Age: 67.0
Sex: F
Vaccine: PNC20
Symptoms: Peripheral swelling, Sleep disorder, Walking aid user
Clinical narrative: Blood pressure had gone up somewhat; knee pain; swelling in knees; legs began to swell; had severe pain in legs; could not walk; Started getting a headache that maybe lasted several weeks; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A 67-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 18Apr2023 as dose 1, 0.5 ml single (Lot number: FX6073) at the age of 67 years intramuscular, in arm for immunisation. The patient's relevant medical history included: "Arthritis", start date: 2005 (ongoing), notes: Arthritis Diagnosed: 18 years ago. There were no concomitant medications. Vaccination history included: Flu vaccine, for immunization. The following information was reported: HEADACHE (non-serious) with onset Apr2023, outcome "recovered", described as "Started getting a headache that maybe lasted several weeks"; GAIT DISTURBANCE (disability) with onset Apr2023, outcome "not recovered", described as "could not walk"; PAIN IN EXTREMITY (disability, medically significant) with onset Apr2023, outcome "unknown", described as "had severe pain in legs"; ARTHRALGIA (disability, medically significant) with onset Apr2023, outcome "unknown", described as "knee pain"; PERIPHERAL SWELLING (disability, medically significant) with onset Apr2023, outcome "recovering", described as "legs began to swell"; JOINT SWELLING (disability, medically significant) with onset Apr2023, outcome "unknown", described as "swelling in knees"; BLOOD PRESSURE INCREASED (non-serious) with onset 23Apr2023, outcome "unknown", described as "Blood pressure had gone up somewhat". The event "blood pressure had gone up somewhat" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (23Apr2023) high; (24Apr2023) 190/110; (26Apr2023) 154/110; Electrocardiogram: (27Apr2023) okay, notes: EKG and heart failure labs on 27Apr2023, both were okay; heart failure labs: (27Apr2023) okay, notes: EKG and heart failure labs on 27Apr2023, both were okay. Therapeutic measures were taken as a result of arthralgia, joint swelling, peripheral swelling, pain in extremity, gait disturbance, headache. Clinical details: patient stated that she had a reaction from the Prevnar 20 vaccine. She mentioned that she is now reluctant and scared in getting additional vaccines due to the reaction she had with the Prevnar 20 vaccine. She usually gets flu vaccine every year and she is scheduled to get the shingles vaccine. The patient's symptoms that happened a few days after patient had that shot. She started getting a headache that maybe lasted several weeks, legs began to swell, and had severe pain in legs. She got to the point could not walk, had muscle pain and joint pain. Legs were really swollen. Test results included: Blood pressure had gone up somewhat. Patient had gone to doctor thinking maybe she was in heart failure, did EKG which was okay, labs were okay, clarified heart failure labs were okay. The headache started probably a couple of days after having the shot, it resolved now but lasted several weeks, maybe 3 weeks. Seriousness was reported as not disabling, was something that needed to take Tylenol for, was a mild headache. Legs began to swell probably a couple of days after having the shot, but right leg was really quite swollen, couldn't wear blue jeans had to wear stretch pants. She had knee pain and swelling in knees, was wearing compression hose to try to get rid of swelling. Seriousness was reported as kept patient from walking for at least a week, been using a walker and cane for about 3 weeks now. She has never been like this before. Could not walk a week after having the shot. It was not ongoing, can walk now, would say stopped about a week ago. Outcome was not completely recovered, has lasting effects. Severe pain in legs that first week was when legs were extremely swollen and patient had severe pain in legs, kept up all night. She was taking Tylenol (Lot: BFAO62, Expiry: Nov2024, Strength and count size: 500mg, 290 gel caps) and Motrin (Lot: IME2015A, Expiry: Oct2023, Strength and count size: 100 coated tablets, 200mg), she is not supposed to take Motrin as she got nauseous. Severe pain in legs comes and goes now, can't walk on legs too much. Seriousness was reported as changed quite a bit, clarified caller keeps track of steps on phone or (withheld) watch, there has been a significant change in steps, caller used to walk 9,000 steps now walking 4,000 steps, cannot walk what used to walk, too much pain. Patient stated Tylenol did not help much. Patient took Motrin a couple of times and helped the pain, only thing that helped the pain and then got nauseous which lasted a couple of weeks. Causality for headache, legs began to swell, could not walk, and severe pain in legs: Stated this all happened right after the shot, was fine until that, can't correlate anything else, didn't do anything else, that's why caller is asking and looking at side effects but can't think of anything else that's why went to doctor to rule out congestive heart failure and doctor said caller's heart is fine. Patient stated nothing has ever happened like this, never not been able to walk.; Sender's Comments: A possibly contributory role of PREVNAR 20 in triggering the onset of these 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