chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: Pregnant at the time of vaccination; Pregnant at the time of vaccination; Miscarriage (symptoms started 08Jan2021, confirmed 10Jan2021); This is a spontaneous report from a contactable physician (patient herself). A 37-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were unknown), via an unspecified route of administration on the right arm on 06Jan2021 12:30 at a single dose for COVID-19 immunization at the hospital facility. The patient had no relevant medical history and no known allergies. Concomitant medication included azelastine;fluticasone nasal sprays, prenatal. The patient did not have any other vaccine in four weeks. She did not have COVID prior to vaccination. The patient was 6 weeks pregnant at the onset of the event. Last menstrual date was on 11Nov2020 and Gestational period was 7. The patient was due to deliver on 26Aug2021. The patient reported miscarriage (symptoms started 08Jan2021 06:00 PM, confirmed 10Jan2021). The event resulted in doctor or other healthcare professional office/clinic visit, Congenital anomaly or birth defect. Treatment and event outcome were unknown. The patient had not been COVID tested post vaccination.   Information on the lot/batch number has been requested.; Sender's Comments: Based on a close compatible temporal association, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to patient's miscarriage cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Hyperhidrosis, Myalgia
Clinical narrative: Sudden onset severe muscle aches; Joint pain; Nausea; Lightheaded; Fever; Cold sweats; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient not pregnant received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Left arm on 18Dec2020 08:15 AM as a single dose for COVID-19 immunization, lot number: EL0140. Medical history was reported as none. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications in two weeks prior to the vaccination included Multivitamins, Vitamin C, Vitamin D3, zinc oxide and fluticasone propionate (FLONASE). On 18Dec2020 04:00 PM patient experienced sudden onset severe muscle aches, joint pain, nausea, lightheaded, fever, cold sweats and fatigue. No treatment was received for the events. Patient recovered from all the events on unknown date in Jan2021. Patient had not been tested for COVID-19 post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021015086 same patient/vaccine, different dose/event
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Sudden onset severe muscle aches; Joint pain; Nausea; Lightheaded; Fever; Cold sweats; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient not pregnant received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Left arm on 18Dec2020 08:15 AM as a single dose for COVID-19 immunization, lot number: EL0140. Medical history was reported as none. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications in two weeks prior to the vaccination included Multivitamins, Vitamin C, Vitamin D3, zinc oxide and fluticasone propionate (FLONASE). On 18Dec2020 04:00 PM patient experienced sudden onset severe muscle aches, joint pain, nausea, lightheaded, fever, cold sweats and fatigue. No treatment was received for the events. Patient recovered from all the events on unknown date in Jan2021. Patient had not been tested for COVID-19 post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021015086 same patient/vaccine, different dose/event
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Cold sweat, Dizziness, Fatigue, Myalgia
Clinical narrative: Sudden onset severe muscle aches; Joint pain; Nausea; Lightheaded; Fever; Cold sweats; Fatigue; This is a spontaneous report from a contactable nurse (patient). A 34-year-old female patient not pregnant received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the Left arm on 18Dec2020 08:15 AM as a single dose for COVID-19 immunization, lot number: EL0140. Medical history was reported as none. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications in two weeks prior to the vaccination included Multivitamins, Vitamin C, Vitamin D3, zinc oxide and fluticasone propionate (FLONASE). On 18Dec2020 04:00 PM patient experienced sudden onset severe muscle aches, joint pain, nausea, lightheaded, fever, cold sweats and fatigue. No treatment was received for the events. Patient recovered from all the events on unknown date in Jan2021. Patient had not been tested for COVID-19 post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021015086 same patient/vaccine, different dose/event
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Injection site pain, Pain, Pyrexia
Clinical narrative: fever; aches; feeling faint; fatigue; This is a spontaneous report from a contactable Nurse (Patient). This 54-year-old female patient (No pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via Intramuscular on Left arm on 08Jan2021 15:00 at single dose (Lot EK9231) for covid-19 immunisation. No other vaccine in four weeks. Medical history included allergies: Sulfa, Augmentin. Concomitant medications included ciclosporin (RESTASIS, eye drops), mometasone furoate (FLONASE), boron, calcium, cimicifuga racemosa extract, folic acid, glycine max extract, magnolia officinalis, nicotinic acid, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos (ESTROVEN), ipratropium and xylometazoline hydrochloride (NASAL SPRAY II). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular on Left arm on 17Dec2020 04:30 PM (Lot: VK5730) for covid-19 immunisation. The patient woke up 09Jan2021 at 7:00 am with fever (did not use thermometer) Aches, feeling faint, fatigue, took Advil and slept until 2pm, then took Tylenol and Felt better by 4pm. Outcome of the events was recovered.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Pain, Pyrexia
Clinical narrative: fever; aches; feeling faint; fatigue; This is a spontaneous report from a contactable Nurse (Patient). This 54-year-old female patient (No pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via Intramuscular on Left arm on 08Jan2021 15:00 at single dose (Lot EK9231) for covid-19 immunisation. No other vaccine in four weeks. Medical history included allergies: Sulfa, Augmentin. Concomitant medications included ciclosporin (RESTASIS, eye drops), mometasone furoate (FLONASE), boron, calcium, cimicifuga racemosa extract, folic acid, glycine max extract, magnolia officinalis, nicotinic acid, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos (ESTROVEN), ipratropium and xylometazoline hydrochloride (NASAL SPRAY II). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular on Left arm on 17Dec2020 04:30 PM (Lot: VK5730) for covid-19 immunisation. The patient woke up 09Jan2021 at 7:00 am with fever (did not use thermometer) Aches, feeling faint, fatigue, took Advil and slept until 2pm, then took Tylenol and Felt better by 4pm. Outcome of the events was recovered.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Syncope, Vomiting projectile
Clinical narrative: passed out; dizzy; hit the ground; nausea; pain at injection site; fever; chills; tired; severe headache; vomiting x 2; cold; experienced orthostatic hypotension; This is a spontaneous report from a contactable other HCP.    A 65-years-old female patient started to receive bnt162b2 (BNT162B2; Lot # EK9231) vaccine  , intramuscular in the left arm  on 07Jan2021 11:00 at single dose for Covid-19 immunisation .  Medical history included rubber sensitivity (Latex).  The patient's concomitant medications were not reported.   On 09Jan2021 12:00 the patient experienced orthostatic hypotension , passed out  with outcome of recovered , dizzy  with outcome of recovered , hit the ground  with outcome of recovered. These events were considered serious because medically significant. On 09Jan2021 12:00 the patient also experienced the following non serious events: nausea   with outcome of recovered , pain at injection site with outcome of recovered , fever with outcome of recovered , chills  with outcome of recovered , tired with outcome of recovered , severe headache on  with outcome of recovered , vomiting twice   with outcome of recovered , cold  with outcome of recovered.    The reporter stated the patient  attempted to get out of bed and she passed and hit the floor. Caller states she think she may have experienced orthostatic hypotension. Caller stated if she had stayed in bed she probably would not have fallen. Her husband found her laying in vomit The patient underwent lab tests and procedures which included body temperature: 99.6 fahrenheit on  unknown date.; Sender's Comments: Based on a chronological temporal association a causal relationship between events orthostatic hypotension , passed out  dizzy and  falling down and BNT162B2 vaccine cannot be completely 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: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Fall, Fatigue, Feeling cold
Clinical narrative: passed out; dizzy; hit the ground; nausea; pain at injection site; fever; chills; tired; severe headache; vomiting x 2; cold; experienced orthostatic hypotension; This is a spontaneous report from a contactable other HCP.    A 65-years-old female patient started to receive bnt162b2 (BNT162B2; Lot # EK9231) vaccine  , intramuscular in the left arm  on 07Jan2021 11:00 at single dose for Covid-19 immunisation .  Medical history included rubber sensitivity (Latex).  The patient's concomitant medications were not reported.   On 09Jan2021 12:00 the patient experienced orthostatic hypotension , passed out  with outcome of recovered , dizzy  with outcome of recovered , hit the ground  with outcome of recovered. These events were considered serious because medically significant. On 09Jan2021 12:00 the patient also experienced the following non serious events: nausea   with outcome of recovered , pain at injection site with outcome of recovered , fever with outcome of recovered , chills  with outcome of recovered , tired with outcome of recovered , severe headache on  with outcome of recovered , vomiting twice   with outcome of recovered , cold  with outcome of recovered.    The reporter stated the patient  attempted to get out of bed and she passed and hit the floor. Caller states she think she may have experienced orthostatic hypotension. Caller stated if she had stayed in bed she probably would not have fallen. Her husband found her laying in vomit The patient underwent lab tests and procedures which included body temperature: 99.6 fahrenheit on  unknown date.; Sender's Comments: Based on a chronological temporal association a causal relationship between events orthostatic hypotension , passed out  dizzy and  falling down and BNT162B2 vaccine cannot be completely 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: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Injection site pain, Loss of consciousness, Nausea, Orthostatic hypotension
Clinical narrative: passed out; dizzy; hit the ground; nausea; pain at injection site; fever; chills; tired; severe headache; vomiting x 2; cold; experienced orthostatic hypotension; This is a spontaneous report from a contactable other HCP.    A 65-years-old female patient started to receive bnt162b2 (BNT162B2; Lot # EK9231) vaccine  , intramuscular in the left arm  on 07Jan2021 11:00 at single dose for Covid-19 immunisation .  Medical history included rubber sensitivity (Latex).  The patient's concomitant medications were not reported.   On 09Jan2021 12:00 the patient experienced orthostatic hypotension , passed out  with outcome of recovered , dizzy  with outcome of recovered , hit the ground  with outcome of recovered. These events were considered serious because medically significant. On 09Jan2021 12:00 the patient also experienced the following non serious events: nausea   with outcome of recovered , pain at injection site with outcome of recovered , fever with outcome of recovered , chills  with outcome of recovered , tired with outcome of recovered , severe headache on  with outcome of recovered , vomiting twice   with outcome of recovered , cold  with outcome of recovered.    The reporter stated the patient  attempted to get out of bed and she passed and hit the floor. Caller states she think she may have experienced orthostatic hypotension. Caller stated if she had stayed in bed she probably would not have fallen. Her husband found her laying in vomit The patient underwent lab tests and procedures which included body temperature: 99.6 fahrenheit on  unknown date.; Sender's Comments: Based on a chronological temporal association a causal relationship between events orthostatic hypotension , passed out  dizzy and  falling down and BNT162B2 vaccine cannot be completely 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: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: passed out; dizzy; hit the ground; nausea; pain at injection site; fever; chills; tired; severe headache; vomiting x 2; cold; experienced orthostatic hypotension; This is a spontaneous report from a contactable other HCP.    A 65-years-old female patient started to receive bnt162b2 (BNT162B2; Lot # EK9231) vaccine  , intramuscular in the left arm  on 07Jan2021 11:00 at single dose for Covid-19 immunisation .  Medical history included rubber sensitivity (Latex).  The patient's concomitant medications were not reported.   On 09Jan2021 12:00 the patient experienced orthostatic hypotension , passed out  with outcome of recovered , dizzy  with outcome of recovered , hit the ground  with outcome of recovered. These events were considered serious because medically significant. On 09Jan2021 12:00 the patient also experienced the following non serious events: nausea   with outcome of recovered , pain at injection site with outcome of recovered , fever with outcome of recovered , chills  with outcome of recovered , tired with outcome of recovered , severe headache on  with outcome of recovered , vomiting twice   with outcome of recovered , cold  with outcome of recovered.    The reporter stated the patient  attempted to get out of bed and she passed and hit the floor. Caller states she think she may have experienced orthostatic hypotension. Caller stated if she had stayed in bed she probably would not have fallen. Her husband found her laying in vomit The patient underwent lab tests and procedures which included body temperature: 99.6 fahrenheit on  unknown date.; Sender's Comments: Based on a chronological temporal association a causal relationship between events orthostatic hypotension , passed out  dizzy and  falling down and BNT162B2 vaccine cannot be completely 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: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Injection soreness; headache; tiredness/feeling rundown; This is a spontaneous report from a contactable consumer (patient).  A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3249) on 20Dec2020 16:30 at single dose in left arm COVID-19 immunization. Medical history included Allergies to Sulfa, Factor IV Leiden, diabetes.  Concomitant medication included acetylsalicylic acid (BABY ASPIRIN), colecalciferol (VITAMIN D), lisinopril and Multivitamin (unspecified) . On 20Dec2020 at 20:00 the patient experienced injection soreness, headache, tiredness/feeling rundown. No treatment given and  patient recovered from all the events on an unknown date. Patient was tested pot vaccination: a Nasal Swab was done on 29Dec2020 and was negative. On 09Jan2021 at 21:00 patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3249) at single dose in Left arm for COVID-19 immunization.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021015299 same patient, different event and vaccine
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain
Clinical narrative: Injection soreness; headache; tiredness/feeling rundown; This is a spontaneous report from a contactable consumer (patient).  A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3249) on 20Dec2020 16:30 at single dose in left arm COVID-19 immunization. Medical history included Allergies to Sulfa, Factor IV Leiden, diabetes.  Concomitant medication included acetylsalicylic acid (BABY ASPIRIN), colecalciferol (VITAMIN D), lisinopril and Multivitamin (unspecified) . On 20Dec2020 at 20:00 the patient experienced injection soreness, headache, tiredness/feeling rundown. No treatment given and  patient recovered from all the events on an unknown date. Patient was tested pot vaccination: a Nasal Swab was done on 29Dec2020 and was negative. On 09Jan2021 at 21:00 patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3249) at single dose in Left arm for COVID-19 immunization.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021015299 same patient, different event and vaccine
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Injection soreness; headache; tiredness/feeling rundown; This is a spontaneous report from a contactable consumer (patient).  A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL3249) on 20Dec2020 16:30 at single dose in left arm COVID-19 immunization. Medical history included Allergies to Sulfa, Factor IV Leiden, diabetes.  Concomitant medication included acetylsalicylic acid (BABY ASPIRIN), colecalciferol (VITAMIN D), lisinopril and Multivitamin (unspecified) . On 20Dec2020 at 20:00 the patient experienced injection soreness, headache, tiredness/feeling rundown. No treatment given and  patient recovered from all the events on an unknown date. Patient was tested pot vaccination: a Nasal Swab was done on 29Dec2020 and was negative. On 09Jan2021 at 21:00 patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3249) at single dose in Left arm for COVID-19 immunization.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021015299 same patient, different event and vaccine
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: Full body myalgia; fatigue; diaphoresis; fever; Left upper arm edema and pain/tenderness.; Left upper arm edema and pain/tenderness.; This is a spontaneous report from a contactable nurse reported for herself.  A 33-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EK9231 via an unspecified route of administration on 09Jan2021 11:00 at SINGLE DOSE  for covid-19 immunisation. Vaccine location: left arm, dose number 2, facility type vaccine: hospital. Historical Vaccine bnt162b2 (BNT162B2) Lot number EL0140  on 21Dec2020 14:45  vaccine location left arm, dose number 1, facility type vaccine: hospital. The patient medical history was not reported. There were no concomitant medications.   The patient experienced left upper arm edema and pain/tenderness onset within 3 hours of receiving the 2nd dose of the vaccine. In addition: full body myalgia, fatigue, diaphoresis and fever. Symptom duration was about 12 hours. Symptoms were relieve with Tylenol and Ibuprofen. The action taken was not applicable.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Hyperhidrosis, Myalgia, Oedema peripheral, Pain in extremity
Clinical narrative: Full body myalgia; fatigue; diaphoresis; fever; Left upper arm edema and pain/tenderness.; Left upper arm edema and pain/tenderness.; This is a spontaneous report from a contactable nurse reported for herself.  A 33-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EK9231 via an unspecified route of administration on 09Jan2021 11:00 at SINGLE DOSE  for covid-19 immunisation. Vaccine location: left arm, dose number 2, facility type vaccine: hospital. Historical Vaccine bnt162b2 (BNT162B2) Lot number EL0140  on 21Dec2020 14:45  vaccine location left arm, dose number 1, facility type vaccine: hospital. The patient medical history was not reported. There were no concomitant medications.   The patient experienced left upper arm edema and pain/tenderness onset within 3 hours of receiving the 2nd dose of the vaccine. In addition: full body myalgia, fatigue, diaphoresis and fever. Symptom duration was about 12 hours. Symptoms were relieve with Tylenol and Ibuprofen. The action taken was not applicable.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Full body myalgia; fatigue; diaphoresis; fever; Left upper arm edema and pain/tenderness.; Left upper arm edema and pain/tenderness.; This is a spontaneous report from a contactable nurse reported for herself.  A 33-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EK9231 via an unspecified route of administration on 09Jan2021 11:00 at SINGLE DOSE  for covid-19 immunisation. Vaccine location: left arm, dose number 2, facility type vaccine: hospital. Historical Vaccine bnt162b2 (BNT162B2) Lot number EL0140  on 21Dec2020 14:45  vaccine location left arm, dose number 1, facility type vaccine: hospital. The patient medical history was not reported. There were no concomitant medications.   The patient experienced left upper arm edema and pain/tenderness onset within 3 hours of receiving the 2nd dose of the vaccine. In addition: full body myalgia, fatigue, diaphoresis and fever. Symptom duration was about 12 hours. Symptoms were relieve with Tylenol and Ibuprofen. The action taken was not applicable.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Diarrhoea, Laboratory test, Nausea, Rash
Clinical narrative: Admitted in Hospital for Anaphylaxis.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash pruritic, Throat tightness
Clinical narrative: Admitted in Hospital for Anaphylaxis.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Admitted in Hospital for Anaphylaxis.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood creatine phosphokinase normal, Blood magnesium normal, Blood thyroid stimulating hormone normal, Borrelia test, Borrelia test negative
Clinical narrative: severe temporary paralysis from the neck down.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count abnormal, Gait inability, Human chorionic gonadotropin negative, Hypoaesthesia, Hypochromic anaemia
Clinical narrative: severe temporary paralysis from the neck down.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Lymphocyte percentage increased, Magnetic resonance imaging brain normal, Magnetic resonance imaging spinal normal, Metabolic function test normal
Clinical narrative: severe temporary paralysis from the neck down.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Muscular weakness, Neutrophil percentage decreased, Red blood cell sedimentation rate increased, SARS-CoV-2 test negative
Clinical narrative: severe temporary paralysis from the neck down.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Scan with contrast normal, Treponema test negative, Vitamin B12 normal, Vitamin D decreased
Clinical narrative: severe temporary paralysis from the neck down.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paralysis
Clinical narrative: severe temporary paralysis from the neck down.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram head, Loss of proprioception, Magnetic resonance imaging, Magnetic resonance imaging brain
Clinical narrative: suddenly lost mobility of left arm; Continue paresthesia and proprioreceptive deficits of left arm; Continue paresthesia and proprioreceptive deficits of left arm; This is a spontaneous report from a contactable nurse (patient). This 46-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EK5730) intramuscular, in right arm, on 16Dec2020 at 14:00, for COVID-19 immunization. No other vaccine was given in 4 weeks. Medical history included hypothyroidism, migraine headaches, IBS and COVID-19 (on an unspecified date prior to vaccination). Past drug history included allergy to morphine. Concomitant medication included levothyroxine sodium (SYNTHROID). On 23Dec2020 at 09:30 the patient experienced suddenly lost mobility of left arm, continue paresthesia and proprioreceptive deficits of left arm. She was transported to the ER and was admitted to hospital for 2 days. CT of brain X3, MRI of brain X2, MRI of C-spine and Brachioplexus were performed with unknown results. The patient was not tested for COVID19 after vaccination. The events resulted in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, disability or permanent damage. No treatment was administered. The events had not yet resolved.; Sender's Comments: Based on the temporal relationship, the association between the events " lost mobility of left arm, continue paresthesia and proprioceptive deficits of left arm" with BNT162b2 can not be fully 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: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging spinal, Mobility decreased, Paraesthesia
Clinical narrative: suddenly lost mobility of left arm; Continue paresthesia and proprioreceptive deficits of left arm; Continue paresthesia and proprioreceptive deficits of left arm; This is a spontaneous report from a contactable nurse (patient). This 46-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EK5730) intramuscular, in right arm, on 16Dec2020 at 14:00, for COVID-19 immunization. No other vaccine was given in 4 weeks. Medical history included hypothyroidism, migraine headaches, IBS and COVID-19 (on an unspecified date prior to vaccination). Past drug history included allergy to morphine. Concomitant medication included levothyroxine sodium (SYNTHROID). On 23Dec2020 at 09:30 the patient experienced suddenly lost mobility of left arm, continue paresthesia and proprioreceptive deficits of left arm. She was transported to the ER and was admitted to hospital for 2 days. CT of brain X3, MRI of brain X2, MRI of C-spine and Brachioplexus were performed with unknown results. The patient was not tested for COVID19 after vaccination. The events resulted in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, disability or permanent damage. No treatment was administered. The events had not yet resolved.; Sender's Comments: Based on the temporal relationship, the association between the events " lost mobility of left arm, continue paresthesia and proprioceptive deficits of left arm" with BNT162b2 can not be fully 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: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head, Computerised tomogram spine, Loss of proprioception, Magnetic resonance imaging, Magnetic resonance imaging brain
Clinical narrative: suddenly lost mobility of left arm; Continue paresthesia and proprioreceptive deficits of left arm; Continue paresthesia and proprioreceptive deficits of left arm; This is a spontaneous report from a contactable nurse (patient). This 46-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EK5730) intramuscular, in right arm, on 16Dec2020 at 14:00, for COVID-19 immunization. No other vaccine was given in 4 weeks. Medical history included hypothyroidism, migraine headaches, IBS and COVID-19 (on an unspecified date prior to vaccination). Past drug history included allergy to morphine. Concomitant medication included levothyroxine sodium (SYNTHROID). On 23Dec2020 at 09:30 the patient experienced suddenly lost mobility of left arm, continue paresthesia and proprioreceptive deficits of left arm. She was transported to the ER and was admitted to hospital for 2 days. CT of brain X3, MRI of brain X2, MRI of C-spine and Brachioplexus were performed with unknown results. The patient was not tested for COVID19 after vaccination. The events resulted in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, disability or permanent damage. No treatment was administered. The events had not yet resolved.; Sender's Comments: Based on the temporal relationship, the association between the events " lost mobility of left arm, continue paresthesia and proprioceptive deficits of left arm" with BNT162b2 can not be fully 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: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mobility decreased, Paraesthesia
Clinical narrative: suddenly lost mobility of left arm; Continue paresthesia and proprioreceptive deficits of left arm; Continue paresthesia and proprioreceptive deficits of left arm; This is a spontaneous report from a contactable nurse (patient). This 46-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EK5730) intramuscular, in right arm, on 16Dec2020 at 14:00, for COVID-19 immunization. No other vaccine was given in 4 weeks. Medical history included hypothyroidism, migraine headaches, IBS and COVID-19 (on an unspecified date prior to vaccination). Past drug history included allergy to morphine. Concomitant medication included levothyroxine sodium (SYNTHROID). On 23Dec2020 at 09:30 the patient experienced suddenly lost mobility of left arm, continue paresthesia and proprioreceptive deficits of left arm. She was transported to the ER and was admitted to hospital for 2 days. CT of brain X3, MRI of brain X2, MRI of C-spine and Brachioplexus were performed with unknown results. The patient was not tested for COVID19 after vaccination. The events resulted in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, disability or permanent damage. No treatment was administered. The events had not yet resolved.; Sender's Comments: Based on the temporal relationship, the association between the events " lost mobility of left arm, continue paresthesia and proprioceptive deficits of left arm" with BNT162b2 can not be fully 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: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling in the L axilla several days after vaccination followed by a warm sensation and swelling at the injection site  5 days after vaccination with subsequent development of numbness and tingling of the L hand  that resolved in a week.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Oedema peripheral, Pain, Paraesthesia, Tenderness
Clinical narrative: Swelling in the L axilla several days after vaccination followed by a warm sensation and swelling at the injection site  5 days after vaccination with subsequent development of numbness and tingling of the L hand  that resolved in a week.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Injection site swelling, Swelling
Clinical narrative: Swelling in the L axilla several days after vaccination followed by a warm sensation and swelling at the injection site  5 days after vaccination with subsequent development of numbness and tingling of the L hand  that resolved in a week.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dizziness, Interleukin level, Throat tightness, Tryptase
Clinical narrative: The symptoms began 20-25 min after administration of the vaccine.  The symptoms were: Chest tightness and dizziness that is moving up to her throat - similar to shellfish allergy reaction. Vitals all stable. No rash, no wheezing on exam, no facial or tongue edema.  Sent to ED for treatment. Did not get epinephrine.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dizziness
Clinical narrative: The symptoms began 20-25 min after administration of the vaccine.  The symptoms were: Chest tightness and dizziness that is moving up to her throat - similar to shellfish allergy reaction. Vitals all stable. No rash, no wheezing on exam, no facial or tongue edema.  Sent to ED for treatment. Did not get epinephrine.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site rash
Clinical narrative: PRURITIS AND ERYTHEMA AROUND THE INJECTION SITE.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: PRURITIS AND ERYTHEMA AROUND THE INJECTION SITE.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Echocardiogram normal, Electrocardiogram normal, Laboratory test normal, Swollen tongue
Clinical narrative: approx. 5 minutes after receiving the vaccine client called a nurse over and started c/o numbness to the tip of her tongue. Approx 10 minutes later she started c/o heart palpitations., feeling hot. EMSA called because her heart rhythm strip was abnormal and her BP elevated. She was transported to Hospital for evaluation. She was monitored for 24hrs and dx with unsustainable ventricular tachycardia.. She is still being monitored and will have to wear a monitor 24hours a day for one month.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ventricular tachycardia
Clinical narrative: approx. 5 minutes after receiving the vaccine client called a nurse over and started c/o numbness to the tip of her tongue. Approx 10 minutes later she started c/o heart palpitations., feeling hot. EMSA called because her heart rhythm strip was abnormal and her BP elevated. She was transported to Hospital for evaluation. She was monitored for 24hrs and dx with unsustainable ventricular tachycardia.. She is still being monitored and will have to wear a monitor 24hours a day for one month.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Cardiac monitoring, Electrocardiogram, Feeling hot, Heart rate abnormal
Clinical narrative: approx. 5 minutes after receiving the vaccine client called a nurse over and started c/o numbness to the tip of her tongue. Approx 10 minutes later she started c/o heart palpitations., feeling hot. EMSA called because her heart rhythm strip was abnormal and her BP elevated. She was transported to Hospital for evaluation. She was monitored for 24hrs and dx with unsustainable ventricular tachycardia.. She is still being monitored and will have to wear a monitor 24hours a day for one month.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia oral, Palpitations, Ventricular tachycardia
Clinical narrative: approx. 5 minutes after receiving the vaccine client called a nurse over and started c/o numbness to the tip of her tongue. Approx 10 minutes later she started c/o heart palpitations., feeling hot. EMSA called because her heart rhythm strip was abnormal and her BP elevated. She was transported to Hospital for evaluation. She was monitored for 24hrs and dx with unsustainable ventricular tachycardia.. She is still being monitored and will have to wear a monitor 24hours a day for one month.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram head, Computerised tomogram normal, Dysgeusia, Headache, Hypoaesthesia
Clinical narrative: EE statement "I was given the COVID vaccine on Friday Jan 8th at around 12:30 pm. I starting tasting metal in my mouth about an hour after the vaccine was given. Saturday 1/9, I woke up at 4am with left sided face numbness from my forehead to the middle of my neck. I also had a headache and some right arm pain at the site of the vaccine. These symptoms continued through Monday 1/11 when I reported to the Emergency Room at. I had a CT scan completed and release with negative results. I had a COVID test completed on Tuesday 1/12. I had an MRI on Wed 1/13 with negative results. I seen my primary physician on Thursday 1/14 as a follow-up. I was informed that I had a reaction to the vaccine and that my symptoms would properly last for 2-3 weeks, marked as Bells Palsy and put on prednisone. Today, I still have some left face numbness and my taste is coming back."
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging, Pain in extremity, SARS-CoV-2 test negative
Clinical narrative: EE statement "I was given the COVID vaccine on Friday Jan 8th at around 12:30 pm. I starting tasting metal in my mouth about an hour after the vaccine was given. Saturday 1/9, I woke up at 4am with left sided face numbness from my forehead to the middle of my neck. I also had a headache and some right arm pain at the site of the vaccine. These symptoms continued through Monday 1/11 when I reported to the Emergency Room at. I had a CT scan completed and release with negative results. I had a COVID test completed on Tuesday 1/12. I had an MRI on Wed 1/13 with negative results. I seen my primary physician on Thursday 1/14 as a follow-up. I was informed that I had a reaction to the vaccine and that my symptoms would properly last for 2-3 weeks, marked as Bells Palsy and put on prednisone. Today, I still have some left face numbness and my taste is coming back."
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy, Computerised tomogram normal, Dysgeusia, Headache, Hypoaesthesia
Clinical narrative: EE statement "I was given the COVID vaccine on Friday Jan 8th at around 12:30 pm. I starting tasting metal in my mouth about an hour after the vaccine was given. Saturday 1/9, I woke up at 4am with left sided face numbness from my forehead to the middle of my neck. I also had a headache and some right arm pain at the site of the vaccine. These symptoms continued through Monday 1/11 when I reported to the Emergency Room at. I had a CT scan completed and release with negative results. I had a COVID test completed on Tuesday 1/12. I had an MRI on Wed 1/13 with negative results. I seen my primary physician on Thursday 1/14 as a follow-up. I was informed that I had a reaction to the vaccine and that my symptoms would properly last for 2-3 weeks, marked as Bells Palsy and put on prednisone. Today, I still have some left face numbness and my taste is coming back."
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pain, Magnetic resonance imaging normal, SARS-CoV-2 test
Clinical narrative: EE statement "I was given the COVID vaccine on Friday Jan 8th at around 12:30 pm. I starting tasting metal in my mouth about an hour after the vaccine was given. Saturday 1/9, I woke up at 4am with left sided face numbness from my forehead to the middle of my neck. I also had a headache and some right arm pain at the site of the vaccine. These symptoms continued through Monday 1/11 when I reported to the Emergency Room at. I had a CT scan completed and release with negative results. I had a COVID test completed on Tuesday 1/12. I had an MRI on Wed 1/13 with negative results. I seen my primary physician on Thursday 1/14 as a follow-up. I was informed that I had a reaction to the vaccine and that my symptoms would properly last for 2-3 weeks, marked as Bells Palsy and put on prednisone. Today, I still have some left face numbness and my taste is coming back."
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Diarrhoea, Dysgeusia, Headache, Hypoaesthesia
Clinical narrative: EE statement "I was given the COVID vaccine on Friday Jan 8th at around 12:30 pm. I starting tasting metal in my mouth about an hour after the vaccine was given. Saturday 1/9, I woke up at 4am with left sided face numbness from my forehead to the middle of my neck. I also had a headache and some right arm pain at the site of the vaccine. These symptoms continued through Monday 1/11 when I reported to the Emergency Room at. I had a CT scan completed and release with negative results. I had a COVID test completed on Tuesday 1/12. I had an MRI on Wed 1/13 with negative results. I seen my primary physician on Thursday 1/14 as a follow-up. I was informed that I had a reaction to the vaccine and that my symptoms would properly last for 2-3 weeks, marked as Bells Palsy and put on prednisone. Today, I still have some left face numbness and my taste is coming back."
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: EE statement "I was given the COVID vaccine on Friday Jan 8th at around 12:30 pm. I starting tasting metal in my mouth about an hour after the vaccine was given. Saturday 1/9, I woke up at 4am with left sided face numbness from my forehead to the middle of my neck. I also had a headache and some right arm pain at the site of the vaccine. These symptoms continued through Monday 1/11 when I reported to the Emergency Room at. I had a CT scan completed and release with negative results. I had a COVID test completed on Tuesday 1/12. I had an MRI on Wed 1/13 with negative results. I seen my primary physician on Thursday 1/14 as a follow-up. I was informed that I had a reaction to the vaccine and that my symptoms would properly last for 2-3 weeks, marked as Bells Palsy and put on prednisone. Today, I still have some left face numbness and my taste is coming back."
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Aphasia
Clinical narrative: Began itching and wheezing approximately 5 minutes after the injection. Gave first epi dose. Throat started tightening, and nausea presented. Gave second epi 5 min after the first. Gave third epi 5 min after the second. EMS arrived, gave 4th epi in ambulance. ER treated with breathing treatment, IV steroids, IV Benadryl, IV Pepcid and IV zofran. Was observed for 6.5 hours.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Stridor
Clinical narrative: Began itching and wheezing approximately 5 minutes after the injection. Gave first epi dose. Throat started tightening, and nausea presented. Gave second epi 5 min after the first. Gave third epi 5 min after the second. EMS arrived, gave 4th epi in ambulance. ER treated with breathing treatment, IV steroids, IV Benadryl, IV Pepcid and IV zofran. Was observed for 6.5 hours.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Pruritus, Throat tightness, Wheezing
Clinical narrative: Began itching and wheezing approximately 5 minutes after the injection. Gave first epi dose. Throat started tightening, and nausea presented. Gave second epi 5 min after the first. Gave third epi 5 min after the second. EMS arrived, gave 4th epi in ambulance. ER treated with breathing treatment, IV steroids, IV Benadryl, IV Pepcid and IV zofran. Was observed for 6.5 hours.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Dyspnoea, Heart rate increased, Hyperhidrosis, Syncope
Clinical narrative: Patient had a syncopal event during 15minute observation period.  He was laid down to the floor with cool compresses and recovered without further treatment.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tunnel vision
Clinical narrative: Patient had a syncopal event during 15minute observation period.  He was laid down to the floor with cool compresses and recovered without further treatment.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Syncope
Clinical narrative: Patient had a syncopal event during 15minute observation period.  He was laid down to the floor with cool compresses and recovered without further treatment.