Age: 81.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cardiac stress test, Chest X-ray, Computerised tomogram, Echocardiogram
Clinical narrative: Lethargy; Fatigue; Couldn't pick himself up off the floor/he was on the floor and didn't have the strength to lift himself off the floor.; This is a spontaneous report received from contactable reporter (consumer or other non HCP).  An 81-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 03Aug2022 as dose 4 (booster), single (Lot number: FP7150) at the age of 81 years, in right deltoid for COVID-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing), notes: Diagnosed for possibly 5-10 years; "Congestive heart failure", start date: Feb2021 (ongoing); "Cardiac stent within the last 20 years" (unspecified if ongoing); "Triple bypass In 1998 or 1999" (unspecified if ongoing); "TIA's" (unspecified if ongoing), notes: had multiple TIA's in the past that have worn away at his cognitive ability; "Pacemaker" (unspecified if ongoing), notes: Has a pacemaker, has had triple bypass and stents; "Covid-19" (unspecified if ongoing), notes: contracted Covid-19 prior to receiving any vaccines; "bowel regularity" (unspecified if ongoing); "pain" (unspecified if ongoing). Concomitant medications included: TAMSULOSIN; OMEPRAZOLE; METFORMIN; FUROSEMIDE; METHYL SALICYLATE; FERROUS SULFATE; BISOPROLOL oral; METAMUCIL [PSYLLIUM HYDROPHILIC MUCILLOID] taken for constipation prophylaxis; POTASSIUM CHLORIDE; LOSARTAN; ACETAMINOPHEN taken for pain; ATORVASTATIN; NITROGLYCERIN; ASPIRIN [ACETYLSALICYLIC ACID]. Vaccination history included: BNT162b2 (Dose 3); BNT162b2 (Dose 2); and BNT162b2 (Dose 1), all for COVID-19 immunization and reported the following reactions for all doses: "laid around a little more and was less active", "fatigue", "felt bad for a couple days", "lethargy" and "didn't feel well". The following information was reported: ASTHENIA (hospitalization) with onset 04Aug2022, outcome "recovering", described as "Couldn't pick himself up off the floor/he was on the floor and didn't have the strength to lift himself off the floor."; FATIGUE (hospitalization) with onset 04Aug2022, outcome "recovering"; LETHARGY (hospitalization) with onset 04Aug2022, outcome "recovering". The patient was hospitalized for lethargy, fatigue, asthenia (start date: 05Aug2022, discharge date: 09Aug2022, hospitalization duration: 4 days. The events required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood test: Unknown results; Cardiac stress test: Unknown results; came back to be at baseline; Chest X-ray: Unknown results; Electrocardiogram: Unknown results; Labs: Unknown results; Ultrasound scan: Unknown results. Additional information: Metamucil: helps counteract constipation that can happen with the iron supplement. The patient had a pacemaker installed 1.5-2 years ago and rarely takes nitroglycerin anymore; possibly over a year since he's taken it. Vaccination Facility Type was a clinic and vaccine was not administered at facility. Fatigue and Lethargy occurred 24hours after vaccination. The adverse events AE(s) required a visit to the Emergency Room. The patient had no prior vaccinations (within 4 weeks). Similar type of reaction as far as lethargy and fatigue following the first three COVID-19 vaccines. The patient laid around a little more and was less active. Didn't feel well. Not close to this severity though. With the fourth dose, he was on the floor and didn't have the strength to lift himself off the floor. Ambulance personnel had to lift him off the floor when they arrived. This was a drastic difference in severity. Previous three vaccines were far less severe. The patient's son will definitely do some thinking before he takes the patient to get a fifth dose. People feel bad the day after the vaccines, but people know that the vaccine is protecting them from something worse. Clinical course: The patient's son was calling on behalf of his father in regards to the COVID-19 vaccine dose #4 or Booster dose #2, which ever it is referred to. The patient received 4th dose of vaccine on Wednesday, 03Aug2022 of last week. The following day, the patient had lethargy, fatigue, and couldn't pick himself up off the floor. On Friday morning, 05Aug2022 about 36hrs after the vaccine dose, the patient was taken to the hospital. The patient has been hospitalized since. Possible AE given onset of symptoms which started 24 hours after vaccination. Previously reported this possible AE to VAERS and felt it was reasonable to call Pfizer as well. The patient's son works in validation in pharmaceuticals and has a history of reviewing annual pharmaceutical reports. He is very patient and willing to help to assist Pfizer in the exploration of this instance and making the information aware to prevent something similar to this from happening again. He wants to aid in his father's recovery and prevent a similar event like this from occurring. His father's baseline is treated congestive heart failure (CHF). He feels like it may be worthwhile to include a warning to consider the risk versus benefit for patients who have the chronic heart conditions at baseline. His father's CHF was controlled. Has a pacemaker, has had triple bypass and stents. The patient has a long cardiac history that may have played a part in all this. CHF was being managed. Could this incident have been a baseline event, yes. Could the vaccine administration have contributed, yes. With the first 3 COVID-19 vaccine doses, it wasn't this bad. The patient's son wants Pfizer to know that making this report is not a knee jerk reaction. After doses 1-3 of the vaccine, his father felt bad for a couple days, but a lot of people do. Nothing severe or life threatening or anything like that. But this time, the severity, and the hospitalization 36hrs later are severe enough to warrant exploration of the specific vaccine lot or to consider the adverse event further and/or aggregate the data from cases like this. May need to consider revising the info sheet or consider whether dose 4 is recommended or not with similar patients. Trying to be transparent to aid in fathers' case but also get the word out to decrease the likelihood of something similar happening. Maybe a warning to physicians to consider something like this happening with other patients with similar health profiles to help them decide if further vaccination is warranted. The patient has since stabilized and improved. Forecasting to leave the hospital today, 09Aug2022 and to enter a rehab center. When an 81 year old man is in bed for 4 days, his strength erodes quickly, so he needs physical rehab to regain his strength. No later than tomorrow, the patient will move from hospital to rehab center. His vitals and testing suggest that it is safe to move from the hospital. The patient's son waited to see the data for his father's testing before making the report to Pfizer. Didn't want to burden Pfizer without cause. If his father had needed an angioplasty or his cardiac health had eroded, he wouldn't have called. But the stress test came back to be at his father's baseline. There hadn't been any further erosion or decline. Upon seeing that, he felt like the primary driver and a significant contributor was receipt of vaccine dose number 4 because his father's baseline health had not changed. It is important for Pfizer to know that the caller has been in pharmaceutical industry for 20 years and is not allowing politics to pollute sound science. He is calling just as a concerned engineer from the pharmaceutical company who is grateful and knows that investigations and changes can be done when robust reporting systems are in place. Knows that revisions are sometimes necessary as information is gained, PI sheet revisions, warnings, etc. He wants to evangelize appropriately and communicate with everyone to decrease the likelihood of an instance like what occurred with his father from happening again. He desires to have an open, transparent conversation with all stake holders to ensure that future decisions are made appropriately around the vaccine. Date, and Lot number for previous three vaccines is unknown at this time. He would need additional time to gather that information for his father but could retrieve the information if needed at a later date. Believes that third dose was administered on 19Aug2021, but unsure. Additional information: Dose #4: Date: 03Aug2022, Lot: FP7150, Site: Right Deltoid, Time of Day: around 3:30-3:45pm. No other vaccines. The patient contracted COVID-19 prior to receiving any vaccines. Since then, he has received the 4 doses of the vaccine. The patient was hospitalized and previously in rehab from that COVID infection. CHF is a real, chronic condition. The vaccine is not the sole cause. His dad's case could enable Pfizer to learn more about CHF and can better weigh the risk and reward to dose or not dose patients with these conditions. One of the biggest populations to protect against COVID are people in their 80's who have heart disease. Does his father's case warrant adding content to the PI sheet because of his level of cardiac function to question further doses based on preexisting cardiac conditions. Wants to be transparent and give knowledge of this event to take it into consideration for similar patients. Wants an outcome so he can be better informed. Knows that another dose update will come up. Will be faced with this decision again. Wants to help identify cause of what happened with his father and risk to dose or not to dose when another dose comes along.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201051461 same patient and different vaccine dose, different event separated in time;US-PFIZER INC-202201051462 same patient and different vaccine dose, different event separated in time;US-PFIZER INC-202201051463 same patient and different vaccine dose, different event separated in time;