chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure measurement, Condition aggravated, Dyspnoea, Limb discomfort, Nervousness
Clinical narrative: Caller had first, second and booster dose Pfizer Covid 19 Vaccine and has shortness of breath and trouble in hands; Caller had first, second and booster dose Pfizer Covid 19 Vaccine and has shortness of breath and trouble in hands; Caller had first, second and booster dose Pfizer Covid 19 Vaccine and has shortness of breath and trouble in hands; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program (COVAX US support 159558). The reporter is the patient. A 79-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 79 years as dose 3 (booster), single for covid-19 immunisation; paroxetine (PAROXETINE), since 2014 (Batch/Lot number: unknown) at 1 mg 1x/day for anxiety, post-traumatic stress disorder; clonazepam (CLONAZEPAM AUDEN) (Batch/Lot number: unknown) at 1 mg for anxiety, post-traumatic stress disorder. Relevant medical history included: "low blood pressure" (unspecified if ongoing); "nervousness" (unspecified if ongoing); "Tremors" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN taken for blood cholesterol (ongoing). Past drug history included: Alprazolam, start date: 2003, stop date: 2019, for anxiety, reaction(s): "never had a single negative side effect from Alprazolam", notes: 1 mg; Alprazolam, start date: 2003, stop date: 2019, for PTSD, reaction(s): "never had a single negative side effect from Alprazolam". Vaccination history included: Bnt162b2 (Dose Number:01), for Covid-19 immunization, reaction(s): "Caller had first, second and booster dose Pfizer Covid 19 Vaccine and has shortness of breath and trouble in hands", "Caller had first, second and booster dose Pfizer Covid 19 Vaccine and has shortness of breath and trouble in hands"; Bnt162b2 (Dose Number:02), for Covid-19 immunization, reaction(s): "Caller had first, second and booster dose Pfizer Covid 19 Vaccine and has shortness of breath and trouble in hands", "Caller had first, second and booster dose Pfizer Covid 19 Vaccine and has shortness of breath and trouble in hands". The following information was reported: IMMUNISATION (non-serious), DYSPNOEA (non-serious), LIMB INJURY (non-serious), outcome "unknown" and all described as "Caller had first, second and booster dose Pfizer Covid 19 Vaccine and has shortness of breath and trouble in hands". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for paroxetine and clonazepam was dosage permanently withdrawn.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Immunisation, Limb injury
Clinical narrative: Caller had first, second and booster dose Pfizer Covid 19 Vaccine and has shortness of breath and trouble in hands; Caller had first, second and booster dose Pfizer Covid 19 Vaccine and has shortness of breath and trouble in hands; Caller had first, second and booster dose Pfizer Covid 19 Vaccine and has shortness of breath and trouble in hands; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program (COVAX US support 159558). The reporter is the patient. A 79-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 79 years as dose 3 (booster), single for covid-19 immunisation; paroxetine (PAROXETINE), since 2014 (Batch/Lot number: unknown) at 1 mg 1x/day for anxiety, post-traumatic stress disorder; clonazepam (CLONAZEPAM AUDEN) (Batch/Lot number: unknown) at 1 mg for anxiety, post-traumatic stress disorder. Relevant medical history included: "low blood pressure" (unspecified if ongoing); "nervousness" (unspecified if ongoing); "Tremors" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN taken for blood cholesterol (ongoing). Past drug history included: Alprazolam, start date: 2003, stop date: 2019, for anxiety, reaction(s): "never had a single negative side effect from Alprazolam", notes: 1 mg; Alprazolam, start date: 2003, stop date: 2019, for PTSD, reaction(s): "never had a single negative side effect from Alprazolam". Vaccination history included: Bnt162b2 (Dose Number:01), for Covid-19 immunization, reaction(s): "Caller had first, second and booster dose Pfizer Covid 19 Vaccine and has shortness of breath and trouble in hands", "Caller had first, second and booster dose Pfizer Covid 19 Vaccine and has shortness of breath and trouble in hands"; Bnt162b2 (Dose Number:02), for Covid-19 immunization, reaction(s): "Caller had first, second and booster dose Pfizer Covid 19 Vaccine and has shortness of breath and trouble in hands", "Caller had first, second and booster dose Pfizer Covid 19 Vaccine and has shortness of breath and trouble in hands". The following information was reported: IMMUNISATION (non-serious), DYSPNOEA (non-serious), LIMB INJURY (non-serious), outcome "unknown" and all described as "Caller had first, second and booster dose Pfizer Covid 19 Vaccine and has shortness of breath and trouble in hands". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for paroxetine and clonazepam was dosage permanently withdrawn.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 89.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Death, Dyspnoea, Pain
Clinical narrative: pt brought to ED by daughter with c/o worsening SOB, dyspnea, wheezing, pain; hx of CHF, gouty arthritis, CKDIII, recent new onset of seizure, dementia; started on BiPAP and diuretics, comfort measures; pt died in the hospital
Age: 89.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Positive airway pressure therapy, SARS-CoV-2 test positive
Clinical narrative: pt brought to ED by daughter with c/o worsening SOB, dyspnea, wheezing, pain; hx of CHF, gouty arthritis, CKDIII, recent new onset of seizure, dementia; started on BiPAP and diuretics, comfort measures; pt died in the hospital
Age: 89.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Dementia, Dyspnoea, Pain, Polyuria
Clinical narrative: pt brought to ED by daughter with c/o worsening SOB, dyspnea, wheezing, pain; hx of CHF, gouty arthritis, CKDIII, recent new onset of seizure, dementia; started on BiPAP and diuretics, comfort measures; pt died in the hospital
Age: 89.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Positive airway pressure therapy, Seizure, Wheezing
Clinical narrative: pt brought to ED by daughter with c/o worsening SOB, dyspnea, wheezing, pain; hx of CHF, gouty arthritis, CKDIII, recent new onset of seizure, dementia; started on BiPAP and diuretics, comfort measures; pt died in the hospital
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Pain, Pain in extremity, Sciatica
Clinical narrative: Severe sciatica pain on my left leg, starting at the hip level and radiating downwards; It is worse when I try to get up in the morning; booster shot we got; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Nov2021 17:00 (Lot number: 32030BD) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: other medical history: No. There were no concomitant medications.   Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6206, Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM), administration date: 22Mar2021, when the patient was 61 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6202, Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM), administration date: 01Mar2021, when the patient was 61 years old, for COVID-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 09Nov2021 17:00, outcome "unknown", described as "booster shot we got"; SCIATICA (non-serious) with onset 11Nov2021 08:00, outcome "not recovered", described as "Severe sciatica pain on my left leg, starting at the hip level and radiating downwards"; CONDITION AGGRAVATED (non-serious) with onset 11Nov2021 08:00, outcome "not recovered", described as "It is worse when I try to get up in the morning".  Additional information: It started one and a half day after I got the vaccine. It is worse when I try to get up in the morning. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. At that point she didn't connect this to the vaccine. Now she thinks that this may be correlated to the booster shot she got. The patient was not diagnosed with COVID-19 prior to vaccination, nor was tested since vaccination. The device date was 14Nov2021.   Follow-up attempts completed. No further information expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101578829 same reporter/drug, different patients.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Immunisation, Sciatica
Clinical narrative: Severe sciatica pain on my left leg, starting at the hip level and radiating downwards; It is worse when I try to get up in the morning; booster shot we got; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Nov2021 17:00 (Lot number: 32030BD) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: other medical history: No. There were no concomitant medications.   Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6206, Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM), administration date: 22Mar2021, when the patient was 61 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6202, Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM), administration date: 01Mar2021, when the patient was 61 years old, for COVID-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 09Nov2021 17:00, outcome "unknown", described as "booster shot we got"; SCIATICA (non-serious) with onset 11Nov2021 08:00, outcome "not recovered", described as "Severe sciatica pain on my left leg, starting at the hip level and radiating downwards"; CONDITION AGGRAVATED (non-serious) with onset 11Nov2021 08:00, outcome "not recovered", described as "It is worse when I try to get up in the morning".  Additional information: It started one and a half day after I got the vaccine. It is worse when I try to get up in the morning. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. At that point she didn't connect this to the vaccine. Now she thinks that this may be correlated to the booster shot she got. The patient was not diagnosed with COVID-19 prior to vaccination, nor was tested since vaccination. The device date was 14Nov2021.   Follow-up attempts completed. No further information expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101578829 same reporter/drug, different patients.
Age: 9.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pityriasis rosea
Clinical narrative: Pityriasis rosea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 9 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Nov2021 10:15 (Lot number: FK5127) at the age of 9 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PITYRIASIS ROSEA (non-serious) with onset 11Nov2021 18:00, outcome "not recovered", described as "Pityriasis rosea". The event "pityriasis rosea" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of pityriasis rosea.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19 and not have any known allergies.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Seizure
Clinical narrative: Two minutes after receiving the PFizer COVID vaccine at the employee vaccination clinic, she experienced chest tightness, throat tightness and shortness of breath / wheezing.  She was sent to the Emergency Department where she was given a dose of Benadryl , Epi-pen, Solu-medrol, famotidine, Ativan and Duo-neb.   Symptoms improved and patient was sent home with a prescription for albuterol.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dyspnoea, Throat tightness, Wheezing
Clinical narrative: Two minutes after receiving the PFizer COVID vaccine at the employee vaccination clinic, she experienced chest tightness, throat tightness and shortness of breath / wheezing.  She was sent to the Emergency Department where she was given a dose of Benadryl , Epi-pen, Solu-medrol, famotidine, Ativan and Duo-neb.   Symptoms improved and patient was sent home with a prescription for albuterol.
Age: 5.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Widespread Hives, no oral Swelling or Shortness of breath
Age: 6.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Electroencephalogram, Loss of consciousness, Magnetic resonance imaging
Clinical narrative: child had a generalized seizure; lost consciousness; stopped breathing; This is a spontaneous report received from a contactable reporter (Other HCP).  A 6 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 18Nov2021 16:00 (Lot number: FK5618) at the age of 6 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications included children's multivitamin. The following information was reported: SEIZURE (hospitalization, medically significant, life threatening) with onset 25Nov2021 09:00, outcome "recovering", described as "child had a generalized seizure"; LOSS OF CONSCIOUSNESS (hospitalization, medically significant, life threatening) with onset 25Nov2021 09:00, outcome "recovering", described as "lost consciousness"; RESPIRATORY ARREST (hospitalization, medically significant, life threatening) with onset 25Nov2021 09:00, outcome "recovering", described as "stopped breathing". The patient was hospitalized for seizure, loss of consciousness, respiratory arrest (hospitalization duration: 2 day(s)). The events "child had a generalized seizure", "lost consciousness" and "stopped breathing" were evaluated at the physician office visit and emergency room visit. On 25Nov2021, around 9am the patient had a generalized seizure, lost consciousness and stopped breathing. The patient was transported via ambulance to hospital where she was seen in the emergency department and admitted to the hospital for a 2-day stay. The patient has no previous history of seizures or any other significant medical events. The patient received a multitude of tests at the hospital including blood work, urinalysis, CT scan and EEG on 25Nov2021. All test results have come back normal at this time and care providers cannot identify another causal factor for the seizure. Child will continue to be evaluated by pediatrician and pediatric neurologist for further testing and follow-up care. There is no covid prior vaccination. The patient tested Covid at hospital on 25Nov2021 post vaccination, Covid test result was negative. The is no other vaccine in four weeks. Therapeutic measures were taken as a result of seizure, loss of consciousness, respiratory arrest.; Sender's Comments: Based on the available information and a possible contributory role of suspect product BNT162B2 to the development of events seizure, loss of consciousness and respiratory arrest cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 6.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Respiratory arrest, Seizure, Urine analysis
Clinical narrative: child had a generalized seizure; lost consciousness; stopped breathing; This is a spontaneous report received from a contactable reporter (Other HCP).  A 6 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 18Nov2021 16:00 (Lot number: FK5618) at the age of 6 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications included children's multivitamin. The following information was reported: SEIZURE (hospitalization, medically significant, life threatening) with onset 25Nov2021 09:00, outcome "recovering", described as "child had a generalized seizure"; LOSS OF CONSCIOUSNESS (hospitalization, medically significant, life threatening) with onset 25Nov2021 09:00, outcome "recovering", described as "lost consciousness"; RESPIRATORY ARREST (hospitalization, medically significant, life threatening) with onset 25Nov2021 09:00, outcome "recovering", described as "stopped breathing". The patient was hospitalized for seizure, loss of consciousness, respiratory arrest (hospitalization duration: 2 day(s)). The events "child had a generalized seizure", "lost consciousness" and "stopped breathing" were evaluated at the physician office visit and emergency room visit. On 25Nov2021, around 9am the patient had a generalized seizure, lost consciousness and stopped breathing. The patient was transported via ambulance to hospital where she was seen in the emergency department and admitted to the hospital for a 2-day stay. The patient has no previous history of seizures or any other significant medical events. The patient received a multitude of tests at the hospital including blood work, urinalysis, CT scan and EEG on 25Nov2021. All test results have come back normal at this time and care providers cannot identify another causal factor for the seizure. Child will continue to be evaluated by pediatrician and pediatric neurologist for further testing and follow-up care. There is no covid prior vaccination. The patient tested Covid at hospital on 25Nov2021 post vaccination, Covid test result was negative. The is no other vaccine in four weeks. Therapeutic measures were taken as a result of seizure, loss of consciousness, respiratory arrest.; Sender's Comments: Based on the available information and a possible contributory role of suspect product BNT162B2 to the development of events seizure, loss of consciousness and respiratory arrest cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 6.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cyanosis, Electroencephalogram normal, Eye movement disorder, General physical condition abnormal, Memory impairment
Clinical narrative: child had a generalized seizure; lost consciousness; stopped breathing; This is a spontaneous report received from a contactable reporter (Other HCP).  A 6 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 18Nov2021 16:00 (Lot number: FK5618) at the age of 6 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications included children's multivitamin. The following information was reported: SEIZURE (hospitalization, medically significant, life threatening) with onset 25Nov2021 09:00, outcome "recovering", described as "child had a generalized seizure"; LOSS OF CONSCIOUSNESS (hospitalization, medically significant, life threatening) with onset 25Nov2021 09:00, outcome "recovering", described as "lost consciousness"; RESPIRATORY ARREST (hospitalization, medically significant, life threatening) with onset 25Nov2021 09:00, outcome "recovering", described as "stopped breathing". The patient was hospitalized for seizure, loss of consciousness, respiratory arrest (hospitalization duration: 2 day(s)). The events "child had a generalized seizure", "lost consciousness" and "stopped breathing" were evaluated at the physician office visit and emergency room visit. On 25Nov2021, around 9am the patient had a generalized seizure, lost consciousness and stopped breathing. The patient was transported via ambulance to hospital where she was seen in the emergency department and admitted to the hospital for a 2-day stay. The patient has no previous history of seizures or any other significant medical events. The patient received a multitude of tests at the hospital including blood work, urinalysis, CT scan and EEG on 25Nov2021. All test results have come back normal at this time and care providers cannot identify another causal factor for the seizure. Child will continue to be evaluated by pediatrician and pediatric neurologist for further testing and follow-up care. There is no covid prior vaccination. The patient tested Covid at hospital on 25Nov2021 post vaccination, Covid test result was negative. The is no other vaccine in four weeks. Therapeutic measures were taken as a result of seizure, loss of consciousness, respiratory arrest.; Sender's Comments: Based on the available information and a possible contributory role of suspect product BNT162B2 to the development of events seizure, loss of consciousness and respiratory arrest cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 6.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity, Respiratory arrest, Resuscitation, Retching
Clinical narrative: child had a generalized seizure; lost consciousness; stopped breathing; This is a spontaneous report received from a contactable reporter (Other HCP).  A 6 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 18Nov2021 16:00 (Lot number: FK5618) at the age of 6 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications included children's multivitamin. The following information was reported: SEIZURE (hospitalization, medically significant, life threatening) with onset 25Nov2021 09:00, outcome "recovering", described as "child had a generalized seizure"; LOSS OF CONSCIOUSNESS (hospitalization, medically significant, life threatening) with onset 25Nov2021 09:00, outcome "recovering", described as "lost consciousness"; RESPIRATORY ARREST (hospitalization, medically significant, life threatening) with onset 25Nov2021 09:00, outcome "recovering", described as "stopped breathing". The patient was hospitalized for seizure, loss of consciousness, respiratory arrest (hospitalization duration: 2 day(s)). The events "child had a generalized seizure", "lost consciousness" and "stopped breathing" were evaluated at the physician office visit and emergency room visit. On 25Nov2021, around 9am the patient had a generalized seizure, lost consciousness and stopped breathing. The patient was transported via ambulance to hospital where she was seen in the emergency department and admitted to the hospital for a 2-day stay. The patient has no previous history of seizures or any other significant medical events. The patient received a multitude of tests at the hospital including blood work, urinalysis, CT scan and EEG on 25Nov2021. All test results have come back normal at this time and care providers cannot identify another causal factor for the seizure. Child will continue to be evaluated by pediatrician and pediatric neurologist for further testing and follow-up care. There is no covid prior vaccination. The patient tested Covid at hospital on 25Nov2021 post vaccination, Covid test result was negative. The is no other vaccine in four weeks. Therapeutic measures were taken as a result of seizure, loss of consciousness, respiratory arrest.; Sender's Comments: Based on the available information and a possible contributory role of suspect product BNT162B2 to the development of events seizure, loss of consciousness and respiratory arrest cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 6.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Somnolence, Tremor, Vomiting
Clinical narrative: child had a generalized seizure; lost consciousness; stopped breathing; This is a spontaneous report received from a contactable reporter (Other HCP).  A 6 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 18Nov2021 16:00 (Lot number: FK5618) at the age of 6 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications included children's multivitamin. The following information was reported: SEIZURE (hospitalization, medically significant, life threatening) with onset 25Nov2021 09:00, outcome "recovering", described as "child had a generalized seizure"; LOSS OF CONSCIOUSNESS (hospitalization, medically significant, life threatening) with onset 25Nov2021 09:00, outcome "recovering", described as "lost consciousness"; RESPIRATORY ARREST (hospitalization, medically significant, life threatening) with onset 25Nov2021 09:00, outcome "recovering", described as "stopped breathing". The patient was hospitalized for seizure, loss of consciousness, respiratory arrest (hospitalization duration: 2 day(s)). The events "child had a generalized seizure", "lost consciousness" and "stopped breathing" were evaluated at the physician office visit and emergency room visit. On 25Nov2021, around 9am the patient had a generalized seizure, lost consciousness and stopped breathing. The patient was transported via ambulance to hospital where she was seen in the emergency department and admitted to the hospital for a 2-day stay. The patient has no previous history of seizures or any other significant medical events. The patient received a multitude of tests at the hospital including blood work, urinalysis, CT scan and EEG on 25Nov2021. All test results have come back normal at this time and care providers cannot identify another causal factor for the seizure. Child will continue to be evaluated by pediatrician and pediatric neurologist for further testing and follow-up care. There is no covid prior vaccination. The patient tested Covid at hospital on 25Nov2021 post vaccination, Covid test result was negative. The is no other vaccine in four weeks. Therapeutic measures were taken as a result of seizure, loss of consciousness, respiratory arrest.; Sender's Comments: Based on the available information and a possible contributory role of suspect product BNT162B2 to the development of events seizure, loss of consciousness and respiratory arrest cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 6.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Electroencephalogram, Loss of consciousness, Respiratory arrest
Clinical narrative: child had a generalized seizure; lost consciousness; stopped breathing; This is a spontaneous report received from a contactable reporter (Other HCP).  A 6 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 18Nov2021 16:00 (Lot number: FK5618) at the age of 6 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications included children's multivitamin. The following information was reported: SEIZURE (hospitalization, medically significant, life threatening) with onset 25Nov2021 09:00, outcome "recovering", described as "child had a generalized seizure"; LOSS OF CONSCIOUSNESS (hospitalization, medically significant, life threatening) with onset 25Nov2021 09:00, outcome "recovering", described as "lost consciousness"; RESPIRATORY ARREST (hospitalization, medically significant, life threatening) with onset 25Nov2021 09:00, outcome "recovering", described as "stopped breathing". The patient was hospitalized for seizure, loss of consciousness, respiratory arrest (hospitalization duration: 2 day(s)). The events "child had a generalized seizure", "lost consciousness" and "stopped breathing" were evaluated at the physician office visit and emergency room visit. On 25Nov2021, around 9am the patient had a generalized seizure, lost consciousness and stopped breathing. The patient was transported via ambulance to hospital where she was seen in the emergency department and admitted to the hospital for a 2-day stay. The patient has no previous history of seizures or any other significant medical events. The patient received a multitude of tests at the hospital including blood work, urinalysis, CT scan and EEG on 25Nov2021. All test results have come back normal at this time and care providers cannot identify another causal factor for the seizure. Child will continue to be evaluated by pediatrician and pediatric neurologist for further testing and follow-up care. There is no covid prior vaccination. The patient tested Covid at hospital on 25Nov2021 post vaccination, Covid test result was negative. The is no other vaccine in four weeks. Therapeutic measures were taken as a result of seizure, loss of consciousness, respiratory arrest.; Sender's Comments: Based on the available information and a possible contributory role of suspect product BNT162B2 to the development of events seizure, loss of consciousness and respiratory arrest cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 6.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test, Seizure, Urine analysis
Clinical narrative: child had a generalized seizure; lost consciousness; stopped breathing; This is a spontaneous report received from a contactable reporter (Other HCP).  A 6 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 18Nov2021 16:00 (Lot number: FK5618) at the age of 6 years as dose 1 (tris), single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications included children's multivitamin. The following information was reported: SEIZURE (hospitalization, medically significant, life threatening) with onset 25Nov2021 09:00, outcome "recovering", described as "child had a generalized seizure"; LOSS OF CONSCIOUSNESS (hospitalization, medically significant, life threatening) with onset 25Nov2021 09:00, outcome "recovering", described as "lost consciousness"; RESPIRATORY ARREST (hospitalization, medically significant, life threatening) with onset 25Nov2021 09:00, outcome "recovering", described as "stopped breathing". The patient was hospitalized for seizure, loss of consciousness, respiratory arrest (hospitalization duration: 2 day(s)). The events "child had a generalized seizure", "lost consciousness" and "stopped breathing" were evaluated at the physician office visit and emergency room visit. On 25Nov2021, around 9am the patient had a generalized seizure, lost consciousness and stopped breathing. The patient was transported via ambulance to hospital where she was seen in the emergency department and admitted to the hospital for a 2-day stay. The patient has no previous history of seizures or any other significant medical events. The patient received a multitude of tests at the hospital including blood work, urinalysis, CT scan and EEG on 25Nov2021. All test results have come back normal at this time and care providers cannot identify another causal factor for the seizure. Child will continue to be evaluated by pediatrician and pediatric neurologist for further testing and follow-up care. There is no covid prior vaccination. The patient tested Covid at hospital on 25Nov2021 post vaccination, Covid test result was negative. The is no other vaccine in four weeks. Therapeutic measures were taken as a result of seizure, loss of consciousness, respiratory arrest.; Sender's Comments: Based on the available information and a possible contributory role of suspect product BNT162B2 to the development of events seizure, loss of consciousness and respiratory arrest cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Laboratory test abnormal, Pain
Clinical narrative: ARTHRALGIA; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. Medical history was reported by patient as healthy. The patient received covid-19 vaccine ad26. cov2. s (suspension for injection) for prophylactic vaccination as a primary vaccination (dose series 1) on 28-JUL-2021. Route of administration, dose, and batch number not reported.  On an unspecified date after, the patient experienced discomfort in joints (dose series 1). The outcome for discomfort in joints was not reported.  The patient subsequently received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 in total, administered on OCT-2021 for prophylactic vaccination on his left arm (dose series 2). The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced arthralgia (dose series 2). About a month after receiving the booster, he complained of unbearable joint pain. The patient reported that after first vaccine he had discomfort but not as bad as after the booster dose. On 25-NOV-2021, he went to hospital (physician office visit) due to joint pain which was experienced all over the body including back and spine. The medical doctor diagnosed the patient with arthralgia. The patient was prescribed Meloxicam 15 mg. He reported that the medication was not helpful and he would visit his primary care physician (PCP). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arthralgia was not reported. This report was non-serious. This case, involving the same patient is linked to 20211161502.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia
Clinical narrative: ARTHRALGIA; This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. Medical history was reported by patient as healthy. The patient received covid-19 vaccine ad26. cov2. s (suspension for injection) for prophylactic vaccination as a primary vaccination (dose series 1) on 28-JUL-2021. Route of administration, dose, and batch number not reported.  On an unspecified date after, the patient experienced discomfort in joints (dose series 1). The outcome for discomfort in joints was not reported.  The patient subsequently received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 in total, administered on OCT-2021 for prophylactic vaccination on his left arm (dose series 2). The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced arthralgia (dose series 2). About a month after receiving the booster, he complained of unbearable joint pain. The patient reported that after first vaccine he had discomfort but not as bad as after the booster dose. On 25-NOV-2021, he went to hospital (physician office visit) due to joint pain which was experienced all over the body including back and spine. The medical doctor diagnosed the patient with arthralgia. The patient was prescribed Meloxicam 15 mg. He reported that the medication was not helpful and he would visit his primary care physician (PCP). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arthralgia was not reported. This report was non-serious. This case, involving the same patient is linked to 20211161502.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Palpitations, Tachycardia
Clinical narrative: symptoms of myocarditis; chest pain; palpitations; This spontaneous case was reported by a pharmacist and describes the occurrence of MYOCARDITIS (symptoms of myocarditis) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (symptoms of myocarditis) (seriousness criterion medically significant), CHEST PAIN (chest pain) and PALPITATIONS (palpitations). At the time of the report, MYOCARDITIS (symptoms of myocarditis), CHEST PAIN (chest pain) and PALPITATIONS (palpitations) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient went to get the second dose of the Moderna vaccine and stated that 2-3 days after their first dose they developed chest pain and palpitations, it happened in the morning and lasted 10 minutes for 6-8 days, then it started happening 2 times a day but less severe, and the last time was 2 days ago.  No concomitant medications were reported.  HCP referred the patient to their doctor and inquired if this patient should receive the second dose and what are Moderna recommendation in this regard.  No treatment medications were reported.  Company comment: This is a spontaneous case concerning a  19-year-old female patient with no reported medical history, who experienced the non-serious  unexpected events chest pain and palpitations, between 2-3 days after the first  dose of mRNA-1273. HCP report chest pain and palpitations as patient experiencing symptoms of myocarditis. No other information was provided to support myocarditis diagnoses. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a  19-year-old female patient with no reported medical history, who experienced the non-serious  unexpected events chest pain and palpitations, between 2-3 days after the first  dose of mRNA-1273. HCP report chest pain and palpitations as patient experiencing symptoms of myocarditis. No other information was provided to support myocarditis diagnoses. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Myocarditis, Palpitations
Clinical narrative: symptoms of myocarditis; chest pain; palpitations; This spontaneous case was reported by a pharmacist and describes the occurrence of MYOCARDITIS (symptoms of myocarditis) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (symptoms of myocarditis) (seriousness criterion medically significant), CHEST PAIN (chest pain) and PALPITATIONS (palpitations). At the time of the report, MYOCARDITIS (symptoms of myocarditis), CHEST PAIN (chest pain) and PALPITATIONS (palpitations) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient went to get the second dose of the Moderna vaccine and stated that 2-3 days after their first dose they developed chest pain and palpitations, it happened in the morning and lasted 10 minutes for 6-8 days, then it started happening 2 times a day but less severe, and the last time was 2 days ago.  No concomitant medications were reported.  HCP referred the patient to their doctor and inquired if this patient should receive the second dose and what are Moderna recommendation in this regard.  No treatment medications were reported.  Company comment: This is a spontaneous case concerning a  19-year-old female patient with no reported medical history, who experienced the non-serious  unexpected events chest pain and palpitations, between 2-3 days after the first  dose of mRNA-1273. HCP report chest pain and palpitations as patient experiencing symptoms of myocarditis. No other information was provided to support myocarditis diagnoses. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a  19-year-old female patient with no reported medical history, who experienced the non-serious  unexpected events chest pain and palpitations, between 2-3 days after the first  dose of mRNA-1273. HCP report chest pain and palpitations as patient experiencing symptoms of myocarditis. No other information was provided to support myocarditis diagnoses. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Vaccination site pain, Vaccination site swelling, Weight
Clinical narrative: feeling drug out; has no energy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 01Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEDATION (non-serious), outcome "unknown", described as "feeling drug out"; ASTHENIA (non-serious), outcome "unknown", described as "has no energy".  Additional Information: The patient was asking if it was okay to take aspirin after the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Sedation
Clinical narrative: feeling drug out; has no energy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 01Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEDATION (non-serious), outcome "unknown", described as "feeling drug out"; ASTHENIA (non-serious), outcome "unknown", described as "has no energy".  Additional Information: The patient was asking if it was okay to take aspirin after the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.