Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Bone pain, Computerised tomogram normal, Gait disturbance, Hypoaesthesia
Clinical narrative: pain in the legs; difficulty walking; numbness in the legs; severe muscle pain in my calves and thighs; It seemed to go from one leg to the other and around the knee and like in the bones and beside the knee/Bone pain; Muscle cramp in his calf and thigh and in the back of his thigh and around the knee; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Sep2023 at 16:00 as dose 1, single (Lot number: HD9835) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "type 2 diabetes" (unspecified if ongoing), notes: type 2 diabetes diagnosed over 5 years ago; "I'm mildly obese" (unspecified if ongoing), notes: moderately obese; "had an accident", start date: 2023 (unspecified if ongoing); "operated on his left knee", start date: 2023, stop date: 2023, notes: On Memorial Day of 2023, he had the operation; "Injury" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Anatomical Site of injection: left arm , Batch/Lot number: EN6202), administration date: 02Mar2021, for Covid-19 Immunization, reaction(s): "Had no reactions at all to these previous COVID-19 Vaccines"; bnt162b2 (DOSE 4 (BOOSTER), SINGLE, Date: 19May2022, Anatomical Site of injection: left arm, Batch/Lot number: FJ4991), administration date: 19May2022, for Covid-19 Immunization, reaction(s): "Had no reactions at all to these previous COVID-19 Vaccines"; bnt162b2, bnt162b2 omi ba.4-5 (DOSE 5 (BOOSTER), SINGLE, Date: 11Oct2022, Anatomical Site of injection: left arm , Batch/Lot number: GH9694), administration date: 11Oct2022, for Covid-19 Immunization, reaction(s): "Had no reactions at all to these previous COVID-19 Vaccines"; Bnt162b2 (DOSE 2, SINGLE, Anatomical Site of injection: left arm , Batch/Lot number: EP7533), for Covid-19 Immunization, reaction(s): "Had no reactions at all to these previous COVID-19 Vaccines"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Anatomical Site of injection: left arm , Batch/Lot number: 30148A), for Covid-19 Immunization, reaction(s): "Had no reactions at all to these previous COVID-19 Vaccines". The following information was reported: BONE PAIN (disability) with onset 24Sep2023, outcome "unknown", described as "It seemed to go from one leg to the other and around the knee and like in the bones and beside the knee/Bone pain"; MUSCLE SPASMS (disability) with onset 24Sep2023, outcome "unknown", described as "Muscle cramp in his calf and thigh and in the back of his thigh and around the knee"; GAIT DISTURBANCE (disability) with onset 24Sep2023, outcome "unknown", described as "difficulty walking"; HYPOAESTHESIA (disability) with onset 24Sep2023, outcome "unknown", described as "numbness in the legs"; PAIN IN EXTREMITY (disability) with onset 24Sep2023, outcome "unknown", described as "pain in the legs"; MYALGIA (disability) with onset 24Sep2023, outcome "unknown", described as "severe muscle pain in my calves and thighs". The events "pain in the legs", "difficulty walking", "numbness in the legs", "severe muscle pain in my calves and thighs", "it seemed to go from one leg to the other and around the knee and like in the bones and beside the knee/bone pain" and "muscle cramp in his calf and thigh and in the back of his thigh and around the knee" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: they didn't find any blood clots, notes: they didn't find any blood clots. None of the tests showed anything; Ultrasound scan: they didn't find any blood clots, notes: they didn't find any blood clots. None of the tests showed anything. Therapeutic measures were taken as a result of pain in extremity, gait disturbance, hypoaesthesia, myalgia, bone pain, muscle spasms. Clinical Course: The agent refers the caller got the Comirnaty, the booster for this year and was looking for information regarding side effects: pain in the legs, difficulty walking and numbness in the legs. It started out as a severe muscle pain in his calves and thighs to the point where he ended up in emergencies twice in one week and the only way he could fight it was with an opioid. Now he was taking a lot of ibuprofen and this disability was unreal. He could barely walk. HCP provided a dose of gabapentin, it will leave him with nerve damage, he was sure. His son did a research on this and he found a medical report said that this could lead to a number of things specially if one had an injury within a reasonable amount of time which he had, diabetes which I had too or obesity and he was mildly obese. Some effects were heart problems, muscle pain and kidney or liver damage. His muscles cramped up so bad he ended up in emergencies. It was like sharp pain, like he had (inaudible) but with sharp pain, and they didn't ease up, they stayed. This had never happened to him before. Got the shot about 4 PM. The day after, Sunday, he couldn't walk hardly. It was painful to walk. Thought it would go away. Immediately thought it was because of shot. It didn't go away but the right leg was getting better and he had a check up with a doctor on Tuesday 26Oct2023. Told the doctor the right leg was getting better and what happened, but nothing was done then. On 27Oct2023, the left leg was extremely worse, and he ended up in Emergency Room at 12:15 AM, with that left leg pain. They took several different tests, he was not sure what some of tests were but stated they couldn't find anything. He was sent home with an opioid. He was supposed to take the opioids for a little over a day and then report back on the following Monday to his doctor. When the opioid wore off, he ended up back in the Emergency Room and all they did was send him home with more opioids if he needed them. That night he did need one, stating the pain, he was laying on the floor with pain. Every time he got up in his leg it was like a muscle cramp in his calf and thigh and in the back of his thigh and around the knee. The pain was extreme, like a sharp knife type pain. He went back to the Emergency Room and was given more of opioid pills. He took one of them that night and then saw his doctor. States on Sunday after, he tolerated the leg pain. He didn't want to take the opioids. Clarified he saw his doctor Monday afternoon. He explained the leg pain was traveling. It seemed to go from one leg to the other and around the knee and like in the bones and beside the knee. There were the muscle cramps with it. He noticed after that, his calves were extremely numb. There was numbness also in the thighs, but not as severe as the calves. His neighbor ended up with a heart problem, but caller doesn't know what vaccine he got. Caller doesn't know the full deal with this. He clarified his Comirnaty shot was on 23Sep2023 and the very next day, 24Sep2023 is when it all began. His legs hit the ground when he got out of bed and he could hardly walk and it was in both legs. He confirmed he was discharged from the emergency room and was never admitted to the hospital. He had an accident and was operated on his left knee. Was not sure of all the drugs they gave him, but an antibiotic was one of them. This occurred on Memorial Day of this year, 2023. They had to cut him open again, because it got infected and sew it back up. The cut was about 12" inches long. Then it kept swelling so they cut it open again and put drains in. Then it healed up. He was walking on it, going up and down stairs with no problem.