Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Hepatic enzyme increased, Hypertension, Malaise
Clinical narrative: avascular necrosis of right shoulder; Felt extremely fatigued; Felt foggy headed; was not feeling good at all; Acute onset hypertension; blood pressure was in 180's over 100's; Facial drooping; Tachycardia; Angina secondary to the acute onset hypertension; Having a heart rate in the 130's; Pulse thready; Confused; Elevated liver enzymes; Antinuclear antibody positive; This is a spontaneous report from a contactable nurse.A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Right on 06Jan2021 14:00 (Batch/Lot Number: EL0142) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history was not reported.There were no concomitant medications.  The patient previously took Flu vaccine. The caller verifies the first vaccine was administered on 06Jan2021 at (withheld). She felt fine immediately after. She got the vaccine around 2 in the afternoon, and that night she felt extremely fatigued. She woke up the next morning and felt foggy headed, didn't feel right. This continued on. She woke up one morning and was not feeling good at all. She drove to work and got to work. She thought she was going to pass out. She went into a little room because she didn't want anyone to see her. She ended up having a heart rate in the 130's. She had acute onset hypertension. She mentions she just had her yearly physical in Dec 2020 prior to her dose on 06Jan2021, and her blood pressure was 125/70 at that time. Her vitals were perfect, her labs were good.It ended up that one of doctors came in and told her that her pulse was thready, She had facial drooping. She also had tachycardia, acute onset hypertension, and angina secondary to the acute onset hypertension. They ended up taking over to the Emergency Room of (withheld). Her blood pressure was in the 180's over 100's range, her blood pressure went crazy. She was also apparently kind of confused. They did an EKG on her and it just showed sinus tachycardia. They did a CT of her head and that was normal. She followed up with her Cardiologist afterwards and she ended up wearing a Holter monitor. She had an echocardiogram done, a perfusion study. Thankfully, her heart looks fine.She also had elevated liver enzymes and a positive ANA (Antinuclear antibody). It's obvious her body clearly reacted to the vaccine in a negative way. Treatment: She was put on Metoprolol, a betablocker to bring her heart rate and blood pressure down.Interestingly enough, she doesn't know if its related at all, but on 18May2021, she had a complete shoulder replacement. She had her vaccine in the right shoulder, and then she had avascular necrosis of that right shoulder. It's hard to conceive the vaccine would cut off blood supply to her shoulder, but it sure did happen all of a sudden. She confirms she had her shoulder surgery on 18May2021. Her shoulder was hurting so she went in. It was initially thought she had tendonitis and she was given a steroid injection. Then, her shoulder continued to deteriorate. She went back and her shoulder was completely collapsed, her bone was gone, her shoulder was completely necrosed. Whether this had anything to do with the vaccine, she doesn't know, but its awfully suspect. She confirms she stayed in the hospital overnight for the surgery. She is still on short term disability. She hasn't been able to go back to work as a nurse because her shoulder was replaced. She has gone to physical therapy. She is continuing to improve. She believes she has done well with the surgery because she is a healthy person. It took about 2 months to recover from her reaction. She did follow back up with her doctor and they repeated her labs. Her liver enzymes went back to normal and her ANA is trending down. She is not on blood pressure medication, Metoprolol, any more. Her shoulder replacement surgery has been very weird. Her blood pressure was in the 90/60's range in the hospital. She didn't take her Metoprolol in the hospital since it was in that range. Every since she came home from the hospital after the surgery, she hasn't taken it.She believes she had an acute reaction to the vaccine. Thankfully, she feels better. She just felt like she needed to report this especially since she is a healthy person. She makes the comment she was a health nut and worked out her whole life.  She doesn't take any medications, doesn't require anything, she doesn't have any issues. Her labs, her cholesterol, everything has always been awesome. She again confirms she had a yearly follow-up in Dec prior to the vaccine and everything was fine, and then suddenly everything wasn't fine. Outcome of events was recovered.When probed for the seriousness criteria for these events, the caller states the adverse reactions such as the tachycardia, acute onset hypertension, angina, she would consider these to be serious, potentially life-threatening events. Caller stated she believes these events are related to the vaccine. She feels in her gut and in her heart, that they were caused by the vaccine. With her shoulder, she can't honestly say. She doesn't know, but it does seem suspect.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the events Hypertension, Tachycardia, Angina Pectoris, Heart rate increased, Facial paralysis and osteonecrosis 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.