Age: 70.0
Sex: M
Vaccine: PNC20
Symptoms: Arthralgia, Exercise tolerance decreased, Joint range of motion decreased, Laboratory test normal, Loss of personal independence in daily activities
Clinical narrative: musculoskeletal arthralgia/extreme pain in both shoulders/ hips were tender; a significant bruise there; tender to the touch; swelling; limited range of motion, cannot raise arms; probably lost some muscle; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team. The reporter is the patient.  A 71-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 08Dec2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for immunisation. The patient's relevant medical history included: "Low thyroid" (ongoing). The patient took one medicine which was his thyroid medicine for low thyroid. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VACCINATION SITE BRUISING (non-serious) with onset Dec2022, outcome "unknown", described as "a significant bruise there"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset Dec2022, outcome "unknown", described as "limited range of motion, cannot raise arms"; ARTHRALGIA (disability) with onset Dec2022, outcome "not recovered", described as "musculoskeletal arthralgia/extreme pain in both shoulders/ hips were tender"; MUSCLE ATROPHY (non-serious) with onset Dec2022, outcome "unknown", described as "probably lost some muscle "; SWELLING (non-serious) with onset Dec2022, outcome "unknown"; VACCINATION SITE PAIN (non-serious) with onset Dec2022, outcome "unknown", described as "tender to the touch". The patient underwent the following laboratory tests and procedures: Exam: (Jan2023) Fine. Clinical course as followed: He had several injections lately because he received all four Covid vaccine and none of those hurt. But this Prevnar 20 was hurt going in. It was noticed later that there was a significant bruise there, and it was very tender to the touch. Bruise didn't go away for 14 days and was tender and swelling. Around then, because it has been going on for at least a month, he has had extreme pain in both shoulders. Patient was extremely sensitive on the side he got the injection. He had limited range of motion, cannot raise arms above shoulder level. Involves his biceps, possibly his trapezius muscle, both hips, all his shoulder muscles. His hips were tender. Shoulders and hips loosen up some during the day, but in the morning and at night it is horrible. Getting in and out of bed and getting dressed was difficult. He hadn't been able to exercise because of this. He had probably lost some muscle over this period. Patient was still experiencing musculoskeletal arthralgia. The only thing he could think of that could be related is the Prevnar 20. There was no medical tests or medical treatment or follow up at the emergency department or urgent care. Just let his primary HCP know about it today.  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 PREVNAR 20 in triggering the onset of musculoskeletal arthralgia/extreme pain in both shoulders/ hips were tender cannot be fully excluded, considering the temporal relationship and known adverse event profile.  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.