Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory rate increased
Clinical narrative: she cannot walk far or do much; massive headache; could not catch her breath or breathe; really high heart rate; high respiration rate; incredibly sore muscle; This is a spontaneous report received from contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 40-year-old female patient received BNT162b2 (BNT162B2), on 02Jun2022 as dose 1, single (Lot number: FM9992) at the age of 40 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CALCIUM; MULTIVITAMINS [VITAMINS NOS]. The following information was reported: DYSPNOEA (medically significant) with onset 02Jun2022, outcome "unknown", described as "could not catch her breath or breathe"; RESPIRATORY RATE INCREASED (non-serious) with onset 02Jun2022, outcome "unknown", described as "high respiration rate"; HEADACHE (non-serious) with onset 02Jun2022, outcome "unknown", described as "massive headache"; HEART RATE INCREASED (non-serious) with onset 02Jun2022, outcome "unknown", described as "really high heart rate"; MYALGIA (non-serious) with onset Jun2022, outcome "unknown", described as "incredibly sore muscle"; GAIT INABILITY (non-serious), outcome "unknown", described as "she cannot walk far or do much". The events "could not catch her breath or breathe", "really high heart rate", "high respiration rate" and "she cannot walk far or do much" required emergency room visit. Therapeutic measures were taken as a result of headache. The patient reported that her primary care provider did not have anything to do with the vaccine, she just went to the Emergency Room(ER) and did not go to see primary care provider. She reported that she would have never gotten it but unfortunately people started to link this to requirements, she never chose to get this, it became a requirement now. She reported that her Pfizer COVID-19 vaccine card was handwritten and NDC/EXP were not provided on vaccine card. She reported her side effect began 02Jun, that evening, she could not breathe and had a really high heart rate and high respiratory rate. She reported that she could not catch her breath or breathe, that was worst one. She reported that she also had obviously incredibly sore muscle, but she mostly could not breath and could not breath catch her breath. She reported that she had a massive headache. She took a lot of Tylenol for the headache, probably 4,000 to 5,000mg throughout the day. She reported that Tylenol was 8 hour Arthritis Pain Relief Tylenol, 650mg Acetaminophen, with UPC: 81131061445, EXP: May2022, LOT: 9HRO470 and the package had 225 capsules. She reported that at the emergency room (ER) they gave her oxygen 4 litre with nasal cannula, and she was only on oxygen while she was at the emergency room (ER). She reported that they gave her no medications for feeling like she could not breathe. She says that got better about the 4th, but she is still having trouble for that, it was definitely not as bad today as was then. She reported that she was still having problems catching her breath, she could not walk far or do much, physical activity drains her and she could not breathe. She reported that she was not admitted when she went to the Emergency Room(ER). She reported that the headache was just constant. She reported that she thought it was pretty significant, she was a healthy person and this happened to her, she did not want to think what could happen to immunocompromised people who get it. She reported that the only meds she took are Calcium and a Multivitamin, which she has taken for years, one a day. She reported she didn't know the dose for the multivitamin. She wanted to make sure someone knew about it.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.