Sex: M
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Death, Dysphonia, Fatigue
Clinical narrative: Fluid in his bottom right lobe of his lung where the cancer is; Inflammation in the bottom of his lung; in lower right lobe of lung; Blood pressure isn't stable; going up and down; Blood pressure issues; Exhausted; fatigue; Trying to control his blood pressure and his pulse issues, pulse incomplete; Muscle weakness was severely progressing; Bad reaction to the Covid vaccine; Blood clot on his lung; Raspy voice; the patient had been sick; Moderate headaches; Passed away; This is a spontaneous report from a contactable consumer (patient) based on the information received by Pfizer from Pharmaceuticals (Manufacturer control number 2020CAT00505). A 74-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at single dose for COVID-19 immunisation. Co-suspect drug included amifampridine phosphate (FIRDAPSE) orally, from 18Sep2020 to an unspecified date at 10 mg thrice daily, from 02Oct2020 to an unspecified date at 20 mg thrice daily, for Lambert-Eaton myasthenic syndrome. Medical history included Lambert-Eaton myasthenic syndrome (he could not walk without FIRDAPSE), migraine ever since he was a kid, small cell lung cancer (in liver and lymph nodes; brain metastases), metastases to liver, metastases to lymph nodes, radiotherapy of his head and lung for his cancer, gait disturbance from an unknown date and unknown if ongoing, muscular weakness from an unknown date and unknown if ongoing. Concomitant medications included pantoprazole, acetylsalicylic acid (ASPIRIN (E.C.), furosemide. The patient experienced blood clot on his lung in Jan2021 with outcome of unknown, fluid in his bottom right lobe of his lung where the cancer was on an unspecified date with outcome of not recovered, inflammation in the bottom of his lung; in lower right lobe of lung on an unspecified date with outcome of not recovered, raspy voice in 2021 with outcome of recovered, blood pressure not stable; going up and down; blood pressure issues on an unspecified date with outcome of not recovered, exhausted; fatigue on an unspecified date with outcome of not recovered, sick in 2021 with outcome of unknown, trying to control his blood pressure and his pulse issues, pulse incomplete on an unspecified date with outcome of unknown, moderate headaches from 19Sep2020 with outcome of recovered, muscle weakness severely progressing on an unspecified date with outcome of unknown, 10 mg 3 times a day wasn't enough (therapeutic product effect incomplete), on an unspecified date with outcome of unknown, he'd switch and do a couple doses of 15 mg and it was better but not enough (intentional product use issue) on an unspecified date with outcome of unknown, after he received the COVID vaccine, he experienced a bad reaction (unspecified) on an unspecified date with outcome of unknown. The events were reported as serious as involved hospitalization. The patient passed away on an unspecified date in Feb2021. It was not reported if an autopsy was performed. The clinical course of the events included the following information. On 21Sep2020, a spontaneous report was received from a consumer, via a company representative, regarding a 74-year-old male who was being treated with FIRDAPSE 10 MG (amifampridine). On 22Sep2020, additional information was received from a consumer. On 02Oct2020, additional information was received from a consumer and chemotherapy was added as a co-suspect. On 01Feb2021, additional information was received from a consumer via a company representative. On 09Feb2021, additional information was received from a consumer, and this case was determined to be the master case for cases 2021CAT00039 and 2021CAT00052 (both invalid, duplicate cases) and the information was merged into this case (2020CAT00505). This case was re-assessed as serious/unexpected, and COVID vaccine was added as co-suspect. On 18Feb2021, additional information was received from a consumer via a company representative. On 19Feb2021, additional information was received from a patient ambassador via a company representative. Medical history included LEMS (Lambert-Eaton myasthenic syndrome) and migraines. Concomitant products included: an unknown statin, pantoprazole, and acetylsalicylic acid (ASPIRIN) 81 mg. On 18Sep2020, the patient started treatment with FIRDAPSE 10 mg at 10 mg, 3x/day orally for LEMS. On 19Sep2020 and 20Sep2020, after starting the product, the patient experienced moderate headaches. On 21Sep2020, the patient did not experience a headache. On 22Sep2020, the patient experienced a headache that was "4/10." He had taken acetaminophen; aspirin; caffeine (EXCEDRIN) and ibuprofen as treatment and it "helped." The patient had not spoken to his HCP (health care provider) about the event but was going to call his HCP and ask to increase his dose of FIRDAPSE. The product was working and he was walking better, but he had heard people taking up to 80 mg a day. As of 22Sep2020, product use was ongoing and headaches were improved. On 02Oct2020, it was learned that his medical history included being prone to headaches (also reported as migraines ever since he was a kid) and "chemo" for small cell lung cancer stage 4 which was in his liver and lymph nodes. Concomitant products included furosemide. It was noted that the patient had been on the product for 4 to 5 days when he experienced his moderate headaches. He had the headaches for just a couple days, but he wasn't sure if it was due to the FIRDAPSE or it was the chemo. He took "a couple" of ibuprofen and he was "alright." On an unspecified date, the patient was in contact with his HCP and he was told to "keep an eye on it" (presumed headaches) and see if it got worse. They agreed that it could have been the chemo or a "fluke" thing. He also spoke to his HCP about his FIRDAPSE dose of 10 mg, 3x/day not being enough. He would switch and do a couple doses of 15 mg and it was better, but not enough. His HCP thought he should be taking 20 mg 3x/day, so he was working with the patient's insurance and pharmacy to get it changed. As of 02Oct2020, FIRDAPSE and chemo treatment were ongoing and moderate headaches were resolved (reported as he'd been good for a few days). On 01Feb2021 and 09Feb2021, it was learned that on 02Oct2020, the patient's FIRDAPSE dose increased to 20 mg, 3x/day. On an unspecified date, the patient received the COVID vaccine at an unreported dose, route, and frequency of administration for an unreported indication. After the patient received the COVID vaccine, he experienced a bad reaction (unspecified). Since 27Jan2021 (reported as since Wednesday, relative to 01Feb2021), the patient had been sick. On 31Jan2021, the patient went to the emergency room, and they thought he had a blood clot on his lung. Subsequently, he was admitted to the hospital. Initially, when the patient was in the hospital, they took all his medications away, including his FIRDAPSE, as the pharmacy was managing his medication. The patient wife was able to get the doctors to let the patient keep his FIRDAPSE in his room with him before he missed any doses because he could not walk without his FIRDAPSE. On an unspecified date in 2021, the patient had radiation of his head and lung for his cancer (previously reported medical history), and "they" (presumed his medical provider) said he could have a raspy voice and headache, which he did experience but then resolved. While in the hospital, the patient's blood pressure was not stable. It went "up and down, up and down." He had fluid in the bottom right lobe of his lung, where the cancer was, and they could not "tap it" due to the blood pressure issues. They were trying to get the fluid out every other way they could. The doctors said he had inflammation in the bottom of his lung. He was given a "good dose" of prednisone, but he was just exhausted. They were trying to control his blood pressure and his pulse. When they got one of them "up," the other went "down." The doctors said that the patient's LEMS had nothing to do with why he was in the hospital. His wife expressed her gratitude for the FIRDAPSE and how it had helped him. As of 09Feb2021, treatment with FIRDAPSE was ongoing. The patient was still in the hospital and not doing well, also reported that he was still the same, he had not improved but he had not worsened. The blood clot on his lung, blood pressure fluctuation and pulse issues, fluid in the bottom right lobe of his lung, inflammation in the bottom of his lung, and exhaustion were not resolved. The status of the bad reaction to the COVID vaccine was not reported. No additional information was provided. On 18Feb2021 and 19Feb2021, it was learned that the patient's medical history included: muscle weakness and lung cancer with brain metastases. On unspecified dates, after starting FIRDAPSE, the patient's muscle weakness began severely progressing, and he experienced fatigue. The weakness was worsening significantly, even after being on the medication (presumed FIRDAPSE). On 14Feb2021 or 15Feb2021, the patient was discharged from the hospital. On 18Feb2021, the patient took his last dose of FIRDAPSE. On 18Feb2021 or 19Feb2021 (reported as last night, relative to 19Feb2021; yet also reported as either 18Feb2021 or 19Feb2021), the patient passed away. The cause of death was unknown. A 74-year-old male, with a history of migraines and chemotherapy for metastatic small cell lung cancer, was taking an unknown statin, furosemide, pantoprazole, and Aspirin. He added FIRDAPSE for LEMS on 18Sep2020 and experienced headaches for a couple days, but he wasn't sure if it was due to the FIRDAPSE or chemo. After COVID vaccine, he experienced a bad reaction (unspecified). Since 27Jan2021, he was hospitalized with a blood clot on his lung. He had brain and lung radiation for cancer. While in the hospital, he had fluid and inflammation in the bottom right lobe of his lung, where the cancer was, which count not be drained due to labile blood pressure. His muscle weakness began progressing and he experienced fatigue. In Feb2021, he was discharged on FIRDAPSE. A few days post-discharge, he died. Based on the information provided, the events were assessed as unrelated. Information on the batch/lot number has been requested.; Reported Cause(s) of Death: Passed away