chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune thyroiditis, Tinnitus
Clinical narrative: Hashimoto Disease; tinnitus; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer Unknown, no side effects in the first 2 doses), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown, no side effects in the first 2 doses), for COVID-19 immunization. The following information was reported: AUTOIMMUNE THYROIDITIS (medically significant), outcome "unknown", described as "Hashimoto Disease"; TINNITUS (non-serious), outcome "unknown", described as "tinnitus". She stated having reported Tinnitus, and then proceeded to report several complaints regarding the available information for the Pfizer COVID-19 Vaccine and then stated that Pfizer and Moderna are not as transparent with the information as (whiteheld). Caller proceeded to state that FDA won't give any side effects unless they are presented above 1% and this can be misleading. She continued by saying that information should be as honest as it is in TV commercials when they are announcing medicines and stated that Pfizer should do the same instead of being a broke record that only states that the vaccine is safe, even with side effects below 1% of occurrence. She then continued to say that Pfizer, Moderna, CDC and FDA can't be trusted. Caller stated that (Name), reported tinnitus being a very common side effect of the COVID-19 Vaccine. Caller then shared some data about 13 thousand people having tinnitus but since the population taking the vaccine is so huge, this fact can go missing. She also shared data about a trial where 800 patients with tinnitus reported a growth in tinnitus causing pain from 1 to 9 in a scale from 1 to 10. Then she stated that tinnitus is so dangerous, that an acquaintance of her (65 years old, male) committed suicide due to the discomfort caused by tinnitus. Caller then stated that she has heard of people having vertigo and misdiagnosis of breast cancer due to the inflammation that the COVID-19 Vaccine causes. She proceeded to complain about how the ingredients on the vaccine are too difficult to understand and that patients should have a right to know what to they are putting in their bodies. She finally stated that she isn't an anti-vaxxer but that the misinformation caused by Pfizer is so big, that she's already heard people believing that the vaccine would kill people in 5 years. In referral to the AE reported, caller stated also having Hashimoto Disease and that the tinnitus was caused after the booster dose of the Pfizer COVID-19 vaccine, but that she had no side effects in the first 2 doses.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dysaesthesia, Neuropathy peripheral, Palpitations, Tachycardia
Clinical narrative: neuropathy; Palpitation; tachycardia; dysesthesias; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Oct2021 (Lot number: FF2589) at the age of 43 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL1284, Location of injection: Arm Left, Route of Administration: Intramuscular), for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EJ1685, Location of injection: Arm Left, Route of Administration: Intramuscular), for COVID-19 Immunization. The following information was reported: NEUROPATHY PERIPHERAL (medically significant) with onset 11Oct2021, outcome "not recovered", described as "neuropathy"; PALPITATIONS (non-serious) with onset 11Oct2021, outcome "not recovered", described as "Palpitation"; TACHYCARDIA (non-serious) with onset 11Oct2021, outcome "not recovered", described as "tachycardia"; DYSAESTHESIA (non-serious) with onset 11Oct2021, outcome "not recovered", described as "dysesthesias". The events "neuropathy", "palpitation", "tachycardia" and "dysesthesias" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of neuropathy peripheral, palpitations, tachycardia, dysaesthesia.The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received medications for events. Prior to vaccination, the patient was not diagnosed as COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pancreatic cyst
Clinical narrative: Pancreatic Cyst; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Jan2022 10:00 (Lot number: FJ1611) at the age of 54 years as dose 1, single for covid-19 immunization in medical facility. Relevant medical history included: "Gout" (unspecified if ongoing), Known allergies: No; "Covid" (unspecified if ongoing), notes: prior vaccination. Concomitant medication(s) in 2 weeks included: ALLOPURINOL. The patient did not receive other vaccine in 4 weeks. The patient did not test Covid-19 post vaccination. The following information was reported: PANCREATIC CYST (disability) with onset 27Jan2022 16:00, outcome "recovering", described as "Pancreatic Cyst". The event "pancreatic cyst" was evaluated at the physician office visit. Therapeutic measures were taken as a result of pancreatic cyst.; Sender's Comments: Pancreatic Cyst onset 20 days after the administration of COVID 19 vaccine, BNT162B2. Apart from the  reasonable temporal association, there is no element suggesting the reported event is related to the suspect vaccine.   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 RA as appropriate.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood alkaline phosphatase, Blood alkaline phosphatase increased, Gamma-glutamyltransferase, Gamma-glutamyltransferase increased, Liver function test
Clinical narrative: GGT elevated to 351; AP suddenly elevated; showing COVID induced liver injury; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 04May2021 (Lot number: EW0716) at the age of 57 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "PLD polycystic liver" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Lot No: EW0162), administration date: 13Apr2021, when the patient was 57 years old, for COVID-19 immunization. The following information was reported: LIVER INJURY (medically significant) with onset 01Jun2021, outcome "not recovered", described as "showing COVID induced liver injury"; GAMMA-GLUTAMYLTRANSFERASE INCREASED (medically significant) with onset Nov2021, outcome "not recovered", described as "GGT elevated to 351"; BLOOD ALKALINE PHOSPHATASE INCREASED (non-serious) with onset Jul2021, outcome "not recovered", described as "AP suddenly elevated". The events "showing covid induced liver injury", "ggt elevated to 351" and "ap suddenly elevated" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood alkaline phosphatase: (unspecified date) 71; (unspecified date) 89; (Jul2021) 158, notes: AP suddenly elevated; gamma-glutamyltransferase: (Nov2021) 351; liver function test: (unspecified date) normal, notes: no abnormality in liver function tests. It was unknown if therapeutic measures were taken as a result of liver injury, gamma-glutamyltransferase increased, blood alkaline phosphatase increased. The patient was not received other vaccine in four weeks. There was no covid prior vaccination or covid tested post vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Liver injury
Clinical narrative: GGT elevated to 351; AP suddenly elevated; showing COVID induced liver injury; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 04May2021 (Lot number: EW0716) at the age of 57 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "PLD polycystic liver" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Lot No: EW0162), administration date: 13Apr2021, when the patient was 57 years old, for COVID-19 immunization. The following information was reported: LIVER INJURY (medically significant) with onset 01Jun2021, outcome "not recovered", described as "showing COVID induced liver injury"; GAMMA-GLUTAMYLTRANSFERASE INCREASED (medically significant) with onset Nov2021, outcome "not recovered", described as "GGT elevated to 351"; BLOOD ALKALINE PHOSPHATASE INCREASED (non-serious) with onset Jul2021, outcome "not recovered", described as "AP suddenly elevated". The events "showing covid induced liver injury", "ggt elevated to 351" and "ap suddenly elevated" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood alkaline phosphatase: (unspecified date) 71; (unspecified date) 89; (Jul2021) 158, notes: AP suddenly elevated; gamma-glutamyltransferase: (Nov2021) 351; liver function test: (unspecified date) normal, notes: no abnormality in liver function tests. It was unknown if therapeutic measures were taken as a result of liver injury, gamma-glutamyltransferase increased, blood alkaline phosphatase increased. The patient was not received other vaccine in four weeks. There was no covid prior vaccination or covid tested post vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Influenza
Clinical narrative: flu symptoms; DVT; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 19Apr2021 (Lot number: EW0158) at the age of 51 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose, lot number: ER8733), administration date: 29Mar2021, when the patient was 51 years old, for COVID-19 immunization. The following information was reported: INFLUENZA (life threatening) with onset 02Aug2021, outcome "recovered with sequelae", described as "flu symptoms "; DEEP VEIN THROMBOSIS (life threatening) with onset 02Aug2021, outcome "recovered with sequelae", described as "DVT". The events "flu symptoms " and "dvt" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of influenza, deep vein thrombosis (Blood thinners). No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: bruising after 2nd shot; This is a spontaneous report received from contactable consumer.  A patient unspecified age and gender (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01), for COVID-19 Immunization, reaction(s): "headache after getting first Covid shot".  The following information was reported: CONTUSION (non-serious), outcome "unknown", described as "bruising after 2nd shot".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Off label use, SARS-CoV-2 test
Clinical narrative: Off label use; Interchange of vaccine products; Drug ineffective; suspected covid-19 infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20220133895(0) (JANSSEN).  A female patient received bnt162b2 (BNT162B2), administration date 29Dec2021 (Batch/Lot number: unknown) as dose 2 ( booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen covid-19 vaccine (Dose 1, Single; Lot number 1805020), for Prophylactic vaccination. The following information was reported: OFF LABEL USE (medically significant), outcome "unknown", described as "Off label use"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Interchange of vaccine products"; DRUG INEFFECTIVE (medically significant) with onset 18Jan2022, outcome "unknown", described as "Drug ineffective"; COVID-19 (medically significant) with onset 17Jan2022, outcome "not recovered", described as "suspected covid-19 infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Jan2022) positive, notes: (NR: Not provided).  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: They were all fully vaccinated, however it was the second time they all had it; they all had COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 33 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 33 years as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (ongoing), notes: current medical condition. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "They were all fully vaccinated, however it was the second time they all had it"; COVID-19 (medically significant), outcome "unknown", described as "they all had COVID".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Fatigue, Feeling abnormal, Interchange of vaccine products
Clinical narrative: COVID-19 virus test postive; COVID-19 virus test postive; fever; tiredness; feellng bad; Interchange of vaccine products; Offlabel use; This is a spontaneous report received from contactable reporter(s) (Physician). Other Case identifier(s): 20220122896 (janssen).  A 31 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Oct2021 (Batch/Lot number: unknown) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation; adalimumab (ADALIMUMAB), subcutaneous (Batch/Lot number: unknown) till 20Dec2021 for colitis ulcerative. Relevant medical history included: "Moderate to severe ulcerative colitis" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Janssen covid-19 vaccine (DOSE 1, SINGLE, Route of administration: Intramuscular), administration date: 01Apr2021, for COVID-19 immunisation; Janssen covid-19 vaccine (DOSE 2, SINGLE), administration date: 2021, for COVID-19 immunisation. The following information was reported: COVID-19 (medically significant) with onset 03Jan2022, outcome "recovered" (Jan2022), DRUG INEFFECTIVE (medically significant) with onset 03Jan2022, outcome "unknown" and all described as "COVID-19 virus test postive"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Oct2021, outcome "unknown", described as "Interchange of vaccine products"; OFF LABEL USE (medically significant) with onset 01Oct2021, outcome "unknown", described as "Offlabel use"; PYREXIA (non-serious) with onset 03Jan2022, outcome "unknown", described as "fever"; FATIGUE (non-serious) with onset 03Jan2022, outcome "unknown", described as "tiredness"; FEELING ABNORMAL (non-serious) with onset 03Jan2022, outcome "unknown", described as "feellng bad". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be ruled out. 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.
Age: 31.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Off label use, Pyrexia, SARS-CoV-2 test
Clinical narrative: COVID-19 virus test postive; COVID-19 virus test postive; fever; tiredness; feellng bad; Interchange of vaccine products; Offlabel use; This is a spontaneous report received from contactable reporter(s) (Physician). Other Case identifier(s): 20220122896 (janssen).  A 31 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Oct2021 (Batch/Lot number: unknown) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation; adalimumab (ADALIMUMAB), subcutaneous (Batch/Lot number: unknown) till 20Dec2021 for colitis ulcerative. Relevant medical history included: "Moderate to severe ulcerative colitis" (ongoing). The patient's concomitant medications were not reported. Vaccination history included: Janssen covid-19 vaccine (DOSE 1, SINGLE, Route of administration: Intramuscular), administration date: 01Apr2021, for COVID-19 immunisation; Janssen covid-19 vaccine (DOSE 2, SINGLE), administration date: 2021, for COVID-19 immunisation. The following information was reported: COVID-19 (medically significant) with onset 03Jan2022, outcome "recovered" (Jan2022), DRUG INEFFECTIVE (medically significant) with onset 03Jan2022, outcome "unknown" and all described as "COVID-19 virus test postive"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Oct2021, outcome "unknown", described as "Interchange of vaccine products"; OFF LABEL USE (medically significant) with onset 01Oct2021, outcome "unknown", described as "Offlabel use"; PYREXIA (non-serious) with onset 03Jan2022, outcome "unknown", described as "fever"; FATIGUE (non-serious) with onset 03Jan2022, outcome "unknown", described as "tiredness"; FEELING ABNORMAL (non-serious) with onset 03Jan2022, outcome "unknown", described as "feellng bad". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be ruled out. 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.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Cerebrovascular accident, Investigation, Visual impairment
Clinical narrative: a blood clot was created which moved to my brain; stroke; It affected my eyesight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm, administration date 02Mar2021 (Lot number: EN6203) at the age of 70 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Cancer" (unspecified if ongoing). There were no concomitant medications. Patient started, "No, that was given to them at that time." Prior vaccination (within 4 weeks, "No. Vaccination history included: Covid-19 vaccine (1st dose of covid vaccine, Manufacturer unknown, LOT#: patient stated, "For the first dose was EL, I do not know if it is a 4 or 9, 264), administration date: 09Feb2021, when the patient was 70 years old, for COVID-19 immunization. The following information was reported: CEREBRAL THROMBOSIS (medically significant) with onset 2021, outcome "unknown", described as "a blood clot was created which moved to my brain"; CEREBROVASCULAR ACCIDENT (medically significant) with onset 2021, outcome "unknown", described as "stroke"; VISUAL IMPAIRMENT (non-serious) with onset 2021, outcome "unknown", described as "It affected my eyesight". The patient underwent the following laboratory tests and procedures: investigation: unknown result, notes: Patient started, "I do them all the time. Yes, I think so. Within the last 4 weeks, I do not know about 2 weeks.". Concern: Patient stated, "I got my vaccine last year and after I got the second shot a blood clot was created which moved to my brain and I had a stroke and it was right after I got the second shot. I have been trying to report this twice and nobody could tell me where can I report this." When paraphrased the concern, patient stated, "I had a blood clot, it travelled to my brain and gave me a stroke. Plus, I keep getting things that I am supposed to get my booster and everything else but I am afraid to get it because of what happened before. I do not want to get it." When asked if do not want to get the booster shot: Patient stated, "Right, I might get the other shot."(further clarification unknown). Patient stated, "When we get the shot, why do not they give us any information to report any issues because I went to all my doctors because it affected my eyesight and I could not do much of anything and nobody seemed to know what to do." No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: fatigue; slight fever; This is a spontaneous report received from a contactable Consumer. The reporter is the patient.  A 68 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot number: unknown), as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. Relevant medical history included:  high blood pressure  "HBP" (ongoing); "Uric Acid" (ongoing); "High Triglyceride" (ongoing); "Problem Urination" (ongoing). Concomitant medications included: LOTREL [AMLODIPINE BESILATE;BENAZEPRIL HYDROCHLORIDE] taken for hypertension (ongoing); ALLOPURINOL taken for blood uric acid (ongoing); VASCEPA taken for blood triglycerides increased (ongoing); ALFUZOSIN taken for dysuria (ongoing).  The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "fatigue"; PYREXIA (non-serious), outcome "recovered", described as "slight fever".  Additional information: After the vaccination, of the first and second dose, the same symptoms only 12 hours after it occurred That's why I did my self-test listed in chronological order the result and date.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (medically significant), outcome "unknown", described as "Tinnitus". The reporter (sister) stated that the tinnitus was very serious.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Investigation, SARS-CoV-2 test
Clinical narrative: only two patients were tested positive for COVID-19 infection/one 46 days after the second dose; only two patients were tested positive for COVID-19 infection/one 46 days after the second dose; This is a literature report for the following literature source(s): "Antibody response to 2-dose SARS-CoV-2 mRNA vaccination in pediatric solid organ transplant recipients", Journal of Transplantation, 2021.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "only two patients were tested positive for COVID-19 infection/one 46 days after the second dose". The patient underwent the following laboratory tests and procedures: investigation: unknown results; sars-cov-2 test: positive. Additional information: In a study, assessing the effectiveness of Pfizer in 12 -18-year-old adolescents, among 57 participants, only two patients were tested positive for COVID-19 infection, one patient before receiving the second dose and another one 46 days after the second dose.; Sender's Comments: Based on the compatible time association, the lack of efficacy cannot be excluded for suspect vaccine BNT162B2 administration. ,Linked Report(s) : US-PFIZER INC-202200200766 Same article/drug/ event and different patient.
Sex: M
Vaccine: COVID19
Symptoms: Blood culture, Blood immunoglobulin G, Blood lactate dehydrogenase, Blood pressure measurement, Body mass index
Clinical narrative: Myopericarditis; Pneumonitis; This is a literature report.  A 40 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "smoker" (unspecified if ongoing), notes: The patient is a current smoker, with a 14 pack-year smoking, history; "marijuana" (unspecified if ongoing), notes: He also uses marijuana occasionally. Family history included: "nonischemic cardiomyopathy" (unspecified if ongoing), notes: his mother developing nonischemic cardiomyopathy with an LVEF of 40%, diagnosed at age of 59 years. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for Covid-19 Immunisation. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "recovering", described as "Myopericarditis"; PNEUMONITIS (hospitalization, medically significat), outcome "recovering", described as "Pneumonitis". The patient underwent the following laboratory tests and procedures: blood culture: unremarkable; blood immunoglobulin g: elevated; positive, notes: Viral serology was only positive for IgG antibodies, indicating past infection; elevated; blood lactate dehydrogenase: 177 IU/l; blood pressure measurement: elevated; body mass index: 28, notes: kg/m2; brain natriuretic peptide: 458 pg/mL, notes: elevated; computerised tomogram: with contrast showed multifocal ill defined, notes: ground glass opacities bilaterally, bronchial wall thickening, gravity dependent small pleural effusions, and mildly prominent mediastinal and bilateral hilar adenopathy; covid-19: negative; c-reactive protein: 5.7 mg/dl; cytomegalovirus test: negative; echocardiogram: are consistent with the diagnosis of suspected, notes: myopericarditis; showed an left ventricular ejection fraction, notes: (LVEF) of 25%, severe diffuse global hypokinesis, and moderate dilation of left atrium and left ventricle; epstein-barr virus antibody: elevated; fibrin d dimer: 0.9 mg/l; hepatitis c antibody: negative; hiv infection: negative; influenza virus test: negative; investigation: normal; 8, notes: cm; positive; leukocytosis: normal procalcitonin; oxygen saturation: 90 %; polymerase chain reaction: negative; negative; pyrexia: 102 Fahrenheit; respiratory distress: mild; serum ferritin: 226 ng/ml; troponin: negative. Therapeutic measures were taken as a result of myocarditis, pneumonitis.  Follow up activities were closed. No further information expected.; Sender's Comments: Based on the Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The case will be reassessed once new information is available
Sex: M
Vaccine: COVID19
Symptoms: Brain natriuretic peptide, C-reactive protein, COVID-19, Computerised tomogram, Cytomegalovirus test
Clinical narrative: Myopericarditis; Pneumonitis; This is a literature report.  A 40 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "smoker" (unspecified if ongoing), notes: The patient is a current smoker, with a 14 pack-year smoking, history; "marijuana" (unspecified if ongoing), notes: He also uses marijuana occasionally. Family history included: "nonischemic cardiomyopathy" (unspecified if ongoing), notes: his mother developing nonischemic cardiomyopathy with an LVEF of 40%, diagnosed at age of 59 years. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for Covid-19 Immunisation. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "recovering", described as "Myopericarditis"; PNEUMONITIS (hospitalization, medically significat), outcome "recovering", described as "Pneumonitis". The patient underwent the following laboratory tests and procedures: blood culture: unremarkable; blood immunoglobulin g: elevated; positive, notes: Viral serology was only positive for IgG antibodies, indicating past infection; elevated; blood lactate dehydrogenase: 177 IU/l; blood pressure measurement: elevated; body mass index: 28, notes: kg/m2; brain natriuretic peptide: 458 pg/mL, notes: elevated; computerised tomogram: with contrast showed multifocal ill defined, notes: ground glass opacities bilaterally, bronchial wall thickening, gravity dependent small pleural effusions, and mildly prominent mediastinal and bilateral hilar adenopathy; covid-19: negative; c-reactive protein: 5.7 mg/dl; cytomegalovirus test: negative; echocardiogram: are consistent with the diagnosis of suspected, notes: myopericarditis; showed an left ventricular ejection fraction, notes: (LVEF) of 25%, severe diffuse global hypokinesis, and moderate dilation of left atrium and left ventricle; epstein-barr virus antibody: elevated; fibrin d dimer: 0.9 mg/l; hepatitis c antibody: negative; hiv infection: negative; influenza virus test: negative; investigation: normal; 8, notes: cm; positive; leukocytosis: normal procalcitonin; oxygen saturation: 90 %; polymerase chain reaction: negative; negative; pyrexia: 102 Fahrenheit; respiratory distress: mild; serum ferritin: 226 ng/ml; troponin: negative. Therapeutic measures were taken as a result of myocarditis, pneumonitis.  Follow up activities were closed. No further information expected.; Sender's Comments: Based on the Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The case will be reassessed once new information is available
Sex: M
Vaccine: COVID19
Symptoms: Echocardiogram, Epstein-Barr virus antibody, Fibrin D dimer, HIV infection, Hepatitis C antibody
Clinical narrative: Myopericarditis; Pneumonitis; This is a literature report.  A 40 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "smoker" (unspecified if ongoing), notes: The patient is a current smoker, with a 14 pack-year smoking, history; "marijuana" (unspecified if ongoing), notes: He also uses marijuana occasionally. Family history included: "nonischemic cardiomyopathy" (unspecified if ongoing), notes: his mother developing nonischemic cardiomyopathy with an LVEF of 40%, diagnosed at age of 59 years. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for Covid-19 Immunisation. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "recovering", described as "Myopericarditis"; PNEUMONITIS (hospitalization, medically significat), outcome "recovering", described as "Pneumonitis". The patient underwent the following laboratory tests and procedures: blood culture: unremarkable; blood immunoglobulin g: elevated; positive, notes: Viral serology was only positive for IgG antibodies, indicating past infection; elevated; blood lactate dehydrogenase: 177 IU/l; blood pressure measurement: elevated; body mass index: 28, notes: kg/m2; brain natriuretic peptide: 458 pg/mL, notes: elevated; computerised tomogram: with contrast showed multifocal ill defined, notes: ground glass opacities bilaterally, bronchial wall thickening, gravity dependent small pleural effusions, and mildly prominent mediastinal and bilateral hilar adenopathy; covid-19: negative; c-reactive protein: 5.7 mg/dl; cytomegalovirus test: negative; echocardiogram: are consistent with the diagnosis of suspected, notes: myopericarditis; showed an left ventricular ejection fraction, notes: (LVEF) of 25%, severe diffuse global hypokinesis, and moderate dilation of left atrium and left ventricle; epstein-barr virus antibody: elevated; fibrin d dimer: 0.9 mg/l; hepatitis c antibody: negative; hiv infection: negative; influenza virus test: negative; investigation: normal; 8, notes: cm; positive; leukocytosis: normal procalcitonin; oxygen saturation: 90 %; polymerase chain reaction: negative; negative; pyrexia: 102 Fahrenheit; respiratory distress: mild; serum ferritin: 226 ng/ml; troponin: negative. Therapeutic measures were taken as a result of myocarditis, pneumonitis.  Follow up activities were closed. No further information expected.; Sender's Comments: Based on the Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The case will be reassessed once new information is available
Sex: M
Vaccine: COVID19
Symptoms: Influenza virus test, Investigation, Leukocytosis, Myocarditis, Oxygen saturation
Clinical narrative: Myopericarditis; Pneumonitis; This is a literature report.  A 40 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "smoker" (unspecified if ongoing), notes: The patient is a current smoker, with a 14 pack-year smoking, history; "marijuana" (unspecified if ongoing), notes: He also uses marijuana occasionally. Family history included: "nonischemic cardiomyopathy" (unspecified if ongoing), notes: his mother developing nonischemic cardiomyopathy with an LVEF of 40%, diagnosed at age of 59 years. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for Covid-19 Immunisation. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "recovering", described as "Myopericarditis"; PNEUMONITIS (hospitalization, medically significat), outcome "recovering", described as "Pneumonitis". The patient underwent the following laboratory tests and procedures: blood culture: unremarkable; blood immunoglobulin g: elevated; positive, notes: Viral serology was only positive for IgG antibodies, indicating past infection; elevated; blood lactate dehydrogenase: 177 IU/l; blood pressure measurement: elevated; body mass index: 28, notes: kg/m2; brain natriuretic peptide: 458 pg/mL, notes: elevated; computerised tomogram: with contrast showed multifocal ill defined, notes: ground glass opacities bilaterally, bronchial wall thickening, gravity dependent small pleural effusions, and mildly prominent mediastinal and bilateral hilar adenopathy; covid-19: negative; c-reactive protein: 5.7 mg/dl; cytomegalovirus test: negative; echocardiogram: are consistent with the diagnosis of suspected, notes: myopericarditis; showed an left ventricular ejection fraction, notes: (LVEF) of 25%, severe diffuse global hypokinesis, and moderate dilation of left atrium and left ventricle; epstein-barr virus antibody: elevated; fibrin d dimer: 0.9 mg/l; hepatitis c antibody: negative; hiv infection: negative; influenza virus test: negative; investigation: normal; 8, notes: cm; positive; leukocytosis: normal procalcitonin; oxygen saturation: 90 %; polymerase chain reaction: negative; negative; pyrexia: 102 Fahrenheit; respiratory distress: mild; serum ferritin: 226 ng/ml; troponin: negative. Therapeutic measures were taken as a result of myocarditis, pneumonitis.  Follow up activities were closed. No further information expected.; Sender's Comments: Based on the Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The case will be reassessed once new information is available
Sex: M
Vaccine: COVID19
Symptoms: Pneumonitis, Polymerase chain reaction, Pyrexia, Respiratory distress, Serum ferritin
Clinical narrative: Myopericarditis; Pneumonitis; This is a literature report.  A 40 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "smoker" (unspecified if ongoing), notes: The patient is a current smoker, with a 14 pack-year smoking, history; "marijuana" (unspecified if ongoing), notes: He also uses marijuana occasionally. Family history included: "nonischemic cardiomyopathy" (unspecified if ongoing), notes: his mother developing nonischemic cardiomyopathy with an LVEF of 40%, diagnosed at age of 59 years. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for Covid-19 Immunisation. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "recovering", described as "Myopericarditis"; PNEUMONITIS (hospitalization, medically significat), outcome "recovering", described as "Pneumonitis". The patient underwent the following laboratory tests and procedures: blood culture: unremarkable; blood immunoglobulin g: elevated; positive, notes: Viral serology was only positive for IgG antibodies, indicating past infection; elevated; blood lactate dehydrogenase: 177 IU/l; blood pressure measurement: elevated; body mass index: 28, notes: kg/m2; brain natriuretic peptide: 458 pg/mL, notes: elevated; computerised tomogram: with contrast showed multifocal ill defined, notes: ground glass opacities bilaterally, bronchial wall thickening, gravity dependent small pleural effusions, and mildly prominent mediastinal and bilateral hilar adenopathy; covid-19: negative; c-reactive protein: 5.7 mg/dl; cytomegalovirus test: negative; echocardiogram: are consistent with the diagnosis of suspected, notes: myopericarditis; showed an left ventricular ejection fraction, notes: (LVEF) of 25%, severe diffuse global hypokinesis, and moderate dilation of left atrium and left ventricle; epstein-barr virus antibody: elevated; fibrin d dimer: 0.9 mg/l; hepatitis c antibody: negative; hiv infection: negative; influenza virus test: negative; investigation: normal; 8, notes: cm; positive; leukocytosis: normal procalcitonin; oxygen saturation: 90 %; polymerase chain reaction: negative; negative; pyrexia: 102 Fahrenheit; respiratory distress: mild; serum ferritin: 226 ng/ml; troponin: negative. Therapeutic measures were taken as a result of myocarditis, pneumonitis.  Follow up activities were closed. No further information expected.; Sender's Comments: Based on the Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The case will be reassessed once new information is available
Sex: M
Vaccine: COVID19
Symptoms: Troponin
Clinical narrative: Myopericarditis; Pneumonitis; This is a literature report.  A 40 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "smoker" (unspecified if ongoing), notes: The patient is a current smoker, with a 14 pack-year smoking, history; "marijuana" (unspecified if ongoing), notes: He also uses marijuana occasionally. Family history included: "nonischemic cardiomyopathy" (unspecified if ongoing), notes: his mother developing nonischemic cardiomyopathy with an LVEF of 40%, diagnosed at age of 59 years. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for Covid-19 Immunisation. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "recovering", described as "Myopericarditis"; PNEUMONITIS (hospitalization, medically significat), outcome "recovering", described as "Pneumonitis". The patient underwent the following laboratory tests and procedures: blood culture: unremarkable; blood immunoglobulin g: elevated; positive, notes: Viral serology was only positive for IgG antibodies, indicating past infection; elevated; blood lactate dehydrogenase: 177 IU/l; blood pressure measurement: elevated; body mass index: 28, notes: kg/m2; brain natriuretic peptide: 458 pg/mL, notes: elevated; computerised tomogram: with contrast showed multifocal ill defined, notes: ground glass opacities bilaterally, bronchial wall thickening, gravity dependent small pleural effusions, and mildly prominent mediastinal and bilateral hilar adenopathy; covid-19: negative; c-reactive protein: 5.7 mg/dl; cytomegalovirus test: negative; echocardiogram: are consistent with the diagnosis of suspected, notes: myopericarditis; showed an left ventricular ejection fraction, notes: (LVEF) of 25%, severe diffuse global hypokinesis, and moderate dilation of left atrium and left ventricle; epstein-barr virus antibody: elevated; fibrin d dimer: 0.9 mg/l; hepatitis c antibody: negative; hiv infection: negative; influenza virus test: negative; investigation: normal; 8, notes: cm; positive; leukocytosis: normal procalcitonin; oxygen saturation: 90 %; polymerase chain reaction: negative; negative; pyrexia: 102 Fahrenheit; respiratory distress: mild; serum ferritin: 226 ng/ml; troponin: negative. Therapeutic measures were taken as a result of myocarditis, pneumonitis.  Follow up activities were closed. No further information expected.; Sender's Comments: Based on the Limited information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events. The case will be reassessed once new information is available
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Ear discomfort, Tinnitus
Clinical narrative: ENT doctor found loss in the right ear. Took the shot on the right harm.; Experiencing ringing and throbbing in the right ear.; throbbing in the right ear.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient received bnt162b2 (BNT162B2), administration date 18Aug2021 (Lot number: ew0185) at the age of 44 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False,, prev dose lot number=ew0185,, prev dose lot unknown=False,, prev dose administration date=28Jul2021,, prev dose dose number=1), administration date: 28Jul2021, when the patient was 44 years old, for Covid-19 immunization. The following information was reported: DEAFNESS (medically significant) with onset 01Dec2021, outcome "unknown", described as "ENT doctor found loss in the right ear. Took the shot on the right harm."; TINNITUS (non-serious) with onset 01Dec2021, outcome "unknown", described as "Experiencing ringing and throbbing in the right ear."; EAR DISCOMFORT (non-serious) with onset 01Dec2021, outcome "unknown", described as "throbbing in the right ear.". The events "ent doctor found loss in the right ear. took the shot on the right harm.", "experiencing ringing and throbbing in the right ear." and "throbbing in the right ear." were evaluated at the physician office visit. Therapeutic measures were taken as a result of deafness, tinnitus, ear discomfort. Patient had not received any other vaccine within four weeks. She was not tested COVID positive prior to vaccination and was not tested positive post vaccination.   No follow-up attempts are possible. No further information is expected.