Age: 63.0
Sex: F
Vaccine: PNC20
Symptoms: Injected limb mobility decreased, Injection site discolouration, Injection site erythema, Injection site reaction, Malaise
Clinical narrative: raised area on the left arm; texture of her  skin at the injection site has changed and it looks like something that is raised and reddish brown; texture of her  skin at the injection site has changed and it looks like something that is raised and reddish brown; It was difficult for her to raise the arm; muscle aches; joint pain; Fever; experienced something that was like the flu/flu like symptoms; Coughing; Diarrhea; Vomiting; Pain in the arm; started getting really sick; terrible abdominal cramps; This is a spontaneous report received from contactable reporter(s) (Pharmacist). The reporter is the patient.  A 63-year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), on 22Nov2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 63 years, in left arm for immunisation; for immunisation. The patient's relevant medical history included: "Hypertension" (ongoing), notes: Diagnosed over 20 years ago; "Hyperlipidemia" (ongoing), notes: Diagnosed a few years ago; "Nodule on thyroid gland" (ongoing), notes: Diagnosed a couple of years back; "Irregular heart beat.", start date: 2023 (ongoing), notes: Diagnosed this year; "sick", start date: 2022 (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, in Nov2023 as dose number unknown, single. Vaccination history included: Influenza vaccine (Has been getting for many years every year), for Immunization. The following information was reported: DIARRHOEA (non-serious) with onset 22Nov2023, outcome "recovered" (23Nov2023), described as "Diarrhea"; PAIN IN EXTREMITY (medically significant) with onset 22Nov2023, outcome "recovering", described as "Pain in the arm"; VOMITING (non-serious) with onset 22Nov2023, outcome "recovered" (23Nov2023); MALAISE (disability) with onset 22Nov2023, outcome "recovered" (27Nov2023), described as "started getting really sick"; ABDOMINAL PAIN (disability) with onset 22Nov2023, outcome "recovered" (23Nov2023), described as "terrible abdominal cramps"; COUGH (non-serious) with onset 23Nov2023, outcome "recovering", described as "Coughing"; PYREXIA (non-serious) with onset 23Nov2023, outcome "recovered" (24Nov2023), described as "Fever"; INFLUENZA LIKE ILLNESS (non-serious) with onset 23Nov2023, outcome "recovered" (27Nov2023), described as "experienced something that was like the flu/flu like symptoms"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "raised area on the left arm"; SKIN TEXTURE ABNORMAL (non-serious), SKIN DISCOLOURATION (non-serious), outcome "not recovered" and all described as "texture of her  skin at the injection site has changed and it looks like something that is raised and reddish brown"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "It was difficult for her to raise the arm"; MYALGIA (non-serious), outcome "recovered" (Nov2023), described as "muscle aches"; ARTHRALGIA (non-serious), outcome "recovered" (Nov2023), described as "joint pain". Therapeutic measures were taken as a result of pyrexia. Clinical courses: Event seriousness of pain in the arm was reported as medically significant by pharmacist. Event seriousness of started getting really sick and terrible abdominal cramps were reported as disability by pharmacist. Caller reported that right after she received the Prevnar 20 there was pain in the arm. As the day went by she started getting really sick. That Wednesday night, overnight, she had terrible abdominal cramps, fever, diarrhea, and vomiting and was vomiting the whole night. The pain in her arm lasted the whole week. Now there is a raised area on the left arm and the texture of her skin at the injection site has changed and it looks like something that is raised and reddish brown. She did not notice the rash before, but stated that the pain in her arm is less. It was difficult for her to raise the arm. It was not serious enough for her to go anywhere for the pain in her arm. The raised reddish brown area was on her left arm, it measured 16cm in length. She is still experiencing that on her arm and it seems to be spreading a little bit. The area was smaller, but is now spreading. After that first night she experienced something that was like the flu and she was coughing the whole week. Some of the muscle aches and joint pain were gone by the weekend. By Monday she was completely recovered from the flu like symptoms. She started getting really sick in the middle of the night on Wednesday 22Nov2023. She could not get out of bed on Thursday morning and could not go to the dinner she was supposed to go to. Only has a small residual cough, but would not call it lasting effects because she is fine. She was feeling much better by monday 27Nov2023. Abdominal cramps was like a 1 time event and was done by Thursday morning the 23Nov2023. Fever started on Thursday morning 23Nov2023. Doesn't think it lasted more than 24 hours and she was taking Tylenol for it. The fever would go down with the Tylenol. Diarrhea was a 1 time thing. She was recovered by Thursday morning, 23Nov2023. It only happened once and then no diarrhea afterwards. Vomiting started Wednesday night 22Nov2023 and resolved by Thursday morning, 23Nov2023. She started coughing Thursday during the day. She is still experiencing a little bit of coughing. She would feel something in her throat and start coughing. She has regular chronic conditions that have nothing to do with this. She has not called her doctor yet to let her know about her symptoms. Time the Vaccination Was Given: 22Nov2023 given between 9:30-10:00am. Influenza vaccine was given on either the 08Nov2023 or 09Nov2023.  The information on the batch/lot number for [PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN)] has been requested and will be submitted if and when received.; Sender's Comments: A possibly contributory role of PREVENAR 20 in triggering the onset of serious events cannot be fully excluded, considering the temporal relationship.  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