Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Pain in extremity, Post-traumatic stress disorder, Red blood cell sedimentation rate, X-ray
Clinical narrative: Excruciating pain in leg/slightly sore arm; Excruciating pain in hip; leg inflammation; she couldn't even sleep; PTSD; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP) from medical information team. The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 01Mar2021 as dose 2, single (Lot number: EN6198) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Hip replacement" (not ongoing); "High cholesterol" (ongoing); "Nerve pain" (ongoing); "Spinal stenosis" (ongoing); "sleep" (ongoing); "high blood pressure" (ongoing); "prediabetic" (ongoing), notes: for sugar, is prediabetic; "Hip pain" (ongoing); "Arthritis" (unspecified if ongoing); "Plastic Surgery on her body" (not ongoing). Concomitant medication(s) included: ROSUVASTATIN taken for blood cholesterol increased (ongoing); METFORMIN taken for glucose tolerance impaired (ongoing); LISINOPRIL taken for hypertension (ongoing); XANAX taken for sleep disorder (ongoing); GABAPENTIN taken for neuralgia, spinal stenosis (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/lot number: EN6201), administration date: 08Feb2021, for Covid-19 immunization, reaction(s): "excruciating pain in hip and leg, every time she got doses of  Pfizer BioNTech Covid-19 vaccine/ sore arm, that she had with each dose", "excruciating pain in hip and leg, every time she got doses of  Pfizer BioNTech Covid-19 vaccine", "leg inflammation", "she couldn't even sleep"; Tetanus vaccine (was 19 then. Normally, does not get bad reactions.), for Immunisation, reaction(s): "Couldn't move arm for a month", "Her arm hurt". The following information was reported: PAIN IN EXTREMITY (medically significant), outcome "unknown", described as "Excruciating pain in leg/slightly sore arm"; ARTHRALGIA (medically significant), outcome "unknown", described as "Excruciating pain in hip"; INFLAMMATION (non-serious), outcome "unknown", described as "leg inflammation"; INSOMNIA (non-serious), outcome "unknown", described as "she couldn't even sleep"; POST-TRAUMATIC STRESS DISORDER (non-serious), outcome "unknown", described as "PTSD". The events "excruciating pain in leg/slightly sore arm", "excruciating pain in hip", "leg inflammation", "she couldn't even sleep" and "ptsd" required physician office visit. The patient underwent the following laboratory tests and procedures: Antinuclear antibody: Normal; Blood test: Normal; Fine, notes: Regular blood work was fine; Magnetic resonance imaging: fine, notes: everything was fine; Red blood cell sedimentation rate: Normal; X-ray: fine, notes: everything was fine. Therapeutic measures were taken as a result of pain in extremity, arthralgia. Clinical course: Patient already had hip issues, since she had to get hip replacement. So, she already had some pain in that hip. After she got first dose, had slightly sore arm, that she had with each dose. Within a few days of second dose, hip pain started and also leg inflammation started. Hip and leg issues didn't seem to go away with first dose. Was so sore, she couldn't even sleep, even with taking Hydrocodone. Entire leg was inflamed, had to sleep with 3 ice packs on leg. By the time she had surgery, hip surgery, 15Mar2021, she was ready for them to chop her leg off. Thinks she had PTSD from it. Clarified that caller was having the hip pain prior to having the vaccines. She also had arthritis. Slightly sore arm was either the next day, after each shot or later that day. It was not severe at all, was mild. She had this pain within a few days of second dose, she states that it happened after first dose as well. She could tell from the calendar dates, when she saw the surgeon and when she got the vaccine. Within 8 or 9 days back there, after the steroid shots wore off, she could not even sleep. The first 2 shots, pain was 3 weeks a part. Most of the pain has subsided but not completely. Thought that is regular hip stuff, not from the vaccine. She had first 2 vaccines at the Health Department set up, like a drive through. Only thing she had was steroid injection at hip, probably, maybe 6 weeks prior to getting Covid vaccinations. Only thing she had was steroid injection at hip, probably, maybe 6 weeks prior to getting Covid vaccinations. There was no Family Medical History Relevant to Adverse Events. She had gone to physician's office; did not went to ER. Caller stated it was the worst pain of her life. She got the vaccine right before getting a hip replacement and already had some pain obviously. She received the first dose in Feb2021 and the second dose three weeks later on 1Mar2021. She only had a slightly sore arm at first with each dose but within a few days of each dose the hip pain and leg inflammation started. The hip/leg pain didn't completely go way after the first dose. It was so severe that she couldn't sleep even with hydrocodone. By the time she had the surgery on 15Mar2021 she was ready for them to chop my leg off. Caller stated she has PTSD from it. The entire leg was inflamed, and she had to go to bed with three ice packs on her leg.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300079702 same patient/drug, different dose/events;