Age: 78.0
Sex: F
Vaccine: COVID19, FLU3, PNC21, VARZOS
Symptoms: Infection, Pain in extremity, Peripheral swelling, Rash, Skin warm
Clinical narrative: infection; pain in extremity; peripheral swelling; rash; skin warm; Information has been received from Food And Drug Administration Agency (FDA) via Vaccine Adverse Events Reporting System (VAERS) (agency # 2799230) on 11-DEC-2024.  This spontaneous report was regarding a 78-year-old female patient. The patient's medical history, concurrent illness and concomitant medications were not reported. History of allergies included to sulfa antibiotics.  On 09-OCT-2024, the patient was vaccinated with the first dose of pneumococcal 21v conj vaccine (crm197) (CAPVAXIVE) injection administered intramuscularly in the right arm as prophylaxis (lot # Y011819 which has been verified to be a valid lot #, expiration date was not provided but upon internal validation was stablished as 01-OCT-2025; strength, dose and scheme were not provided); with a dose of tozinameran (PFIZER BIONTECH COVID-19 VACCINE) administered in the left arm intramuscularly (lot # LM221; formulation, strength, dose, scheme, expiration date and indication was not provided); with a dose of influenza vaccine (FLUZONE) administered in the left arm  (lot # UT8473AA; formulation, strength, dose, scheme, expiration date, route of administration and indication was not provided); and with the second dose of varicella zoster vaccine rge (cho) (SHINGRIX) administered in the right arm  (lot # E7335; formulation, strength, dose, scheme, expiration date, route of administration and indication was not provided).  On 11-OCT-2024, the patient's right arm had swollen up (peripheral swelling), was sore (pain in extremity), hot (skin warm), had a rash (rash) and was painful. The patient also experienced infection. Moreover, on the same date, she went to urgent care. On 13-OCT-2024, she received cefalexin (KEFLEX). On 14-OCT-2024, the patient was admitted to the hospital. On 15-OCT-2024 (reported as 2025, conflicting information), the doctors still where not sure what infection was and were starting steroids. At the reporting time, the patient has not recovered from any of the events.  The causal relationship between all the events and the suspect vaccines was not provided.  This is one of several reports received from the same reporter.  Investigation Summary for pneumococcal 21v conj vaccine (crm197) (CAPVAXIVE), Batch/Lot#: Y011819  Reviews performed as a result of this adverse event concluded that no unexpected events arose during the manufacture of Capvaxive Batch number 0001774623 material number 2017970 at MSD which could have impacted on product quality.  No deviations were deemed to have an impact on the batch prior to batch disposition. All acceptance criteria were met. All components utilized in the batch underwent QC inspection and release as per applicable quality standards and site procedures prior to use in the batch.  Sterility, Bioburden and endotoxin testing were performed as per approved site procedures and results met specification. Release testing conformed to all specifications. Based on this investigation of the adverse event, no systemic manufacturing inadequacy was identified at the MSD manufacturing facility that could impact the quality attributes of the product.  There have been no additional requests for information or additional testing relating to this Adverse Event.