Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Cardiomegaly, Chest discomfort, Chest pain, Compression garment application
Clinical narrative: unable to walk regularly; Massive heart attack; his right foot started swelling; tightening in heart/Chest tightening/pulling a muscle in chest; Chest pains; enlarged heart; Leg pain; Leg stiffness; Fast heart rate; Varicose veins; Obesity; Discomfort; walking funny; one leg was shorter than the other/His discomfort he felt with his legs swell; His discomfort he felt with his legs swell; fatigue; sweating; swelling; barely had an appetite; loose his balance; He fell once; Shortness of breath; This is a spontaneous report from a contactable consumer (patient's daughter). A 73-year-old male patient (reporter's father) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9809, Expiry Date: 30Jun2021) intramuscularly, administered in the arm, on 17Feb2021 at 11:00 AM (at age of 73 years old) as dose 1, single for COVID-19 immunization. Medical history included ongoing high blood pressure and high cholesterol. High blood pressure was under control because he lost a lot of weight and changed his eating diet. Family medical history included high blood pressure (mother). Concomitant medications included atenolol for hypertension/ high blood pressure from 1998 to 04Mar2021, and Amlodipine for high blood pressure. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Report was not related to a study or programme. The patient passed away on 15Jun2021 after taking COVID vaccine. He never had a heart problem until he took the first COVID vaccine shot. The patient experienced massive heart attack on 04Mar2021, two days after he started having pains in his chest on an unspecified date in Feb2021 with treatment received. One or two days after vaccine he started with shortness of the breath tightening in heart. He thought that he pulled a muscle from exercising on 03Mar2021. He thought the vaccine would allow for him to be normal again. The reporter believed the vaccine enhanced and compromised the patient's underlying condition. It was terrific to find him dead in the bed on the day the patient was going to accompany him to his second appointment for his second shot. As of 18Oct2021, the patient also experienced leg pain, leg stiffness, chest pain, fast heart rate, obesity, varicose veins, enlarged heart, on an unspecified date. There was no specific relevant test for thromboembolic events with thrombocytopenia was done. 48 years after he received the shot, the patient experienced chest tightness, no treatment was given to the patient for chest tightness and massive heart attack. It was thought that patient pulled muscles in chest from exercising. The patient received vaccine on 17Feb2021 medication was in syringe, 12 to 24 hours later experienced something like pulling a muscle in chest on an unspecified date in 2021. Continuously happened but feeling subsided. The night before death patient associated discomfort of pulling muscle in chest from exercising, next morning died of massive heart attack with no heart problems, day of second vaccine shot. Massive heart attack was also assessed by the reporter as persistent/significant/disability/ Incapacity. The patient died on 15Jun2021 due to massive heart attack. No autopsy was performed to the patient. Upon follow up on 03Nov2021, Family medical history relevant to AEs included High blood pressure, high cholesterol, obesity, knee problems, cure knee replacement, never done, shortness of breath, chest pain, massive heart attack, swelling in right foot on 03 Mar2021, tenderness, and pain wAMLODIPINE to touch. On 17Feb2021, patient received the vaccine two days after he felt as if he pulled a muscle working but he just wanted to go back to bring normal. Several days he started walking funny they could not get a doctor appointment. He walked as if one leg was shorter than the other. His discomfort he felt with his legs swell and he was just uncomfortable thinking maybe he had cold in his body. His blood pressure was under control from him losing weight, but the pressure went down, he felt fatigue, sweating and swelling, unable to walk regularly. He felt as if once he got the second dose he would be back to normal. He barely had an appetite and just stayed in his room in the chair. He told me that he had almost urinated on himself because the pain was so bad in his legs that he couldn't even get up so he thought that he couldn't make. Reporter came to his house to clean up after his accidents, urine bowl. So, this went on he asked reporter to promise him that he would go to his second appointment. He believed his appointment was 04Mar2021 at 11.00 am their plan was for reporter to come to his house by 9.15 am. Reporter found him dead lying on the bed with his eyes opened he called for help they released the body to reporter because there was no sign of foul play. He was in great health reporter believed the vaccine compromised his health condition and pronounced it. The vaccine attacked his underlying condition. Reporter was in the process of losing the family home and nightmares and sweats were unbearable patient leg and foot stayed swollen on the right side he always thought it was from the arches that were made for his feet. Reporter constantly gave him a foot massage in the foot spa brought all kinds of pain relief creams and also purchased compression socks daily the foot never went down he told me he would have to hold on to reporter to walk so he would not lose his balance and fall. He fell once thank God he didn't hit his head. So that's why he stayed off his feet and sat in the chair. He often slept in the chair because he couldn't get up and the bed was right next to the bed. Reporter believed the vaccine aggressively compromised patient's underlying pre-existing health condition. Autopsy information: No (No signs of foul play massive heart attack). Outcome of the event massive heart attack was fatal while outcome of other events was unknown.  Product investigation result: Lot EN9809, Expiration date:30Jun2021  Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EL3247 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN9809. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Additional information: Reporter stated she was calling regarding the Pfizer vaccine with lot number EN9809 and has a manufacturer report number and was checking on the status of the report. She stated that they keep sending duplicate copies of the same form. She provided the manufacturer report number as 202101033683. When attempting to clarify the Pfizer vaccine the caller was referring to, she stated that it was the first dose, the Pfizer vaccine shot that killed her father, (name withheld). The date of the second dose was the day he died. Her father was supposed to take the second shot 4Mar2021, which was the day he died. Was unable to clarify the name of the Pfizer vaccine that the caller was referring to. She provided the suspect product number as BNT16B2. The reporter stated that she called about 2 weeks ago and spoke to a nurse, and nobody has contacted her since, and she was advised that her request for follow up regarding her report would be noted in that report. Reporter was asking to be connected to someone so she can find out more information about that. She stated that she called them, and they started sending about 4 packets to fill out and all of them had been filled out. She guesses every time she sends it back, another packet gets sent out. It has been about 3 or 4 weeks and she has not received any kind of information. Reporter stated that she sent a 7-page letter about that. She does not know what was going to make that situation move faster, like a class action lawsuit. A lot of people that she knows that far, and her father has died, have been hospitalized with blood clots in the lungs and legs and all kinds of stuff like that. It was the recurring same situation like with other people; she does not know if other people have to die before they get to the bottom of the problem. She just does not understand. In a couple of days, it will be 9 months since her father died and they are in the process of losing her father's house. This was because he wanted to take the Pfizer vaccine shot, to have some type of normality with that Corona virus. She just does not know what to do. Reporter was offered to be transferred to USMI to address any questions she may have regarding the vaccine. She stated that she does not need to ask any questions, she was just checking the status of her report. The reporter was advised that all of that would be documented in that report and if Pfizer was in need of any further information, they would contact her. Upon Follow-up on 20Jun2022, reporter states that 6 months she provided documentation about her father passing away due to the Pfizer COVID 19 vaccine. She has not heard anything from anyone. What is the status? AER#. She received documentation that she has filled out about 4 or 5 times and she mailed it back to who sent it to her. Reporter was reported in regards to her father who passed away after receiving the Pfizer COVID 19 vaccine, provided documentation 6 months ago and filled out a form 4-5 times and mailed it back and has not heard back from anyone.  Follow-up attempts are completed. No further information is expected.  Follow-up (13Sep2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  Follow-up (30Sep2021): New information reported from a contactable consumer included: suspect drug details, medical history, concomitant medications, new events (massive heart attack, shortness of breath, tightening in heart, chest pains).  Follow-up (18Oct2021): New information reported from a contactable consumer included: added patient medical history, lab data, updated patient's age, suspect drug details (therapy start date and route of administration) and event details (added leg pain, leg stiffness, chest pain, fast heart rate, obesity, varicose veins, enlarged heart, discomfort; added disability as seriousness for heart attack).  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (03Nov2021, 08Nov2021): New information received from a contactable consumer included: suspect drug information, concomitant medication, reaction data (add walking funny, one leg was shorter than the other/His discomfort he felt with his legs swell, His discomfort he felt with his legs swell, fatigue, sweating, swelling, unable to walk regularly, barely had an appetite, loose his balance, He fell once), event details.  Follow-up attempts are completed. No further information is expected.  Follow-up (17Nov2021): New information reported from a contactable consumer (patient's daughter). New information included: age, age at vaccination, death date, was added and clinical course of narrative was updated.  No follow-up attempts are needed. No further information is expected.  Follow-up (29Nov2021): This is a follow-up spontaneous report received from a contactable consumer (patient's daughter): Added additional information.  Follow-up attempts are completed. No further information is expected.  Follow-up (04Jan2022): This is a spontaneous follow-up report received from the same contactable consumer. Updated information included event and vaccine start date.  Follow-up attempts are completed. No further information is expected.  Follow-up (06Jan2022): New information received from product quality group which included: Expiry date and Product investigation result.  Follow-up attempts are completed. No further information is expected.  Follow up (14Jan2022): Follow-up attempts are completed. No further information is expected.  Follow-up (20Jun2022): This is a spontaneous follow-up report from a contactable consumer. This consumer reported for a male patient. Updated information: Narrative was updated for additional information.  Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: massive heart attack