Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Speech disorder, Upper respiratory tract infection, Vocal cord inflammation
Clinical narrative: thought she was going to have a stroke; Blood pressure was high, 220/110; Upper respiratory infection; Runny nose; Congestion; Inflammation of vocal cords; Fatigue, so tired, exhaustion; Didn't feel well; Shortness of breath/couldn't breathe; Frozen shoulder/couldn't move her left arm. Clarified left arm was the injection arm; Heavy in her chest; Flushed face; she couldn't speak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 76 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset 2021, outcome "unknown", described as "thought she was going to have a stroke"; HYPERTENSION (medically significant) with onset 2021, outcome "recovered" (2021), described as "Blood pressure was high, 220/110"; UPPER RESPIRATORY TRACT INFECTION (non-serious) with onset 2021, outcome "not recovered", described as "Upper respiratory infection"; RHINORRHOEA (non-serious) with onset 2021, outcome "not recovered", described as "Runny nose"; NASAL CONGESTION (non-serious) with onset 2021, outcome "not recovered", described as "Congestion"; VOCAL CORD INFLAMMATION (non-serious) with onset 2021, outcome "not recovered", described as "Inflammation of vocal cords"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "Fatigue, so tired, exhaustion"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "Didn't feel well"; DYSPNOEA (non-serious) with onset 2021, outcome "recovering", described as "Shortness of breath/couldn't breathe"; PERIARTHRITIS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Frozen shoulder/couldn't move her left arm. Clarified left arm was the injection arm"; CHEST DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "Heavy in her chest"; FLUSHING (non-serious) with onset 2021, outcome "unknown", described as "Flushed face"; SPEECH DISORDER (non-serious) with onset 2021, outcome "not recovered", described as "she couldn't speak". The events "thought she was going to have a stroke", "blood pressure was high, 220/110", "upper respiratory infection", "runny nose", "congestion", "inflammation of vocal cords", "fatigue, so tired, exhaustion", "didn't feel well", "shortness of breath/couldn't breathe", "frozen shoulder/couldn't move her left arm. clarified left arm was the injection arm", "heavy in her chest", "flushed face" and "she couldn't speak" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood pressure measurement: 220/110, notes: was high.   Clinical course: Report related to a study or programme, details: 5570-Pfizer Patient Assistance Program. First dose on 01Mar2021, second dose 07Apr2021. Reaction to it started the following week, following the first dose. Got worse after the second dose. Clarified her reaction is the upper respiratory infection. She has not been the same person after the whole thing. Patient did not visit with her family during the holiday because since she received the Pfizer vaccine, has been struggling with an upper respiratory infection. Patient was pretty active walking four miles a day three times a week. Since the vaccine, she is so tired, so fatigued. Had runny nose. Inflammation of vocal cords, which was pretty bad for the first few days after the vaccine, she could not speak. This has gotten better, but not gone away. Says it can be heard in her voice. Congestion just goes on and on. A lot of times, a couple hours after she wakes up, she has to go back to bed because she is so tired and exhausted. Patient never had a fever and did not have other symptoms of body aches or stuff like that. After the first dose, she got frozen shoulder. Immediately after getting the first dose, she could not move her left arm. Clarified left arm was the injection arm. Patient administered the COVID-19 Vaccine, stating they probably injected it near a tendon or something. She had bad frozen shoulder for 3-4 days. She could not move her left arm, but she could lift her 5 fingers, but she was one-handed. That went away. Then a week after the injection she woke up with shortness of breath. She had to site down she could not breathe. Was heavy in her chest. Had a flushed face. Her blood pressure was high, 220/110, thought she was going to have a stroke. States it was 2-230. She sent a note to her cardiologist and called him when they opened the office. They asked her how she was doing, she stated her breathing was a little better, but the blood pressure is still high. The cardiologist office asked her to continue to monitor her blood pressure and if it continues to be high, to go to the ER. Eventually it dissipated and went, but the difficulty breathing continued. Not as bad as her waking up, but she was short of breath. She could not do her exercises anymore. States shortness of breath kind of has gotten better. Fatigue, runny nose, and congestion, continues. Patient had not been feeling well since the second dose of the COVID-19 Vaccine. Her entire family has had the Pfizer COVID-19 Vaccine, including the booster and they were infected with the COVID virus. Caller does not know which variant, but they are all positive. Caller did not go to this family gathering because she did not feel well. With regards to her family who are positive for COVID virus, she does not wish to provide any further information. States there are 13-14 people and they can report themselves or let their doctors know. She refuses to get the booster COVID-19 Vaccine because she does not want to add to the problems she already has. She was not expecting Pfizer to do anything. States this report is not going to benefit her. Whether what she is experiencing is going to go away or not, she cannot undo it. Caller asked another doctor to order an antibody test. She needs to know if she has any residual immunity after the two Pfizer COVID-19 Vaccines. If there was some immunity left, she was not going to get the booster because of her problems. Caller has 13-14 family members, all had the Pfizer COVID-19 Vaccine, including the booster, and they were infected with the COVID virus. Caller does not know which variant, but they are all positive. Caller declines to complete report. Full details unable to be obtained.  The lot number for bnt162b2 was not provided and will be requested during follow up.