chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Facial discomfort, Hypoaesthesia, Hypoaesthesia oral, Oral pruritus
Clinical narrative: 59 yo female with h/o HTN and allergy (shellfish and chorine) who received the Pfizer vaccine. About 10 minutes later, she c/o lips and nose numbness. Several minutes later she c/o hands itching followed by soft palate itching, followed by face( B/L maxillary region)- itching/numb. At this point she had been with us for 30 mins so we gave Benadryl IN 50mg. She told us that she had chest tightness and racing heart with her lips/nose became numb. She maintained no SOB or DIB. BP 142/92 HR 80. One hour later she again c/o chest tightness and left side of tongue burning. Other symptoms had resolved. EMS called. EMS checked BP 124/82. EKG NSR and O2 sat 100%. She was taken to Hopsital. She was in no apparent distress.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Pruritus, Tongue discomfort
Clinical narrative: 59 yo female with h/o HTN and allergy (shellfish and chorine) who received the Pfizer vaccine. About 10 minutes later, she c/o lips and nose numbness. Several minutes later she c/o hands itching followed by soft palate itching, followed by face( B/L maxillary region)- itching/numb. At this point she had been with us for 30 mins so we gave Benadryl IN 50mg. She told us that she had chest tightness and racing heart with her lips/nose became numb. She maintained no SOB or DIB. BP 142/92 HR 80. One hour later she again c/o chest tightness and left side of tongue burning. Other symptoms had resolved. EMS called. EMS checked BP 124/82. EKG NSR and O2 sat 100%. She was taken to Hopsital. She was in no apparent distress.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Nausea, Pain in extremity, SARS-CoV-2 test negative
Clinical narrative: Sore arm; nausea; Headache; currently breastfeeding; This is a spontaneous report from a contactable Nurse. A 32-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Deltoid Left (at the age of 33-year-old) on 12Jan2021 12:55 (Batch/Lot Number: ET1685) at single dose for covid-19 immunisation. Medical history included herpes simplex from 01May2008 (Ongoing outbreak unknown year, exacerbated with viral infections), viral infection from 19Dec2020 to 01Jan2021 (I was COVID negative 21Dec2020), oropharyngeal pain from 19Dec2020 to 01Jan2021 (I was COVID negative 21Dec2020), nasal congestion from 19Dec2020 to 01Jan2021 (I was COVID negative 21Dec2020), breast feeding from 05Apr2020 to an unknown date (no change in breastfeeding frequency or output). Historical vaccine included BNT162B2 for Covid-19 immunization. Concomitant medication(s) included docosahexaenoic acid (DHA) from 03Aug2019 to an unspecified date; ibuprofen and paracetamol (TYLENOL). The patient reported, She had a viral infection (day 3) during my first dose of the vaccine (22Dec2020). She believed this exacerbated the expected side effects of vaccination. Her body needed extra care to recover. Her second vaccine was much easier to recover from. The patient experienced, On 05Feb2021, currently breastfeeding, on 12Jan2021, sore arm, nausea and headache. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 21Dec2020. Therapeutic measures were taken as a result of events. The outcome of event for headache was recovering, for breastfeeding it was unknown and for the rest of the events it was recovered.  Amendment: This follow-up is being submitted to amend the previous reported information which included: removed at-risk classification in the general tab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020510892 Same reporter/ drug and different events/patients.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Exposure via breast milk, Headache, Nausea, Pain in extremity, SARS-CoV-2 test negative
Clinical narrative: Sore arm; nausea; Headache; currently breastfeeding; This is a spontaneous report from a contactable Nurse. A 32-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Deltoid Left (at the age of 33-year-old) on 12Jan2021 12:55 (Batch/Lot Number: ET1685) at single dose for covid-19 immunisation. Medical history included herpes simplex from 01May2008 (Ongoing outbreak unknown year, exacerbated with viral infections), viral infection from 19Dec2020 to 01Jan2021 (I was COVID negative 21Dec2020), oropharyngeal pain from 19Dec2020 to 01Jan2021 (I was COVID negative 21Dec2020), nasal congestion from 19Dec2020 to 01Jan2021 (I was COVID negative 21Dec2020), breast feeding from 05Apr2020 to an unknown date (no change in breastfeeding frequency or output). Historical vaccine included BNT162B2 for Covid-19 immunization. Concomitant medication(s) included docosahexaenoic acid (DHA) from 03Aug2019 to an unspecified date; ibuprofen and paracetamol (TYLENOL). The patient reported, She had a viral infection (day 3) during my first dose of the vaccine (22Dec2020). She believed this exacerbated the expected side effects of vaccination. Her body needed extra care to recover. Her second vaccine was much easier to recover from. The patient experienced, On 05Feb2021, currently breastfeeding, on 12Jan2021, sore arm, nausea and headache. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 21Dec2020. Therapeutic measures were taken as a result of events. The outcome of event for headache was recovering, for breastfeeding it was unknown and for the rest of the events it was recovered.  Amendment: This follow-up is being submitted to amend the previous reported information which included: removed at-risk classification in the general tab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020510892 Same reporter/ drug and different events/patients.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product preparation issue
Clinical narrative: Unknown pregnancy history.   Patient received a dose of vaccine that was mixed with sterile water instead of normal saline. Patient was re-vaccinated on 4/13/2021.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation, Product preparation issue
Clinical narrative: Unknown pregnancy history.   Patient received a dose of vaccine that was mixed with sterile water instead of normal saline. Patient was re-vaccinated on 4/13/2021.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Lip swelling, Rash
Clinical narrative: 4/7/21 symptpoms began tired & aches. Nighttime severe swelling of face, lips & throat. Gave Benedryl  4/8/21 Visit Urgent Care, swelling slightly less, slight rash appears on arms & body. They gave a Cortisone injection & continue Benedryl.  4/9/21 Visit to PCP Doctor,  swelling much less, rash became defined circles & trail lines over arms, knees & upper body. He determined allergic reaction to Covid Shot due to no exposure to other new factors. Determined the rash to be "Erytthema Multiforme". Give Allergra allergy medication. 4/10/21 swelling gone, rash only slightly visable, still some body aches.  4/12/21 swelling, rash gone, pretty much back to normal. This whole event began one week after shot.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema multiforme, Fatigue, Hypersensitivity, Lip swelling, Pain
Clinical narrative: 4/7/21 symptpoms began tired & aches. Nighttime severe swelling of face, lips & throat. Gave Benedryl  4/8/21 Visit Urgent Care, swelling slightly less, slight rash appears on arms & body. They gave a Cortisone injection & continue Benedryl.  4/9/21 Visit to PCP Doctor,  swelling much less, rash became defined circles & trail lines over arms, knees & upper body. He determined allergic reaction to Covid Shot due to no exposure to other new factors. Determined the rash to be "Erytthema Multiforme". Give Allergra allergy medication. 4/10/21 swelling gone, rash only slightly visable, still some body aches.  4/12/21 swelling, rash gone, pretty much back to normal. This whole event began one week after shot.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling, Rash, Swelling face
Clinical narrative: 4/7/21 symptpoms began tired & aches. Nighttime severe swelling of face, lips & throat. Gave Benedryl  4/8/21 Visit Urgent Care, swelling slightly less, slight rash appears on arms & body. They gave a Cortisone injection & continue Benedryl.  4/9/21 Visit to PCP Doctor,  swelling much less, rash became defined circles & trail lines over arms, knees & upper body. He determined allergic reaction to Covid Shot due to no exposure to other new factors. Determined the rash to be "Erytthema Multiforme". Give Allergra allergy medication. 4/10/21 swelling gone, rash only slightly visable, still some body aches.  4/12/21 swelling, rash gone, pretty much back to normal. This whole event began one week after shot.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: a week later tested positive for COVID-19; This is a spontaneous report from a Pfizer-sponsored program by a contactable reporter (patient). A 27-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration date: Not available), via an unspecified route of administration on 29Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. In Feb2021, a week after receiving the first dose, the patient was tested positive for COVID-19. The patients second dose is already due and would like to know if she is okay to get it or if there is a specific timeline that she should wait. The clinical outcome of the event COVID-19 was recovered. The patient underwent lab tests and procedures which included Covid test which was positive in Feb2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-1 test
Clinical narrative: a week later tested positive for COVID-19; This is a spontaneous report from a Pfizer-sponsored program by a contactable reporter (patient). A 27-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number and expiration date: Not available), via an unspecified route of administration on 29Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. In Feb2021, a week after receiving the first dose, the patient was tested positive for COVID-19. The patients second dose is already due and would like to know if she is okay to get it or if there is a specific timeline that she should wait. The clinical outcome of the event COVID-19 was recovered. The patient underwent lab tests and procedures which included Covid test which was positive in Feb2021.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, UNK, COVID19
Symptoms: Dizziness, Flushing
Clinical narrative: Flush & Light Headed
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Dry mouth, Feeling cold, Hyperhidrosis, Hypoaesthesia
Clinical narrative: After patient received vaccine they reported they felt "off", said there was tingling and burning sensation down arm.  After 5 minutes patient said they still felt off, 10 minutes no change, 15 minutes patient said they felt hot and their throat was dry,  offered antihistamine (Benadryl) and asked if the patient could have someone pick them up, the called their physician on base and they physician stated for the patient to come in for observation.   Patient  refused Benadryl but arranged for a family friend pick him up at my request because I did not feel comfortable releasing the patient without observation.  45 minutes later the patient was picked up and they went to their physician to be observed.  Called patient at 7pm to check in and they stated they "felt better but still off".
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction
Clinical narrative: After patient received vaccine they reported they felt "off", said there was tingling and burning sensation down arm.  After 5 minutes patient said they still felt off, 10 minutes no change, 15 minutes patient said they felt hot and their throat was dry,  offered antihistamine (Benadryl) and asked if the patient could have someone pick them up, the called their physician on base and they physician stated for the patient to come in for observation.   Patient  refused Benadryl but arranged for a family friend pick him up at my request because I did not feel comfortable releasing the patient without observation.  45 minutes later the patient was picked up and they went to their physician to be observed.  Called patient at 7pm to check in and they stated they "felt better but still off".
Age: 34.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dry throat, Feeling abnormal, Feeling hot, Paraesthesia, Skin burning sensation
Clinical narrative: After patient received vaccine they reported they felt "off", said there was tingling and burning sensation down arm.  After 5 minutes patient said they still felt off, 10 minutes no change, 15 minutes patient said they felt hot and their throat was dry,  offered antihistamine (Benadryl) and asked if the patient could have someone pick them up, the called their physician on base and they physician stated for the patient to come in for observation.   Patient  refused Benadryl but arranged for a family friend pick him up at my request because I did not feel comfortable releasing the patient without observation.  45 minutes later the patient was picked up and they went to their physician to be observed.  Called patient at 7pm to check in and they stated they "felt better but still off".
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Chest discomfort, Chest pain, Computerised tomogram thorax, Cough
Clinical narrative: Fever developed about 10 hours after the injection. Average temp throughout the night and first part of the next day was 104.7, also experienced severe  headache, chills, and muscle aches and pains. Throughout the day after the injection 4-10-2021 these symptoms improved but did not completely resolve. Overnight from the 10th into the morning of the 11th I developed a cough and felt short of breath. The afternoon of the 11th my oxygen saturation began to drop upon light exertion (walking around inside my home). I checked in to the Emergency Dept. at around 7 p.m. on the 11th of April 2021. I had elevated D-dimer, and abnormal Troponin. I was admitted with a diagnosis of myocarditis.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Fever developed about 10 hours after the injection. Average temp throughout the night and first part of the next day was 104.7, also experienced severe  headache, chills, and muscle aches and pains. Throughout the day after the injection 4-10-2021 these symptoms improved but did not completely resolve. Overnight from the 10th into the morning of the 11th I developed a cough and felt short of breath. The afternoon of the 11th my oxygen saturation began to drop upon light exertion (walking around inside my home). I checked in to the Emergency Dept. at around 7 p.m. on the 11th of April 2021. I had elevated D-dimer, and abnormal Troponin. I was admitted with a diagnosis of myocarditis.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein increased, Chills, Computerised tomogram abnormal, Cough, Dyspnoea
Clinical narrative: Fever developed about 10 hours after the injection. Average temp throughout the night and first part of the next day was 104.7, also experienced severe  headache, chills, and muscle aches and pains. Throughout the day after the injection 4-10-2021 these symptoms improved but did not completely resolve. Overnight from the 10th into the morning of the 11th I developed a cough and felt short of breath. The afternoon of the 11th my oxygen saturation began to drop upon light exertion (walking around inside my home). I checked in to the Emergency Dept. at around 7 p.m. on the 11th of April 2021. I had elevated D-dimer, and abnormal Troponin. I was admitted with a diagnosis of myocarditis.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Fibrin D dimer increased, Headache, Laboratory test abnormal, Magnetic resonance imaging heart
Clinical narrative: Fever developed about 10 hours after the injection. Average temp throughout the night and first part of the next day was 104.7, also experienced severe  headache, chills, and muscle aches and pains. Throughout the day after the injection 4-10-2021 these symptoms improved but did not completely resolve. Overnight from the 10th into the morning of the 11th I developed a cough and felt short of breath. The afternoon of the 11th my oxygen saturation began to drop upon light exertion (walking around inside my home). I checked in to the Emergency Dept. at around 7 p.m. on the 11th of April 2021. I had elevated D-dimer, and abnormal Troponin. I was admitted with a diagnosis of myocarditis.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Myocarditis, Oxygen saturation decreased, Pyrexia, Troponin abnormal
Clinical narrative: Fever developed about 10 hours after the injection. Average temp throughout the night and first part of the next day was 104.7, also experienced severe  headache, chills, and muscle aches and pains. Throughout the day after the injection 4-10-2021 these symptoms improved but did not completely resolve. Overnight from the 10th into the morning of the 11th I developed a cough and felt short of breath. The afternoon of the 11th my oxygen saturation began to drop upon light exertion (walking around inside my home). I checked in to the Emergency Dept. at around 7 p.m. on the 11th of April 2021. I had elevated D-dimer, and abnormal Troponin. I was admitted with a diagnosis of myocarditis.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Carotid endarterectomy, Embolic stroke
Clinical narrative: 13 days following vaccine experienced dizziness, and later that day had stroke/CVA.    He was given the ?clott buster?, monitored, and admitted to ICU.     MRI, CT scans showed a large clot and blockage to his artery.  surgery was preformed and all was removed.   He was then in CCU.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arterial thrombosis, Cerebrovascular accident, Computerised tomogram head abnormal, Dizziness, Intensive care
Clinical narrative: 13 days following vaccine experienced dizziness, and later that day had stroke/CVA.    He was given the ?clott buster?, monitored, and admitted to ICU.     MRI, CT scans showed a large clot and blockage to his artery.  surgery was preformed and all was removed.   He was then in CCU.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Magnetic resonance imaging head abnormal, Thrombectomy
Clinical narrative: 13 days following vaccine experienced dizziness, and later that day had stroke/CVA.    He was given the ?clott buster?, monitored, and admitted to ICU.     MRI, CT scans showed a large clot and blockage to his artery.  surgery was preformed and all was removed.   He was then in CCU.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperacusis, Magnetic resonance imaging head, Migraine, Photophobia, Ultrasound scan
Clinical narrative: Left leg peroneal DVT
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Varicose vein
Clinical narrative: Left leg peroneal DVT
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Ultrasound Doppler
Clinical narrative: Left leg peroneal DVT
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Carotid artery stenosis, Cerebral infarction, Dysarthria, Ear discomfort
Clinical narrative: CVA and cerebral venous sinus thrombosis
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye pain, Hypoaesthesia, Intensive care, Jaw disorder, Magnetic resonance imaging head abnormal
Clinical narrative: CVA and cerebral venous sinus thrombosis
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Tongue discomfort
Clinical narrative: CVA and cerebral venous sinus thrombosis
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebral venous sinus thrombosis, Cerebrovascular accident
Clinical narrative: CVA and cerebral venous sinus thrombosis
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram pulmonary abnormal, Anticoagulant therapy, Computerised tomogram thorax, Pericardial effusion, Pulmonary embolism
Clinical narrative: 3/11/2021 Blood clots both lungs, CT scan diagnosis, Xarelto blood thinner prescribed,  3/23 admitted again plural effusion both lungs and pericarditis , hospitalized five days
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Blood test, Chest X-ray, Computerised tomogram abnormal, Pericarditis
Clinical narrative: 3/11/2021 Blood clots both lungs, CT scan diagnosis, Xarelto blood thinner prescribed,  3/23 admitted again plural effusion both lungs and pericarditis , hospitalized five days
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pleural effusion, Pulmonary thrombosis
Clinical narrative: 3/11/2021 Blood clots both lungs, CT scan diagnosis, Xarelto blood thinner prescribed,  3/23 admitted again plural effusion both lungs and pericarditis , hospitalized five days
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Dizziness, Dyspnoea, Throat tightness, Tremor
Clinical narrative: I started to feel dizzy and nauseated. Then my throat started to swell at the back of my mouth. My heart rate went way up and I believe so did my pulse. I was shaking and getting chilled. I was given an EPI shot and a shot of Benadryl. My symptoms did not get better so they shot me again with an EPI. Paramedics took me to the hospital for observation. After a few hours, I was feeling better. The hospital gave me another dose of Benadryl and anti-nausea meds.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Heart rate increased, Nausea, Pharyngeal swelling
Clinical narrative: I started to feel dizzy and nauseated. Then my throat started to swell at the back of my mouth. My heart rate went way up and I believe so did my pulse. I was shaking and getting chilled. I was given an EPI shot and a shot of Benadryl. My symptoms did not get better so they shot me again with an EPI. Paramedics took me to the hospital for observation. After a few hours, I was feeling better. The hospital gave me another dose of Benadryl and anti-nausea meds.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Carotid artery stenosis, Computerised tomogram, Eye haemorrhage, Magnetic resonance imaging
Clinical narrative: LEFT central retinal artery occlusion
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Carotid artery stenosis, Retinal artery occlusion, SARS-CoV-2 test positive, Ultrasound Doppler
Clinical narrative: LEFT central retinal artery occlusion
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Acute coronary syndrome, Acute myocardial infarction, Blood creatinine increased, Catheterisation cardiac abnormal
Clinical narrative: Received 2nd dose Pfizer COVID-19 vaccine on 4/13/2021 (first dose 3/23/2021). Patient called call center 4/14/21 03:42 to report nausea, vomiting. Went to ED on 4/15/21. Diagnosed with acute STEMI on EKG, elevated troponin, sent to cath lab and received stent to LAD, transferred to another Hospital for cardiogenic shock treatment requiring intubation and intraaortic balloon pump assist device. Treatment ongoing.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest X-ray abnormal, Chest pain, Chills, Coronary arterial stent insertion, Coronary artery occlusion
Clinical narrative: Received 2nd dose Pfizer COVID-19 vaccine on 4/13/2021 (first dose 3/23/2021). Patient called call center 4/14/21 03:42 to report nausea, vomiting. Went to ED on 4/15/21. Diagnosed with acute STEMI on EKG, elevated troponin, sent to cath lab and received stent to LAD, transferred to another Hospital for cardiogenic shock treatment requiring intubation and intraaortic balloon pump assist device. Treatment ongoing.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Diarrhoea, Dyspnoea, Echocardiogram, Echocardiogram abnormal, Ejection fraction
Clinical narrative: Received 2nd dose Pfizer COVID-19 vaccine on 4/13/2021 (first dose 3/23/2021). Patient called call center 4/14/21 03:42 to report nausea, vomiting. Went to ED on 4/15/21. Diagnosed with acute STEMI on EKG, elevated troponin, sent to cath lab and received stent to LAD, transferred to another Hospital for cardiogenic shock treatment requiring intubation and intraaortic balloon pump assist device. Treatment ongoing.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ejection fraction decreased, Endotracheal intubation, Intra-aortic balloon placement, Nausea, Pain in extremity
Clinical narrative: Received 2nd dose Pfizer COVID-19 vaccine on 4/13/2021 (first dose 3/23/2021). Patient called call center 4/14/21 03:42 to report nausea, vomiting. Went to ED on 4/15/21. Diagnosed with acute STEMI on EKG, elevated troponin, sent to cath lab and received stent to LAD, transferred to another Hospital for cardiogenic shock treatment requiring intubation and intraaortic balloon pump assist device. Treatment ongoing.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pallor, Percutaneous coronary intervention, Peripheral coldness, Pulmonary oedema, Respiratory failure
Clinical narrative: Received 2nd dose Pfizer COVID-19 vaccine on 4/13/2021 (first dose 3/23/2021). Patient called call center 4/14/21 03:42 to report nausea, vomiting. Went to ED on 4/15/21. Diagnosed with acute STEMI on EKG, elevated troponin, sent to cath lab and received stent to LAD, transferred to another Hospital for cardiogenic shock treatment requiring intubation and intraaortic balloon pump assist device. Treatment ongoing.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Restlessness, Vomiting
Clinical narrative: Received 2nd dose Pfizer COVID-19 vaccine on 4/13/2021 (first dose 3/23/2021). Patient called call center 4/14/21 03:42 to report nausea, vomiting. Went to ED on 4/15/21. Diagnosed with acute STEMI on EKG, elevated troponin, sent to cath lab and received stent to LAD, transferred to another Hospital for cardiogenic shock treatment requiring intubation and intraaortic balloon pump assist device. Treatment ongoing.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute myocardial infarction, Cardiogenic shock, Coronary arterial stent insertion, Electrocardiogram abnormal, Endotracheal intubation
Clinical narrative: Received 2nd dose Pfizer COVID-19 vaccine on 4/13/2021 (first dose 3/23/2021). Patient called call center 4/14/21 03:42 to report nausea, vomiting. Went to ED on 4/15/21. Diagnosed with acute STEMI on EKG, elevated troponin, sent to cath lab and received stent to LAD, transferred to another Hospital for cardiogenic shock treatment requiring intubation and intraaortic balloon pump assist device. Treatment ongoing.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Troponin increased, Vomiting
Clinical narrative: Received 2nd dose Pfizer COVID-19 vaccine on 4/13/2021 (first dose 3/23/2021). Patient called call center 4/14/21 03:42 to report nausea, vomiting. Went to ED on 4/15/21. Diagnosed with acute STEMI on EKG, elevated troponin, sent to cath lab and received stent to LAD, transferred to another Hospital for cardiogenic shock treatment requiring intubation and intraaortic balloon pump assist device. Treatment ongoing.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Feeling cold, Pain in extremity, Skin discolouration, Thrombosis
Clinical narrative: Received 2nd dose Pfizer COVID-19 vaccine on 4/13/2021 (first dose 3/23/2021). Patient called call center 4/14/21 03:42 to report nausea, vomiting. Went to ED on 4/15/21. Diagnosed with acute STEMI on EKG, elevated troponin, sent to cath lab and received stent to LAD, transferred to another Hospital for cardiogenic shock treatment requiring intubation and intraaortic balloon pump assist device. Treatment ongoing.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Received 2nd dose Pfizer COVID-19 vaccine on 4/13/2021 (first dose 3/23/2021). Patient called call center 4/14/21 03:42 to report nausea, vomiting. Went to ED on 4/15/21. Diagnosed with acute STEMI on EKG, elevated troponin, sent to cath lab and received stent to LAD, transferred to another Hospital for cardiogenic shock treatment requiring intubation and intraaortic balloon pump assist device. Treatment ongoing.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: went out positive on 01Feb; This is a spontaneous report from a contactable other health care professional (Patient) via Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and Expiry Date: Unknown), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 01Feb2021, the patient experienced went out positive on 01Feb. 27Jan2021, The patient stated that she had COVID-19 symptoms. The patient underwent lab test which included SARS-COV-2 test with positive result on 01Feb2021. The patient second dose is scheduled on 11Feb2021 and enquired if she can get the second dose or wait longer. The caller mentioned she finished the quarantine on 07Feb2021 and went back to work The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Glossodynia, Herpes zoster, Oral pain
Clinical narrative: Painful tongue; Mouth sores; I was told the sore on my tongue was herpes zoster (shingles); This is a spontaneous report from a contactable physician (Patient himself).     A 70-years-old male patient received first dose of BNT162B2 (BNT162B2, solution for injection, Batch/Lot number: unknown) via an unspecified route of administration, administered in left arm on 08Jan2021 at 12:30 as SINGLE DOSE for COVID-19 immunization. On 29Jan2021, patient received second dose of BNT162B2 (BNT162B2, solution for injection, Batch/Lot number: unknown) via an unspecified route of administration, as SINGLE DOSE for COVID-19 immunization. The medical history and concomitant medications were not reported. Patient developed painful tongue and mouth sores starting 4 days after the first vaccine (08Jan2021) which have persisted over a month. They started to subside but then increased again after the second dose (29Jan2021). Patient had never suffered from any tongue or mouth sores before. Patient told the sore on her tongue was herpes zoster (shingles) and  he took valtrex with gradual improvement. But the other sores in my mouth have not responded. Patient not had COVID prior vaccination and patient not tested for COVID post vaccination. At the time of this report events tongue pain and sore mouth were not recovered and the event shingles was recovering.   Information about batch/lot number has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EM9810), via an unspecified route of administration in left arm, on 09Feb2021 at 12:45 PM, at a single dose, for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications included atorvastatin, fish oil, and an unspecified multivitamin. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 09Feb2021 at 10:00 PM (22:00), the patient had injection site pain for 3 days. No treatment was received for the adverse event. The patient had not been tested for COVID-19 post vaccination. The patient recovered from the event on 12Feb2021.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer (patient's child). An 86-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 11Feb2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the second dose of the vaccine on Thursday (11Feb2021) evening. Today (13Feb2021), the patient has the runs (diarrhea). The event was considered non-serious. The patient's child was asking if that was normal and if it would last for three days. The outcome of the event was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Pain
Clinical narrative: Headache; chills; fatigue; complete body aches; sore joints (similar to an RA flareup).; This is a spontaneous report from a contactable consumer(patient). A 74-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number, expiration date were not reported), dose 1 via an unspecified route of administration, administered in left arm on 12Feb2021 14:00 as SINGLE DOSE for covid-19 immunisation. Patient was 74 years old at the time of vaccination. Medical history included rheumatoid arthritis and the patient has been previously diagnosed for covid-19. Patient had no known allergies. Patient did not receive vaccines within 4 weeks prior to the COVID vaccine. Patient also had other medications within 2 weeks of vaccination. On 13Feb2021 at 13:00 the patient experienced headache, chills, fatigue, complete body aches, sore joints (similar to an RA flareup). Patient received Tyleol for treatment of the events. Outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Lymphadenopathy, Myalgia
Clinical narrative: tiredness; muscle and joint aches; muscle and joint aches; chills; swollen underarm lymph node; This is a spontaneous report from a contactable consumer (patient). A 40-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 12Feb2021 14:15 (Batch/Lot Number: EL3247) as SINGLE DOSE for covid-19 immunisation. Other medical history was none. Concomitant medication(s) included ibuprofen (ADVIL [IBUPROFEN]) taken for an unspecified indication, start and stop date were not reported; calcium (CALCIUM) taken for an unspecified indication, start and stop date were not reported; biotin (BIOTIN) taken for an unspecified indication, start and stop date were not reported. Other medications in two weeks also included oral birth control. The patient had no other vaccine in four weeks. No covid prior vaccination and not tested covid post vaccination. The patient had no known allergies. The patient previously received first dose of BNT162B2 (COMIRNATY, Batch/Lot number EL3247), in Arm Left on 22Jan2021 14:15 as single dose for COVID-19 immunization. Since 13Feb2021 10:00 AM, the patient experienced tiredness, muscle and joint aches, chills, swollen underarm lymph node. The patient did not receive any treatment for AE. Outcome of the events was recovering.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Headache
Clinical narrative: Rising blood pressures starting overnight 10Feb2021; Persistent headache as well; This is a spontaneous report from a contactable physician, the patient. A 48-year-old female patient (non pregnant) received dose number 1 of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number: EL9264) via an unspecified route of administration on 09Feb2021 at 12:15 PM(at 48-year-old ) in left arm as a single dose for COVID-19 immunization. Medical history included Hypertension (well controlled prior) and glaucoma. Patient had known allergies of cephalosporins. Concomitant medications included Diovan, Biotin, Vitamin D, Magnesium and Glucosamine (within two weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On 10Feb2021 at 03:00 AM, rising blood pressures started overnight that led to doubling of Diovan dose, then switch to a different agent, followed by ER visit on 13Feb2021 for BP 175/103 and another medication was added and experienced persistent headache as well. Both symptoms persist at this time. New medication for BP control were given, EKG and labs done. Outcome of the event was not recovered.; Sender's Comments: A contributory role of vaccine BNT162B2 to the event rising blood pressures cannot be fully excluded based on the close temporal relationship.  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: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: After second vaccine felt nauseous for 2 hours; vomit two times; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received bnt162b2 (brand: PFIZER), dose 2 via an unspecified route of administration, administered in left arm on 08Feb2021 (lot number: EM9808) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No known allergies. The patient previously received 1st dose of bnt162b2 (brand: PFIZER, lot number: EL3247) on 18Jan2021 04:30 PM for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. After second vaccine felt nauseous for 2 hours and vomit two times on 13Feb2021 23:30. Outcome of events was recovering. No treatment was given for the events. The patient was not diagnosed of covid prior vaccination and has not been tested for covid post vaccination.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Very severe headache 3-1/2 days after shot that lasted over 4 hours, unlike any headache I've ever had. I am not prone to headaches; This is a spontaneous report received from a contactable consumer. A 68-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not reported), via an unspecified route of administration at the right arm on 09Feb2021 10:45 at single dose for COVID-19 immunization. The patient's medical history included asthma and had allergies to contrast dye and shellfish. Concomitant medications included serrapeptase. On 12Feb2021 8:30 pm, the patient had very severe headache and lasted over 4 hours. It was reported that unlike any headache patient had ever had and she was not prone to headaches. Outcome of event was reported as recovered on unspecified date on Feb2021.  Information about batch/lot number has been requested.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Skin rash; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 30Jan2021 08:00 (at the age of 69years) as single dose for Covid-19 immunization. Medical history included hypertension and allergies: penicillin, both from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that 13 days after first dose on Friday 12Feb2021 (22:00), a skin rash occurred in all of the patient's body. The patient used Benadryl in tablets and topical Benadryl. Rash worsened 5 hours after first Benadryl dose. The patient was still monitoring the symptoms. The patient has not been tested for COVID-19 since the vaccination. The outcome of event was recovering.  Information about batch/lot number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen tender lymph node in upper neck (under chin) on right side.; This is a spontaneous report from a contactable consumer (patient).   A 50-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 09Feb2021 10:30 (Lot Number: EL3247), at the age of 50-years at vaccination, as SINGLE DOSE for covid-19 immunisation.  Medical history included Hypertension, hypothyroidism, elevated platelets. The patient did not have COVID-19 prior vaccination. The patient previously took prednisone and experienced fast heart rate. Concomitant medications included varicella zoster vaccine rge (cho) (SHINGRIX) taken for an unspecified indication from 25Jan2021 to 25Jan2021; irbesartan taken for an unspecified indication, start and stop date were not reported; amlodipine besylate taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium taken for an unspecified indication, start and stop date were not reported.  The patient experienced swollen tender lymph node in upper neck (under chin) on right side on 13Feb2021 14:00 with outcome of not recovered. No treatment was given for the event. The patient has not been tested for COVID-19 post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: aching muscles; The case was initially processed as Invalid (as there is no indication that the patient experienced an adverse event under the suspect product BNT162B2) but upon follow up event was reported so the case is upgraded as Valid Case.   This is a spontaneous report from a contactable consumer (patient) via Pfizer Sponsored Program . A 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL9264 and expiration date were not reported) intramuscularly in left arm on 02Mar2021 at 10:30 at single dose for covid-19 immunisation. Patient had a first dose (Historical vaccine) of BNT162B2 on 09Jan2021 at 16:00 intramuscularly in left arm (Batch/Lot number: EL3302). On 02Mar2021 (after 2nd shot on the same day) at 18:00 patient aching muscle. Patient took Tylenol for event and was fine. The case was non-serious as per reporter. The outcome of the events was recovered.   Follow-up (30Mar2020): This is a follow-up spontaneous report received from a contactable consumer. This consumer responded in response to the Non-HCP letter sent to the patient which included that: event, treatment, outcome added related to Second dose of vaccine, first dose captured as historical vaccine.   No follow up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Investigation, Nausea
Clinical narrative: very faintly nauseous/got severely nauseous; faintly off-balance; dizzy; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 22Jan2021 as a single dose (at the age of 72-years-old) for covid-19 immunisation. The patient medical history included lupus anticoagulant, chronic obstructive pulmonary disease (COPD) and gastrooesophageal reflux disease (GERD); all from an unknown date. The patient's concomitant medications were not reported. On 22Jan2021, the first time, when the patient was still at the site, very faintly nauseous, feeling like she was going to get nauseous, and faintly off-balance, very faint. Five hours later, when she got home, she got severely nauseous, severely dizzy and she just went to bed and then next day, she was fine. Each day, she felt more normal. The patient underwent lab tests and procedures which included physical investigation: unknown results on 04Jan2021. The outcome of the events was recovering. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9266) on 13Feb2021.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Insomnia, Pain
Clinical narrative: headache; swelling in left armpit; difficulty sleeping; fever; fatigue; body aches; sweating; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient received second dose of bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6201) via an unspecified route of administration, administered into left arm on 12Feb2021 08:45 (at the age of 43-year-old) as single dose for COVID-19 immunisation. The patient's medical history was not reported. Patient was not pregnant. It was also reported that the patient was taking unspecified concomitant medications. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3249) administered into left arm on 22Jan2021 08:30 AM (at the age of 42-year-old) for COVID-19 immunization. On 12Feb2021 14:00, patient experienced headache, swelling in left armpit, difficulty sleeping, fever, fatigue, body aches and sweating. The patient did not receive treatment for the events reported. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 01Feb2021. Outcome of events was not recovered.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Swelling
Clinical narrative: headache; swelling in left armpit; difficulty sleeping; fever; fatigue; body aches; sweating; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient received second dose of bnt162b2 BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6201) via an unspecified route of administration, administered into left arm on 12Feb2021 08:45 (at the age of 43-year-old) as single dose for COVID-19 immunisation. The patient's medical history was not reported. Patient was not pregnant. It was also reported that the patient was taking unspecified concomitant medications. Historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3249) administered into left arm on 22Jan2021 08:30 AM (at the age of 42-year-old) for COVID-19 immunization. On 12Feb2021 14:00, patient experienced headache, swelling in left armpit, difficulty sleeping, fever, fatigue, body aches and sweating. The patient did not receive treatment for the events reported. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 01Feb2021. Outcome of events was not recovered.