Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Hypoaesthesia, Neuropathy peripheral, Pain in extremity, Palpitations
Clinical narrative: neuropathy; Afib; Deep pain in the legs starting from the foot to the ankle to the shin to my calf / pain in my foot; something strange; Deep pain / going up to my arm; numbness / in my foot; something strange; Tingling / in my foot; something strange; Heart palpitations; This is a spontaneous report received from a Consumer or other non HCP.  A 62-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in 2023 as dose 1, single (Batch/Lot number: unknown), in upper arm for covid-19 immunisation. The patient's relevant medical history included: "Prediabetes" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "long term COVID" (unspecified if ongoing), notes: Before. Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for influenza immunisation, in Oct2023 (2 weeks before BNT162b2 omi xbb.1.5) as single; METFORMIN taken for glucose tolerance impaired; LEVOTHYROXINE taken for hypothyroidism; FLUOXETINE taken for depression. Vaccination history included: Johnson & johnson (DOSE 1. Deep pain after few days, did not find a blood clot.), for Covid-19 immunization, reaction(s): "deep pain in my legs"; Johnson & johnson (DOSE 2. Arm pain went away.), for Covid-19 immunization, reaction(s): "some arm pain". The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 2023, outcome "not recovered", described as "Afib"; PAIN IN EXTREMITY (non-serious) with onset 2023, outcome "not recovered", described as "Deep pain / going up to my arm"; PAIN IN EXTREMITY (non-serious) with onset 2023, outcome "not recovered", described as "Deep pain in the legs starting from the foot to the ankle to the shin to my calf / pain in my foot; something strange"; PALPITATIONS (non-serious) with onset 2023, outcome "not recovered", described as "Heart palpitations"; PARAESTHESIA (non-serious) with onset 2023, outcome "not recovered", described as "Tingling / in my foot; something strange"; NEUROPATHY PERIPHERAL (medically significant) with onset 2023, outcome "unknown", described as "neuropathy"; HYPOAESTHESIA (non-serious) with onset 2023, outcome "not recovered", described as "numbness / in my foot; something strange". The patient reported adverse events that she had after having the BNT162b2 omi xbb.1.5 about a month ago (2023). The patient had the vaccine a month and a half ago, probably late October, early November. The patient developed a lot of deep pain in her legs starting from the foot to the ankle to the shin to her calf and going up to her arm, it was like neuropathy, there was some numbness, tingling but mostly it was the deep pain. The deep pain, tingling, numbness and pain in her foot was still going on and the doctor wanted to rule out Deep Vein Thrombosis (DVT) but they did not have a good ultrasound. They got her to have it but she had all that pain that was excruciating at times, it was like something was chewing at her legs, it was really a strange feeling and it was painful. The left leg was the worse. Now, they were both flaring up again. All this had been for a long time, like 5-6 weeks. The patient had not been doing good. She was concerned because it was like over a month and it was painful. The consumer reported that she was a little bit overweight. The patient had heart palpitations and Afib that started really after she had the vaccine and still going on. Therapeutic measures were taken as a result of pain in extremity, pain in extremity, hypoaesthesia, paraesthesia. The patient took AMITRIPTYLINE at night to ease the pain or GABAPENTIN but she couldn't  take them during the day because they made her too sleepy and then there was a gel or cream for muscle aches, it was a pharmacy driven product. The patient never had a reaction like this to a flu shot. She got them every single year.  The lot number for BNT162b2 omi xbb.1.5, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400004066 Same patient, different drug and event;