Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Respiratory distress, SARS-CoV-2 test, Tachypnoea, Throat tightness
Clinical narrative: Respiratory distress; Pressure in chest, tightening, pain- inability to breath / tightness of chest to abdomen, squeezing unable to get breath; Cannot catch my breath / shortness of breath (SOB) upon exertion just talking; Bilateral wheeze/bronchospasm; Tachypnoea; Dry cough; Sensation of throat closure; Abdominal pain; Nausea; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 05Oct2021, this case now contains serious adverse reactions. Information processed together. This is spontaneous report from a contactable Nurse (patient).   A 51-year-old female patient received the second dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) intramuscular, administered in Arm Left on 30Jul2021 11:30 (at the age of 51 years old) (Lot Number: FA7484) as dose 2, single for COVID-19 immunisation. Medical history included Colon cancer. Not known drug allergies (NKDA), not known allergies (NKA). No known family history. Patient was taking Multivitamins prior to the events. No prior vaccination (within 4 weeks). Patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 Vaccine nor for any other conditions prior to the events. The patient previously took the first dose of BNT162B2 (Lot: EW0183) on 09Jul2021 16:00 (at the age of 51 years old) intramuscular to left arm for COVID-19 immunisation. On 01Aug2021, patient had significant shortness of breath (SOB) upon exertion just talking. Pressure in chest, tightening, pain- inability to breath. Patient received her second vaccine (COVID-19 Vaccine) on Friday this past on 30Jul2021, probably within the first 24 hours, patient ended up with shortness of breath that she did not had before. She didn't have this breathing issue before, she was perfectly fine. Patient called her physician and ended up in the emergency room (ER). Ruled me out for a PE (pulmonary embolism) or an MI (myocardial infarction) but patient was still not right. She cannot catch her breath. Patient was out for work until she can figure out what's going on. Patient tried to get in to see a cardiology as well.  In the ER, patient underwent laboratory tests and was COVID negative. Chest X-ray was performed (unknown results). Computed tomography angiography (CTA) was performed to rule out, a PE; electrocardiogram (EKG), CBC (complete blood count), and PMP to be specific; (all unknown result). Information on organ involvement - Respiratory Cardiovascular: Respiratory: Yes, dyspnea. Bilateral wheeze/bronchospasm: Yes, unable to catch breath. Stridor: No. Upper airway swelling: Unknown. Respiratory distress: Yes. Tachypnoea Yes. Increased use of accessory respiratory muscles Yes. Recession No. Cyanosis No. Grunting No. Dry cough Yes. Difficulty breathing (without wheeze or stridor) Yes. Sensation of throat closure Yes. Sneezing No. Rhinorrhea No. Cardiovascular Yes: Measured hypotension Unknown. Shock No. Tachycardia: Unknown. Capillary refill > 3 sec No. Reduced central pulse volume unknown. Decreased level of consciousness No. Loss of consciousness No. Dermatological/Mucosal unknown. Generalized urticaria (hives} No. Generalized erythema No. Angioedema (not hereditary) No. Generalized pruritus with skin rash No. Generalized pruritus without skin rash No. Generalized prickle sensation No. Localized injection site urticaria No. Red and itchy eyes No. Gastrointestinal Yes. Diarrhea No. Abdominal pain Yes. Nausea Yes. Vomiting No. Any Other Symptoms/Signs: tightness of chest to abdomen, squeezing unable to get breath. Treatment given was Methocarbamol (ROBAXIN) and Ibuprofen (MOTRIN) intravenous (IV) fluids for the pain. She didn't want any narcotics. Muscle relaxers were also given. Albuterol was given but was ineffective. The patient was not hospitalized nor admitted to an Intensive Care Unit. The outcome of the events was recovering at the time of report.; Sender's Comments: Based on temporal relationship the possibility of causal association between the reported events Respiratory distress, Chest pain, exertional dyspnoea, bronchospasm, tachypnoea, dry cough, throat tightness, abdominal pain, nausea and the suspect drug BNT162B2 cannot be 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.