Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Haematology test, Heart rate, Inflammation, Investigation, Irritable bowel syndrome
Clinical narrative: wheezing; Coughing; back pain; morning nausea; kidney problems; joint problems; heart problems; general system inflammation symptoms; joint pain; muscle pain; skin issues; asthma; irritable bowel; erratic blood pressure; tachycardia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101698158 (Pfizer).  A 68 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 22Mar2021 (Lot number: EN6202) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Mild asthma" (unspecified if ongoing), notes: Mild asthma, borderline hypertension; "borderline hypertension" (unspecified if ongoing); "Allergies: Avacado" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Tetracycline, reaction(s): "Allergy", notes: 11. The patient have a previous history allergy to specific products, or any conditions indicative of an allergy medication was reported as Tetracycline's. Vaccination history included: Bnt162b2 (product : COVID 19, brand: Pfizer, Lot number: ER2613, administration date: 02Mar2021, dose 1, single vaccine location: Left arm) when the patient was 67 years old, for COVID-19 immunization. The following information was reported: INFLAMMATION (non-serious) with onset Apr2021, outcome "not recovered", described as "general system inflammation symptoms"; ARTHRALGIA (non-serious) with onset Apr2021, outcome "not recovered", described as "joint pain"; MYALGIA (non-serious) with onset Apr2021, outcome "not recovered", described as "muscle pain"; SKIN DISORDER (non-serious) with onset Apr2021, outcome "not recovered", described as "skin issues"; ASTHMA (non-serious) with onset Apr2021, outcome "not recovered", described as "asthma"; IRRITABLE BOWEL SYNDROME (non-serious) with onset Apr2021, outcome "not recovered", described as "irritable bowel"; BLOOD PRESSURE ABNORMAL (non-serious) with onset Apr2021, outcome "not recovered", described as "erratic blood pressure"; TACHYCARDIA (non-serious) with onset Apr2021, outcome "not recovered", described as "tachycardia"; WHEEZING (non-serious), outcome "unknown", described as "wheezing"; COUGH (non-serious), outcome "unknown", described as "Coughing"; BACK PAIN (non-serious), outcome "not recovered", described as "back pain"; NAUSEA (non-serious), outcome "not recovered", described as "morning nausea"; RENAL DISORDER (non-serious), outcome "not recovered", described as "kidney problems"; ARTHROPATHY (non-serious), outcome "not recovered", described as "joint problems"; CARDIAC DISORDER (non-serious), outcome "not recovered", described as "heart problems". The events "general system inflammation symptoms", "joint pain", "muscle pain", "skin issues", "asthma", "irritable bowel", "erratic blood pressure", "tachycardia", "kidney problems", "joint problems" and "heart problems" were evaluated at the physician office visit. Treatment was given. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of inflammation, arthralgia, myalgia, skin disorder, asthma, irritable bowel syndrome, blood pressure abnormal, wheezing, cough, back pain, nausea, renal disorder, arthropathy, cardiac disorder. It was unknown if therapeutic measures were taken as a result of tachycardia.  Additional information: No other vaccine in four weeks. Other medications in two weeks was multi-vitamin. The symptoms was never going away, and some have gotten worse. They are affecting his regular activities. No prior covid vaccination. Covid tested post vaccination was reported as yes. Multivitamin cannot be characterized by the proprietary medicinal product name or by the active substances and, as per EMEA guidelines, has not been coded in the concomitant medication but only captured in the narrative section.  Follow-up attempts are completed. No further information is expected.  Upon follow-Up on 22Oct2021: This is a follow-up spontaneous report received from a contactable Other HCP. This other HCP reported in response to HCP letter sent that includes patient provide information to reporter regarding the reported adverse event(s) with the use of the product was reported as yes. If yes above, do you consider the Pfizer product had a causal effect to the adverse event was reported as yes.  Follow-up questions was describing all the signs and symptoms of the anaphylactic reaction [please also see Section 7] was reported as no anaphylaxis occurred and the time course. The patient did not require medical intervention; not went to emergency department; and the patient was not hospitalized; not requiring admission at Intensive Care Unit. Information regarding organ involvement was Multiorgan involvement and the applicable systems are Respiratory and Cardiovascular. In the respiratory system Bilateral wheeze/bronchospasm was reported as yes which follows wheezing, coughing return (illegible) after extended time. Stridor, Upper airway swelling Tachypnoea, Increased use of accessory respiratory muscles, Recession, Dry cough, Hoarse voice, Difficulty breathing (without wheeze or stridor), Sensation of throat closure, Sneezing Rhinorrhea was reported as unknown. It was reported that no Respiratory distress, Cyanosis Grunting. In the cardiovascular system. Tachycardia was reported as yes, Intermittent tachycardia 105BPM, Nausea was reported as yes, occasional morning nausea. Diarrhea was reported as unknown. Other symptoms was reported as Generalized joint pain, back pain, muscle pain. Required of new medication or other treatment or procedure was reported as NSAIDS for pain. There were no anaphylaxis took place. The laboratory tests was Hematology with normal ranges; performed clinical chemistry was reported as yes, with normal ranges; relevant tests was sed rate on 16Sep2021 with normal ranges; CRP on 16Sep2021 with normal ranges; RF/Anti CCP on 16Sep2021 with normal ranges; ANA (illegible) on 16Sep2021 with normal range. History of previous allergies to specific products or any conditions indicative of an allergy was tetracycline's; no previous history of allergies; patient was taking any medications prior to the event being reported; no recent vaccines received; no recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 vaccine; patient have not received any other vaccines around the time of Pfizer-BioNTech COVID-19 vaccine vaccination.  Follow-up attempts are completed. No further information is expected.  Upon follow-up on 30Nov2021: This is a follow-up spontaneous report received from a contactable consumer. This consumer reported (patient) which includes Caller stated that transferred from DSU agent (withheld), NTID (withheld), report. Caller states that his doctors think the vaccine triggered a "huge autoimmune response". He has heart, kidney, and joint problems, relieved only by steroids. Caller was looking for other reports of similar adverse effects. DSU: e-transmitting potential duplicate AE. Reaction as per reported by primary source was caller as now seeing a cardiologist, a rheumatologist, a general practitioner, and a nephrologist. Dates for caller was seeing a cardiologist, a rheumatologist, a general practitioner, and a nephrologist: (From: Unspecified To: Unspecified). The caller was calling regarding the covid vaccine. The caller assures us that he was pro-vaccination and not a lunatic. The caller had a real serious, negative impact from the vaccine. It has been around 7-8 months since all of this happened. The caller was having heart problems, kidney problems, and joint problems. The reporters doctors think  the vaccine triggered a huge autoimmune response. The caller stated that went to the Pfizer website previously and reported this event but hasn't heard anything back from Pfizer. The caller's doctor reached out to Pfizer to see if we can provide any guidance and he has not heard back from us either. The caller confirms that he filed a safety report and doesn't have the previous report number. The caller wants to also add that they gave him a steroid pack, the ones that gives 6 pills the first day, 5 pills the next day. The steroid was called Methylprednisone and that seemed to make a significant improvement. The improvement lasted maybe a month and now the caller was going down hill again. The caller's doctors gave the caller another pack of steroids but told him that they can't keep prescribing steroids for him and need to find a different solution. The caller is currently half way through the second pack of steroids. The caller couldn't even walk his daughter down the wedding aisle because his symptoms were so bad. The caller can't get out of bed some days and it is dangerous for him to get in and out of the shower.  Follow-up attempts are completed. No further information is expected.