Age: 50.0
Sex: F
Vaccine: FLUX, PNC20
Symptoms: Pain in extremity, Pyrexia, Vaccination site erythema, Vaccination site warmth
Clinical narrative: redness is spreading to the back of my upper arm behind my upper elbow it is red and very painful; redness is spreading to the back of my upper arm behind my upper elbow it is red and very painful; R arm still warm to touch and painful to touch; redness right below where the Vaccine site; redness right below where the Vaccine site. It is warm to touch; fatigued; muscle aches; joint pain; fever; chills; unable to sleep; This is a spontaneous report received from a Nurse.  A 50-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 19Feb2024 at 12:30 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years, in right deltoid for immunisation; influenza vaccine (INFLUENZA VACCINE), on 19Feb2024 as dose 1, single), in left arm for immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "HTN" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; JARDIANCE. The following information was reported: SLEEP DISORDER DUE TO GENERAL MEDICAL CONDITION, INSOMNIA TYPE (non serious)  with onset Feb2024, outcome "recovering", described as "unable to sleep"; CHILLS (non-serious) with onset 19Feb2024, outcome "recovering"; FATIGUE (non-serious) with onset 19Feb2024, outcome "recovering", described as "fatigued"; PYREXIA (non-serious) with onset 19Feb2024, outcome "recovering", described as "fever"; ARTHRALGIA (non-serious) with onset 19Feb2024, outcome "recovering", described as "joint pain"; MYALGIA (non-serious) with onset 19Feb2024, outcome "recovering", described as "muscle aches"; VACCINATION SITE ERYTHEMA (medically significant) with onset 20Feb2024 at 15:00, outcome "recovering", described as "redness right below where the Vaccine site"; VACCINATION SITE WARMTH (medically significant) with onset 20Feb2024 at 15:00, outcome "recovering", described as "redness right below where the Vaccine site. It is warm to touch"; VACCINATION SITE PAIN (medically significant) with onset 21Feb2024, outcome "recovering", described as "R arm still warm to touch and painful to touch"; ERYTHEMA (medically significant), PAIN IN EXTREMITY (medically significant) all with onset 23Feb2024, outcome "recovering" and all described as "redness is spreading to the back of my upper arm behind my upper elbow it is red and very painful". The events "redness right below where the vaccine site", "redness right below where the vaccine site. it is warm to touch", "r arm still warm to touch and painful to touch", "redness is spreading to the back of my upper arm behind my upper elbow it is red and very painful" and "unable to sleep" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site erythema, vaccination site warmth, vaccination site pain, erythema, pain in extremity, fatigue, myalgia, arthralgia, pyrexia. Additional information: No other vaccine in four weeks. Received the Prevnar 20 at the nurses clinic on patient's R deltoid on 19Feb2024. The same night she felt fatigued, muscle aches, joint pain and with fever 100F. Took Tylenol and it helped with the fever and pain. Patient had chills. Second day she had redness right below where the Vaccine site. It is warm to touch, she had the same symptoms, chills, fever, fatigue, muscle aches and joints pain. Patient started taking Advil for the muscle pain and joint pain. Third, Fourth and day the symptoms is subsiding but still has the redness on her R arm still warm to touch and painful to touch. Fifth and Sixth day the Other symptoms are almost gone except she still had the redness, warmth and painful to touch and noticed the redness is spreading to the back of upper arm behind upper elbow it is red and very painful. Patient was unable to sleep. Sunday morning she was taken by husband to be evaluated and given high dose of antibiotics and anti inflammatory.  Causality for "redness right below where the vaccine site", "redness right below where the vaccine site. it is warm to touch", "r arm still warm to touch and painful to touch", "redness is spreading to the back of my upper arm behind my upper elbow it is red and very painful", "unable to sleep", "fatigued", "muscle aches", "joint pain", "fever" and "chills" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.; Sender's Comments: Based on a drug event temporal association and on the compatibility with the known adverse event profile of the suspect product, the company cannot completely exclude a reasonable possibility that the suspect PREVNAR 20 may have contributed to the onset of reported serioius events including vaccinatied  arm red, warm to touch and painful to touch spreading to the back of upper arm behind upper elbow necessitating high dose of antibiotics and anti inflammatory.  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.