Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Burning sensation, Insomnia, Pain in extremity, Paraesthesia, Tinnitus
Clinical narrative: burning in the back and front of his head/his arms were burning; ringing in his ears; burning in his ears; blurry vision; cannot sleep; visual acuity isn't the same; he has to squint more; pain from the burning; gastroparesis/all under control but after the vaccine it was exacerbated; gastroparesis/all under control but after the vaccine it was exacerbated; pain in the occipital and frontal areas of his head; increased stomach pain; losing weight; developed gastric reflux; coughing continuously; anxiety; depression; sick; This is a spontaneous report from a contactable consumer (patient) and nurse (patient's sister). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FA7485, expiry date: 01Oct2021), via an unspecified route of administration on 05Aug2021 (at the age of 61 years old) as dose 1, single for COVID-19 immunization. Medical history included headaches, neck pain and gastroparesis, all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced gastroparesis/all under control but after the vaccine it was exacerbated on an unspecified date in 2021, burning in the back and front of his head/his arms were burning, ringing in his ears on 05Aug2021, burning in his ears, blurry vision, cannot sleep, visual acuity isn't the same; he has to squint more, pain from the burning on an unspecified date in Aug2021, pain in the occipital and frontal areas of his head, increased stomach pain, losing weight, developed gastric reflux, coughing continuously, anxiety, depression and sick on an unspecified date in 2021. It was reported that the since the first dose of BNT162B2, the patient has had burning in his ears, burning in the back and front of his head as well as ringing in his ears. He also has reports of blurry vision. These symptoms are noted to be somewhat manageable during the day but when he lays down to sleep its unbearable and he cannot sleep. He noted that this has been a horrendous week he has had and wishes to get all the help he can so he can figure out how to get this squared away soon. He was currently taking Ibuprofen. The patient also experienced blurry vision. Stated that his visual acuity isn't the same; he has to squint more. It started right away after getting the vaccine and hasn't gotten any better. He got the 1st dose of the vaccine on 05Aug2021 in the afternoon. By the time he got home, his arms were burning, and when he went to bed that night his arms were burning and he had burning on the front and back of his head. He also had ringing in his ears. When he got up in morning, he noticed that his vision was blurry. That Saturday was worst day. And even last night his arms and head were burning and his ears were ringing. It has been terrible. He was hoping it would be gone in a week, but it hasn't gotten any better. During the day, it's somewhat manageable, but when he lays down he can't sleep at night because of the pain from the burning. He hasn't slept more than a few hours in the last week. Last night he slept for half an hour and woke up because his arms were burning, then got up and had to put ice on his head for the burning. Before he got the vaccine, he called his doctors and asked for recommendations on which of the vaccines to get for the least amount of side effects, and they said to get Pfizer. But now he can barely function with the pain from these side effects. He has been taking Ibuprofen 400mg twice a day, after lunch and at night because the pain was overbearing at night. On 23Sep2021, the patient's sister reported that the patient started having pain in the occipital and frontal areas of his head. The patient was having insomnia and has only slept about 2 hours a night for a month. He was also having increased stomach pain and increased pain. The patient has consulted with a doctor who has referred him to a neurologist. The patient has had cortisone injections. He did not want to take Klonopin but nothing else helps for sleep. He has also seen a gastrointestinal doctor and he will have a SmartPill test where her brother will swallow a capsule and the doctor is able to view what the capsule sees on a monitor. The patient was losing weight and he has developed gastric reflux and he was coughing continuously. The patient's sister has checked the patient's oxygen level and she doesn't think he has had the Covid 19 virus that she knows of. It was also reported that the patient has a history of gastroparesis and it was all under control but after the vaccine it was exacerbated and he was having insomnia, stomach, pain, increased pain and has only slept for about 2 hours a night for a month. He has seen a doctor, neurologist and GI doctor. They are calling to see if there is any help for him such as any programs or facilities that can offer support or assistance. The patient had blurred vision and had to see an ophthalmologist and still having blurred vision and they treat all of this. The patient also experienced anxiety and depression, and insomnia but they would not accept him because he didn't have COVID although he was having symptoms of COVID after the vaccine. The patient's sister stated that she just wanted to help her brother find better treatment because everyone throws their hands up in the air. The patient underwent lab tests and procedures which included oxygen level: unknown results on an unspecified date in 2021. The outcome of the events burning in the back and front of his head/his arms were burning, ringing in his ears, blurry vision, cannot sleep, visual acuity isn't the same; he has to squint more, pain from the burning was not recovered while the outcome of all other events was unknown.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, the causal relationship between the event Gastroparesis, Condition aggravated (Gastroparesis) and suspect drug BNT162B2 cannot be excluded, but consider also possible contributory effects from patient's medical history. 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.