Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Fibrin D dimer, Heart rate, Insomnia, Investigation
Clinical narrative: Palpitations; Respiratory distress; Chest pain; She could not breathe; felt like something was sitting on her chest; It was a burning sensation out to the sides, both sides; She couldn't sleep/ She was up all night long; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in Deltoid Right on 13Sep2021 18:55 (Batch/Lot Number: FC3183; Expiration Date: 31Oct2021) as 0.3 ml single for COVID-19 immunisation (age at vaccination was 42-year-old). Medical history included allergic to a lot of antibiotics, wolff-parkinson-white syndrome from Jun2003, celiac, a congenital heart defect when she was a newborn, she did have COVID Mar2021 and lost her sense of smell, seasonal allergies, tachy, early pregnancy and yeast. Concomitant medications included fluconazole (DIFLUCAN) taken for yeast from Aug2021 and ongoing; mefenidramium metilsulfate (ALLERGA) taken for seasonal allergy, start and stop date were not reported. The patient previously took clindamycin in 2007 for a jaw surgery and experienced throat swelling, azithromycin in Oct2006 and experienced hives, She had an anaphylactic reaction after having IV saccharated iron oxide (VENOFER) 2 years ago (2019), she had just kept coughing and could not breath right. Historical vaccine included flu shot and hepatitis vaccines, Tdap booster in Mar2021, MMR Vaccine for immunization and experienced pink circles. The patient experienced respiratory distress on 13Sep2021 20:25,  chest pain on 13Sep2021 20:25, palpitations on 15Sep2021, it was a burning sensation out to the sides, both sides on 13Sep2021 19:40, she couldn't sleep/ she was up all night long in Sep2021, she could not breathe and felt like something was sitting on her chest on 13Sep2021 20:25. The patient underwent lab tests and procedures which included biopsy (Sep2021): infectious disease, EKG (2021): ablated, stating that it would dip below baseline, d-dimer: elevated, tachy: 300 to 350, titer (2002): low. Clinical course was reported as Monday, 13Sep2021, she went to get the vaccine. She got it at 6:55pm (18:55). She took mefenidramium metilsulfate 180mg about 5 minutes before the vaccine for seasonal allergies. She took it just in case. It was 45 minutes after the dose. It was bizarre, it was from her sternum and out to the sides, it was a burning sensation out to the sides, both sides. After 10 or 15 minutes, it seemed to lessen. After she got home, all of a sudden, she felt like something didn't feel right. She could not take deep breaths all the way and it was like 90 minutes after the vaccine. It felt like something was sitting on her chest and she could not breathe. She started getting these chest pains on the right side, left side and in the center. She felt that it was not right and did not know if she should have gone to the emergency department. She sat for like 2 or 3 hours with chest pains in her family room. Later, in the middle of the night, she couldn't sleep but didn't really want to go to sleep. She didn't want to go to sleep and die. She was up all night long and it dissipated. In the morning, she started having random chest pains and a surge that would come and go. Wednesday night, she was at work, and started having chest pains and runs of heart palpitations. A respiratory therapist on her unit, who does EKGs took her in and did an EKG and told her he could tell she had been ablated, stating that it would dip below baseline. He told her that if it kept going down, they would have to do another EKG. Caller states it has been random since then. She would of heart palpitations and chest pains. Her doctor ordered another echo. The events resulted in Physician Office Visit. No treatment was received for the events. Outcome of the events was resolving.; Sender's Comments: Based on the close temporal relationship, the association between the event respiratory distress with COMIRNATY use can not be fully excluded.  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.