Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Hypertension, Investigation, Myocarditis, Oxygen saturation
Clinical narrative: he has developed myocarditis; Chest was hurting; Chest pain; Tachycardia; Hypertension; his temperature was 99.7; Tight chest; shortness of breath; This is a spontaneous report from a contactable consumer (patient's mother). A 15-years-old male patient received bnt162b2, dose 1 via an unspecified route of administration, administered in Arm Left on 13May2021 16:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation at the age of 15 years old. Medical history included Autism and ADHD. Concomitant medication(s) included guanfacine. The patient experienced he has developed myocarditis, inflammation of the muscle in his heart that was caused by covid vaccine, chest was hurting; chest pain, tachycardia, hypertension on an unknown date, shortness of breath, tight chest  on 15May2021. Clinical course details was reported as: She thinks he has developed myocarditis. Experienced shortness of breath, went to the Emergency Department. She wishes for him to receive second dose. "They did a bunch of tests". Saturday he had to rush in to the hospital because his chest was hurting, he has chest pain on Saturday that's why he went to the emergency room. The doctor said, he had inflammation of the muscle in his heart that was caused by COVID vaccine, she wants to submit that to Pfizer." Reporter stated, "No, not exactly, he got the COVID vaccine on May 13th. He started developing shortness of breath and tight chest on Saturday night which is May 15th, I woke him up  because all night long he was complaining, I take him to the emergency room at the morning like 4:30 am, 4:30 in the morning of May 16th. The doctor told me that, he said that he didn't believe that it was a side effect of a vaccine because it was not, it didn't developed like within 1 or 4 hours to the vaccine like now when I've seen on the news that the inflammation that is happening to some kind on the heart, he matches all the symptoms of that. So I need to know what do I need to make and what do we do for the second dose?" Lab test: They did when he was in the hospital, When he was in the hospital 2 days after they did a bunch of lab test." Treatment: They did give him some medication in the hospital. The notes from the hospital they gave, they says he has tachycardia, hypertension, shortness of breath, chest pain. They gave him Ativan. Caller states she is calling about the Pfizer COVID19 vaccine and states she is thinking her son had the side effect that is being reported of myocarditis and took the 1st dose of the vaccine on 13May2021 and on 15May2021, at night he complained of shortness of breath, and a very heavy chest and moaned all night long; states at 4:00am she and her husband got up and took the patient's blood pressure and oxygen level and pulse and his blood pressure was elevated at 151/108, oxygen levels were ok at 96-97 and his pulse was 128, and his temperature was 99.7 she thinks. States they took him to the emergency room at that time because they did not know if something was going on with his blood pressure elevated. Caller states she has not reported this information to the patient's HCP and is calling to ask if she should wait or have to wait on the patient's 2nd dose of the Pfizer COVID19 vaccine. Caller states she did previously file this report but was not given a report reference number and had to call back to ask for her questions. States the patient's 2nd dose of the Pfizer COVID19 vaccine is scheduled for 04Jun2021. States given that they did not expect the patient to have any side effects and they do not want to be in this situation and are planning on traveling the day the patient is scheduled for his 2nd dose of the Pfizer COVID19 vaccine would they have to wait for his 2nd dose; states she wants to do things the proper way. States given that they did not expect the patient to have any side effects and they do not want to be in this situation and are planning on traveling the day the patient is scheduled for his 2nd dose of the Pfizer COVID19 vaccine would they have to wait for his 2nd dose; states she wants to do things the proper way. Pfizer is aware of the observations of myocarditis that occurred predominantly in a population of young men who received the Pfizer-BioNTech COVID-19 vaccine. Adverse events are regularly and thoroughly reviewed and we have not observed a higher rate of myocarditis than what would be expected in the general population. A causal link to the vaccine has not been established. There is no evidence at this time to conclude that myocarditis is a risk associated with the use of Pfizer/BioNTech COVID-19 vaccine. More than 260 million doses of the Pfizer-BioNTech COVID-19 vaccine have been administered globally. Serious adverse events unrelated to, but close in timing to vaccination, are expected to occur at a similar rate in vaccinated individuals as they would in the overall population. [for non-HCPs]: we refer you to your healthcare provider to discuss this topic. Your healthcare provider knows your medical history, can discuss the risks and benefits of the vaccine, and can provide vaccination  recommendations to you. Pfizer is aware of the reports of myocarditis in recipients of the Pfizer-BioNTech COVID-19 vaccine. More than 260 million people globally have now been vaccinated with the Pfizer/BioNTech COVID-19 vaccine and we have not observed a higher rate of myocarditis than what would be expected in the general population. A causal link to the vaccine has not been established. Serious adverse events unrelated to but close in timing to vaccination will likely occur at a similar rate in vaccinated individuals as they would in the overall population. With a vast number of people vaccinated to date, the benefit risk profile of our vaccine remains positive. If asked on the specific casesMore specific information on the specific cases or demographics are not currently available to Pfizer Medical Information. The outcome of the events was unknown.  No follow attempts are needed; information about lot/batch number cannot be obtained.