chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure fluctuation, Blood pressure measurement, Flushing, Heart rate, Heart rate increased
Clinical narrative: Having SVT events (e.g., pulse jumped from 70 to 172 for 10 seconds); BP is erratic, and today (08Mar) has vascillated between normal (117/79) and 143/85; B/P: 192/118, 173/108, 158/100; Increased heart rate, resting HR 57 usually, now currently 92 and 110 bpm; Flushing; BP reached nearly 197/123; This is a spontaneous report from a contactable consumer (patient) and other hcp. A 53-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6204, Expiry date not reported), via intramuscular, administered in Arm Left on 06Mar2021 15:30 (at the age of 53-year-old) as dose 1, single for covid-19 immunisation administered in Clinic/facility. The patient was not pregnant at the time of vaccination. Medical history included minor persistent asthma, hypothyroidism, osteopenia, heart arrhythmia with (SVT) supraventricular tachycardia, drug hypersensitivity (sulfa drugs) and patient had no food allergies, seasonal and cat/dog allergies. Concomitant medications included fluticasone propionate (FLOVENT), levothyroxine sodium (LEVOTHYROXINE SODIUM), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) and bioidentical HRT (Hormone replacement therapy) since an unknown date for unknown indication. On 06Mar2021 after receiving the vaccine shot within 10 min (at 15:40), patient's blood pressure reached nearly 197/123. On 06Mar2021 16:00, patient felt increased heart rate, as resting HR 57 usually, now currently 92 and 110 bpm and flushing. Patient's skin pink, warm and dry, able to tolerate water well. And BP was 192/118, 173/108, 158/100. Provider on duty cleared patient to leave and instructed patient to follow up with PCP for bp monitoring. Patient communicated understanding and was discharged home. And two days later, patient had SVT events (e.g., pulse jumped from 70 to 172 for 10 seconds), Bp was erratic and today (08mar2021) had vascillated between normal 117/79 and 143/85. The patient did not receive any corrective treatments. The patient did not receive any other vaccine in four weeks. The patient did not test covid positive prior and post vaccination. The outcome of events was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypertension
Clinical narrative: Having SVT events (e.g., pulse jumped from 70 to 172 for 10 seconds); BP is erratic, and today (08Mar) has vascillated between normal (117/79) and 143/85; B/P: 192/118, 173/108, 158/100; Increased heart rate, resting HR 57 usually, now currently 92 and 110 bpm; Flushing; BP reached nearly 197/123; This is a spontaneous report from a contactable consumer (patient) and other hcp. A 53-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6204, Expiry date not reported), via intramuscular, administered in Arm Left on 06Mar2021 15:30 (at the age of 53-year-old) as dose 1, single for covid-19 immunisation administered in Clinic/facility. The patient was not pregnant at the time of vaccination. Medical history included minor persistent asthma, hypothyroidism, osteopenia, heart arrhythmia with (SVT) supraventricular tachycardia, drug hypersensitivity (sulfa drugs) and patient had no food allergies, seasonal and cat/dog allergies. Concomitant medications included fluticasone propionate (FLOVENT), levothyroxine sodium (LEVOTHYROXINE SODIUM), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) and bioidentical HRT (Hormone replacement therapy) since an unknown date for unknown indication. On 06Mar2021 after receiving the vaccine shot within 10 min (at 15:40), patient's blood pressure reached nearly 197/123. On 06Mar2021 16:00, patient felt increased heart rate, as resting HR 57 usually, now currently 92 and 110 bpm and flushing. Patient's skin pink, warm and dry, able to tolerate water well. And BP was 192/118, 173/108, 158/100. Provider on duty cleared patient to leave and instructed patient to follow up with PCP for bp monitoring. Patient communicated understanding and was discharged home. And two days later, patient had SVT events (e.g., pulse jumped from 70 to 172 for 10 seconds), Bp was erratic and today (08mar2021) had vascillated between normal 117/79 and 143/85. The patient did not receive any corrective treatments. The patient did not receive any other vaccine in four weeks. The patient did not test covid positive prior and post vaccination. The outcome of events was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy skin, Eye swelling, Injection site pain, Injection site pustule, Lip swelling
Clinical narrative: PCP for Hives, treated with steroids, no change. Recheck at PCP, sent to allergist, referred to dermatologist by allergist, dermatologist suggests  Syndrome, sent to ER. Admitted to hospital, numerous treatments given over 3 days including immunoglobulin G, then transferred hospitals to burn unit. Diagnosis changed to Toxic Epidermal Necrolysis, treated for burns then released. Currently resumed normal life with few restrictions
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Oral disorder, Peripheral swelling, Pustule, Rash, Skin burning sensation
Clinical narrative: PCP for Hives, treated with steroids, no change. Recheck at PCP, sent to allergist, referred to dermatologist by allergist, dermatologist suggests  Syndrome, sent to ER. Admitted to hospital, numerous treatments given over 3 days including immunoglobulin G, then transferred hospitals to burn unit. Diagnosis changed to Toxic Epidermal Necrolysis, treated for burns then released. Currently resumed normal life with few restrictions
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Skin lesion, Swelling face
Clinical narrative: PCP for Hives, treated with steroids, no change. Recheck at PCP, sent to allergist, referred to dermatologist by allergist, dermatologist suggests  Syndrome, sent to ER. Admitted to hospital, numerous treatments given over 3 days including immunoglobulin G, then transferred hospitals to burn unit. Diagnosis changed to Toxic Epidermal Necrolysis, treated for burns then released. Currently resumed normal life with few restrictions
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drug eruption, Erythema multiforme, Impetigo, Mucosal biopsy, Perioral dermatitis
Clinical narrative: PCP for Hives, treated with steroids, no change. Recheck at PCP, sent to allergist, referred to dermatologist by allergist, dermatologist suggests  Syndrome, sent to ER. Admitted to hospital, numerous treatments given over 3 days including immunoglobulin G, then transferred hospitals to burn unit. Diagnosis changed to Toxic Epidermal Necrolysis, treated for burns then released. Currently resumed normal life with few restrictions
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Skin exfoliation, Toxic epidermal necrolysis
Clinical narrative: PCP for Hives, treated with steroids, no change. Recheck at PCP, sent to allergist, referred to dermatologist by allergist, dermatologist suggests  Syndrome, sent to ER. Admitted to hospital, numerous treatments given over 3 days including immunoglobulin G, then transferred hospitals to burn unit. Diagnosis changed to Toxic Epidermal Necrolysis, treated for burns then released. Currently resumed normal life with few restrictions
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immunoglobulin therapy, Thermal burn, Toxic epidermal necrolysis, Urticaria
Clinical narrative: PCP for Hives, treated with steroids, no change. Recheck at PCP, sent to allergist, referred to dermatologist by allergist, dermatologist suggests  Syndrome, sent to ER. Admitted to hospital, numerous treatments given over 3 days including immunoglobulin G, then transferred hospitals to burn unit. Diagnosis changed to Toxic Epidermal Necrolysis, treated for burns then released. Currently resumed normal life with few restrictions
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Cough, Dyspnoea, Headache, Malaise
Clinical narrative: Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; This is a spontaneous report from a contactable consumer (patient herself). A 48-year-old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Batch/Lot number: EN6206, expiry date was not reported), via an unspecified route of administration in the left arm on 05Mar2021 at 11:45 (at the age of 58-year-old) as a dose 1 single for COVID-19 immunisation. Medical history included asthma, bronchiectasis, CVID (Common variable immunodeficiency) and patient was diagnosed with covid prior vaccination, all from an unknown date and unknown if ongoing. Concomitant medications included montelukast sodium (singulair), ergocalciferol (vit d), albuterol (salbutamol), doxycycline and fexofenadine hydrochloride (ALLEGRA) taken from an unknown date for an unknown indication. The patient previously took Serevent and had allergy from an unknown date. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient developed fever 102.4, sore arm, congestion, cough, shortness of breath, wheezing, chills, malaise, bad headache on 06Mar2021 at 03:30 AM. The patient underwent lab tests which included temperature which was 102.4 and nasal swab which showed negative on 06Mar2021. The adverse events resulted in emergency room or department or urgent care. Therapeutic measures were taken as a result of fever 102.4, sore arm, congestion, cough, shortness of breath, wheezing, chills, malaise, bad headache with breathing treatment (nebulizer), IV steroids and IV. The clinical outcomes of the events fever 102.4, sore arm, congestion, cough, shortness of breath, wheezing, chills, malaise, bad headache was recovered on an unknown date in 2021.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nasal congestion, Pain in extremity, Pyrexia, Wheezing
Clinical narrative: Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; This is a spontaneous report from a contactable consumer (patient herself). A 48-year-old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Batch/Lot number: EN6206, expiry date was not reported), via an unspecified route of administration in the left arm on 05Mar2021 at 11:45 (at the age of 58-year-old) as a dose 1 single for COVID-19 immunisation. Medical history included asthma, bronchiectasis, CVID (Common variable immunodeficiency) and patient was diagnosed with covid prior vaccination, all from an unknown date and unknown if ongoing. Concomitant medications included montelukast sodium (singulair), ergocalciferol (vit d), albuterol (salbutamol), doxycycline and fexofenadine hydrochloride (ALLEGRA) taken from an unknown date for an unknown indication. The patient previously took Serevent and had allergy from an unknown date. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient developed fever 102.4, sore arm, congestion, cough, shortness of breath, wheezing, chills, malaise, bad headache on 06Mar2021 at 03:30 AM. The patient underwent lab tests which included temperature which was 102.4 and nasal swab which showed negative on 06Mar2021. The adverse events resulted in emergency room or department or urgent care. Therapeutic measures were taken as a result of fever 102.4, sore arm, congestion, cough, shortness of breath, wheezing, chills, malaise, bad headache with breathing treatment (nebulizer), IV steroids and IV. The clinical outcomes of the events fever 102.4, sore arm, congestion, cough, shortness of breath, wheezing, chills, malaise, bad headache was recovered on an unknown date in 2021.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Cough, Dyspnoea, Headache
Clinical narrative: Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; This is a spontaneous report from a contactable consumer (patient herself). A 48-year-old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Batch/Lot number: EN6206, expiry date was not reported), via an unspecified route of administration in the left arm on 05Mar2021 at 11:45 (at the age of 58-year-old) as a dose 1 single for COVID-19 immunisation. Medical history included asthma, bronchiectasis, CVID (Common variable immunodeficiency) and patient was diagnosed with covid prior vaccination, all from an unknown date and unknown if ongoing. Concomitant medications included montelukast sodium (singulair), ergocalciferol (vit d), albuterol (salbutamol), doxycycline and fexofenadine hydrochloride (ALLEGRA) taken from an unknown date for an unknown indication. The patient previously took Serevent and had allergy from an unknown date. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient developed fever 102.4, sore arm, congestion, cough, shortness of breath, wheezing, chills, malaise, bad headache on 06Mar2021 at 03:30 AM. The patient underwent lab tests which included temperature which was 102.4 and nasal swab which showed negative on 06Mar2021. The adverse events resulted in emergency room or department or urgent care. Therapeutic measures were taken as a result of fever 102.4, sore arm, congestion, cough, shortness of breath, wheezing, chills, malaise, bad headache with breathing treatment (nebulizer), IV steroids and IV. The clinical outcomes of the events fever 102.4, sore arm, congestion, cough, shortness of breath, wheezing, chills, malaise, bad headache was recovered on an unknown date in 2021.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Nasal congestion, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; This is a spontaneous report from a contactable consumer (patient herself). A 48-year-old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Batch/Lot number: EN6206, expiry date was not reported), via an unspecified route of administration in the left arm on 05Mar2021 at 11:45 (at the age of 58-year-old) as a dose 1 single for COVID-19 immunisation. Medical history included asthma, bronchiectasis, CVID (Common variable immunodeficiency) and patient was diagnosed with covid prior vaccination, all from an unknown date and unknown if ongoing. Concomitant medications included montelukast sodium (singulair), ergocalciferol (vit d), albuterol (salbutamol), doxycycline and fexofenadine hydrochloride (ALLEGRA) taken from an unknown date for an unknown indication. The patient previously took Serevent and had allergy from an unknown date. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient developed fever 102.4, sore arm, congestion, cough, shortness of breath, wheezing, chills, malaise, bad headache on 06Mar2021 at 03:30 AM. The patient underwent lab tests which included temperature which was 102.4 and nasal swab which showed negative on 06Mar2021. The adverse events resulted in emergency room or department or urgent care. Therapeutic measures were taken as a result of fever 102.4, sore arm, congestion, cough, shortness of breath, wheezing, chills, malaise, bad headache with breathing treatment (nebulizer), IV steroids and IV. The clinical outcomes of the events fever 102.4, sore arm, congestion, cough, shortness of breath, wheezing, chills, malaise, bad headache was recovered on an unknown date in 2021.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wheezing
Clinical narrative: Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; Developed fever 102.4, sore arm, congestion, cough, shortness of breathe, wheezing, chills, malaise, bad headache; This is a spontaneous report from a contactable consumer (patient herself). A 48-year-old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution for injection, Batch/Lot number: EN6206, expiry date was not reported), via an unspecified route of administration in the left arm on 05Mar2021 at 11:45 (at the age of 58-year-old) as a dose 1 single for COVID-19 immunisation. Medical history included asthma, bronchiectasis, CVID (Common variable immunodeficiency) and patient was diagnosed with covid prior vaccination, all from an unknown date and unknown if ongoing. Concomitant medications included montelukast sodium (singulair), ergocalciferol (vit d), albuterol (salbutamol), doxycycline and fexofenadine hydrochloride (ALLEGRA) taken from an unknown date for an unknown indication. The patient previously took Serevent and had allergy from an unknown date. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient developed fever 102.4, sore arm, congestion, cough, shortness of breath, wheezing, chills, malaise, bad headache on 06Mar2021 at 03:30 AM. The patient underwent lab tests which included temperature which was 102.4 and nasal swab which showed negative on 06Mar2021. The adverse events resulted in emergency room or department or urgent care. Therapeutic measures were taken as a result of fever 102.4, sore arm, congestion, cough, shortness of breath, wheezing, chills, malaise, bad headache with breathing treatment (nebulizer), IV steroids and IV. The clinical outcomes of the events fever 102.4, sore arm, congestion, cough, shortness of breath, wheezing, chills, malaise, bad headache was recovered on an unknown date in 2021.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Amnesia, Blister, Blood test, Burning sensation
Clinical narrative: Heavy vaginal bleeding for 2 weeks; Severe migraine that wont go away; Diarrhea; chills; fever; High blood pressure; Hands randomly turn red and burn; Hands randomly turn red and burn; phlegm; headache; body aches; nausea; sun sensitivity and sunburn last 2 weeks; sun sensitivity and sunburn last 2 weeks; This is a spontaneous report from a contactable other Health Care Professional. A 35-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6199 and Expiry date: Unknown)via an unspecified route of administration, administered in left Arm on 05Mar2021 at 10:45 as Dose 2,Single for COVID-19 immunization. The patient's medical history included endometriosis, Allergies to medications, food, or other products PNC, tetracycline, and methlyparaben. Patient took first dose of bnt162b2 (-PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201 was not reported) on 12-FEB-2021 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and on 18Mar2021has been tested for COVID-19 resulted in Negative.On 05Mar2021 the patient experienced heavy vaginal bleeding for 2 weeks, severe migraine that wont go away, diarrhea, chills, fever, high blood pressure, hands randomly turn red and burn, phlegm, sun sensitivity and sunburn last 2 weeks, nausea, body aches, headache. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 18Mar2021.Therapeutic measures were taken as a result of the adverse events. Patient's treatment for the adverse event included Headache cocktail, imitrex, steroids, zofran, bent. On Mar2021 the outcome of events Heavy vaginal bleeding for 2 weeks, nausea, body aches, was recovered while the outcome of events Severe migraine that wont go away , Diarrhea , chills , fever , High blood pressure , Hands randomly turn red and burn,phlegm ,sun sensitivity and sunburn last 2 weeks,headache was not recovered .; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Vaginal hemorrhage, Migraine, Diarrhea, Chills, Pyrexia, Blood pressure increased, Erythema, Burning sensation, Productive cough, Photo sensitivity, Sunburn and Headache and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Contusion, Dizziness, Fatigue, Hypertension
Clinical narrative: Heavy vaginal bleeding for 2 weeks; Severe migraine that wont go away; Diarrhea; chills; fever; High blood pressure; Hands randomly turn red and burn; Hands randomly turn red and burn; phlegm; headache; body aches; nausea; sun sensitivity and sunburn last 2 weeks; sun sensitivity and sunburn last 2 weeks; This is a spontaneous report from a contactable other Health Care Professional. A 35-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6199 and Expiry date: Unknown)via an unspecified route of administration, administered in left Arm on 05Mar2021 at 10:45 as Dose 2,Single for COVID-19 immunization. The patient's medical history included endometriosis, Allergies to medications, food, or other products PNC, tetracycline, and methlyparaben. Patient took first dose of bnt162b2 (-PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201 was not reported) on 12-FEB-2021 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and on 18Mar2021has been tested for COVID-19 resulted in Negative.On 05Mar2021 the patient experienced heavy vaginal bleeding for 2 weeks, severe migraine that wont go away, diarrhea, chills, fever, high blood pressure, hands randomly turn red and burn, phlegm, sun sensitivity and sunburn last 2 weeks, nausea, body aches, headache. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 18Mar2021.Therapeutic measures were taken as a result of the adverse events. Patient's treatment for the adverse event included Headache cocktail, imitrex, steroids, zofran, bent. On Mar2021 the outcome of events Heavy vaginal bleeding for 2 weeks, nausea, body aches, was recovered while the outcome of events Severe migraine that wont go away , Diarrhea , chills , fever , High blood pressure , Hands randomly turn red and burn,phlegm ,sun sensitivity and sunburn last 2 weeks,headache was not recovered .; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Vaginal hemorrhage, Migraine, Diarrhea, Chills, Pyrexia, Blood pressure increased, Erythema, Burning sensation, Productive cough, Photo sensitivity, Sunburn and Headache and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Migraine, Muscle spasms, Nausea, Pain, Photosensitivity reaction
Clinical narrative: Heavy vaginal bleeding for 2 weeks; Severe migraine that wont go away; Diarrhea; chills; fever; High blood pressure; Hands randomly turn red and burn; Hands randomly turn red and burn; phlegm; headache; body aches; nausea; sun sensitivity and sunburn last 2 weeks; sun sensitivity and sunburn last 2 weeks; This is a spontaneous report from a contactable other Health Care Professional. A 35-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6199 and Expiry date: Unknown)via an unspecified route of administration, administered in left Arm on 05Mar2021 at 10:45 as Dose 2,Single for COVID-19 immunization. The patient's medical history included endometriosis, Allergies to medications, food, or other products PNC, tetracycline, and methlyparaben. Patient took first dose of bnt162b2 (-PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201 was not reported) on 12-FEB-2021 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and on 18Mar2021has been tested for COVID-19 resulted in Negative.On 05Mar2021 the patient experienced heavy vaginal bleeding for 2 weeks, severe migraine that wont go away, diarrhea, chills, fever, high blood pressure, hands randomly turn red and burn, phlegm, sun sensitivity and sunburn last 2 weeks, nausea, body aches, headache. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 18Mar2021.Therapeutic measures were taken as a result of the adverse events. Patient's treatment for the adverse event included Headache cocktail, imitrex, steroids, zofran, bent. On Mar2021 the outcome of events Heavy vaginal bleeding for 2 weeks, nausea, body aches, was recovered while the outcome of events Severe migraine that wont go away , Diarrhea , chills , fever , High blood pressure , Hands randomly turn red and burn,phlegm ,sun sensitivity and sunburn last 2 weeks,headache was not recovered .; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Vaginal hemorrhage, Migraine, Diarrhea, Chills, Pyrexia, Blood pressure increased, Erythema, Burning sensation, Productive cough, Photo sensitivity, Sunburn and Headache and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, Pyrexia, Rash macular, Swelling, Vaginal haemorrhage
Clinical narrative: Heavy vaginal bleeding for 2 weeks; Severe migraine that wont go away; Diarrhea; chills; fever; High blood pressure; Hands randomly turn red and burn; Hands randomly turn red and burn; phlegm; headache; body aches; nausea; sun sensitivity and sunburn last 2 weeks; sun sensitivity and sunburn last 2 weeks; This is a spontaneous report from a contactable other Health Care Professional. A 35-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6199 and Expiry date: Unknown)via an unspecified route of administration, administered in left Arm on 05Mar2021 at 10:45 as Dose 2,Single for COVID-19 immunization. The patient's medical history included endometriosis, Allergies to medications, food, or other products PNC, tetracycline, and methlyparaben. Patient took first dose of bnt162b2 (-PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201 was not reported) on 12-FEB-2021 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and on 18Mar2021has been tested for COVID-19 resulted in Negative.On 05Mar2021 the patient experienced heavy vaginal bleeding for 2 weeks, severe migraine that wont go away, diarrhea, chills, fever, high blood pressure, hands randomly turn red and burn, phlegm, sun sensitivity and sunburn last 2 weeks, nausea, body aches, headache. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 18Mar2021.Therapeutic measures were taken as a result of the adverse events. Patient's treatment for the adverse event included Headache cocktail, imitrex, steroids, zofran, bent. On Mar2021 the outcome of events Heavy vaginal bleeding for 2 weeks, nausea, body aches, was recovered while the outcome of events Severe migraine that wont go away , Diarrhea , chills , fever , High blood pressure , Hands randomly turn red and burn,phlegm ,sun sensitivity and sunburn last 2 weeks,headache was not recovered .; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Vaginal hemorrhage, Migraine, Diarrhea, Chills, Pyrexia, Blood pressure increased, Erythema, Burning sensation, Productive cough, Photo sensitivity, Sunburn and Headache and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Heavy vaginal bleeding for 2 weeks; Severe migraine that wont go away; Diarrhea; chills; fever; High blood pressure; Hands randomly turn red and burn; Hands randomly turn red and burn; phlegm; headache; body aches; nausea; sun sensitivity and sunburn last 2 weeks; sun sensitivity and sunburn last 2 weeks; This is a spontaneous report from a contactable other Health Care Professional. A 35-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6199 and Expiry date: Unknown)via an unspecified route of administration, administered in left Arm on 05Mar2021 at 10:45 as Dose 2,Single for COVID-19 immunization. The patient's medical history included endometriosis, Allergies to medications, food, or other products PNC, tetracycline, and methlyparaben. Patient took first dose of bnt162b2 (-PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201 was not reported) on 12-FEB-2021 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and on 18Mar2021has been tested for COVID-19 resulted in Negative.On 05Mar2021 the patient experienced heavy vaginal bleeding for 2 weeks, severe migraine that wont go away, diarrhea, chills, fever, high blood pressure, hands randomly turn red and burn, phlegm, sun sensitivity and sunburn last 2 weeks, nausea, body aches, headache. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 18Mar2021.Therapeutic measures were taken as a result of the adverse events. Patient's treatment for the adverse event included Headache cocktail, imitrex, steroids, zofran, bent. On Mar2021 the outcome of events Heavy vaginal bleeding for 2 weeks, nausea, body aches, was recovered while the outcome of events Severe migraine that wont go away , Diarrhea , chills , fever , High blood pressure , Hands randomly turn red and burn,phlegm ,sun sensitivity and sunburn last 2 weeks,headache was not recovered .; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Vaginal hemorrhage, Migraine, Diarrhea, Chills, Pyrexia, Blood pressure increased, Erythema, Burning sensation, Productive cough, Photo sensitivity, Sunburn and Headache and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Burning sensation, Chills, Diarrhoea, Erythema
Clinical narrative: Heavy vaginal bleeding for 2 weeks; Severe migraine that wont go away; Diarrhea; chills; fever; High blood pressure; Hands randomly turn red and burn; Hands randomly turn red and burn; phlegm; headache; body aches; nausea; sun sensitivity and sunburn last 2 weeks; sun sensitivity and sunburn last 2 weeks; This is a spontaneous report from a contactable other Health Care Professional. A 35-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6199 and Expiry date: Unknown)via an unspecified route of administration, administered in left Arm on 05Mar2021 at 10:45 as Dose 2,Single for COVID-19 immunization. The patient's medical history included endometriosis, Allergies to medications, food, or other products PNC, tetracycline, and methlyparaben. Patient took first dose of bnt162b2 (-PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201 was not reported) on 12-FEB-2021 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and on 18Mar2021has been tested for COVID-19 resulted in Negative.On 05Mar2021 the patient experienced heavy vaginal bleeding for 2 weeks, severe migraine that wont go away, diarrhea, chills, fever, high blood pressure, hands randomly turn red and burn, phlegm, sun sensitivity and sunburn last 2 weeks, nausea, body aches, headache. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 18Mar2021.Therapeutic measures were taken as a result of the adverse events. Patient's treatment for the adverse event included Headache cocktail, imitrex, steroids, zofran, bent. On Mar2021 the outcome of events Heavy vaginal bleeding for 2 weeks, nausea, body aches, was recovered while the outcome of events Severe migraine that wont go away , Diarrhea , chills , fever , High blood pressure , Hands randomly turn red and burn,phlegm ,sun sensitivity and sunburn last 2 weeks,headache was not recovered .; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Vaginal hemorrhage, Migraine, Diarrhea, Chills, Pyrexia, Blood pressure increased, Erythema, Burning sensation, Productive cough, Photo sensitivity, Sunburn and Headache and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Migraine, Nausea, Pain, Photosensitivity reaction
Clinical narrative: Heavy vaginal bleeding for 2 weeks; Severe migraine that wont go away; Diarrhea; chills; fever; High blood pressure; Hands randomly turn red and burn; Hands randomly turn red and burn; phlegm; headache; body aches; nausea; sun sensitivity and sunburn last 2 weeks; sun sensitivity and sunburn last 2 weeks; This is a spontaneous report from a contactable other Health Care Professional. A 35-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6199 and Expiry date: Unknown)via an unspecified route of administration, administered in left Arm on 05Mar2021 at 10:45 as Dose 2,Single for COVID-19 immunization. The patient's medical history included endometriosis, Allergies to medications, food, or other products PNC, tetracycline, and methlyparaben. Patient took first dose of bnt162b2 (-PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201 was not reported) on 12-FEB-2021 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and on 18Mar2021has been tested for COVID-19 resulted in Negative.On 05Mar2021 the patient experienced heavy vaginal bleeding for 2 weeks, severe migraine that wont go away, diarrhea, chills, fever, high blood pressure, hands randomly turn red and burn, phlegm, sun sensitivity and sunburn last 2 weeks, nausea, body aches, headache. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 18Mar2021.Therapeutic measures were taken as a result of the adverse events. Patient's treatment for the adverse event included Headache cocktail, imitrex, steroids, zofran, bent. On Mar2021 the outcome of events Heavy vaginal bleeding for 2 weeks, nausea, body aches, was recovered while the outcome of events Severe migraine that wont go away , Diarrhea , chills , fever , High blood pressure , Hands randomly turn red and burn,phlegm ,sun sensitivity and sunburn last 2 weeks,headache was not recovered .; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Vaginal hemorrhage, Migraine, Diarrhea, Chills, Pyrexia, Blood pressure increased, Erythema, Burning sensation, Productive cough, Photo sensitivity, Sunburn and Headache and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Productive cough, Pyrexia, SARS-CoV-2 test, Sunburn, Vaginal haemorrhage
Clinical narrative: Heavy vaginal bleeding for 2 weeks; Severe migraine that wont go away; Diarrhea; chills; fever; High blood pressure; Hands randomly turn red and burn; Hands randomly turn red and burn; phlegm; headache; body aches; nausea; sun sensitivity and sunburn last 2 weeks; sun sensitivity and sunburn last 2 weeks; This is a spontaneous report from a contactable other Health Care Professional. A 35-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6199 and Expiry date: Unknown)via an unspecified route of administration, administered in left Arm on 05Mar2021 at 10:45 as Dose 2,Single for COVID-19 immunization. The patient's medical history included endometriosis, Allergies to medications, food, or other products PNC, tetracycline, and methlyparaben. Patient took first dose of bnt162b2 (-PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201 was not reported) on 12-FEB-2021 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and on 18Mar2021has been tested for COVID-19 resulted in Negative.On 05Mar2021 the patient experienced heavy vaginal bleeding for 2 weeks, severe migraine that wont go away, diarrhea, chills, fever, high blood pressure, hands randomly turn red and burn, phlegm, sun sensitivity and sunburn last 2 weeks, nausea, body aches, headache. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 18Mar2021.Therapeutic measures were taken as a result of the adverse events. Patient's treatment for the adverse event included Headache cocktail, imitrex, steroids, zofran, bent. On Mar2021 the outcome of events Heavy vaginal bleeding for 2 weeks, nausea, body aches, was recovered while the outcome of events Severe migraine that wont go away , Diarrhea , chills , fever , High blood pressure , Hands randomly turn red and burn,phlegm ,sun sensitivity and sunburn last 2 weeks,headache was not recovered .; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events Vaginal hemorrhage, Migraine, Diarrhea, Chills, Pyrexia, Blood pressure increased, Erythema, Burning sensation, Productive cough, Photo sensitivity, Sunburn and Headache and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Pain
Clinical narrative: Severe low back and both legs nerve and muscle pains every day especially upon standing in morning.  Cramping, etc.   everyday  beginning a week and half post vaccination.  Ongoing.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Severe low back and both legs nerve and muscle pains every day especially upon standing in morning.  Cramping, etc.   everyday  beginning a week and half post vaccination.  Ongoing.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Muscle spasms, Myalgia, Neuralgia
Clinical narrative: Severe low back and both legs nerve and muscle pains every day especially upon standing in morning.  Cramping, etc.   everyday  beginning a week and half post vaccination.  Ongoing.