chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Paraesthesia, Throat tightness
Clinical narrative: I ended up feeling I passed out woke up about 30 seconds after trying to catch my breath and making strange noises with my throat I lost consciousness; I felt a tingling on my left arm and spreading to my back; Shortness of breath; Very dizzy; My throat was swollen, closed, I felt air passage is closed or closing and when I woke up I was making funny noises with my throat trying to clear an air passage; My throat was swollen, closed I felt air passage is closed or closing and when I woke up I was making funny noises with my throat trying to clear an air passage; My arm could not be lifted for 17 hours; Very tired for 2 days 2-4 days; This is a spontaneous report from a contactable consumer or non-HCP reported about herself (patient).  A 48-year-old female patient received first dose of bnt162b2 (BNT162B2; Solution for injection; Lot Number: EW0177), via an unspecified route of administration, administered in left arm as dose 1, single on 08Jun2021 13:00 (at the age of 48-year-old) for covid-19 immunisation. The patient medical history, family medical history and concomitant medications were not reported. As per reporter, patient received the first dose of vaccine on 08Jun2021 and about a minute later had some side effects, she felt a tingling on left arm and spreading to her back, shortness of breath, very dizzy and ended up felt she passed out. Patient lost consciousness for 30 seconds and then woke up and had shortness of breath and throat was swollen, closed, she felt air passage was closed or closing, closing and made funny or strange noises with her throat tried to clear an air passage. She laid down for 30 minutes there at the pharmacy where they monitored her and then they sent her home. Patient's arm could not be lifted for 17 hours and just very tired for 2 days, 2-4 days. Patient's doctor recommended to see an allergist and do not get the second dose. Patient do not have a second vaccination appointment. No treatment was received for side effect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. At the time of this report, outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Developed a blood clot 3 days later; This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative.  A male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), at an unknown route, dose number unknown, single for COVID-19 immunization. The patient medical history included DVT from an unknown date and unknown if ongoing. The patient received Eliquis for DVT. The patient concomitant medications were not reported. The patient developed a blood clot 3 days later. The patient received treatment for the event. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event Thrombosis . The case will be reassessed once new information is available.   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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Drug ineffective, Pain
Clinical narrative: covid test date=21Aug2021, covid test result=Positive/Body aches, lost of smell and taste; covid test date=21Aug2021, covid test result=Positive/Body aches, lost of smell and taste; Body aches; Lost of smell and taste; Lost of smell and taste; This is a spontaneous report from a contactable other health care professional (patient). A 39-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FA7485), via an unspecified route of administration, administered in arm left on 29Jul2021 at 12:30 PM (at the age of 39 years) as DOSE 1, SINGLE and second dose of bnt162b2 (Batch/Lot Number: FC3182) via an unspecified route of administration, administered in arm left on 19Aug2021 at 08:30 AM (at the age of 39 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Vaccine was administered at pharmacy or drug store. No other vaccines were received within four weeks prior to the administration of bnt162b2. Medical history included asthma, neurofibromatosis and penicillin allergy; all from an unknown date and unknown if ongoing. Concomitant medication included montelukast sodium (SINGULAIR) taken within two weeks of vaccination for an unspecified indication, start and stop date were not reported. On 30Jul2021 at 07:30 AM, the patient experienced body aches, lost of smell and taste. The report was non serious (as reported). On 21Jul2021, the patient underwent covid test post vaccination at hospital with covid test type nasal swab: negative, on 31Jul2021, covid test post vaccination as Binaxnow test with covid test type nasal swab: negative, on 21Aug2021, covid test post vaccination as Binaxnow test with covid test type nasal swab: positive. Events were considered as medically significant. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was tested for COVID-19. No treatment was received for the adverse events. Outcome of the events was not recovered.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event Covid 19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: covid test date=21Aug2021, covid test result=Positive/Body aches, lost of smell and taste; covid test date=21Aug2021, covid test result=Positive/Body aches, lost of smell and taste; Body aches; Lost of smell and taste; Lost of smell and taste; This is a spontaneous report from a contactable other health care professional (patient). A 39-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FA7485), via an unspecified route of administration, administered in arm left on 29Jul2021 at 12:30 PM (at the age of 39 years) as DOSE 1, SINGLE and second dose of bnt162b2 (Batch/Lot Number: FC3182) via an unspecified route of administration, administered in arm left on 19Aug2021 at 08:30 AM (at the age of 39 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Vaccine was administered at pharmacy or drug store. No other vaccines were received within four weeks prior to the administration of bnt162b2. Medical history included asthma, neurofibromatosis and penicillin allergy; all from an unknown date and unknown if ongoing. Concomitant medication included montelukast sodium (SINGULAIR) taken within two weeks of vaccination for an unspecified indication, start and stop date were not reported. On 30Jul2021 at 07:30 AM, the patient experienced body aches, lost of smell and taste. The report was non serious (as reported). On 21Jul2021, the patient underwent covid test post vaccination at hospital with covid test type nasal swab: negative, on 31Jul2021, covid test post vaccination as Binaxnow test with covid test type nasal swab: negative, on 21Aug2021, covid test post vaccination as Binaxnow test with covid test type nasal swab: positive. Events were considered as medically significant. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was tested for COVID-19. No treatment was received for the adverse events. Outcome of the events was not recovered.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event Covid 19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable consumer or other non hcp.    A 44-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in left arm on 15Mar2021 15:00 (Batch/Lot number was not reported, age at vaccination 44-year-old) as single for COVID-19 immunisation. Medical history was reported as none and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported) via an unspecified route of administration, administered in left arm on 22Feb2021 03:00 pm as single dose for COVID-19 immunisation. On 17Aug2021 13:00, the patient experienced bell's palsy. He received treatment medications as prednisone and valacyclovir. The seriousness of event considered as disability. It was reported that patient had emergency room visit and physician office visit. He had no known allergies. No COVID prior vaccination and no COVID tested post vaccination. No other vaccine in four weeks and no other medications in two weeks. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cardiac failure, Pericarditis, Pyrexia, Renal failure
Clinical narrative: treated for suspected UTI (though urinalysis was normal) with antibiotic; kidney failure; He passed away on 24Mar2021 due to heart failure; diagnosed with pericarditis; Developing fever; weakness; This is a spontaneous report from a contactable consumer. A 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 13Feb2021 12:00 (Batch/Lot number was not reported) (at age of 81-year-old) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included atrial fibrillation, stroke, kidney disease, hyperlipidemia and Known allergies: NKDA. There was no other vaccine in four weeks. Concomitant medications included rivaroxaban (XARELTO); allopurinol; and acetylsalicylic acid (ASPIRIN 81). On 20Feb2021, The patient started developing fever, weakness. Saw family Dr on 26Feb2021, treated for suspected UTI (though urinalysis was normal) with antibiotic. On 01Mar2021 high fever returned with extreme weakness. Admitted to hospital from 01Mar2021 to 18Mar2021 and diagnosed with pericarditis. He was sent home on Hospice. He passed away on 24Mar2021 due to heart failure. Prior to the vaccination, he was having no symptoms of infection, he was active and healthy, and he was seeing a cardiologist regularly.AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Patient died on 24Mar2021. Death cause: heart failure, kidney failure. AE treatment: numerous medications given during hospitalization. No covid prior vaccination.Covid tested post vaccination: was Yes. Covid test type post vaccination: Nasal Swab, Covid test result: Negative. No autopsy performed. The outcome of the events heart failure and kidney failure was fatal, of the rest of events was unknown.   The lot number for BNT162b2, was not provided and will be requested during follow up; Reported Cause(s) of Death: kidney failure; heart failure
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: treated for suspected UTI (though urinalysis was normal) with antibiotic; kidney failure; He passed away on 24Mar2021 due to heart failure; diagnosed with pericarditis; Developing fever; weakness; This is a spontaneous report from a contactable consumer. A 81-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 13Feb2021 12:00 (Batch/Lot number was not reported) (at age of 81-year-old) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included atrial fibrillation, stroke, kidney disease, hyperlipidemia and Known allergies: NKDA. There was no other vaccine in four weeks. Concomitant medications included rivaroxaban (XARELTO); allopurinol; and acetylsalicylic acid (ASPIRIN 81). On 20Feb2021, The patient started developing fever, weakness. Saw family Dr on 26Feb2021, treated for suspected UTI (though urinalysis was normal) with antibiotic. On 01Mar2021 high fever returned with extreme weakness. Admitted to hospital from 01Mar2021 to 18Mar2021 and diagnosed with pericarditis. He was sent home on Hospice. He passed away on 24Mar2021 due to heart failure. Prior to the vaccination, he was having no symptoms of infection, he was active and healthy, and he was seeing a cardiologist regularly.AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Patient died on 24Mar2021. Death cause: heart failure, kidney failure. AE treatment: numerous medications given during hospitalization. No covid prior vaccination.Covid tested post vaccination: was Yes. Covid test type post vaccination: Nasal Swab, Covid test result: Negative. No autopsy performed. The outcome of the events heart failure and kidney failure was fatal, of the rest of events was unknown.   The lot number for BNT162b2, was not provided and will be requested during follow up; Reported Cause(s) of Death: kidney failure; heart failure
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Brain injury, Emotional disorder, Inflammation, Investigation, Malaise
Clinical narrative: i see stacked cells and dangers possibility of blood clotting; Feeling deathly ill; Cellularly my body having difficult time communicating to my brain; Inflammation of many internal organs; physical internal pain; i am deeply intuitively feeling that this is spiritual warfare; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm right on 07Aug2021 14:00 (Lot Number: EW0217) at age of 28-year-old as single dose for covid-19 immunisation. The patient medical history was not reported.    The patient's concomitant medications were not reported. No other vaccine in four weeks.The patient experienced Its a poison to my body, Feeling deathly ill, Cellularly my body having difficult time communicating to my brain., Inflammation of many internal organs never felt this way ever in my life. After conducting microscopic research with microscope I see stacked cells and dangers possibility of blood clotting. As a spiritual being who communicates with divine entities, This is 100% the work of the devil. Not only am I receiving physical internal pain but I am deeply intuitively feeling that this is spiritual warfare. Adverse event start date was 15Aug2021 at time of 14:00. AE resulted in: Life threatening illness (immediate risk of death from the event). No treatment received. No covid prior vaccination. No covid tested post vaccination. The outcome of events was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Thrombosis
Clinical narrative: i see stacked cells and dangers possibility of blood clotting; Feeling deathly ill; Cellularly my body having difficult time communicating to my brain; Inflammation of many internal organs; physical internal pain; i am deeply intuitively feeling that this is spiritual warfare; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm right on 07Aug2021 14:00 (Lot Number: EW0217) at age of 28-year-old as single dose for covid-19 immunisation. The patient medical history was not reported.    The patient's concomitant medications were not reported. No other vaccine in four weeks.The patient experienced Its a poison to my body, Feeling deathly ill, Cellularly my body having difficult time communicating to my brain., Inflammation of many internal organs never felt this way ever in my life. After conducting microscopic research with microscope I see stacked cells and dangers possibility of blood clotting. As a spiritual being who communicates with divine entities, This is 100% the work of the devil. Not only am I receiving physical internal pain but I am deeply intuitively feeling that this is spiritual warfare. Adverse event start date was 15Aug2021 at time of 14:00. AE resulted in: Life threatening illness (immediate risk of death from the event). No treatment received. No covid prior vaccination. No covid tested post vaccination. The outcome of events was not recovered.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral
Clinical narrative: complete hearing loss in her right ear; This is a spontaneous report from a Pfizer-sponsored program. A contactable 77-year-old female consumer (patient) reported that she received second dose of bnt162b2 (COVID 19 Vaccine, mRNA, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included clopidogrel bisulfate (PLAVIX) and aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) for blood thinners (when she received the vaccine). Other concomitant medication included adalimumab (HUMIRA) taken for an unspecified indication, start and stop date were not reported. The patient was previously received as first dose of bnt162b2 (COVID 19 Vaccine, mRNA, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. She received both doses of COMIRNATY. After receiving her second dose at 10 AM, caller stated that, on an unspecified date, she had complete hearing loss in her right ear at 8 PM the same day. The event was serious (medically significant). Caller sought information on this side effect with COMIRNATY vaccine. Caller stated that she did not blame Pfizer, but she wished there was information out there whether or not she should take the booster dose. The outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: my 13 year old daughter received her 2nd covid vaccine on 06Jul2021 and tested positive for covid 20Aug2021; my 13 year old daughter received her 2nd covid vaccine on 06Jul2021 and tested positive for covid 20Aug2021; This is a spontaneous report from a contactable consumer. This consumer reported for a 13-year-old female consumer (daughter) that:   A 44-year-old (non-pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0196), via an unspecified route of administration, administered in Arm Left on 06Jul2021 (at the age of 44-years-old) as DOSE 2, SINGLE and patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0196), via an unspecified route of administration, administered in Arm Left on 04Jun2021 (at the age of 44-years-old) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  Patient was not pregnant at the time of vaccination. It was reported that no other vaccine administered in four weeks. Prior to vaccination, the patient did not diagnose with COVID-19. The patient did not tested for COVID-19 post vaccination. The patient experienced my 13 year old daughter received her 2nd covid vaccine on 06Jul2021 and tested positive for covid 20Aug2021 on 20Aug2021.  Therapeutic measure were taken as no as a result of event. The patient underwent lab tests and procedures which included Nasal swab (sars-cov-2 test): positive on 20Aug2021 (Nasal Swab). The outcome of event was unknown
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: death; This is a spontaneous report from a Pfizer-sponsored-program. A contactable consumer reported that a male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter stated "You are despicable. Your VAX caused my dad's death. Apparently, lives are disposable as long as you make your money. I hope your family members don't die slow, agonizing deaths from this vax like my dad did". It was unknown if autopsy was done. The outcome of the event was fatal.  Information on the lot/batch number has been requested.; Reported Cause(s) of Death: death
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: died; This is a spontaneous report from a contactable consumer. An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number and expiration date not provided) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient died on an unspecified date due to unknown cause of death. Unknown treatment received. It was unknown if an autopsy was performed.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: died
Sex: M
Vaccine: COVID19
Symptoms: Chills, Conjunctivitis, Pyrexia, Rash, Respiratory viral panel
Clinical narrative: Fevers with a Tmax of 102; Chills; Conjunctivitis; Stocking glove rash to the hands and feet; C-reactive protein increased; Ejection fraction decreased; Red blood cell sedimentation rate increased; Tongue eruption; Troponin I increased; White blood cell count increased; Respiratory Viral Panel; Brain natriuretic peptide; This is a spontaneous report from a non contactable consumer, reports were pulled from the FDA VAERS site by a Pfizer Colleague. The consumer reported for a 17-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: none, Expiry Date: not reported),via intramuscular on an unknown site on 26Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route on an unspecified date as dose 1, single for covid-19 immunisation. Patient presented 4 days after the start of symptoms, which started 14 days after the second dose of the vaccine. Patient presented with fevers with a Tmax of 102, chills, conjunctivitis, stocking glove rash to the hands and feet, C-reactive protein increased, ejection fraction decreased, red blood cell sedimentation rate increased, tongue eruption, troponin I increased, white blood cell count increased, respiratory viral panel, brain natriuretic peptide on an unknown date in 2021. The patient was hospitalized for 3 days due to all events on an unspecified date and all events were considered as life-threatening. The patient did not visit emergency room or physician office. The patient underwent lab tests and procedures on an unspecified date in 2021 which included body temperature: 102, brain natriuretic peptide: unknown, c-reactive protein: increased, ejection fraction: decreased, red blood cell sedimentation rate: increased, respiratory viral panel: unknown, sars-cov-2 test: negative, troponin i: increased, white blood cell count: increased. The outcome of all event was recovered on unspecified date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Tongue eruption
Clinical narrative: Fevers with a Tmax of 102; Chills; Conjunctivitis; Stocking glove rash to the hands and feet; C-reactive protein increased; Ejection fraction decreased; Red blood cell sedimentation rate increased; Tongue eruption; Troponin I increased; White blood cell count increased; Respiratory Viral Panel; Brain natriuretic peptide; This is a spontaneous report from a non contactable consumer, reports were pulled from the FDA VAERS site by a Pfizer Colleague. The consumer reported for a 17-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: none, Expiry Date: not reported),via intramuscular on an unknown site on 26Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: not reported), via an unspecified route on an unspecified date as dose 1, single for covid-19 immunisation. Patient presented 4 days after the start of symptoms, which started 14 days after the second dose of the vaccine. Patient presented with fevers with a Tmax of 102, chills, conjunctivitis, stocking glove rash to the hands and feet, C-reactive protein increased, ejection fraction decreased, red blood cell sedimentation rate increased, tongue eruption, troponin I increased, white blood cell count increased, respiratory viral panel, brain natriuretic peptide on an unknown date in 2021. The patient was hospitalized for 3 days due to all events on an unspecified date and all events were considered as life-threatening. The patient did not visit emergency room or physician office. The patient underwent lab tests and procedures on an unspecified date in 2021 which included body temperature: 102, brain natriuretic peptide: unknown, c-reactive protein: increased, ejection fraction: decreased, red blood cell sedimentation rate: increased, respiratory viral panel: unknown, sars-cov-2 test: negative, troponin i: increased, white blood cell count: increased. The outcome of all event was recovered on unspecified date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Lactic acidosis, Myocarditis, Pyrexia, Rash maculo-papular
Clinical narrative: septic shock with myopericarditis; septic shock with myopericarditis; rigors; fever; diffuse maculopapular rash; tachycardic; tachypneic; blood lactic acid increased; electrocardiogram abnormal; lactic acidosis; troponin increased; This is a spontaneous report from a non-contactable consumer or other non hcp.  A 18-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown), via intramuscular route of administration, administered on 06Jun2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown), via unspecified route of administration, administered on unspecified date as single dose for COVID-19 immunisation. It was reported that medications at time of Vaccination was none. No known allergies. The patient experienced septic shock with myopericarditis, rigors, fever, diffuse maculopapular rash, tachycardic, tachypneic, blood lactic acid increased, electrocardiogram abnormal, lactic acidosis, troponin increased on 06Jun2021. Symptoms started out with rigors and a fever. This progressed to a diffuse maculopapular rash that resolved within 24 hours. It was reported that event were Serious, Life Threatening Hospitalized and patient visited emergency room. It was reported that Permanent Disability and Congenital Anomaly / Birth Defect was no. Following day, he was tachycardic and tachypneic when he presented to the emergency department. Ultimately he was found to be in septic shock with myopericarditis. He required pressors. He was currently still in the hospital. It was reported that Prolonged Hospitalization Existence was no and days in hospital was unknown. The patient underwent lab tests and procedures which included blood lactic acid: increased, electrocardiogram: pericarditis positive on 06Jun2021 (pericarditis Positive), lactic acidosis: 5.5 on 06Jun2021(peaking at 5.5), troponin: increased on 06Jun2021 (peaking at 2.9 approximately. The outcome of event septic shock with myopericarditis , tachycardic, tachypneic, blood lactic acid increased, electrocardiogram abnormal, lactic acidosis and troponin increased was not recovered and for rest event outcome was recovered on 07Jun2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Septic shock, Tachycardia, Tachypnoea
Clinical narrative: septic shock with myopericarditis; septic shock with myopericarditis; rigors; fever; diffuse maculopapular rash; tachycardic; tachypneic; blood lactic acid increased; electrocardiogram abnormal; lactic acidosis; troponin increased; This is a spontaneous report from a non-contactable consumer or other non hcp.  A 18-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown), via intramuscular route of administration, administered on 06Jun2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown), via unspecified route of administration, administered on unspecified date as single dose for COVID-19 immunisation. It was reported that medications at time of Vaccination was none. No known allergies. The patient experienced septic shock with myopericarditis, rigors, fever, diffuse maculopapular rash, tachycardic, tachypneic, blood lactic acid increased, electrocardiogram abnormal, lactic acidosis, troponin increased on 06Jun2021. Symptoms started out with rigors and a fever. This progressed to a diffuse maculopapular rash that resolved within 24 hours. It was reported that event were Serious, Life Threatening Hospitalized and patient visited emergency room. It was reported that Permanent Disability and Congenital Anomaly / Birth Defect was no. Following day, he was tachycardic and tachypneic when he presented to the emergency department. Ultimately he was found to be in septic shock with myopericarditis. He required pressors. He was currently still in the hospital. It was reported that Prolonged Hospitalization Existence was no and days in hospital was unknown. The patient underwent lab tests and procedures which included blood lactic acid: increased, electrocardiogram: pericarditis positive on 06Jun2021 (pericarditis Positive), lactic acidosis: 5.5 on 06Jun2021(peaking at 5.5), troponin: increased on 06Jun2021 (peaking at 2.9 approximately. The outcome of event septic shock with myopericarditis , tachycardic, tachypneic, blood lactic acid increased, electrocardiogram abnormal, lactic acidosis and troponin increased was not recovered and for rest event outcome was recovered on 07Jun2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: lost a friend; This is a spontaneous report from a non-contactable consumer reporting same event under the same suspect product for 12 patients. This is one of 12 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified routed of administration on unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter had lost a friend. The cause of death was unknown. It was unknown if autopsy was done. The outcome of the event was fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101100128 Same reporter/event/drug, different patient;US-PFIZER INC-202101100129 Same reporter/event/drug, different patient;US-PFIZER INC-202101100127 Same reporter/event/drug, different patient; Reported Cause(s) of Death: lost a friend
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: I have lost 3 friends in Spain; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for twelve patients. This is one of twelve reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified routed of administration on unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter stated "I have lost 7 friends in , 3 in , 1 in and a friend of my son 14 years." The cause of death was unknown. It was unknown if autopsy was done. The outcome of the event was fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101100059 Same reporter/event/product, different patient; Reported Cause(s) of Death: lost 3 friends
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: lost a friend of my son 14 years; This is a spontaneous report from a non-contactable consumer reporting same event under the same suspect product for 12 patients. This is one of 12 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified routed of administration on unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter had lost a friend of the reporter's son 14 years (seems the reporter's son's age who is not the patient). The cause of death was unknown. It was unknown if autopsy was done. The outcome of the event was fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101100059 Same reporter/event/drug, different patient; Reported Cause(s) of Death: lost a friend of my son 14 years
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Renal failure, Tremor
Clinical narrative: Renal failure; periodic uncontrollable shaking; This is a spontaneous report from a contactable consumer. A 94-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Feb2021 12:00 (Batch/Lot number was not reported) (at the age of 94-years-old) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history was none, she was just old. There were no known allergies. The patient did not get covid prior vaccination. There was no other vaccine in four weeks. Concomitant medications in two weeks included temazepam; ascorbic acid, calcium, minerals nos, retinol, tocopheryl acetate, vitamin b nos, vitamins nos, zinc (CENTRUM SILVER); ascorbic acid, retinol, tocopherol (OCUVITE) all taken for an unspecified indication, start and stop date were not reported. The patient experienced renal failure and periodic uncontrollable shaking on 24Feb2021 13:00. The events resulted in doctor or other healthcare professional office/clinic visit. There was no treatment received. The outcome of the event periodic uncontrollable shaking and renal failure was unknown. Covid was not tested post vaccination.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Glaucoma, Hypoaesthesia, Pain in extremity, Vision blurred
Clinical narrative: glaucoma; sharp pains to his right middle and index fingers; sharp pains to feet and toes of both feet; sharp pains to feet and toes of both feet; far sight is blurry; slight numbness to the right side of his face; dull pain in his stomach; This is a spontaneous report from a contactable consumer. This male consumer (patient) reported that: A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on Aug2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered on unspecified date as DOSE 1, SINGLE for covid-19 immunization. On an unspecified date, the patient experienced glaucoma, sharp pains to his right middle and index fingers, sharp pains to feet and toes of both feet, sharp pains to feet and toes of both feet, far sight is blurry, slight numbness to the right side of his face, dull pain in his stomach. Consumer called about the Pfizer COVID-19 vaccine who said it has been a week since he got his second injection and he is still experiencing side effects. He said that he has a dull pain in his stomach also that feels like he got punched in the stomach that hasn't gone away and has slight numbness to the right side of his face, which he had the shot in his right side arm. He do not know if it has to do with his glaucoma or not, but before all the shots his vision was good, now looking further his far sight is blurry. He said he called the eye doctor and has an appointment to check that out and seemed like everyone he knows was done with all side effects in one to two days, so he was concerned that he still has the feeling like he was punched in the stomach. Caller declined to complete a report, and says he just needed to know if this could be life threatening or if he just needed to see his doctor. No further details provided about other people who had side effects. Event glaucoma was considered as serious (medically significant). The clinical outcome of events were unknown.  Information on the Lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dizziness, Dysphagia, Obstructive airways disorder, Speech disorder
Clinical narrative: difficulty swallowing; lightheaded; anaphylaxis; obstructed airway; stridor; inability to talk; This is a spontaneous report from a contactable Nurse (patient). A 52-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 20Jan2021 10:00 (Batch/Lot Number: EL0140) (at the age of 52-years-old) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included hypertension from an unknown date, Known allergies: Flu Shot, Raw egg. The patient did not receive other vaccine in four weeks. The patient did not get covid prior vaccination. Concomitant medications in two weeks included metoprolol; losartan; minocycline; bupropion hydrochloride (WELLBUTRIN) and colecalciferol (D3) all taken for an unspecified indication, start and stop date were not reported.  On 20Jan2021 13:00, approximately 4 hours post vaccine the patient developed difficulty swallowing, lightheaded, she went home but ended up in ER with anaphylaxis treated with Epinephrine, solumedrol and benadryl. She was discharged that evening from the ER, symptoms resolved. The same symptoms started the next day on 21Jan2021 around 11am, this time symptoms were much quicker onset, she left work for ER and had totally obstructed airway and stridor, inability to talk. She was hospitalized after ER treatment and was discharged the next day on 22Jan2021, early afternoon. She was advised not to get the 2nd vaccine, which she had not. The patient was hospitalized for the events from 21Jan2021 to 22Jan2021. The adverse events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of all the events included Epinephrine, Solumedrol, Diphenhydramine, zofran. The patient did not get covid tested post vaccination. The outcome of the events was resolved in 2021.; Sender's Comments: Based on the available information in the case, the causal association between the events, dysphagia, dizziness, anaphylactic reaction, obstructive airway disorder, stridor, speech disorder and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Stridor
Clinical narrative: difficulty swallowing; lightheaded; anaphylaxis; obstructed airway; stridor; inability to talk; This is a spontaneous report from a contactable Nurse (patient). A 52-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 20Jan2021 10:00 (Batch/Lot Number: EL0140) (at the age of 52-years-old) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included hypertension from an unknown date, Known allergies: Flu Shot, Raw egg. The patient did not receive other vaccine in four weeks. The patient did not get covid prior vaccination. Concomitant medications in two weeks included metoprolol; losartan; minocycline; bupropion hydrochloride (WELLBUTRIN) and colecalciferol (D3) all taken for an unspecified indication, start and stop date were not reported.  On 20Jan2021 13:00, approximately 4 hours post vaccine the patient developed difficulty swallowing, lightheaded, she went home but ended up in ER with anaphylaxis treated with Epinephrine, solumedrol and benadryl. She was discharged that evening from the ER, symptoms resolved. The same symptoms started the next day on 21Jan2021 around 11am, this time symptoms were much quicker onset, she left work for ER and had totally obstructed airway and stridor, inability to talk. She was hospitalized after ER treatment and was discharged the next day on 22Jan2021, early afternoon. She was advised not to get the 2nd vaccine, which she had not. The patient was hospitalized for the events from 21Jan2021 to 22Jan2021. The adverse events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). Therapeutic measures were taken as a result of all the events included Epinephrine, Solumedrol, Diphenhydramine, zofran. The patient did not get covid tested post vaccination. The outcome of the events was resolved in 2021.; Sender's Comments: Based on the available information in the case, the causal association between the events, dysphagia, dizziness, anaphylactic reaction, obstructive airway disorder, stridor, speech disorder and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  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.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Anaphylactic shock, Anger, Arthralgia, Back pain
Clinical narrative: The patient felt like death. The patient literally felt like dying.; Anaphylactic shock; whole body was in the seizure; stomach felt like bonfire; lungs, back, shoulder blade, stomach and legs hurt; lungs, back, shoulder blade, stomach and legs hurt; lungs, back, shoulder blade, stomach and legs hurt; lungs, back, shoulder blade, stomach and legs hurt; legs hurt; angry; This is a spontaneous report from a non-contactable consumer (patient self).  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 24Aug2021 (Batch/Lot number was not reported) at the age of unknown as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unknown date at the age of unknown as single dose for COVID-19 immunization.  The patient was angry in Aug2021 because the last night (24Aug2021) he/she was in an anaphylactic shock after taking second Pfizer jab. The stomach felt like bonfire on 24Aug2021.  The patient felt like death.  The patient literally felt like dying.  The patient called doctor.  And a bunch of other conditions. The vaccine destroyed the whole body. It was not the shock. It was lungs, back, shoulder blade, stomach and legs hurt on 24Aug2021.  The whole body was in the seizure on 24Aug2021.  Outcome of the events was unknown.  No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dyspepsia, Near death experience, Pain in extremity, Pulmonary pain, Seizure
Clinical narrative: The patient felt like death. The patient literally felt like dying.; Anaphylactic shock; whole body was in the seizure; stomach felt like bonfire; lungs, back, shoulder blade, stomach and legs hurt; lungs, back, shoulder blade, stomach and legs hurt; lungs, back, shoulder blade, stomach and legs hurt; lungs, back, shoulder blade, stomach and legs hurt; legs hurt; angry; This is a spontaneous report from a non-contactable consumer (patient self).  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 24Aug2021 (Batch/Lot number was not reported) at the age of unknown as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on an unknown date at the age of unknown as single dose for COVID-19 immunization.  The patient was angry in Aug2021 because the last night (24Aug2021) he/she was in an anaphylactic shock after taking second Pfizer jab. The stomach felt like bonfire on 24Aug2021.  The patient felt like death.  The patient literally felt like dying.  The patient called doctor.  And a bunch of other conditions. The vaccine destroyed the whole body. It was not the shock. It was lungs, back, shoulder blade, stomach and legs hurt on 24Aug2021.  The whole body was in the seizure on 24Aug2021.  Outcome of the events was unknown.  No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.