Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Cardiac function test, Chest discomfort, Computerised tomogram abdomen, Decreased appetite
Clinical narrative: Experiencing a heaviness in her chest; jaw pain; like she is freezing outside; she could barely walk with her walker; severe nausea; shaking from head to toe/having tremble; felt like burning up inside; Weakness; Has zero appetite; Anxiety.; This is a spontaneous report from a contactable consumer (daughter). This consumer reported for an 86-year-old female patient that: An 86-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: ER8735), via an unspecified route of administration, administered in Arm Right on 27Apr2021 at 11:00 (at the age of 86 year) as single dose for covid-19 immunisation. Medical history included Chronic hives from an unknown date and unknown if ongoing, ongoing Unspecified reactions, ongoing Unspecified medication allergies and patient had a prior fall where she suffered a broken ankle. Concomitant medication(s) included dupilumab (DUPIXENT) taken for eczema from Sep2020 and ongoing and latanoprost (LATANOPROST) taken for glaucoma from an unspecified start date and ongoing. Patient historical vaccine includes shingles vaccine for immunization and within 48 hours, the patient broke out in severe eczema from head to toe and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EP7533), via unspecified route of administration on Right arm for Covid-19 immunization and experienced no adverse event. She had Called on behalf of her mother who was 86 years old. Mother received the second dose of the Pfizer BioNTech Covid-19 vaccine last 27Apr2021, within 24 hours, mother experienced severe nausea with shaking from head to toe and felt like burning up inside. The weekend after the second dose, the mother experienced heaviness in the chest and jaw pain and was brought to the ER. Full cardiac work up was done, and results were fine. Doctors said this may be due to anxiety. Mother had CT abdomen, an endo scan, and blood works but they were all fine. Mother continues to weaken, having tremble and is nauseous. These symptoms would come and go. Mother was in the ER twice this past week and they could not find anything. Nausea got worse. It would come back strong around 3:30 in the morning. Caller wanted to know if these were reported with the Pfizer Covid-19 vaccine and if there was anything they could do further. Mother was taken to different doctors and tests were done but no findings. caller mentioned that the symptoms happened right after the shot. She reported that the patient has been seeing an infectious diseases doctor as during her lifetime, the patient has always had chronic hives. Caller reported that the patient has reactions to many things and is allergic to many medications. She reported that that weekend it got so severe, the patient was experiencing a heaviness in her chest and jaw pain. She reported that they thought the heaviness in the patient's chest and jaw pain might be cardiac, so the patient was taken to the emergency room. She reported that the patient stayed 2 nights in the hospital. Caller reported that the patient's heart was ruled out and her bloodwork came back ok. Caller reported that the hospital physicians thought that the heaviness and jaw pain could be anxiety and prescribed anxiety medication for the patient. She reported that the patient went to her primary care physician after leaving the hospital. Caller reported that the patient got worse and was experiencing nausea more and more. She reported that the patient's physician ordered an endoscopy and brain scan to rule out everything medically. Caller reported that the patient's physician informed her that her blood pressure was fine, her bloodwork was fine, and that all of her test results were normal. She reported that the patient just continues to weaken and trembles and burns up. Caller reported that the patient was so severely nauseous but never throws up. She reported that they are just at their wits end and do not know where to turn. Caller inquired if anyone else was calling with these side effects and if there was anything they can do. She reported that the patient went from being just fine, on no medications, to this. Caller reported that everyone keeps saying they do not know what was wrong with the patient. Caller reported that the patient's physician keeps saying that maybe it is anxiety, but the patient has been on the anxiety medications for 6 weeks and there are no signs of improvement. She reported that she does not want the patient to take the anxiety medications if they are not helping. The patient has been taking the generics for Lexapro and Xanax, escitalopram and alprazolam, for 6 weeks and has shown no improvement. Product strength and count size dispensed: Escitalopram 5 mg; dispensed in pharmacy bottle Alprazolam 0.25 mg; dispensed in pharmacy bottle Additional lot numbers: Caller unable to provide product lot numbers as they were dispensed in a pharmacy bottle. Caller reported that the Escitalopram was manufactured by Accord and the Alprazolam was manufactured by Sandoz. She reported that the patient was started on 5 mg of Lexapro, but the dose has been increased to 10 mg. Caller reported that the patient was taking two 5 mg tablets. Severe nausea: Caller reported that the patient's nausea has worsened. Caller reported that the patient initially would experience nausea for a couple of hours then it would ease. Caller reported that the last 10 days, the patient's nausea is almost all the time. Caller reported that the patient gets a couple good hours maybe before going to bed and that is it. Caller reported that the patient wakes up with severe nausea around 3:30 in the morning like clockwork. Shaking from head to toe: Caller reported that the patients shaking comes and goes. Caller reported that the patients shaking was definitely worse in the morning when she was the weakest or if she was getting a bad bout of it, like the nausea comes on stronger. Burning up inside: Caller reported that the patient feels like she is freezing outside when she was burning up inside. Heaviness in chest: Caller reported that the patient experiences heaviness in her chest when she gets episodes where the nausea and burning up inside, freezing outside come on. Caller reported that the patient does not always have the heaviness in her chest. Weakness: Caller reported that they took the patient to the emergency room a second time because she could barely walk with her walker. Jaw pain: Caller reported that the patients jaw pain comes and goes. Has zero appetite: Caller reported that they have to force the patient to eat. The patient underwent lab tests and procedures which included abdominal x-ray: normal on Apr2021, blood pressure measurement: fine on Apr2021, blood test: normal on 30Apr2021, cardiac function test: normal on 30Apr2021 results were fine computerised tomogram abdomen: all fine on Apr2021, endometriosis: all fine on Apr2021, endoscopy: normal on May2021 and scan brain: normal on May2021. Patient was visited to emergency room and physician's office for the events Jaw pain, heaviness in chest, nausea and weakness. Patient was hospitalized for the events experiencing a heaviness in her chest and jaw pain from 30Apr2021 to 02May2021. Therapeutic measures were taken as a result of the events with Escitalopram and Alprazolam. The outcome of the event's severe nausea, shaking from head to toe, felt like burning up inside, jaw pain, Weakness, has zero appetite, anxiety was not recovered and experiencing a heaviness in her chest, she could barely walk with her walker, like she is freezing outside and she could barely walk with her walker was unknown.  Information on Lot/Batch number has been requested.