Age: 85.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Feeding disorder, Fluid retention, Swallow study, Swelling, Weight fluctuation
Clinical narrative: having difficulty breath; too much stress for the heart; Having problems swallowing was reported as worsened; He is not able to eat or drink; swelling; She stated patient's weight has fluctuated; Fluid retention/ Fluid retention and high level of CO2 in blood system; CO2 was high/ Elevated CO2 levels and unable to arouse; This is a spontaneous report from a contactable consumer (patient's daughter). A 85-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on an unspecified date as 2nd dose, single (at the age of 85-years-old) for COVID-19 immunization; tafamidis (VYNDAMAX, 61mg once daily by mouth), via an unspecified route of administration from an unspecified date for amyloidosis. Medical history included amyloidosis, sleep apnea which was diagnosed before he was taking either Vyndamax or Vyndaqel. There were no concomitant medications. Previously patient received first dose of BNT162B2 as 1st dose, single (at the age of 85-years-old) for COVID-19 immunization. Patient was on Vyndaqel 4 times a day and had some diarrhea. He was switched to Vyndamax about 3 months ago and in the last month, he started to have problems with swallowing. He was hospitalized and had to be intubated because he was having difficulty breath and his CO2 was high and the doctors thought it was too much stress for the heart, so they intubated him. While in the hospital, a feeding tube was put in because he could not pass the swallow test and they gave him one Vyndamax through the feeding tube but no more. He has been in the hospital twice and since then, has had difficulty swallowing food and pills. She has read on social media that other people on Vyndamax have had difficulty swallowing. The swallowing issues also started after having received his second dose of Pfizer's covid vaccine. Maybe about a month and a half ago, he started having problems swallowing and realizing it was possibly a side effect from it. He was having problem with the pills. He is currently in the hospital. He ended up where they had to intubate him and now extubate him. He is not able to eat or drink. Because of him being intubated, they were not able to continue giving him the medication. He has not taken it for 7-8 days. If the swelling is partly from being intubated, she is guessing that was part of the problem before, once they have been off the medication for a while, if that occurred with the swelling, would that go down after a while. She stated patient's weight has fluctuated. This occurred during the whole time, off and on. He was on Vyndaqel before this and does not know how long. It has been over a month that he has been having issues swallowing. He actually came home from the first hospitalization on 05Jun2021 and was only home for a day and a half before they had to take him back. He was again experiencing effects of CO2 where he was sleeping and they could not wake him up. On an unspecified date in May2021, the patient experienced having difficulty breath, too much stress for the heart, fluid retention/ fluid retention and high level of co2 in blood system, having problems swallowing was reported as worsened, have problems with swallowing, on 07Jun2021, the patient experienced co2 was high/ elevated co2 levels and unable to arouse, on an unspecified date in 2021, the patient experienced he is not able to eat or drink, swelling, she stated patient's weight has fluctuated. The patient was hospitalized for all events. Reporter seriousness for Having problems swallowing was reported as worsened, reporter seriousness for Fluid retention and high level of CO2 in blood system was hospitalization from 22May2021 to 05Jun2021, reporter seriousness for Elevated CO2 levels and unable to arouse was Hospitalization from 07Jun2021 to Ongoing. The patient underwent lab tests which included CO2 with high, swallow test which was not pass. Patient received treatment for having difficulty breath, co2 was high/ elevated co2 levels and unable to arouse, too much stress for the heart, having problems swallowing was reported as worsened, have problems with swallowing. The outcome of events (having difficulty breath, CO2 was high/ Elevated CO2 levels and unable to arouse, too much stress for the heart, Fluid retention/ Fluid retention and high level of CO2 in blood system, He is not able to eat or drink, swelling, She stated patient's weight has fluctuated) was unknown, the outcome of events (Having problems swallowing was reported as worsened, have problems with swallowing) was not recovered.  Information about lot/batch number has been requested.