Sex: U
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Hypoaesthesia, Overweight, Pain in extremity, Paraesthesia
Clinical narrative: ATRIAL  FIBRILLATION; DEEP PAIN IN THE LEGS STARTING FROM THE FOOT TO THE ANKLE TO THE SHIN TO MY CALF AND GOING UP TO MY ARM, IT'S LIKE NEUROPATHY; NUMBNESS; TINGLING; OVERWEIGHT; PATIENT TOO SLEEPY; ARM PAIN; This spontaneous report received from a consumer by a Business partner (Pfizer Inc.) on 08-JAN-2024 was received on 08-JAN-2024 and concerned a 62 year old of unspecified sex. The patient's weight was 220 pounds, and height was 162.56 centimeters. The patient's past medical history included: covid-19, and concurrent conditions included: prediabetes, depression, and hypothyroidism. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis and booster covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: amitriptyline ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for ease the pain. ; and gabapentin ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for ease the pain. Concomitant medications included fluoxetine for depression, metformin for diabetes, and levothyroxine for prediabetes.  On an unspecified date following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced deep pain in the legs starting from the foot to the ankle to the shin to my calf and going up to my arm, it's like neuropathy, numbness, tingling, overweight, patient too sleepy, and arm pain (Dose number in series 1).  On an unspecified date, the patient received non-company suspect vaccine included: tozinameran (Dose number in series 3)(form of admin, route of admin, and batch number were not reported), dose (dose series 3), start therapy date were not reported for covid-19 prophylaxis. On an unspecified date following vaccination with tozinameran, the patient experienced atrial fibrillation (Dose number in series 3).  Patient developed a lot of deep pain in legs. The side effect was deep pain in the legs starting from the foot to the ankle to the shin to calf and going up to arm, it's like neuropathy, there was some numbness, tingling but mostly it was the deep pain. When the patient first had the COVID company vaccine, the patient had deep pain in legs, so they were concerned about DVT." When clarified the side effects: Consumer stated, "Deep pain that was after few days but I told the doctor and he wanted to run a test for DVT and did not have, they did not find a blood clot, they couldn't but it was a deep pain and then the patient had the second one and was encroached to have the second one because COVID was still around and did not have as many. The patient had some arm pain, but it went away but this third one was kind of hesitant about getting Pfizer vaccine. The patient developed deep pain and tingling and numbness and pain in my foot was still going on and the doctor wanted to rule out Deep Vein Thrombosis or DVT but did not have a good ultrasound or did not know something, the patient had it the second time. The patient was having all this pain that was excruciating at times, it was like something chewing at legs, its really a strange feeling which was painful. The left leg was the worse, the left leg does not and let it be which was flaring up again. The patient did not know if it was a reaction or sensitivity, what caused all this but this has been a long time, it's been 5-6 weeks. The patient was little bit overweight. The patient had a heart palpitations, AFib (atrial fibrillation) was going on.  The patient was instructed to take Amitriptyline at night to ease the pain or Gabapentin but the patient did not take them during the day because they make the patient too sleepy. The patient never had a reaction like that to flu shot. The patient gets it every single year. The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable; and action taken with amitriptyline, and gabapentin was not reported. The patient recovered from arm pain, had not recovered from deep pain in the legs starting from the foot to the ankle to the shin to my calf and going up to my arm, it's like neuropathy, numbness, and tingling, and the outcome of atrial fibrillation, overweight, and patient too sleepy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: Atrial fibrillation. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: MEDICAL HISTORY(Hypothyroidism increases risk for AF). Therefore, this event is considered inconsistent with vaccine administration.