Age: 47.0
Sex: F
Vaccine: PNC20
Symptoms: Vaccination site pain
Clinical narrative: limited range of motion on her left shoulder and the skin is light red in color; limited range of motion on her left shoulder and the skin is light red in color; she immediately felt pain during the injection into her left deltoid and also she continued to have a pain and was experiencing swelling; she immediately felt pain during the injection into her left deltoid and also she continued to have a pain and was experiencing swelling; warm to touch; possible infected or edema in the capsule; possible infected or edema in the capsule; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID.  A 47-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 09Feb2024 as dose 1 (0.5 ml), single (Lot number: HE6176, Expiration Date: 31Mar2025) at the age of 47 years, in left deltoid for immunisation. The NDC number of Prevnar 20: 0005-2000-01. The patient's relevant medical history included: "Insomnia" (unspecified if ongoing); "Vitamin D deficiency" (unspecified if ongoing); "Acid reflux" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 1, LOT# EH9899), administration date: 30Dec2020, for COVID-19 immunisation; BNT162b2 (Dose 2, LOT# EL3248), administration date: 19Jan2021, for COVID-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 09Feb2024, outcome "unknown", VACCINATION SITE SWELLING (non-serious) with onset Feb2024, outcome "unknown" and all described as "she immediately felt pain during the injection into her left deltoid and also she continued to have a pain and was experiencing swelling"; VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 13Feb2024, outcome "unknown" and all described as "limited range of motion on her left shoulder and the skin is light red in color"; VACCINATION SITE INFECTION (non-serious), VACCINATION SITE OEDEMA (non-serious) all with onset Feb2024, outcome "unknown" and all described as "possible infected or edema in the capsule"; VACCINATION SITE WARMTH (non-serious) with onset Feb2024, outcome "unknown", described as "warm to touch". The events "she immediately felt pain during the injection into her left deltoid and also she continued to have a pain and was experiencing swelling", "warm to touch" and "possible infected or edema in the capsule" required physician office visit. The patient underwent the following laboratory tests and procedures: Glycosylated haemoglobin: normal. Therapeutic measures were taken as a result of vaccination site pain, vaccination site swelling, vaccination site warmth, vaccination site infection, vaccination site oedema.  Causality for "she immediately felt pain during the injection into her left deltoid and also she continued to have a pain and was experiencing swelling", "warm to touch", "possible infected or edema in the capsule" and "limited range of motion on her left shoulder and the skin is light red in color" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).  Additional information: the reporter stated, "So, patient came to our clinic and then she received the Prevnar 20 on Friday, February 9th and then she messaged through the patient portal to the provider on yesterday which was the February 12th and then stating that on Friday she immediately felt pain during the injection into her left deltoid and also she continued to have a pain and was experiencing swelling, tenderness at the Pneumoniae vaccine site and our provider had her come to the office yesterday and observed the swelling which was the left arm was tender and then warm to touch and the provider covered her with the like antibiotic (Unspecified Medication) in case of like underlining infection. So, today the patient messaged the provider in update and then she said she woke up with the continued pain limited range of motion on her left shoulder and the skin is light red in color and then she is concerned for possible infected or edema in the capsule."