Age: 80.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Cerebrovascular accident, Chest pain, Colitis, Dysphagia
Clinical narrative: very very ill; colitis; long COVID; coughing up thick tissue-like material-described as "honeycomb-like"; respiratory problems; Lost 45 Pounds; severe pain, well most of it was muscular; chest pain going down the arms; pneumonia; myocarditis; massive cardiac arrest; Stroke; Guillain-Barre syndrome; heart attack; swallowing difficulties; This is a spontaneous report received from a Physician from medical information team.  An 80-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 06Jan2025 as dose 1, single (Batch/Lot number: unknown) at the age of 80 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "chronic illnesses" (unspecified if ongoing), notes: have a lot of chronic illnesse; "heart attack" (unspecified if ongoing), notes: heart attack was my third one in last two years. I have had a whole lot of problems of other problems including probably close to now a 'fifty strokes'.". The patient took concomitant medications. Vaccination history included: Bnt162b2, for COVID-19 immunization, reaction(s): "Loss of smell and taste", "loss of smell", "mild COVID-19 infection", "mild COVID-19 infection", "bad headache". The following information was reported: PNEUMONIA (prolonged hospitalization, life threatening), outcome "unknown"; MYOCARDITIS (prolonged hospitalization, life threatening), outcome "unknown"; CARDIAC ARREST (prolonged hospitalization, life threatening), outcome "unknown", described as "massive cardiac arrest"; CEREBROVASCULAR ACCIDENT (prolonged hospitalization, life threatening), outcome "unknown", described as "Stroke"; GUILLAIN-BARRE SYNDROME (prolonged hospitalization, life threatening), outcome "unknown"; MYOCARDIAL INFARCTION (prolonged hospitalization, life threatening), outcome "unknown", described as "heart attack"; DYSPHAGIA (prolonged hospitalization), outcome "unknown", described as "swallowing difficulties"; ILLNESS (hospitalization), outcome "unknown", described as "very very ill"; COLITIS (medically significant), outcome "unknown"; POST-ACUTE COVID-19 SYNDROME (non-serious), outcome "unknown", described as "long COVID"; PRODUCTIVE COUGH (non-serious), outcome "unknown", described as "coughing up thick tissue-like material-described as "honeycomb-like""; RESPIRATORY DISORDER (non-serious), outcome "unknown", described as "respiratory problems"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "Lost 45 Pounds"; MYALGIA (non-serious), outcome "unknown", described as "severe pain, well most of it was muscular"; CHEST PAIN (non-serious), outcome "unknown", described as "chest pain going down the arms". The patient prolonged hospitalization for pneumonia, myocarditis, cardiac arrest, cerebrovascular accident, guillain-barre syndrome, myocardial infarction, dysphagia (start date: 30Jan2025). The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; didn't test positive; Weight: high, notes: 180s; Weight: 148 lbs; Weight decreased: 45 lbs.  Clinical course: Consumer stated, "Well, this is kind of complex, I got a Pfizer COVID Vaccine (Later clarified as Pfizer COVID-19 Vaccine) update on 06Jan and had a reaction to it which was deemed to be Guillain-Barre reaction, where it kind of attacked on my own cells and it turned out may or may not to have been the case. I have already submitted a report to VAERS. As it turned out by the end of the month, I was very very ill but I have a lot of chronic illnesses and I ended up admitted to a hospital in name withheld  and I was confirmed to have a whole lot of problems from the COVID and dependent of a massive cardiac arrest, a new stroke, I had double pneumonia, Myocarditis which  turned out during the stay in the hospital which was prolonged. I had swallowing difficulties and aspiration recurrently and I also was with all of the hawking , coughing and respiratory problems was bringing up by the honeycomb material which I did not know what to make of at the time but I found out, has been reported with COVID and Pneumonia. I was admitted 30Jan to the hospital, I am still in 24 hours care and maybe for the foreseeable future because of the disability that has arrived. I did get a substantial improvement all about a month and a half ago while in some acute care for six weeks which surprised everybody. At the time they were to send me away, the way for me to die and frankly, I was very surprised, I survived the trip to the hospital. So, I ended up with COVID where is a question if that is possibly has come from the vaccine, I really have not found any report of that happening before but you never know so, the people there suggested, I talked to you about this and they report all these bad things that happens to me." When probed to clarify the vaccine date as 06Jan2025, consumer stated, "That is right, I got it at a Pharmacy name withheld. This is a new thing for me to look up online and it's been a problem. I did get that at a Pharmacy name withheld." When paraphrased the concern, consumer stated, "Well, I was not hospitalized then. I actually saw my, I started doctor's and they decided it was most likely a Guillain-Barre reaction because I did not test positive for COVID right at the beginning and then, I just got sicker and sicker and also had an evening of six hours of chest pain going down the arms because I knew what that was because it was my third heart attack and I ended up in the hospital on the 30Jan, where they found all these things they actually told me the Pneumonia had probably been there for a quite a while before I came to the hospital, so, weeks maybe longer. I had a very brief episode of mild COVID after the third Pfizer vaccine, this was the fifth and I also had got a very brief episode which was thought to be a mild Guillain-Barre reaction' as well. When I did not test positive for the COVID that I had a electric shock up and down my spine and all this my body and was sick for just a few days and really nothing happens so that was like a couple years before."  The information on the batch/lot number for [BNT162B2 OMICRON (KP.2)] has been requested and will be submitted if and when received.; Sender's Comments: A possibly contributory role of BNT162B2 in triggering the onset of myocarditis cannot be fully excluded, considering the temporal relationship and known adverse profile of the suspect vaccine; Currently available data are insufficient to establish a causal relationship between Guillain-Barre reaction and BNT162B2.  More epidemiologic and accumulative clinical data, together with immunological workups and infectious panels would be needed to explore alternative etiologies and identify the possible causal link between the vaccination and such occurrence.   Other events are more likely associated with prior COVID 19 infection or represent intercurrent medical conditions in association with underlying predispositions including hypertension, high cholesterol and multiple episodes of heart attack.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202500081840 same patient, different event, different dose of vaccine;