Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis, X-ray
Clinical narrative: Pain in her chest, lungs, and ribs; Costochondritis; Myalgia; This is a spontaneous report from a contactable physician (patient's father). This is one of the 2 reports from same patient. A 16-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 21Mar2021 as single dose for covid-19 immunization. Patient received first dose of bnt162b2 on unknown date in 2021, 3 weeks before the second dose for covid-19 immunization. Medical history included asthma (Diagnosed when she was 5 years old), allergies (Pollen, dust, walnuts, coconut, diagnosed when she was 3 years old) and migraine from Sep2019. Concomitant medications included Amitriptyline 25 mg for migraine, Macrogol 3350 (MIRALAX) daily for constipation and salbutamol sulfate (VENTOLIN HFA) asthma pump taken as needed for asthma which patient had not used this for a while before the vaccine. The patient received the second dose and then 5 days later she had to be taken to the emergency room. The patient was only 16 years old but was able to be vaccinated because she had asthma, so she is high risk. In Mar2021, 5 days after the second dose, the patient had horrible pain in her chest, lungs, and ribs. On 26Mar2021 or 27Mar2021 the patient woke up with this pain, then that night it hurt when the patient breathed or talked. The patient was taken to the emergency room at that time and was diagnosed with costochondritis, the patient was not ever admitted to the hospital. The patient was given ibuprofen 600 mg prescribed but it didn't help. Unknown lot, NDC, and expiration date for the Ibuprofen. The pain was still there so the patient was given naproxen and she has been taking that for almost 2 months now. Sometimes the pain gets better but sometimes it gets worse. Unknown lot, NDC, and expiration date for the Naproxen. The first 4 weeks the patient had to lay down because she couldn't sit or stand for more than 15 minutes because of the pain. The patient was fine and then 5 days after the second dose she got the pain, and it doesn't go away. The pain is under the breast like 4 fingers under it and in the middle near the sternum. The pain hurts more when the patient moves and changes positions. It was reported that "Two days ago, the pain was a 2 out of 10, but randomly it goes to 5,6, or 7. Today the pain is a 4 out of 10". The caller said this event was ongoing and persisting. When the patient went to the emergency room on 26Mar2021 or 27Mar2021 they checked her for inflammation and rheumatoid arthritis, but it was negative. The patient's blood work was normal, the chest x-rays were normal too. The patient also went to the emergency room on 05May2021 and was not admitted. The care team checked the patient again and they said it was myalgia or something. The patient was not resolved from the events. The causality assessment with suspect vaccine reported as Related to the events pain in her chest, lungs, and ribs.   Follow up attempts are needed. Further information has been requested.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Pulmonary pain, Costochondritis and Myalgia. 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.