleep apnea of adult -per sleep study done fall of 2016 - on continuous positive airway pressure (CPAP) (first day was 14-Dec-2016), Osteoarthritis of knee (Onset: 17-May-2017), Palpitations (Onset: 29-Aug-2017), Non-ulcer dyspepsia (Onset: 14-Dec-2017), Hiatal hernia (Onset: 22-May-2020), Hypercholesterolemia (Onset: 02-Dec-2021), Recurrent urinary tract infection (Onset: 17-Jul-2023), Metabolic dysfunction-associated steatotic liver disease (Onset: 19-Apr-2024), Gastroesophageal reflux disease (Onset: 25-Apr-2024), Metabolic dysfunction-associated steatohepatitis (Onset: 12-Jul-2024), Iron deficiency anemia (Onset: 18-Oct-2024), Asthma, Seasonal allergic rhinitis, Hypomagnesemia, Osteoarthritis, Dysphagia, Obesity, Calcaneal spur, right, Essential hypertension, Reactive depression (situational), and Allergy to Iodinated Contrast Media. Concomitant therapies included Fexofenadine hydrochloride (ALLEGRA ALLERGY) 180 mg tablet (Take 1 tablet every day by oral route), Calcium 600 + D(3) 600 mg-10 mcg (400 unit) tablet (Take 2 tablets every day by oral route), d-mannose 500 mg capsule (Take 2 capsules every day by oral route), estradiol 0. The current illness was reported as none (conflicting information). On 02-Jun-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot #Y011819, expiration date not reported, but upon internal validation established as 01-Oct-2025) 1 dose in total, administered by intramuscular route in right arm for prophylaxis (strength was not reported). On 13-Jun-2025, the patient experience Guillain Barre Syndrome (Severe). Since that day, the patient had right hand numbness that progressed (Hypoaesthesia). On 14-Jun-2025, pain in lower back and bilateral thighs started (Back pain, Pain in extremity). On 15-Jun-2025 (Sunday), the patient developed bilateral feet numbness, lower extremity numbness to the point she could not ambulate and fell (Gait inability, Fall). On 16-Jun-2025 (Monday), symptoms progressed to tingling on tongue (Paranesthesia oral) and Headache to bilateral temporal area. On that day (16-Jun-2025), she was admitted to hospital as a result of all the events. On an unknown date in June 2025, she was started on intravenous immunoglobin (IVVG) 400mg mg/kg/day x 5 days (Immunoglobulin therapy) for Guillain Barre syndrome. She also developed Respiratory distress. On 17-Jun-2025, she was transferred to Intensive care unit (ICU) due concern for deteriorating respiratory status. On 19-Jun-2025, she was intubated due to worsening respiratory status (Endotracheal intubation). On 20-Jun-2025, she was transferred to a higher level of care for Plasmapheresis. On 04-Jul-2025, the patient died due to Guillain Barre Syndrome (Severe) caused from Pneumonia Vaccine (Death). and as of this moment, the events were not recovered (outcome for all the events considered as fatal). It was unknown whether an autopsy was performed. Records from hospital regarding the lab data was not available. The action taken with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) regarding the events was not applicable. The reporter considered the events of Guillain Barre Syndrome, Death, Hypoaesthesia, Back pain, Pain in extremity, Gait inability, Fall, Paranesthesia oral, Headache and Respiratory distress to be related to Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE). The causal relationship between the events of Immunoglobulin therapy, Intensive care, Endotracheal intubation, Plasmapheresis and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided. The reporter considered all the events to be life-threatening and disabling/incapacitating. It has been determined that the case safety report 2316654 is a duplicate of case safety report 2316095 is being delated from our files and the cases are consolidated into case safety report 2316095.; Reported Cause(s) of Death: GUILLAIN-BARRE SYNDROME
Asthma; Calcaneal spur; Contrast media allergy; CPAP; Essential hypertension; Hiatal hernia; Hypercholesterolemia; Obstructive sleep apnea; Osteoarthritis; Osteoarthritis knee; Seasonal allergic rhinitis
Medical History/Concurrent Conditions: Cholecystectomy; Dysphagia; Gastroesophageal reflux disease; Hypomagnesemia; Iron deficiency anaemia; Metabolic dysfunction-associated steatohepatitis; Metabolic dysfunction-associated steatotic liver disease; Non-ulcer dyspepsia; Obesity; Palpitations; Reactive depression; Recurrent urinary tract infection
Allegra Allergy; Calcium 600 + D(3) 600 mg-10 mcg (400 unit) tablet; d-mannose; estradiol