chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Chest discomfort, Dyspnoea, Hypertension, Pruritus
Clinical narrative: severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath; This is a spontaneous report from a contactable nurse (reporting for herself).  A 41-year-old non-pregnant female patient received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), both via an unspecified route of administration in the left arm, the first dose on 16Dec2020 09:00 (lot number: EH9899) and the second dose on 08Jan2021 07:15 (lot number: EL0140), both at a single dose for COVID-19 immunization.  Medical history included ongoing anxiety, from an unspecified date. The patient had no known allergies.  Concomitant medication included escitalopram oxalate (LEXAPRO), acetaminophen (MANUFACTURER UNKNOWN), naproxen sodium (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.  On 09Jan2021 at 01:30 AM, the patient experienced severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath, all of which were reported as being life-threatening.  The patient went to the Emergency room due to the events.  Therapeutic measures were taken as a result of the events and included: methylprednisolone sodium succinate (SOLUMEDROL) 125 mg, famotidine (MANUFACTURER UNKNOWN) 20 mg and diphenhydramine hydrochloride (BENADRYL) 50 mg.   The clinical outcome of severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  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: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia, Urticaria
Clinical narrative: severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath.; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath; severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath; This is a spontaneous report from a contactable nurse (reporting for herself).  A 41-year-old non-pregnant female patient received two doses of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), both via an unspecified route of administration in the left arm, the first dose on 16Dec2020 09:00 (lot number: EH9899) and the second dose on 08Jan2021 07:15 (lot number: EL0140), both at a single dose for COVID-19 immunization.  Medical history included ongoing anxiety, from an unspecified date. The patient had no known allergies.  Concomitant medication included escitalopram oxalate (LEXAPRO), acetaminophen (MANUFACTURER UNKNOWN), naproxen sodium (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.  On 09Jan2021 at 01:30 AM, the patient experienced severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath, all of which were reported as being life-threatening.  The patient went to the Emergency room due to the events.  Therapeutic measures were taken as a result of the events and included: methylprednisolone sodium succinate (SOLUMEDROL) 125 mg, famotidine (MANUFACTURER UNKNOWN) 20 mg and diphenhydramine hydrochloride (BENADRYL) 50 mg.   The clinical outcome of severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset severe angioedema, hives, tachycardia, hypertension, pruritus, chest tightness and shortness of breath cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  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: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure decreased, Chills, Malaise, Pyrexia, Syncope
Clinical narrative: fever and chills; fever and chills; blood pressure was low, about 90/50; did not feel well; syncope episode; unconscious; This is a spontaneous report from a contactable other health professional.  A 27-year-old non-pregnant female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899), via an unspecified route of administration in the left arm on 08Jan2021 at 12:00 at a single dose for COVID-19 immunization; received at a nursing home/senior living facility. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Medical history included COVID-19 from an unknown date and unknown if ongoing. No known allergies. Concomitant medications included unspecified birth control taken for an unspecified indication from an unknown date to an unknown date; within two weeks of vaccination. The patient experienced the following events and outcomes: syncope episode in Jan2021 with outcome of unknown, unconscious in Jan2021 with outcome of unknown, fever and chills on 09Jan2021 with outcome of unknown, blood pressure was low, about 90/50  on 09Jan2021 with outcome of unknown, did not feel well in Jan2021 with outcome of unknown; all of which were assessed as medically significant. The clinical course was reported as follows: the fever and chills began about one hour after vaccination (as reported). About 18 hours after the vaccination, the patient was getting up to take more paracetamol (TYLENOL) and did not feel well. The patient had a syncope episode in the bathroom (no issues as she sat on the floor before hand). The patient was unconscious for about 1-2 minutes. The patient's blood pressure several minutes later was low, about 90/50; however, the patient took the blood pressure measurement herself, so it may not have been exactly accurate. The patient underwent lab tests and procedures which included blood pressure measurement: low, about 90/50 on 09Jan2021.  Therapeutic measures were taken as a result of fever. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of all reported serious events cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  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: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Hypotension, Loss of consciousness, Malaise, Pyrexia
Clinical narrative: fever and chills; fever and chills; blood pressure was low, about 90/50; did not feel well; syncope episode; unconscious; This is a spontaneous report from a contactable other health professional.  A 27-year-old non-pregnant female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899), via an unspecified route of administration in the left arm on 08Jan2021 at 12:00 at a single dose for COVID-19 immunization; received at a nursing home/senior living facility. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Medical history included COVID-19 from an unknown date and unknown if ongoing. No known allergies. Concomitant medications included unspecified birth control taken for an unspecified indication from an unknown date to an unknown date; within two weeks of vaccination. The patient experienced the following events and outcomes: syncope episode in Jan2021 with outcome of unknown, unconscious in Jan2021 with outcome of unknown, fever and chills on 09Jan2021 with outcome of unknown, blood pressure was low, about 90/50  on 09Jan2021 with outcome of unknown, did not feel well in Jan2021 with outcome of unknown; all of which were assessed as medically significant. The clinical course was reported as follows: the fever and chills began about one hour after vaccination (as reported). About 18 hours after the vaccination, the patient was getting up to take more paracetamol (TYLENOL) and did not feel well. The patient had a syncope episode in the bathroom (no issues as she sat on the floor before hand). The patient was unconscious for about 1-2 minutes. The patient's blood pressure several minutes later was low, about 90/50; however, the patient took the blood pressure measurement herself, so it may not have been exactly accurate. The patient underwent lab tests and procedures which included blood pressure measurement: low, about 90/50 on 09Jan2021.  Therapeutic measures were taken as a result of fever. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of all reported serious events cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  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: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: fever and chills; fever and chills; blood pressure was low, about 90/50; did not feel well; syncope episode; unconscious; This is a spontaneous report from a contactable other health professional.  A 27-year-old non-pregnant female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EH9899), via an unspecified route of administration in the left arm on 08Jan2021 at 12:00 at a single dose for COVID-19 immunization; received at a nursing home/senior living facility. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Medical history included COVID-19 from an unknown date and unknown if ongoing. No known allergies. Concomitant medications included unspecified birth control taken for an unspecified indication from an unknown date to an unknown date; within two weeks of vaccination. The patient experienced the following events and outcomes: syncope episode in Jan2021 with outcome of unknown, unconscious in Jan2021 with outcome of unknown, fever and chills on 09Jan2021 with outcome of unknown, blood pressure was low, about 90/50  on 09Jan2021 with outcome of unknown, did not feel well in Jan2021 with outcome of unknown; all of which were assessed as medically significant. The clinical course was reported as follows: the fever and chills began about one hour after vaccination (as reported). About 18 hours after the vaccination, the patient was getting up to take more paracetamol (TYLENOL) and did not feel well. The patient had a syncope episode in the bathroom (no issues as she sat on the floor before hand). The patient was unconscious for about 1-2 minutes. The patient's blood pressure several minutes later was low, about 90/50; however, the patient took the blood pressure measurement herself, so it may not have been exactly accurate. The patient underwent lab tests and procedures which included blood pressure measurement: low, about 90/50 on 09Jan2021.  Therapeutic measures were taken as a result of fever. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of all reported serious events cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  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: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood chloride decreased, Chest X-ray normal, Cough, Dyspnoea, Eosinophil count increased
Clinical narrative: Patient experienced low O2 saturations (88-90%) and shortness of breath on 1/7/21 in the evening that improved with benadryl.  Continued shortness of breath on 1/8 and 1/9/21 and reported to Urgent Care on 1/9/21.  Was diagnosed with allergic reaction.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eosinophil percentage increased, Full blood count, Hyponatraemia, Metabolic function test
Clinical narrative: Patient experienced low O2 saturations (88-90%) and shortness of breath on 1/7/21 in the evening that improved with benadryl.  Continued shortness of breath on 1/8 and 1/9/21 and reported to Urgent Care on 1/9/21.  Was diagnosed with allergic reaction.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Dyspnoea, Full blood count, Hypersensitivity, Metabolic function test
Clinical narrative: Patient experienced low O2 saturations (88-90%) and shortness of breath on 1/7/21 in the evening that improved with benadryl.  Continued shortness of breath on 1/8 and 1/9/21 and reported to Urgent Care on 1/9/21.  Was diagnosed with allergic reaction.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oxygen saturation decreased
Clinical narrative: Patient experienced low O2 saturations (88-90%) and shortness of breath on 1/7/21 in the evening that improved with benadryl.  Continued shortness of breath on 1/8 and 1/9/21 and reported to Urgent Care on 1/9/21.  Was diagnosed with allergic reaction.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deafness unilateral
Clinical narrative: complete hearing loss at the right ear, 5 hours post injection, continued till now 3 days past injection, not resolved yet prior to report; This is a spontaneous report from a contactable physician. A 72-years-old male patient started to receive bnt162b2 (BNT162B2) Lot number# ek9231 intramuscularly on 06Jan2021 12:00 at single dose for covid-19 immunisation. Anatomical Location: Arm Right. Facility where the most recent COVID-19 vaccine was administered: Hospital. Medical history included diabetes mellitus, hypertension. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included alprazolam (AZOR [ALPRAZOLAM]), metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET [METFORMIN HYDROCHLORIDE;SITAGLIPTIN PHOSPHATE MONOHYDRATE]), atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]). The patient on 06Jan2021 18:00 reported complete hearing loss at the right ear, 5 hours post injection, continued till now 3 days past injection, not resolved yet prior to report. The action taken was not applicable.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported hearing loss 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: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deafness, Deafness unilateral
Clinical narrative: complete hearing loss at the right ear, 5 hours post injection, continued till now 3 days past injection, not resolved yet prior to report; This is a spontaneous report from a contactable physician. A 72-years-old male patient started to receive bnt162b2 (BNT162B2) Lot number# ek9231 intramuscularly on 06Jan2021 12:00 at single dose for covid-19 immunisation. Anatomical Location: Arm Right. Facility where the most recent COVID-19 vaccine was administered: Hospital. Medical history included diabetes mellitus, hypertension. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included alprazolam (AZOR [ALPRAZOLAM]), metformin hydrochloride, sitagliptin phosphate monohydrate (JANUMET [METFORMIN HYDROCHLORIDE;SITAGLIPTIN PHOSPHATE MONOHYDRATE]), atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]). The patient on 06Jan2021 18:00 reported complete hearing loss at the right ear, 5 hours post injection, continued till now 3 days past injection, not resolved yet prior to report. The action taken was not applicable.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported hearing loss 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: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Feeling hot, Heart rate increased, Hyperhidrosis, Paraesthesia
Clinical narrative: Immediately complained of feeling hot, tingly, anxious, shaky.  Noted to have elevated blood pressure and pulse.  Symptoms continued for one hour.  Patient was seen in the Emergency Department for monitoring and discharged to home.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness, Feeling hot, Flushing, Nausea
Clinical narrative: Immediately complained of feeling hot, tingly, anxious, shaky.  Noted to have elevated blood pressure and pulse.  Symptoms continued for one hour.  Patient was seen in the Emergency Department for monitoring and discharged to home.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia, Tremor
Clinical narrative: Immediately complained of feeling hot, tingly, anxious, shaky.  Noted to have elevated blood pressure and pulse.  Symptoms continued for one hour.  Patient was seen in the Emergency Department for monitoring and discharged to home.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Blood pressure increased, Feeling hot, Heart rate increased, Immediate post-injection reaction
Clinical narrative: Immediately complained of feeling hot, tingly, anxious, shaky.  Noted to have elevated blood pressure and pulse.  Symptoms continued for one hour.  Patient was seen in the Emergency Department for monitoring and discharged to home.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nervousness, Paraesthesia
Clinical narrative: Immediately complained of feeling hot, tingly, anxious, shaky.  Noted to have elevated blood pressure and pulse.  Symptoms continued for one hour.  Patient was seen in the Emergency Department for monitoring and discharged to home.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Chest discomfort, Dyspnoea
Clinical narrative: Sore throat, severe chest tightness and pressure, very hard to breathe in, more than 30 minutes after covid vaccine, dizziness, headache, lightheadedness; severe chest tightness and pressure; very hard to breathe in, more than 30 minutes after covid vaccine; Dizziness /lightheadedness; headache; This is a spontaneous report from a contactable consumer (patient).  A 35-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142), via an unspecified route of administration at left arm on 09Jan2021 10:30 at single dose for COVID-19 immunization at a hospital. The patient's medical history included migraines, asthma, diabetes, sleep apnea, low immune system, post-traumatic stress disorder (PTSD), depression, panic attacks, insomnia, borderline personality disorder, and known allergies to medications, food, or other product (10 total). Concomitant medications included adult tetanus vaccine on 04Jan2021 received at right arm, for immunization (within 4 weeks prior to the COVID vaccine); first dose of botulinum toxin type a (BOTOX) on 06Jan2021 at single (31 shots in 7 muscle groups) for migraines (within 4 weeks prior to the COVID vaccine); and clindamycin antibiotic for infection in finger (took within in two weeks). The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for COVID-19 since the vaccination. On 09Jan2021 11:00, the patient experienced sore throat, severe chest tightness and pressure, very hard to breathe in, more than 30 minutes after COVID vaccine, "dizziness/lightheadedness", and headache. The above mentioned events resulted in emergency room/department or urgent care visit, and patient received breathing treatment, oxygen for over an hour for these events. The outcome of the events was unknown. The reporter considered the events as non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Headache, Oropharyngeal pain
Clinical narrative: Sore throat, severe chest tightness and pressure, very hard to breathe in, more than 30 minutes after covid vaccine, dizziness, headache, lightheadedness; severe chest tightness and pressure; very hard to breathe in, more than 30 minutes after covid vaccine; Dizziness /lightheadedness; headache; This is a spontaneous report from a contactable consumer (patient).  A 35-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142), via an unspecified route of administration at left arm on 09Jan2021 10:30 at single dose for COVID-19 immunization at a hospital. The patient's medical history included migraines, asthma, diabetes, sleep apnea, low immune system, post-traumatic stress disorder (PTSD), depression, panic attacks, insomnia, borderline personality disorder, and known allergies to medications, food, or other product (10 total). Concomitant medications included adult tetanus vaccine on 04Jan2021 received at right arm, for immunization (within 4 weeks prior to the COVID vaccine); first dose of botulinum toxin type a (BOTOX) on 06Jan2021 at single (31 shots in 7 muscle groups) for migraines (within 4 weeks prior to the COVID vaccine); and clindamycin antibiotic for infection in finger (took within in two weeks). The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for COVID-19 since the vaccination. On 09Jan2021 11:00, the patient experienced sore throat, severe chest tightness and pressure, very hard to breathe in, more than 30 minutes after COVID vaccine, "dizziness/lightheadedness", and headache. The above mentioned events resulted in emergency room/department or urgent care visit, and patient received breathing treatment, oxygen for over an hour for these events. The outcome of the events was unknown. The reporter considered the events as non-serious.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Dizziness, Headache, Pyrexia, Respiratory arrest
Clinical narrative: death 2 days after vaccine; 101 fever on day of booster shot; This is a spontaneous report from a contactable consumer. A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 09Jan2021 (at the age of 65-years-old) as a single dose for COVID-19 immunization. Medical history included high blood pressure, high cholesterol, enlarged prostate, and lifelong digestive issues/irritable bowel syndrome (IBS). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced 101 fever on day of booster shot on 09Jan2021 and death 2 days after vaccine on 10Jan2021. The event, death 2 days after vaccine, was reported as fatal. The patient underwent lab tests and procedures, which included body temperature: 101 on 09Jan2021. The patient did not receive treatment for the events. The clinical outcome of 101 fever on day of booster shot was unknown and of death 2 days after vaccine was fatal. The patient died on 10Jan2021. The cause of death was unknown. It was unknown if an autopsy was done. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Reported Cause(s) of Death: death 2 days after vaccine
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Resuscitation
Clinical narrative: death 2 days after vaccine; 101 fever on day of booster shot; This is a spontaneous report from a contactable consumer. A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 09Jan2021 (at the age of 65-years-old) as a single dose for COVID-19 immunization. Medical history included high blood pressure, high cholesterol, enlarged prostate, and lifelong digestive issues/irritable bowel syndrome (IBS). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced 101 fever on day of booster shot on 09Jan2021 and death 2 days after vaccine on 10Jan2021. The event, death 2 days after vaccine, was reported as fatal. The patient underwent lab tests and procedures, which included body temperature: 101 on 09Jan2021. The patient did not receive treatment for the events. The clinical outcome of 101 fever on day of booster shot was unknown and of death 2 days after vaccine was fatal. The patient died on 10Jan2021. The cause of death was unknown. It was unknown if an autopsy was done. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Reported Cause(s) of Death: death 2 days after vaccine
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Feeling abnormal
Clinical narrative: death 2 days after vaccine; 101 fever on day of booster shot; This is a spontaneous report from a contactable consumer. A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 09Jan2021 (at the age of 65-years-old) as a single dose for COVID-19 immunization. Medical history included high blood pressure, high cholesterol, enlarged prostate, and lifelong digestive issues/irritable bowel syndrome (IBS). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced 101 fever on day of booster shot on 09Jan2021 and death 2 days after vaccine on 10Jan2021. The event, death 2 days after vaccine, was reported as fatal. The patient underwent lab tests and procedures, which included body temperature: 101 on 09Jan2021. The patient did not receive treatment for the events. The clinical outcome of 101 fever on day of booster shot was unknown and of death 2 days after vaccine was fatal. The patient died on 10Jan2021. The cause of death was unknown. It was unknown if an autopsy was done. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Reported Cause(s) of Death: death 2 days after vaccine
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Pyrexia
Clinical narrative: death 2 days after vaccine; 101 fever on day of booster shot; This is a spontaneous report from a contactable consumer. A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 09Jan2021 (at the age of 65-years-old) as a single dose for COVID-19 immunization. Medical history included high blood pressure, high cholesterol, enlarged prostate, and lifelong digestive issues/irritable bowel syndrome (IBS). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced 101 fever on day of booster shot on 09Jan2021 and death 2 days after vaccine on 10Jan2021. The event, death 2 days after vaccine, was reported as fatal. The patient underwent lab tests and procedures, which included body temperature: 101 on 09Jan2021. The patient did not receive treatment for the events. The clinical outcome of 101 fever on day of booster shot was unknown and of death 2 days after vaccine was fatal. The patient died on 10Jan2021. The cause of death was unknown. It was unknown if an autopsy was done. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Reported Cause(s) of Death: death 2 days after vaccine
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram cerebral, Arteriogram carotid, Chest X-ray, Computerised tomogram head, Facial paresis
Clinical narrative: Systemic: Rash (other than injection site)-Mild, Systemic: Fever-Mild, Systemic: shortness of breath, dizziness, red from head to toe -Severe; symptoms lasted 0 days
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Full blood count, Hypoaesthesia, International normalised ratio, Magnetic resonance imaging, Metabolic function test
Clinical narrative: Systemic: Rash (other than injection site)-Mild, Systemic: Fever-Mild, Systemic: shortness of breath, dizziness, red from head to toe -Severe; symptoms lasted 0 days
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscular weakness, Prothrombin time, Visual field defect
Clinical narrative: Systemic: Rash (other than injection site)-Mild, Systemic: Fever-Mild, Systemic: shortness of breath, dizziness, red from head to toe -Severe; symptoms lasted 0 days
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Erythema, Pyrexia, Rash
Clinical narrative: Systemic: Rash (other than injection site)-Mild, Systemic: Fever-Mild, Systemic: shortness of breath, dizziness, red from head to toe -Severe; symptoms lasted 0 days
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blindness unilateral, Computerised tomogram head, Differential white blood cell count, Full blood count, Haematology test
Clinical narrative: Systemic: Rash (other than injection site)-Mild, Systemic: Fever-Mild, Systemic: shortness of breath, dizziness, red from head to toe -Severe; symptoms lasted 0 days
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Head discomfort, Headache, Hemiparesis, Hypoaesthesia, Intensive care
Clinical narrative: Systemic: Rash (other than injection site)-Mild, Systemic: Fever-Mild, Systemic: shortness of breath, dizziness, red from head to toe -Severe; symptoms lasted 0 days
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, Magnetic resonance imaging brain, Memory impairment
Clinical narrative: Systemic: Rash (other than injection site)-Mild, Systemic: Fever-Mild, Systemic: shortness of breath, dizziness, red from head to toe -Severe; symptoms lasted 0 days
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Gastrointestinal disorder, Headache
Clinical narrative: Fever; weakness; horrific headache; body aches; pain at administration site; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient (no pregnancy) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly at site of left arm at 15:00 on 05Jan2021 at single dose for COVID-19 immunization. Medical history included hon, asthma and allergies: metronidazole (FLAGYL). Prior to vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient experienced fever, weakness, horrific headache, body aches, and pain at administration site at 08:30 on 06Jan2021. The patient underwent Nasal Swab for COVID test with negative on 04Jan2021. Facility where the most recent COVID-19 vaccine was administered in Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications that the patient received within 2 weeks of vaccination. No treatment received for the adverse event. Since the vaccination, the patient has been tested for COVID-19. This case was identified as non-serious by reporter. The outcome of events was recovering.  Information on the lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Myalgia, Pyrexia
Clinical narrative: Fever; weakness; horrific headache; body aches; pain at administration site; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient (no pregnancy) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly at site of left arm at 15:00 on 05Jan2021 at single dose for COVID-19 immunization. Medical history included hon, asthma and allergies: metronidazole (FLAGYL). Prior to vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient experienced fever, weakness, horrific headache, body aches, and pain at administration site at 08:30 on 06Jan2021. The patient underwent Nasal Swab for COVID test with negative on 04Jan2021. Facility where the most recent COVID-19 vaccine was administered in Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications that the patient received within 2 weeks of vaccination. No treatment received for the adverse event. Since the vaccination, the patient has been tested for COVID-19. This case was identified as non-serious by reporter. The outcome of events was recovering.  Information on the lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Body temperature, Headache, Pain, Pyrexia
Clinical narrative: Fever; weakness; horrific headache; body aches; pain at administration site; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient (no pregnancy) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly at site of left arm at 15:00 on 05Jan2021 at single dose for COVID-19 immunization. Medical history included hon, asthma and allergies: metronidazole (FLAGYL). Prior to vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient experienced fever, weakness, horrific headache, body aches, and pain at administration site at 08:30 on 06Jan2021. The patient underwent Nasal Swab for COVID test with negative on 04Jan2021. Facility where the most recent COVID-19 vaccine was administered in Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications that the patient received within 2 weeks of vaccination. No treatment received for the adverse event. Since the vaccination, the patient has been tested for COVID-19. This case was identified as non-serious by reporter. The outcome of events was recovering.  Information on the lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Fever; weakness; horrific headache; body aches; pain at administration site; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient (no pregnancy) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly at site of left arm at 15:00 on 05Jan2021 at single dose for COVID-19 immunization. Medical history included hon, asthma and allergies: metronidazole (FLAGYL). Prior to vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient experienced fever, weakness, horrific headache, body aches, and pain at administration site at 08:30 on 06Jan2021. The patient underwent Nasal Swab for COVID test with negative on 04Jan2021. Facility where the most recent COVID-19 vaccine was administered in Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications that the patient received within 2 weeks of vaccination. No treatment received for the adverse event. Since the vaccination, the patient has been tested for COVID-19. This case was identified as non-serious by reporter. The outcome of events was recovering.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Nausea
Clinical narrative: 99 degrees; felt really bad/feels like a 3 or 4 out of 10; muscle aches and pains; tired and fatigue; felt like he was going to throw up; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: PFI302), via an unspecified route of administration in left arm on 05Jan2021 11:00 at single dose for ''front line worker''. Medical history included Crohn's disease from 2012.  Concomitant medications included adalimumab (HUMIRA, injection, Lot: R22-03-A-01, Expiry: Feb2021) from Feb2019 and ongoing at 40 ml twice monthly for Crohn's disease (When providing weight he adds that he has had some weight gain due to medication side effects with Humira), ibuprofen (He took Ibuprofen on Tuesday night and 1 last night. He has not taken any today).  Caller received the Pfizer covid-19 vaccine two days ago (05Jan2021). He has mild side effects to report. He is a Clinic Social Worker. Following the vaccine he experienced muscle aches and pains on 05Jan2021. He was tired and fatigued on 05Jan2021. His temperature was 97.5 yesterday (06Jan2021). It now 99 degrees (07Jan2021). His temperature went up 1.5 degrees. He felt like he was going to throw up in Jan2021. He received the vaccine at 11:00 am. At 05Jan2021 4:00 pm he felt really bad. He feels like a 3 or 4 out of 10. He is scheduled to get his second dose on 26Jan2021. The outcome of the events muscle aches and pains and tired and fatigue was recovering. The outcome of other events was unknown.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Fatigue, Feeling abnormal, Investigation, Myalgia
Clinical narrative: 99 degrees; felt really bad/feels like a 3 or 4 out of 10; muscle aches and pains; tired and fatigue; felt like he was going to throw up; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: PFI302), via an unspecified route of administration in left arm on 05Jan2021 11:00 at single dose for ''front line worker''. Medical history included Crohn's disease from 2012.  Concomitant medications included adalimumab (HUMIRA, injection, Lot: R22-03-A-01, Expiry: Feb2021) from Feb2019 and ongoing at 40 ml twice monthly for Crohn's disease (When providing weight he adds that he has had some weight gain due to medication side effects with Humira), ibuprofen (He took Ibuprofen on Tuesday night and 1 last night. He has not taken any today).  Caller received the Pfizer covid-19 vaccine two days ago (05Jan2021). He has mild side effects to report. He is a Clinic Social Worker. Following the vaccine he experienced muscle aches and pains on 05Jan2021. He was tired and fatigued on 05Jan2021. His temperature was 97.5 yesterday (06Jan2021). It now 99 degrees (07Jan2021). His temperature went up 1.5 degrees. He felt like he was going to throw up in Jan2021. He received the vaccine at 11:00 am. At 05Jan2021 4:00 pm he felt really bad. He feels like a 3 or 4 out of 10. He is scheduled to get his second dose on 26Jan2021. The outcome of the events muscle aches and pains and tired and fatigue was recovering. The outcome of other events was unknown.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: 99 degrees; felt really bad/feels like a 3 or 4 out of 10; muscle aches and pains; tired and fatigue; felt like he was going to throw up; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: PFI302), via an unspecified route of administration in left arm on 05Jan2021 11:00 at single dose for ''front line worker''. Medical history included Crohn's disease from 2012.  Concomitant medications included adalimumab (HUMIRA, injection, Lot: R22-03-A-01, Expiry: Feb2021) from Feb2019 and ongoing at 40 ml twice monthly for Crohn's disease (When providing weight he adds that he has had some weight gain due to medication side effects with Humira), ibuprofen (He took Ibuprofen on Tuesday night and 1 last night. He has not taken any today).  Caller received the Pfizer covid-19 vaccine two days ago (05Jan2021). He has mild side effects to report. He is a Clinic Social Worker. Following the vaccine he experienced muscle aches and pains on 05Jan2021. He was tired and fatigued on 05Jan2021. His temperature was 97.5 yesterday (06Jan2021). It now 99 degrees (07Jan2021). His temperature went up 1.5 degrees. He felt like he was going to throw up in Jan2021. He received the vaccine at 11:00 am. At 05Jan2021 4:00 pm he felt really bad. He feels like a 3 or 4 out of 10. He is scheduled to get his second dose on 26Jan2021. The outcome of the events muscle aches and pains and tired and fatigue was recovering. The outcome of other events was unknown.
Age: 69.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Death, Fall, Posture abnormal, Resuscitation, Unresponsive to stimuli
Clinical narrative: no reported adverse events, signs, symptoms. The individual was witnessed unresponsive and died the day after the vaccine, a full autopsy had been performed
Age: 69.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Autopsy, Death, Unresponsive to stimuli
Clinical narrative: no reported adverse events, signs, symptoms. The individual was witnessed unresponsive and died the day after the vaccine, a full autopsy had been performed
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Local reaction, Pharyngeal swelling, Pruritus, Rash
Clinical narrative: About 20 minutes after receiving vaccine, back sides of tongue with swelling, hives and rash on face, chest.  received Benadryl 25 mg, and epi -taken to ER rec?d additional benadryl, steroid, Pepcid and fluids-monitored and able to go home. Continued Benadryl at home and steroids.  30 hours after vaccine  had severe nausea and vomitting that resolved after a couple of hours.  Left arm extremely sore. Day 3 after vaccine felt much better. Followed up with PCP and will not get the 2nd dose.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash macular, Sensation of foreign body
Clinical narrative: About 20 minutes after receiving vaccine, back sides of tongue with swelling, hives and rash on face, chest.  received Benadryl 25 mg, and epi -taken to ER rec?d additional benadryl, steroid, Pepcid and fluids-monitored and able to go home. Continued Benadryl at home and steroids.  30 hours after vaccine  had severe nausea and vomitting that resolved after a couple of hours.  Left arm extremely sore. Day 3 after vaccine felt much better. Followed up with PCP and will not get the 2nd dose.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Nausea, Pain in extremity, Rash, Swollen tongue
Clinical narrative: About 20 minutes after receiving vaccine, back sides of tongue with swelling, hives and rash on face, chest.  received Benadryl 25 mg, and epi -taken to ER rec?d additional benadryl, steroid, Pepcid and fluids-monitored and able to go home. Continued Benadryl at home and steroids.  30 hours after vaccine  had severe nausea and vomitting that resolved after a couple of hours.  Left arm extremely sore. Day 3 after vaccine felt much better. Followed up with PCP and will not get the 2nd dose.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria, Vomiting
Clinical narrative: About 20 minutes after receiving vaccine, back sides of tongue with swelling, hives and rash on face, chest.  received Benadryl 25 mg, and epi -taken to ER rec?d additional benadryl, steroid, Pepcid and fluids-monitored and able to go home. Continued Benadryl at home and steroids.  30 hours after vaccine  had severe nausea and vomitting that resolved after a couple of hours.  Left arm extremely sore. Day 3 after vaccine felt much better. Followed up with PCP and will not get the 2nd dose.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Flushing, Lip swelling, Tachycardia
Clinical narrative: Anaphylactic reaction - swollen lips, dizziness, flushing, rapid heart rate