chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Pericarditis
Clinical narrative: Pericarditis/ light chest tightness and cough; This is a spontaneous report received from contactable reporter (consumer) from medical information team. The reporter is the patient.  A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 27Oct2021 16:00 (lot number: FF2593) at the age of 27-years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Epilepsy", start date: 1997 (ongoing), notes: Diagnosed with Epilepsy at 3-years-old. Concomitant medication included: KEPPRA [LEVETIRACETAM] taken for epilepsy (ongoing). Vaccination history included: BNT162B2 (lot number: EJ1686, administered in right arm at 11:30 as dose 1, single), administration date: 29Dec2020, when the patient was 26-years-old, for COVID-19 immunisation; BNT162B2 (lot number: EJ1686, administered in right arm at 11:30 as dose 2, single), administration date: 19Jan2021, when the patient was 26-years-old, for COVID-19 immunisation; and Flu shot, administration date: 2021, for Immunisation. The following information was reported: PERICARDITIS (hospitalization, medically significant) with onset Nov2021, outcome "recovering", described as "Pericarditis/ light chest tightness and cough." The patient was hospitalized for pericarditis (start date: 01Jan2022, discharge date: 02Jan2022, hospitalization duration: 1 day). The event "pericarditis/ light chest tightness and cough" was evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (2021) unknown result. Therapeutic measures were taken as a result of pericarditis. Clinical course: The patient was hospitalized for pericarditis after receiving the booster dose of Pfizer COVID-19 vaccine. When asked for the date of the adverse event, he mentioned that it became severe enough on 31Dec2021. It progressively increased. It probably started a month after the vaccine. It presented as light chest tightness and cough that progressively got worse until 31Dec2021. He is on medication for the next 3 months. The medication has helped, and the pericarditis was improving.  Family medical history relevant to the adverse event and additional vaccines administered on the same date as BNT162B2 were reported as none  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Deafness unilateral, Nasal operation, Paranasal sinus inflammation
Clinical narrative: loss of hearing in my left hear; sinus inflamation; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19May2021 10:00 (Lot number: ew0167) at the age of 58 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: SINUS DECONGESTANT. Past drug history included: Aspirin, reaction: "Known allergies: Aspirin". The following information was reported: DEAFNESS (medically significant), outcome "recovered", described as "loss of hearing in my left hear"; SINUSITIS (medically significant), outcome "unknown", described as "sinus inflamation". The event "sinus inflamation" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative Notes: Nasal Swab. Therapeutic measures were taken as a result of deafness, sinusitis.  Course of the event: The 1st vaccine caused loss of hearing in my left hear and extreme sinus inflamation - hearing came back after a round of antibiotics and predisone I required a sinus Turbinate procedure to open up my sinuses - done by an ENT specialist.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : 202200145660 same reporter/pt/drug, different dose/event.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deafness, SARS-CoV-2 test, Sinusitis
Clinical narrative: loss of hearing in my left hear; sinus inflamation; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19May2021 10:00 (Lot number: ew0167) at the age of 58 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: SINUS DECONGESTANT. Past drug history included: Aspirin, reaction: "Known allergies: Aspirin". The following information was reported: DEAFNESS (medically significant), outcome "recovered", described as "loss of hearing in my left hear"; SINUSITIS (medically significant), outcome "unknown", described as "sinus inflamation". The event "sinus inflamation" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative Notes: Nasal Swab. Therapeutic measures were taken as a result of deafness, sinusitis.  Course of the event: The 1st vaccine caused loss of hearing in my left hear and extreme sinus inflamation - hearing came back after a round of antibiotics and predisone I required a sinus Turbinate procedure to open up my sinuses - done by an ENT specialist.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : 202200145660 same reporter/pt/drug, different dose/event.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac stress test normal, Echocardiogram abnormal, Electrocardiogram normal, Immediate post-injection reaction, Myocarditis
Clinical narrative: myocarditis; Dose 1 was given on 19May2021; Dose 2 was given on 12Sep2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Sep2021 14:00 (Lot number: FW3592) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SINUS DECONGESTANT. Past drug history included: Aspirin, reaction(s): "Known alleries: aspirin". Vaccination history included: Bnt162b2 (dose 1, single; administered in the right arm, administration time: 10:00, lot number ew0167), administration date: 19May2021, when the patient was 58 years old, for Covid-19 immunization, reaction(s): "loss of hearing in my left hear", "sinus inflamation". The following information was reported: MYOCARDITIS (medically significant) with onset 14Sep2021 07:00, outcome "not recovered", described as "myocarditis"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 12Sep2021, outcome "unknown", described as "Dose 1 was given on 19May2021; Dose 2 was given on 12Sep2021". The event "myocarditis" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: cardiac stress test: unknown results; echocardiogram: still has myocarditis; unknown results; electrocardiogram: unknown results; pulmonary function test: unknown results; sars-cov-2 antibody test: negative; ultrasound scan: unknown results. Therapeutic measures were taken as a result of myocarditis and included prednisone, a diuretic, antibiotics. Clinical course: The 1st dose of the vaccine caused loss of hearing in his left hear and extreme sinus inflammation. His hearing came back after a round of antibiotics and prednisone. The patient was required a sinus turbinate procedure to open up his sinuses which was done by an ENT specialist. The 2nd dose of the vaccine immediately caused myocarditis. After 4 months of treatments by a cardiologist, the patient still has myocarditis as indicated in recent echocardiograms. The patient is now being referred to the cardiology group for additional assessment and hopefully resolution. The patient had EKGs, several echos, nuclear stress tests, pulmonary assessment, etc. and had been on numerous rounds of prednisone, a diuretic, antibiotics and he still have myocarditis. He never had any heart issues (or ear loss or major sinus issues) until getting the vaccines. These 9 months have been terrible and have impacted all aspects of his life. He needs a resolution to the myocarditis.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200144603 same reporter/pt/drug, different dose/event
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary function test normal
Clinical narrative: myocarditis; Dose 1 was given on 19May2021; Dose 2 was given on 12Sep2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Sep2021 14:00 (Lot number: FW3592) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SINUS DECONGESTANT. Past drug history included: Aspirin, reaction(s): "Known alleries: aspirin". Vaccination history included: Bnt162b2 (dose 1, single; administered in the right arm, administration time: 10:00, lot number ew0167), administration date: 19May2021, when the patient was 58 years old, for Covid-19 immunization, reaction(s): "loss of hearing in my left hear", "sinus inflamation". The following information was reported: MYOCARDITIS (medically significant) with onset 14Sep2021 07:00, outcome "not recovered", described as "myocarditis"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 12Sep2021, outcome "unknown", described as "Dose 1 was given on 19May2021; Dose 2 was given on 12Sep2021". The event "myocarditis" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: cardiac stress test: unknown results; echocardiogram: still has myocarditis; unknown results; electrocardiogram: unknown results; pulmonary function test: unknown results; sars-cov-2 antibody test: negative; ultrasound scan: unknown results. Therapeutic measures were taken as a result of myocarditis and included prednisone, a diuretic, antibiotics. Clinical course: The 1st dose of the vaccine caused loss of hearing in his left hear and extreme sinus inflammation. His hearing came back after a round of antibiotics and prednisone. The patient was required a sinus turbinate procedure to open up his sinuses which was done by an ENT specialist. The 2nd dose of the vaccine immediately caused myocarditis. After 4 months of treatments by a cardiologist, the patient still has myocarditis as indicated in recent echocardiograms. The patient is now being referred to the cardiology group for additional assessment and hopefully resolution. The patient had EKGs, several echos, nuclear stress tests, pulmonary assessment, etc. and had been on numerous rounds of prednisone, a diuretic, antibiotics and he still have myocarditis. He never had any heart issues (or ear loss or major sinus issues) until getting the vaccines. These 9 months have been terrible and have impacted all aspects of his life. He needs a resolution to the myocarditis.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200144603 same reporter/pt/drug, different dose/event
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac stress test, Echocardiogram, Electrocardiogram, Inappropriate schedule of product administration, Myocarditis
Clinical narrative: myocarditis; Dose 1 was given on 19May2021; Dose 2 was given on 12Sep2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Sep2021 14:00 (Lot number: FW3592) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SINUS DECONGESTANT. Past drug history included: Aspirin, reaction(s): "Known alleries: aspirin". Vaccination history included: Bnt162b2 (dose 1, single; administered in the right arm, administration time: 10:00, lot number ew0167), administration date: 19May2021, when the patient was 58 years old, for Covid-19 immunization, reaction(s): "loss of hearing in my left hear", "sinus inflamation". The following information was reported: MYOCARDITIS (medically significant) with onset 14Sep2021 07:00, outcome "not recovered", described as "myocarditis"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 12Sep2021, outcome "unknown", described as "Dose 1 was given on 19May2021; Dose 2 was given on 12Sep2021". The event "myocarditis" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: cardiac stress test: unknown results; echocardiogram: still has myocarditis; unknown results; electrocardiogram: unknown results; pulmonary function test: unknown results; sars-cov-2 antibody test: negative; ultrasound scan: unknown results. Therapeutic measures were taken as a result of myocarditis and included prednisone, a diuretic, antibiotics. Clinical course: The 1st dose of the vaccine caused loss of hearing in his left hear and extreme sinus inflammation. His hearing came back after a round of antibiotics and prednisone. The patient was required a sinus turbinate procedure to open up his sinuses which was done by an ENT specialist. The 2nd dose of the vaccine immediately caused myocarditis. After 4 months of treatments by a cardiologist, the patient still has myocarditis as indicated in recent echocardiograms. The patient is now being referred to the cardiology group for additional assessment and hopefully resolution. The patient had EKGs, several echos, nuclear stress tests, pulmonary assessment, etc. and had been on numerous rounds of prednisone, a diuretic, antibiotics and he still have myocarditis. He never had any heart issues (or ear loss or major sinus issues) until getting the vaccines. These 9 months have been terrible and have impacted all aspects of his life. He needs a resolution to the myocarditis.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200144603 same reporter/pt/drug, different dose/event
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary function test, SARS-CoV-2 antibody test, Ultrasound scan
Clinical narrative: myocarditis; Dose 1 was given on 19May2021; Dose 2 was given on 12Sep2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Sep2021 14:00 (Lot number: FW3592) at the age of 58 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SINUS DECONGESTANT. Past drug history included: Aspirin, reaction(s): "Known alleries: aspirin". Vaccination history included: Bnt162b2 (dose 1, single; administered in the right arm, administration time: 10:00, lot number ew0167), administration date: 19May2021, when the patient was 58 years old, for Covid-19 immunization, reaction(s): "loss of hearing in my left hear", "sinus inflamation". The following information was reported: MYOCARDITIS (medically significant) with onset 14Sep2021 07:00, outcome "not recovered", described as "myocarditis"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 12Sep2021, outcome "unknown", described as "Dose 1 was given on 19May2021; Dose 2 was given on 12Sep2021". The event "myocarditis" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: cardiac stress test: unknown results; echocardiogram: still has myocarditis; unknown results; electrocardiogram: unknown results; pulmonary function test: unknown results; sars-cov-2 antibody test: negative; ultrasound scan: unknown results. Therapeutic measures were taken as a result of myocarditis and included prednisone, a diuretic, antibiotics. Clinical course: The 1st dose of the vaccine caused loss of hearing in his left hear and extreme sinus inflammation. His hearing came back after a round of antibiotics and prednisone. The patient was required a sinus turbinate procedure to open up his sinuses which was done by an ENT specialist. The 2nd dose of the vaccine immediately caused myocarditis. After 4 months of treatments by a cardiologist, the patient still has myocarditis as indicated in recent echocardiograms. The patient is now being referred to the cardiology group for additional assessment and hopefully resolution. The patient had EKGs, several echos, nuclear stress tests, pulmonary assessment, etc. and had been on numerous rounds of prednisone, a diuretic, antibiotics and he still have myocarditis. He never had any heart issues (or ear loss or major sinus issues) until getting the vaccines. These 9 months have been terrible and have impacted all aspects of his life. He needs a resolution to the myocarditis.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200144603 same reporter/pt/drug, different dose/event
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: severe tinnitus in both ears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Dec2021 11:45 (Lot number: FH8027) at the age of 63 years as dose 3  (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8734, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 05Apr2021, when the patient was 62 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EM6206, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 15Mar2021, when the patient was 62 years old, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset 10Dec2021 16:00, outcome "not recovered", described as "severe tinnitus in both ears". The event "severe tinnitus in both ears" was evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus.  Additional information: No other vaccine in four weeks. AE treatment included Audiology test. No Covid prior vaccination. No known allergy. No Covid tested post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Hormone level abnormal, Raynaud's phenomenon, Rheumatoid arthritis
Clinical narrative: Several Raynaud's and rheumatoid arthritis symptoms never experienced before; Several Raynaud's and rheumatoid arthritis symptoms never experienced before; experience sever hot flashes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jun2021 18:00 (Lot number: EW0187, expiration date unknown) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Diary" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0187, Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM), administration date: 17May2021, when the patient was 49 years old, for Covid-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), RAYNAUD'S PHENOMENON (non-serious) all with onset 16Jul2021 20:00, outcome "not recovered" and all described as "Several Raynaud's and rheumatoid arthritis symptoms never experienced before"; HOT FLUSH (non-serious) with onset 16Jul2021 20:00, outcome "not recovered", described as "experience sever hot flashes". The all events were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Jan2022) positive, notes: covid test type post vaccination= Nasal Swab. Therapeutic measures were taken as a result of rheumatoid arthritis, raynaud's phenomenon, hot flush and treatment included IV supplement. There was no other vaccine in four weeks or other medications in two weeks.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hot flush, Raynaud's phenomenon, Rheumatoid arthritis, SARS-CoV-2 test
Clinical narrative: Several Raynaud's and rheumatoid arthritis symptoms never experienced before; Several Raynaud's and rheumatoid arthritis symptoms never experienced before; experience sever hot flashes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jun2021 18:00 (Lot number: EW0187, expiration date unknown) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Diary" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0187, Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM), administration date: 17May2021, when the patient was 49 years old, for Covid-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), RAYNAUD'S PHENOMENON (non-serious) all with onset 16Jul2021 20:00, outcome "not recovered" and all described as "Several Raynaud's and rheumatoid arthritis symptoms never experienced before"; HOT FLUSH (non-serious) with onset 16Jul2021 20:00, outcome "not recovered", described as "experience sever hot flashes". The all events were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Jan2022) positive, notes: covid test type post vaccination= Nasal Swab. Therapeutic measures were taken as a result of rheumatoid arthritis, raynaud's phenomenon, hot flush and treatment included IV supplement. There was no other vaccine in four weeks or other medications in two weeks.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Several Raynaud's and rheumatoid arthritis symptoms never experienced before; Several Raynaud's and rheumatoid arthritis symptoms never experienced before; experience sever hot flashes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jun2021 18:00 (Lot number: EW0187, expiration date unknown) at the age of 50 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Diary" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0187, Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM), administration date: 17May2021, when the patient was 49 years old, for Covid-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), RAYNAUD'S PHENOMENON (non-serious) all with onset 16Jul2021 20:00, outcome "not recovered" and all described as "Several Raynaud's and rheumatoid arthritis symptoms never experienced before"; HOT FLUSH (non-serious) with onset 16Jul2021 20:00, outcome "not recovered", described as "experience sever hot flashes". The all events were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (08Jan2022) positive, notes: covid test type post vaccination= Nasal Swab. Therapeutic measures were taken as a result of rheumatoid arthritis, raynaud's phenomenon, hot flush and treatment included IV supplement. There was no other vaccine in four weeks or other medications in two weeks.   No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Computerised tomogram, Diplegia, Electrocardiogram, Guillain-Barre syndrome
Clinical narrative: Patient has paralysis in both legs and hands.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Sep2021 06:00 (Lot number: 301458A) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cancer" (unspecified if ongoing); "bipolarity" (unspecified if ongoing); "migraine" (unspecified if ongoing); "arthritis" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, lot number: fd8448, in the left arm), administration date: 02Sep2021, for Covid-19 immunization. The following information was reported: PARALYSIS (hospitalization, disability) with onset Oct2021, outcome "not recovered", described as "Patient has paralysis in both legs and hands.". The patient was hospitalized for paralysis (hospitalization duration: 14 day(s)). The event "patient has paralysis in both legs and hands." was evaluated at the emergency room visit. It was unknown if therapeutic measures were taken as a result of paralysis.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Immunoglobulin therapy, Joint stiffness, Laboratory test, Lumbar puncture
Clinical narrative: Patient has paralysis in both legs and hands.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Sep2021 06:00 (Lot number: 301458A) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cancer" (unspecified if ongoing); "bipolarity" (unspecified if ongoing); "migraine" (unspecified if ongoing); "arthritis" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, lot number: fd8448, in the left arm), administration date: 02Sep2021, for Covid-19 immunization. The following information was reported: PARALYSIS (hospitalization, disability) with onset Oct2021, outcome "not recovered", described as "Patient has paralysis in both legs and hands.". The patient was hospitalized for paralysis (hospitalization duration: 14 day(s)). The event "patient has paralysis in both legs and hands." was evaluated at the emergency room visit. It was unknown if therapeutic measures were taken as a result of paralysis.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Monoplegia, Muscle spasms, Scan with contrast, Tic
Clinical narrative: Patient has paralysis in both legs and hands.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Sep2021 06:00 (Lot number: 301458A) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cancer" (unspecified if ongoing); "bipolarity" (unspecified if ongoing); "migraine" (unspecified if ongoing); "arthritis" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, lot number: fd8448, in the left arm), administration date: 02Sep2021, for Covid-19 immunization. The following information was reported: PARALYSIS (hospitalization, disability) with onset Oct2021, outcome "not recovered", described as "Patient has paralysis in both legs and hands.". The patient was hospitalized for paralysis (hospitalization duration: 14 day(s)). The event "patient has paralysis in both legs and hands." was evaluated at the emergency room visit. It was unknown if therapeutic measures were taken as a result of paralysis.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paralysis
Clinical narrative: Patient has paralysis in both legs and hands.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). A 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Sep2021 06:00 (Lot number: 301458A) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cancer" (unspecified if ongoing); "bipolarity" (unspecified if ongoing); "migraine" (unspecified if ongoing); "arthritis" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose, lot number: fd8448, in the left arm), administration date: 02Sep2021, for Covid-19 immunization. The following information was reported: PARALYSIS (hospitalization, disability) with onset Oct2021, outcome "not recovered", described as "Patient has paralysis in both legs and hands.". The patient was hospitalized for paralysis (hospitalization duration: 14 day(s)). The event "patient has paralysis in both legs and hands." was evaluated at the emergency room visit. It was unknown if therapeutic measures were taken as a result of paralysis.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy, Blood test, Urticaria
Clinical narrative: Broke out with hives; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 16:00 (Lot number: FH8030) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergy" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Auto-brewery syndrome" (unspecified if ongoing); "COVID-19", start date: 14Aug2021 (not ongoing). The patient took concomitant medications. Past drug history included: Azithromycin, reaction(s): "Drug allergy"; Azithromycin, reaction(s): "Hives". The following information was reported: URTICARIA (medically significant) with onset 14Nov2021 08:00, outcome "not recovered", described as "Broke out with hives". The event "broke out with hives" was evaluated at the physician office visit. Therapeutic measures were taken as a result of urticaria. Additional information: the patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Treatment received for the adverse event included Benadryl injection, steroid injection, steroid tabs.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported event URTICARIA cannot be excluded.  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: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Broke out with hives; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 16:00 (Lot number: FH8030) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergy" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Auto-brewery syndrome" (unspecified if ongoing); "COVID-19", start date: 14Aug2021 (not ongoing). The patient took concomitant medications. Past drug history included: Azithromycin, reaction(s): "Drug allergy"; Azithromycin, reaction(s): "Hives". The following information was reported: URTICARIA (medically significant) with onset 14Nov2021 08:00, outcome "not recovered", described as "Broke out with hives". The event "broke out with hives" was evaluated at the physician office visit. Therapeutic measures were taken as a result of urticaria. Additional information: the patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Treatment received for the adverse event included Benadryl injection, steroid injection, steroid tabs.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported event URTICARIA cannot be excluded.  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: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy skin, Blood test, Dermatitis contact, Rash, Rash erythematous
Clinical narrative: contact dermatitis; red; itchy rash; is having an histamine reaction in overdrive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Nov2021 (Lot number: 301358BA) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, administration date 07Dec2021. Vaccination history included: Bnt162b2 (1st dose- 25JAN2021, Lot Number: EL9262, Is COVID vaccine a Pfizer product Yes), administration date: 25Jan2021, when the patient was 70 years old, for covid-19 immunization, reaction(s): "pain in arm"; Bnt162b2 (2nd dose: 15FEB2021 , Lot Number: EM9809, Is COVID vaccine a Pfizer product? Yes), administration date: 15Feb2021, when the patient was 70 years old, for Covid-19 Immunization. The following information was reported: ERYTHEMA (non-serious) with onset Nov2021, outcome "not recovered", described as "red"; RASH PRURITIC (non-serious) with onset Nov2021, outcome "not recovered", described as "itchy rash"; HYPERSENSITIVITY (non-serious) with onset Nov2021, outcome "not recovered", described as "is having an histamine reaction in overdrive"; DERMATITIS CONTACT (non-serious), outcome "unknown", described as "contact dermatitis". The events "red", "itchy rash" and "is having an histamine reaction in overdrive" were evaluated at the physician office visit and emergency room visit. The event "contact dermatitis" was evaluated at the physician office visit. Therapeutic measures were taken as a result of erythema, rash pruritic, hypersensitivity.  Additional information: She had developed a red, itchy rash all over her trunk. She has seen 4 to 5 specialists and they have determined that she is having a histamine reaction. The official diagnosis is contact dermatitis and she has never had that in her life. She has never been allergic to anything and since Nov2021 she has seen 3 dermatologist, 2 different allergists and her medical doctor. She has been tested for everything under the sun and the only conclusion they are coming to is that they think her histaminic system is in overdrive and it is possible that this could be from the vaccines. This began in Nov2021, probably within a week of getting the booster dose. It was ongoing and it comes and goes but it gets worse later at night. She has seen 2 allergists and 2 dermatologist who have biopsied it and the only thing that they came up with is that it is some form of a contact dermatitis but it still hasn't gone away. She was being treated with antihistamines and steroid creams.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash pruritic, Skin test
Clinical narrative: contact dermatitis; red; itchy rash; is having an histamine reaction in overdrive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Nov2021 (Lot number: 301358BA) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, administration date 07Dec2021. Vaccination history included: Bnt162b2 (1st dose- 25JAN2021, Lot Number: EL9262, Is COVID vaccine a Pfizer product Yes), administration date: 25Jan2021, when the patient was 70 years old, for covid-19 immunization, reaction(s): "pain in arm"; Bnt162b2 (2nd dose: 15FEB2021 , Lot Number: EM9809, Is COVID vaccine a Pfizer product? Yes), administration date: 15Feb2021, when the patient was 70 years old, for Covid-19 Immunization. The following information was reported: ERYTHEMA (non-serious) with onset Nov2021, outcome "not recovered", described as "red"; RASH PRURITIC (non-serious) with onset Nov2021, outcome "not recovered", described as "itchy rash"; HYPERSENSITIVITY (non-serious) with onset Nov2021, outcome "not recovered", described as "is having an histamine reaction in overdrive"; DERMATITIS CONTACT (non-serious), outcome "unknown", described as "contact dermatitis". The events "red", "itchy rash" and "is having an histamine reaction in overdrive" were evaluated at the physician office visit and emergency room visit. The event "contact dermatitis" was evaluated at the physician office visit. Therapeutic measures were taken as a result of erythema, rash pruritic, hypersensitivity.  Additional information: She had developed a red, itchy rash all over her trunk. She has seen 4 to 5 specialists and they have determined that she is having a histamine reaction. The official diagnosis is contact dermatitis and she has never had that in her life. She has never been allergic to anything and since Nov2021 she has seen 3 dermatologist, 2 different allergists and her medical doctor. She has been tested for everything under the sun and the only conclusion they are coming to is that they think her histaminic system is in overdrive and it is possible that this could be from the vaccines. This began in Nov2021, probably within a week of getting the booster dose. It was ongoing and it comes and goes but it gets worse later at night. She has seen 2 allergists and 2 dermatologist who have biopsied it and the only thing that they came up with is that it is some form of a contact dermatitis but it still hasn't gone away. She was being treated with antihistamines and steroid creams.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dermatitis contact, Erythema, Hypersensitivity, Rash pruritic
Clinical narrative: contact dermatitis; red; itchy rash; is having an histamine reaction in overdrive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Nov2021 (Lot number: 301358BA) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, administration date 07Dec2021. Vaccination history included: Bnt162b2 (1st dose- 25JAN2021, Lot Number: EL9262, Is COVID vaccine a Pfizer product Yes), administration date: 25Jan2021, when the patient was 70 years old, for covid-19 immunization, reaction(s): "pain in arm"; Bnt162b2 (2nd dose: 15FEB2021 , Lot Number: EM9809, Is COVID vaccine a Pfizer product? Yes), administration date: 15Feb2021, when the patient was 70 years old, for Covid-19 Immunization. The following information was reported: ERYTHEMA (non-serious) with onset Nov2021, outcome "not recovered", described as "red"; RASH PRURITIC (non-serious) with onset Nov2021, outcome "not recovered", described as "itchy rash"; HYPERSENSITIVITY (non-serious) with onset Nov2021, outcome "not recovered", described as "is having an histamine reaction in overdrive"; DERMATITIS CONTACT (non-serious), outcome "unknown", described as "contact dermatitis". The events "red", "itchy rash" and "is having an histamine reaction in overdrive" were evaluated at the physician office visit and emergency room visit. The event "contact dermatitis" was evaluated at the physician office visit. Therapeutic measures were taken as a result of erythema, rash pruritic, hypersensitivity.  Additional information: She had developed a red, itchy rash all over her trunk. She has seen 4 to 5 specialists and they have determined that she is having a histamine reaction. The official diagnosis is contact dermatitis and she has never had that in her life. She has never been allergic to anything and since Nov2021 she has seen 3 dermatologist, 2 different allergists and her medical doctor. She has been tested for everything under the sun and the only conclusion they are coming to is that they think her histaminic system is in overdrive and it is possible that this could be from the vaccines. This began in Nov2021, probably within a week of getting the booster dose. It was ongoing and it comes and goes but it gets worse later at night. She has seen 2 allergists and 2 dermatologist who have biopsied it and the only thing that they came up with is that it is some form of a contact dermatitis but it still hasn't gone away. She was being treated with antihistamines and steroid creams.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Blood test abnormal, Chest X-ray, Chest pain, Chills, Delirium
Clinical narrative: myocarditis; was delirious; severe chills; nerve and body pain; nerve and body pain; fever; chest pain; difficulty breathing; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the parent. A 17-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Jan2022 16:30 (Lot number: FJ6369) at the age of 17 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history (other medical history: No). The patient had no known allergies. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot No: EN6207, Location of injection: Arm Left, Vaccine Administration Time: 12:30 PM), administration date: 02Apr2021, when the patient was 16 years old, for Covid-19 Immunization; Bnt162b2 (Dose 2, Batch/Lot No: EW0162, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 23Apr2021, when the patient was 16 years old, for Covid-19 Immunization. On 25Jan2022 03:00, the patient experienced myocarditis (medically significant), was delirious (medically significant), severe chills, nerve and body pain, fever, chest pain, and difficulty breathing, all (hospitalization, disability) with outcome of not recovered. The patient was hospitalized for delirium, myocarditis, chills, neuralgia, pain, pyrexia, chest pain, dyspnoea (hospitalization duration: 4 day(s)). The events "was delirious", "myocarditis", "severe chills", "nerve and body pain", "nerve and body pain", "fever", "chest pain" and "difficulty breathing" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (Jan2022) unknown results; echocardiogram: (Jan2022) unknown results; electrocardiogram: (Jan2022) unknown results. Therapeutic measures were taken as a result of delirium, myocarditis, chills, neuralgia, pain, pyrexia, chest pain, dyspnoea. Additional information: the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was mentioned that the reporter's son suffered severe chills, nerve and body pain, was delirious, had fever, chest pain and difficulty breathing. Subsequently the patient was hospitalized for myocarditis. The treatment of the events included EKG, EchoCardiogram, multiple blood tests and medications. The patient was not diagnosed with COVID-19 prior to vaccination. It was unknown if the patient has been tested for COVID-19 since the vaccination.  Follow-up attempts are completed. No further information is expected.