chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives first appeared on 11/25/21.   Increased in frequency and severity through January.  Saw Primary Care Doc early Feb.   Then referred to Allergist, Rheumatologist, Dermatologist and Immunologist.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Constant ringing in my ears. It gets louder and more subtle but it is constant and maddening.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Hyperhidrosis, Illness, Moaning
Clinical narrative: 12 hours after a FULL 3rd dose (not booster) I became severely ill for approximately 8hrs. Severe sweating, mild fever (100) and just a horrible feeling of being. Came very close to going to the E.R. After about 8hrs sickness subsided and I was tired but fine! Never had any other problems! Again I was severely ill, laid in a chair and moaned and moaned, probably one of the sicker times I?ve ever experienced.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased
Clinical narrative: 12 hours after a FULL 3rd dose (not booster) I became severely ill for approximately 8hrs. Severe sweating, mild fever (100) and just a horrible feeling of being. Came very close to going to the E.R. After about 8hrs sickness subsided and I was tired but fine! Never had any other problems! Again I was severely ill, laid in a chair and moaned and moaned, probably one of the sicker times I?ve ever experienced.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Tinnitus
Clinical narrative: Approx at 1pm today, I developed an excruciating headache, I am not prone to migraines. I currently have the headache  at 12 midnight, with a very loud ringing in my left ear.  I also experienced terrible body aches, blurred vision, fever and chills.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Approx at 1pm today, I developed an excruciating headache, I am not prone to migraines. I currently have the headache  at 12 midnight, with a very loud ringing in my left ear.  I also experienced terrible body aches, blurred vision, fever and chills.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm swelling down to elbow area, redness, warm to touch, tender palpitation, cellulitis of left upper arm.
Age: 1.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, VARCEL
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: No reaction only vaccine error   Saline diluent was out of date
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Urticaria
Clinical narrative: Developed hives and tingling around my mouth and in my tongue approximately 36 hours following the vaccine.  Usual allergy medications have been taken, nothing further has been done at this time.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 67 year-old male patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 22Feb2021 (Lot number: EL9266) at the age of 66 years as dose 1, single and administered in arm right, administration date 17Mar2021 08:30 (Lot number: EP7534) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "eye infection" (unspecified if ongoing); "diuretic" (unspecified if ongoing). Concomitant medication(s) included: KLONOPIN taken for anxiety; LISINOPRIL taken for blood pressure measurement; NIFEDIPINE taken for blood pressure measurement, start date: Mar2010; LABETALOL taken for diuretic therapy. Vaccination history included: Flu vaccine (He usually get flu vaccine but he was late getting to it and the flu season was over so he didn't get flu vaccine.). The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angiogram cerebral abnormal, Arteriogram carotid, Cerebrovascular accident, Magnetic resonance imaging head abnormal
Clinical narrative: it lead to me having a storke
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aphasia, Cerebrovascular accident, Hemiplegia, Thrombosis
Clinical narrative: it lead to me having a storke
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: it lead to me having a storke
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Antibody test positive, Blood test, Cardiac monitoring, Cardiac stress test, Chest X-ray
Clinical narrative: covid test date 10Jan2022 covid test result Positive; covid test date 10Jan2022 covid test result Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date Sep2021 (Lot number: fe3592) at the age of 59 years as dose 2, single and administered in arm right, administration date 20Aug2021 (Lot number: fc3183) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid test date 10Jan2022 covid test result Positive". The event "covid test date 10jan2022 covid test result positive" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) positive, notes: Nasal swab Home test.  Clinical Course: Shortness breath, chest pain, tingling/electrical shocks throughout extremities, bloodwork is off high d dimer, abnormal ekg, vaccine spike antibody over 150.Patient did not receive treatment ae. No covid prior vaccination. Patient did not other vaccine in four weeks.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Echocardiogram, Electric shock sensation, Electrocardiogram abnormal
Clinical narrative: covid test date 10Jan2022 covid test result Positive; covid test date 10Jan2022 covid test result Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date Sep2021 (Lot number: fe3592) at the age of 59 years as dose 2, single and administered in arm right, administration date 20Aug2021 (Lot number: fc3183) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid test date 10Jan2022 covid test result Positive". The event "covid test date 10jan2022 covid test result positive" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) positive, notes: Nasal swab Home test.  Clinical Course: Shortness breath, chest pain, tingling/electrical shocks throughout extremities, bloodwork is off high d dimer, abnormal ekg, vaccine spike antibody over 150.Patient did not receive treatment ae. No covid prior vaccination. Patient did not other vaccine in four weeks.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fibrin D dimer increased, Hypoaesthesia, Nerve conduction studies, Palpitations, Paraesthesia
Clinical narrative: covid test date 10Jan2022 covid test result Positive; covid test date 10Jan2022 covid test result Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date Sep2021 (Lot number: fe3592) at the age of 59 years as dose 2, single and administered in arm right, administration date 20Aug2021 (Lot number: fc3183) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid test date 10Jan2022 covid test result Positive". The event "covid test date 10jan2022 covid test result positive" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) positive, notes: Nasal swab Home test.  Clinical Course: Shortness breath, chest pain, tingling/electrical shocks throughout extremities, bloodwork is off high d dimer, abnormal ekg, vaccine spike antibody over 150.Patient did not receive treatment ae. No covid prior vaccination. Patient did not other vaccine in four weeks.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sleep disorder
Clinical narrative: covid test date 10Jan2022 covid test result Positive; covid test date 10Jan2022 covid test result Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date Sep2021 (Lot number: fe3592) at the age of 59 years as dose 2, single and administered in arm right, administration date 20Aug2021 (Lot number: fc3183) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid test date 10Jan2022 covid test result Positive". The event "covid test date 10jan2022 covid test result positive" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) positive, notes: Nasal swab Home test.  Clinical Course: Shortness breath, chest pain, tingling/electrical shocks throughout extremities, bloodwork is off high d dimer, abnormal ekg, vaccine spike antibody over 150.Patient did not receive treatment ae. No covid prior vaccination. Patient did not other vaccine in four weeks.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid test date 10Jan2022 covid test result Positive; covid test date 10Jan2022 covid test result Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date Sep2021 (Lot number: fe3592) at the age of 59 years as dose 2, single and administered in arm right, administration date 20Aug2021 (Lot number: fc3183) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid test date 10Jan2022 covid test result Positive". The event "covid test date 10jan2022 covid test result positive" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) positive, notes: Nasal swab Home test.  Clinical Course: Shortness breath, chest pain, tingling/electrical shocks throughout extremities, bloodwork is off high d dimer, abnormal ekg, vaccine spike antibody over 150.Patient did not receive treatment ae. No covid prior vaccination. Patient did not other vaccine in four weeks.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Electric shock sensation, Electrocardiogram, Electrocardiogram abnormal
Clinical narrative: covid test date 10Jan2022 covid test result Positive; covid test date 10Jan2022 covid test result Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date Sep2021 (Lot number: fe3592) at the age of 59 years as dose 2, single and administered in arm right, administration date 20Aug2021 (Lot number: fc3183) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid test date 10Jan2022 covid test result Positive". The event "covid test date 10jan2022 covid test result positive" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) positive, notes: Nasal swab Home test.  Clinical Course: Shortness breath, chest pain, tingling/electrical shocks throughout extremities, bloodwork is off high d dimer, abnormal ekg, vaccine spike antibody over 150.Patient did not receive treatment ae. No covid prior vaccination. Patient did not other vaccine in four weeks.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fibrin D dimer, Fibrin D dimer increased, Investigation, Paraesthesia, SARS-CoV-2 test
Clinical narrative: covid test date 10Jan2022 covid test result Positive; covid test date 10Jan2022 covid test result Positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date Sep2021 (Lot number: fe3592) at the age of 59 years as dose 2, single and administered in arm right, administration date 20Aug2021 (Lot number: fc3183) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "covid test date 10Jan2022 covid test result Positive". The event "covid test date 10jan2022 covid test result positive" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (10Jan2022) positive, notes: Nasal swab Home test.  Clinical Course: Shortness breath, chest pain, tingling/electrical shocks throughout extremities, bloodwork is off high d dimer, abnormal ekg, vaccine spike antibody over 150.Patient did not receive treatment ae. No covid prior vaccination. Patient did not other vaccine in four weeks.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Antibody test positive, Blood test, Cardiac monitoring, Cardiac stress test, Chest X-ray
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date Sep2021 (Lot number: FE3592) at the age of 59 years as dose 2, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. Vaccination history included: Bnt162b2 (previous dose product=COVID 19,, previous dose brand=Pfizer,, previous  dose brand unknown=False,, previous  dose lot number=fc3183,, previous  dose lot unknown=False,, previous  dose administration date=20Aug2021, previous  dose dose number=1,, previous  dose vaccine location=Right arm), administration date: 20Aug2021, for Covid-19 Immunization. The following information was reported: DYSPNOEA (non-serious) with onset 04Oct2021, outcome "not recovered", described as "Shortness breath"; CHEST PAIN (non-serious) with onset 04Oct2021, outcome "not recovered", described as "chest pain"; PARAESTHESIA (non-serious), ELECTRIC SHOCK SENSATION (non-serious) all with onset 04Oct2021, outcome "not recovered" and all described as "tingling/electrical shocks throughout extremities"; FIBRIN D DIMER INCREASED (non-serious) with onset 04Oct2021, outcome "not recovered", described as "bloodwork is off high D Dimer"; ELECTROCARDIOGRAM ABNORMAL (non-serious) with onset 04Oct2021, outcome "not recovered", described as "abnormal EKG". The events "shortness breath", "chest pain", "tingling/electrical shocks throughout extremities", "tingling/electrical shocks throughout extremities", "bloodwork is off high d dimer" and "abnormal EKG" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dyspnoea, chest pain, paraesthesia, electric shock sensation, fibrin D Dimer increased, electrocardiogram abnormal. Additional information: Patient did not received any other vaccine in four weeks. If Covid prior vaccination reported as no and If Covid tested post vaccination reported as yes. Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Echocardiogram, Electric shock sensation, Electrocardiogram abnormal
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date Sep2021 (Lot number: FE3592) at the age of 59 years as dose 2, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. Vaccination history included: Bnt162b2 (previous dose product=COVID 19,, previous dose brand=Pfizer,, previous  dose brand unknown=False,, previous  dose lot number=fc3183,, previous  dose lot unknown=False,, previous  dose administration date=20Aug2021, previous  dose dose number=1,, previous  dose vaccine location=Right arm), administration date: 20Aug2021, for Covid-19 Immunization. The following information was reported: DYSPNOEA (non-serious) with onset 04Oct2021, outcome "not recovered", described as "Shortness breath"; CHEST PAIN (non-serious) with onset 04Oct2021, outcome "not recovered", described as "chest pain"; PARAESTHESIA (non-serious), ELECTRIC SHOCK SENSATION (non-serious) all with onset 04Oct2021, outcome "not recovered" and all described as "tingling/electrical shocks throughout extremities"; FIBRIN D DIMER INCREASED (non-serious) with onset 04Oct2021, outcome "not recovered", described as "bloodwork is off high D Dimer"; ELECTROCARDIOGRAM ABNORMAL (non-serious) with onset 04Oct2021, outcome "not recovered", described as "abnormal EKG". The events "shortness breath", "chest pain", "tingling/electrical shocks throughout extremities", "tingling/electrical shocks throughout extremities", "bloodwork is off high d dimer" and "abnormal EKG" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dyspnoea, chest pain, paraesthesia, electric shock sensation, fibrin D Dimer increased, electrocardiogram abnormal. Additional information: Patient did not received any other vaccine in four weeks. If Covid prior vaccination reported as no and If Covid tested post vaccination reported as yes. Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fibrin D dimer increased, Hypoaesthesia, Nerve conduction studies, Palpitations, Paraesthesia
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date Sep2021 (Lot number: FE3592) at the age of 59 years as dose 2, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. Vaccination history included: Bnt162b2 (previous dose product=COVID 19,, previous dose brand=Pfizer,, previous  dose brand unknown=False,, previous  dose lot number=fc3183,, previous  dose lot unknown=False,, previous  dose administration date=20Aug2021, previous  dose dose number=1,, previous  dose vaccine location=Right arm), administration date: 20Aug2021, for Covid-19 Immunization. The following information was reported: DYSPNOEA (non-serious) with onset 04Oct2021, outcome "not recovered", described as "Shortness breath"; CHEST PAIN (non-serious) with onset 04Oct2021, outcome "not recovered", described as "chest pain"; PARAESTHESIA (non-serious), ELECTRIC SHOCK SENSATION (non-serious) all with onset 04Oct2021, outcome "not recovered" and all described as "tingling/electrical shocks throughout extremities"; FIBRIN D DIMER INCREASED (non-serious) with onset 04Oct2021, outcome "not recovered", described as "bloodwork is off high D Dimer"; ELECTROCARDIOGRAM ABNORMAL (non-serious) with onset 04Oct2021, outcome "not recovered", described as "abnormal EKG". The events "shortness breath", "chest pain", "tingling/electrical shocks throughout extremities", "tingling/electrical shocks throughout extremities", "bloodwork is off high d dimer" and "abnormal EKG" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dyspnoea, chest pain, paraesthesia, electric shock sensation, fibrin D Dimer increased, electrocardiogram abnormal. Additional information: Patient did not received any other vaccine in four weeks. If Covid prior vaccination reported as no and If Covid tested post vaccination reported as yes. Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Sleep disorder
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date Sep2021 (Lot number: FE3592) at the age of 59 years as dose 2, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. Vaccination history included: Bnt162b2 (previous dose product=COVID 19,, previous dose brand=Pfizer,, previous  dose brand unknown=False,, previous  dose lot number=fc3183,, previous  dose lot unknown=False,, previous  dose administration date=20Aug2021, previous  dose dose number=1,, previous  dose vaccine location=Right arm), administration date: 20Aug2021, for Covid-19 Immunization. The following information was reported: DYSPNOEA (non-serious) with onset 04Oct2021, outcome "not recovered", described as "Shortness breath"; CHEST PAIN (non-serious) with onset 04Oct2021, outcome "not recovered", described as "chest pain"; PARAESTHESIA (non-serious), ELECTRIC SHOCK SENSATION (non-serious) all with onset 04Oct2021, outcome "not recovered" and all described as "tingling/electrical shocks throughout extremities"; FIBRIN D DIMER INCREASED (non-serious) with onset 04Oct2021, outcome "not recovered", described as "bloodwork is off high D Dimer"; ELECTROCARDIOGRAM ABNORMAL (non-serious) with onset 04Oct2021, outcome "not recovered", described as "abnormal EKG". The events "shortness breath", "chest pain", "tingling/electrical shocks throughout extremities", "tingling/electrical shocks throughout extremities", "bloodwork is off high d dimer" and "abnormal EKG" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dyspnoea, chest pain, paraesthesia, electric shock sensation, fibrin D Dimer increased, electrocardiogram abnormal. Additional information: Patient did not received any other vaccine in four weeks. If Covid prior vaccination reported as no and If Covid tested post vaccination reported as yes. Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date Sep2021 (Lot number: FE3592) at the age of 59 years as dose 2, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. Vaccination history included: Bnt162b2 (previous dose product=COVID 19,, previous dose brand=Pfizer,, previous  dose brand unknown=False,, previous  dose lot number=fc3183,, previous  dose lot unknown=False,, previous  dose administration date=20Aug2021, previous  dose dose number=1,, previous  dose vaccine location=Right arm), administration date: 20Aug2021, for Covid-19 Immunization. The following information was reported: DYSPNOEA (non-serious) with onset 04Oct2021, outcome "not recovered", described as "Shortness breath"; CHEST PAIN (non-serious) with onset 04Oct2021, outcome "not recovered", described as "chest pain"; PARAESTHESIA (non-serious), ELECTRIC SHOCK SENSATION (non-serious) all with onset 04Oct2021, outcome "not recovered" and all described as "tingling/electrical shocks throughout extremities"; FIBRIN D DIMER INCREASED (non-serious) with onset 04Oct2021, outcome "not recovered", described as "bloodwork is off high D Dimer"; ELECTROCARDIOGRAM ABNORMAL (non-serious) with onset 04Oct2021, outcome "not recovered", described as "abnormal EKG". The events "shortness breath", "chest pain", "tingling/electrical shocks throughout extremities", "tingling/electrical shocks throughout extremities", "bloodwork is off high d dimer" and "abnormal EKG" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dyspnoea, chest pain, paraesthesia, electric shock sensation, fibrin D Dimer increased, electrocardiogram abnormal. Additional information: Patient did not received any other vaccine in four weeks. If Covid prior vaccination reported as no and If Covid tested post vaccination reported as yes. Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Electric shock sensation, Electrocardiogram, Electrocardiogram abnormal
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date Sep2021 (Lot number: FE3592) at the age of 59 years as dose 2, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. Vaccination history included: Bnt162b2 (previous dose product=COVID 19,, previous dose brand=Pfizer,, previous  dose brand unknown=False,, previous  dose lot number=fc3183,, previous  dose lot unknown=False,, previous  dose administration date=20Aug2021, previous  dose dose number=1,, previous  dose vaccine location=Right arm), administration date: 20Aug2021, for Covid-19 Immunization. The following information was reported: DYSPNOEA (non-serious) with onset 04Oct2021, outcome "not recovered", described as "Shortness breath"; CHEST PAIN (non-serious) with onset 04Oct2021, outcome "not recovered", described as "chest pain"; PARAESTHESIA (non-serious), ELECTRIC SHOCK SENSATION (non-serious) all with onset 04Oct2021, outcome "not recovered" and all described as "tingling/electrical shocks throughout extremities"; FIBRIN D DIMER INCREASED (non-serious) with onset 04Oct2021, outcome "not recovered", described as "bloodwork is off high D Dimer"; ELECTROCARDIOGRAM ABNORMAL (non-serious) with onset 04Oct2021, outcome "not recovered", described as "abnormal EKG". The events "shortness breath", "chest pain", "tingling/electrical shocks throughout extremities", "tingling/electrical shocks throughout extremities", "bloodwork is off high d dimer" and "abnormal EKG" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dyspnoea, chest pain, paraesthesia, electric shock sensation, fibrin D Dimer increased, electrocardiogram abnormal. Additional information: Patient did not received any other vaccine in four weeks. If Covid prior vaccination reported as no and If Covid tested post vaccination reported as yes. Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fibrin D dimer, Fibrin D dimer increased, Investigation, Paraesthesia, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date Sep2021 (Lot number: FE3592) at the age of 59 years as dose 2, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. Vaccination history included: Bnt162b2 (previous dose product=COVID 19,, previous dose brand=Pfizer,, previous  dose brand unknown=False,, previous  dose lot number=fc3183,, previous  dose lot unknown=False,, previous  dose administration date=20Aug2021, previous  dose dose number=1,, previous  dose vaccine location=Right arm), administration date: 20Aug2021, for Covid-19 Immunization. The following information was reported: DYSPNOEA (non-serious) with onset 04Oct2021, outcome "not recovered", described as "Shortness breath"; CHEST PAIN (non-serious) with onset 04Oct2021, outcome "not recovered", described as "chest pain"; PARAESTHESIA (non-serious), ELECTRIC SHOCK SENSATION (non-serious) all with onset 04Oct2021, outcome "not recovered" and all described as "tingling/electrical shocks throughout extremities"; FIBRIN D DIMER INCREASED (non-serious) with onset 04Oct2021, outcome "not recovered", described as "bloodwork is off high D Dimer"; ELECTROCARDIOGRAM ABNORMAL (non-serious) with onset 04Oct2021, outcome "not recovered", described as "abnormal EKG". The events "shortness breath", "chest pain", "tingling/electrical shocks throughout extremities", "tingling/electrical shocks throughout extremities", "bloodwork is off high d dimer" and "abnormal EKG" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dyspnoea, chest pain, paraesthesia, electric shock sensation, fibrin D Dimer increased, electrocardiogram abnormal. Additional information: Patient did not received any other vaccine in four weeks. If Covid prior vaccination reported as no and If Covid tested post vaccination reported as yes. Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus, SARS-CoV-2 test, Urticaria
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Aug2021 13:15 (Lot number: FC3182) at the age of 43 years as dose 2, single and administered in arm left, administration date 25Jul2021 11:00 (Lot number: FA6780) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 03Jan2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 03Jan2022, outcome "recovered" (08Jan2022) and all described as "got Covid-19 (mild symptoms)". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Mar2022) negative, notes: Covid test type post vaccination: Nasal Swab; (2021) negative, notes: Since Sep-Dec, patient was tested negative on Covid-19. Therapeutic measures were not taken as a result of suspected Covid-19. Clinical Course: Patient reported that haven't seen a doctor, or received treatment. Patient experienced symptoms of Covid-19 a week before 2nd dose (15Aug2021) and did recover. Since Sep-Dec, patient was tested negative on Covid-19. Patient got Covid-19 (mild symptoms) beginning of the year 03Jan2022 and was able to recover after 5 days. Patient got tested daily with Covid-19 which resulted negative up to this date. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination patient has been tested for COVID-19. It was reported that relevant past drug has no history of allergies. Name of no drug as reported. Reaction includes Allergy. No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Hypersensitivity, Malaise, SARS-CoV-2 test negative, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Aug2021 13:15 (Lot number: FC3182) at the age of 43 years as dose 2, single and administered in arm left, administration date 25Jul2021 11:00 (Lot number: FA6780) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 03Jan2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 03Jan2022, outcome "recovered" (08Jan2022) and all described as "got Covid-19 (mild symptoms)". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Mar2022) negative, notes: Covid test type post vaccination: Nasal Swab; (2021) negative, notes: Since Sep-Dec, patient was tested negative on Covid-19. Therapeutic measures were not taken as a result of suspected Covid-19. Clinical Course: Patient reported that haven't seen a doctor, or received treatment. Patient experienced symptoms of Covid-19 a week before 2nd dose (15Aug2021) and did recover. Since Sep-Dec, patient was tested negative on Covid-19. Patient got Covid-19 (mild symptoms) beginning of the year 03Jan2022 and was able to recover after 5 days. Patient got tested daily with Covid-19 which resulted negative up to this date. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination patient has been tested for COVID-19. It was reported that relevant past drug has no history of allergies. Name of no drug as reported. Reaction includes Allergy. No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Headache, Lethargy, SARS-CoV-2 test
Clinical narrative: positive for COVID-19; positive for COVID-19; Pneumonia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Sep2021 (Lot number: EWD172) at the age of 54 years as dose 2, single and administered in arm left, administration date 01Aug2021 (Lot number: EWD172) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (hospitalization), DRUG INEFFECTIVE (hospitalization), outcome "unknown" and all described as "positive for COVID-19"; PNEUMONIA (hospitalization, medically significant), outcome "unknown", described as "Pneumonia". The events "positive for covid-19", "positive for covid-19" and "pneumonia" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Pneumonia, SARS-CoV-2 test
Clinical narrative: positive for COVID-19; positive for COVID-19; Pneumonia; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Sep2021 (Lot number: EWD172) at the age of 54 years as dose 2, single and administered in arm left, administration date 01Aug2021 (Lot number: EWD172) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (hospitalization), DRUG INEFFECTIVE (hospitalization), outcome "unknown" and all described as "positive for COVID-19"; PNEUMONIA (hospitalization, medically significant), outcome "unknown", described as "Pneumonia". The events "positive for covid-19", "positive for covid-19" and "pneumonia" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia, White blood cell count, White blood cell count decreased
Clinical narrative: Patient is not sure if the third dose was a complete dose or a Booster dose because she does not know the dosage. But she believes it was the Booster dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient is not sure if the third dose was a complete dose or a Booster dose because she does not know the dosage. But she believes it was the Booster dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A, 03BA21A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer, Adhesive tape allergy (Adhesive allergy, allergic to tape.), Seasonal allergy (Seasonal environmental allergies), Drug allergy (Allergies to medicines for osteopenia) and Drug allergy (Allergies to medicines for osteoporosis). Concomitant products included CALCIUM and PREDNISONE for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (Patient is not sure if the third dose was a complete dose or a Booster dose because she does not know the dosage. But she believes it was the Booster dose). At the time of the report, ACCIDENTAL UNDERDOSE (Patient is not sure if the third dose was a complete dose or a Booster dose because she does not know the dosage. But she believes it was the Booster dose) outcome was unknown.            The patient was receiving immune drugs for cancer when she received the first and second doses of the vaccine. The patient never had positive COVID-19 test or diagnosis. The patient received  seasonal allergy shot last fall and believes it was on Sep 2021. No treatment information was provided.   This case was linked to MOD-2022-527617 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Accidental underdose
Clinical narrative: Patient is not sure if the third dose was a complete dose or a Booster dose because she does not know the dosage. But she believes it was the Booster dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient is not sure if the third dose was a complete dose or a Booster dose because she does not know the dosage. But she believes it was the Booster dose) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A, 03BA21A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer, Adhesive tape allergy (Adhesive allergy, allergic to tape.), Seasonal allergy (Seasonal environmental allergies), Drug allergy (Allergies to medicines for osteopenia) and Drug allergy (Allergies to medicines for osteoporosis). Concomitant products included CALCIUM and PREDNISONE for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (Patient is not sure if the third dose was a complete dose or a Booster dose because she does not know the dosage. But she believes it was the Booster dose). At the time of the report, ACCIDENTAL UNDERDOSE (Patient is not sure if the third dose was a complete dose or a Booster dose because she does not know the dosage. But she believes it was the Booster dose) outcome was unknown.            The patient was receiving immune drugs for cancer when she received the first and second doses of the vaccine. The patient never had positive COVID-19 test or diagnosis. The patient received  seasonal allergy shot last fall and believes it was on Sep 2021. No treatment information was provided.   This case was linked to MOD-2022-527617 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: eye stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200500705 (Pfizer).  A 51 year-old male patient received bnt162b2 (BNT162B2), administration date 23Feb2022 (Lot number: FM0698) at the age of 50 years as dose 2, single and administration date 24Jan2022 (Lot number: FK9896) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RETINAL ARTERY OCCLUSION (medically significant) with onset 08Mar2022, outcome "not recovered", described as "eye stroke". The event "eye stroke" was evaluated at the physician office visit. Therapeutic measures were taken as a result of retinal artery occlusion.  Clinical course: Caller states he was calling about the some problem, got the Pfizer vaccine, thinks he has some bad things, states he got the first vaccine 24Jan2022 and on 10Feb2022 when he went to the eye doctor, they said he had an eye stroke, states the doctor took a picture, told him he had an eye stroke, states at that time he could read the biggest letters and then on 23Feb2022 he got the second vaccine and on 8Mar2022 when he went back to the eye specialist, he can't read with that eye nothing. States his right eye is affected. Caller states the doctor said this could be due to the vaccines. doctor told him that he would not get back his vision, states that it could turn into glaucoma. Treatment: gave him a shot for him, some medicine, details unknown.  Follow up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200462068 same patient and drug, different event separated in time
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Retinal artery occlusion
Clinical narrative: eye stroke; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200500705 (Pfizer).  A 51 year-old male patient received bnt162b2 (BNT162B2), administration date 23Feb2022 (Lot number: FM0698) at the age of 50 years as dose 2, single and administration date 24Jan2022 (Lot number: FK9896) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RETINAL ARTERY OCCLUSION (medically significant) with onset 08Mar2022, outcome "not recovered", described as "eye stroke". The event "eye stroke" was evaluated at the physician office visit. Therapeutic measures were taken as a result of retinal artery occlusion.  Clinical course: Caller states he was calling about the some problem, got the Pfizer vaccine, thinks he has some bad things, states he got the first vaccine 24Jan2022 and on 10Feb2022 when he went to the eye doctor, they said he had an eye stroke, states the doctor took a picture, told him he had an eye stroke, states at that time he could read the biggest letters and then on 23Feb2022 he got the second vaccine and on 8Mar2022 when he went back to the eye specialist, he can't read with that eye nothing. States his right eye is affected. Caller states the doctor said this could be due to the vaccines. doctor told him that he would not get back his vision, states that it could turn into glaucoma. Treatment: gave him a shot for him, some medicine, details unknown.  Follow up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200462068 same patient and drug, different event separated in time