chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Haemorrhage, Headache, Maternal exposure during pregnancy, SARS-CoV-2 test
Clinical narrative: Severe cramping massive bleeding; severe cramping massive bleeding on 24May2021; I found out I was pregnant a few days after receiving my first vaccine a few days later, Severe cramping massive bleeding; This is a spontaneous report from a contactable consumer (patient). A 38-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 administered in Arm Left on 30Apr2021 12:15 (Lot Number: Ew1067) at 38-year-old as 1st dose single for covid-19 immunisation. The patient medical history and the concomitant medications were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient found out she was pregnant a few days after receiving her first vaccine a few days later, severe cramping massive bleeding on 24May2021. The patient ended up bleeding for a total of 19 days. The outcome was unknown. The patient became pregnant while taking bnt162b2.  The patient was due to deliver on 07Jan2022.  The lab tests included blood test: negative  on 28May2021. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Haemorrhage, Maternal exposure during pregnancy, Muscle spasms
Clinical narrative: I found out I was pregnant a few days after receiving my first vaccine a few days later/ I ended up bleeding for a total of 19 days after my second dose; I found out I was pregnant a few days after receiving my first vaccine a few days later/ I ended up bleeding for a total of 19 days after my second dose; headaches; This is a spontaneous report from a contactable consumer (patient).  A 38-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 30Apr2021 12:15 (Batch/Lot Number: Ew1068) (at the age of 38) as single dose for covid-19 immunisation. First dose (lot number: Ew1067) was administered on '30Apr2021' (as reported, to be clarified). The patient medical history was not reported. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient found out she was pregnant a few days after receiving my first vaccine a few days later/ i ended up bleeding for a total of 19 days after my second dose on 24May2021, headaches on 24May2021. The events outcome was unknown. The mother was 7 weeks pregnant at the onset of the event. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The mother was due to deliver on 07Jan2022. No treatment received. The patient underwent lab tests and procedures which included blood test: negative  on 28May2021, sars-cov-2 test: negative on 28May2021.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Haemorrhage, Headache, Maternal exposure during pregnancy, SARS-CoV-2 test
Clinical narrative: I found out I was pregnant a few days after receiving my first vaccine a few days later/ I ended up bleeding for a total of 19 days after my second dose; I found out I was pregnant a few days after receiving my first vaccine a few days later/ I ended up bleeding for a total of 19 days after my second dose; headaches; This is a spontaneous report from a contactable consumer (patient).  A 38-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 30Apr2021 12:15 (Batch/Lot Number: Ew1068) (at the age of 38) as single dose for covid-19 immunisation. First dose (lot number: Ew1067) was administered on '30Apr2021' (as reported, to be clarified). The patient medical history was not reported. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient found out she was pregnant a few days after receiving my first vaccine a few days later/ i ended up bleeding for a total of 19 days after my second dose on 24May2021, headaches on 24May2021. The events outcome was unknown. The mother was 7 weeks pregnant at the onset of the event. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The mother was due to deliver on 07Jan2022. No treatment received. The patient underwent lab tests and procedures which included blood test: negative  on 28May2021, sars-cov-2 test: negative on 28May2021.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Inappropriate schedule of product administration
Clinical narrative: Two days post first vaccine onset of early, heavy bleeding. Stopped after 7 daysTwo days after second vaccine, extreme bleeding for 3 full weeks so heavy; received dose1 and dose 2 on 08Apr2021; This is a spontaneous report from a contactable consumer (patient).  A 37-years-old female patient (not pregnant at time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 08Apr2021 13:00 at the age of 37-years-old(Batch/Lot Number: EW0179) as 2ND DOSE, SINGLE, dose 1 via an unspecified route of administration, administered in Leg Left on 08Apr2021 at the age of 37-years-old (Batch/Lot Number: EW0151) as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included covid-19 from an unknown date, Prior to vaccination, the patient was diagnosed with COVID-19. IUD from an unknown date, having little to no period with IUD. Concomitant medication included bupropion hydrochloride (BUPROPION) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient stated despite having little to no period with IUD, two days (as reported) post first vaccine onset of early, heavy bleeding on 01May2021 08:00. Stopped after 7 days. Two days (as reported) after second vaccine, extreme bleeding for 3 full weeks so heavy that her body expelled her IUD. Sought treatment from OBGYN. Had to take four progesterone pills a day for four days to get bleeding to stop and was still taking them 6 weeks after vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event bleeding included progesterone and scheduled uterine ablation. The outcome of the event heavy bleeding was resolving.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Product administered at inappropriate site
Clinical narrative: Two days post first vaccine onset of early, heavy bleeding. Stopped after 7 daysTwo days after second vaccine, extreme bleeding for 3 full weeks so heavy; received dose1 and dose 2 on 08Apr2021; This is a spontaneous report from a contactable consumer (patient).  A 37-years-old female patient (not pregnant at time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 08Apr2021 13:00 at the age of 37-years-old(Batch/Lot Number: EW0179) as 2ND DOSE, SINGLE, dose 1 via an unspecified route of administration, administered in Leg Left on 08Apr2021 at the age of 37-years-old (Batch/Lot Number: EW0151) as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included covid-19 from an unknown date, Prior to vaccination, the patient was diagnosed with COVID-19. IUD from an unknown date, having little to no period with IUD. Concomitant medication included bupropion hydrochloride (BUPROPION) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient stated despite having little to no period with IUD, two days (as reported) post first vaccine onset of early, heavy bleeding on 01May2021 08:00. Stopped after 7 days. Two days (as reported) after second vaccine, extreme bleeding for 3 full weeks so heavy that her body expelled her IUD. Sought treatment from OBGYN. Had to take four progesterone pills a day for four days to get bleeding to stop and was still taking them 6 weeks after vaccine. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event bleeding included progesterone and scheduled uterine ablation. The outcome of the event heavy bleeding was resolving.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Malaise, Nausea
Clinical narrative: High fever 102.7 to 103,2; general full body malaise; Chills; extreme soreness at injection site; Nausea; Headache; body aches; This is a spontaneous report received from a contactable consumer (patient). A 15-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0217 and expiration date not provided), via an unspecified route of administration, in arm left, on 04Jun2021 15:45 (at the age of 15-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history and concomitant medications were reported as "none". Patient had no known allergies. No other medical history. Prior to vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9264 and expiration date not provided), via an unspecified route of administration, in right arm, on 14May2021 15:45 (at the age of 15-year-old), at single dose, for COVID-19 immunization. On 05Jun2021 02:45, the patient experienced high fever 102.7 to 103.2, general full body malaise, chills, extreme soreness at injection site, nausea, headache, and body aches. The patient underwent lab tests and procedures which included body temperature: 102.7 to 103.2 on 05Jun2021 02:45. Since the vaccination, patient had not been tested for COVID-19. No treatment received for events. The outcome of evens was unknown.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: High fever 102.7 to 103,2; general full body malaise; Chills; extreme soreness at injection site; Nausea; Headache; body aches; This is a spontaneous report received from a contactable consumer (patient). A 15-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0217 and expiration date not provided), via an unspecified route of administration, in arm left, on 04Jun2021 15:45 (at the age of 15-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history and concomitant medications were reported as "none". Patient had no known allergies. No other medical history. Prior to vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9264 and expiration date not provided), via an unspecified route of administration, in right arm, on 14May2021 15:45 (at the age of 15-year-old), at single dose, for COVID-19 immunization. On 05Jun2021 02:45, the patient experienced high fever 102.7 to 103.2, general full body malaise, chills, extreme soreness at injection site, nausea, headache, and body aches. The patient underwent lab tests and procedures which included body temperature: 102.7 to 103.2 on 05Jun2021 02:45. Since the vaccination, patient had not been tested for COVID-19. No treatment received for events. The outcome of evens was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Bone disorder
Clinical narrative: I feel like I am having my pregnancies miscarriage's all over again /  My pelvic, back, legs, spine, neck, head and all my bones are killing me.; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient (110 pounds) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 03Jun2021 18:00 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation in Pharmacy or Drug Store. Medical history included heart condition and known allergies: Sulfa. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No medications the patient received within 2 weeks of vaccination. The patient previously took bnt162b2 for covid-19 immunisation at Left arm on 13May2021 18:00. The patient reported that she felt like she was having her pregnancies miscarriage was all over again / her pelvic, back, legs, spine, neck, head and all her bones are killing her on 04Jun2021 12:00 with outcome of unknown. It was unknown if any treatment was received. The patient was just wondering if the same dose or different doses of this vaccine should be the same. Her husband was 200 pounds and she was 110 pounds. She was a smaller person. Should she had a smaller does? She felt like she had been overdosed with Pfizer. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Heart rate increased, Viral test
Clinical narrative: Labored breathing; chest pains; fast heart rate; This is a spontaneous report from a contactable consumer reported for himself. A 16-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Right on 13May2021 11:30 AM as unknown, single (at age of 15-years-old) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Medical history included choanal atresia, tonsils and adenoids removed, ear tags. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were none. On 04Jun2021 09:00, the patient experienced labored breathing, chest pains, fast heart rate. The adverse events resulted in emergency room/department or urgent care, hospitalization for 2 days. The adverse events received treatment included Aspirin, Ibuprofen. The patient underwent lab tests and procedures which included Nasal Swab: negative on 05Jun2021. Outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis, SARS-CoV-2 test
Clinical narrative: Pericarditis; This is a spontaneous report from a contactable consumer (patient). A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 28Mar2021 08:00 (Lot Number: EN6260) age at vaccination 42 years as 1ST DOSE, SINGLE for covid-19 immunization. Medical history was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were none. The patient experienced pericarditis on 30Mar2021 02:00. The patient was hospitalized for pericarditis for 3 days. Event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. Patient received anti-inflammatory mesicarions to treat pericarditis. The patient underwent lab tests and procedures which included Both nasal and blood test: negative on 30Mar2021. The outcome was recovered.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This was after second covid vaccine-rash on arms legs and stomach doctors have tried many treatments nothing has worked; This is a spontaneous report received from a contactable consumer (patient). This 63-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Apr2021 12:00 PM at age of 63-year-old as 2nd dose, single for COVID-19 immunisation. Medical history included diabetes and heart stent. No known allergies. No covid prior vaccination. Concomitant medications included apixaban (ELIQUIS), empagliflozin (JARDIANCE), metformin, and clopidogrel bisulfate (PLAVIX). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. This was after second covid vaccine on 16Apr2021 08:00 AM, rash on arms legs and stomach doctors have tried many treatments nothing has worked. Event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Since the vaccination, has the patient had not been tested for COVID-19. Different prescription creams and prednisone received. Outcome of the event was not recovered.  Information about batch/lot number has been requested.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Dizziness, Electrocardiogram, Hypoaesthesia, Magnetic resonance imaging
Clinical narrative: right shoulder felt numb/ the numbness spread to the rest of the right arm, hand, shoulder, side of the neck, and side of the face.; I feel intense tingling sensations throughout the day; lose of control of my right arm and leg; dizzy; nauseous; This is a spontaneous report from a contactable consumer (patient). This 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 08Apr2021 07:00 AM (Lot Number: EP7533) at the age of 28-year-old as single dose for covid-19 immunisation. The patient medical history was none. No known allergies or other medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications the patient received within 2 weeks of vaccination included multivitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On the evening of the first day after getting the vaccine, on 08Apr2021 at 04:00 PM, patient right shoulder felt numb. Over the course of the next few days, the numbness spread to the rest of the right arm, hand, shoulder, side of the neck, and side of the face. At this point, he went to the ER and then they admitted him to hospital for 3 days, gave him steroids, did an MRI of his neck and a CT of head. After discharged, in Apr2021, patient felt intense tingling sensations throughout the day making him dizzy, nauseous, and loss of control of his right arm and leg.  Patient has had regular visits with the recommended neurologist where they did an EKG test, and patient is now waiting on a lumbar puncture test. Event numbness resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for three days. Since the vaccination, the patient had not been tested for COVID-19. Treatment received for the adverse event numbness as steroids. Outcome of the events was not recovered.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Motor dysfunction, Nausea, Paraesthesia
Clinical narrative: right shoulder felt numb/ the numbness spread to the rest of the right arm, hand, shoulder, side of the neck, and side of the face.; I feel intense tingling sensations throughout the day; lose of control of my right arm and leg; dizzy; nauseous; This is a spontaneous report from a contactable consumer (patient). This 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 08Apr2021 07:00 AM (Lot Number: EP7533) at the age of 28-year-old as single dose for covid-19 immunisation. The patient medical history was none. No known allergies or other medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications the patient received within 2 weeks of vaccination included multivitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On the evening of the first day after getting the vaccine, on 08Apr2021 at 04:00 PM, patient right shoulder felt numb. Over the course of the next few days, the numbness spread to the rest of the right arm, hand, shoulder, side of the neck, and side of the face. At this point, he went to the ER and then they admitted him to hospital for 3 days, gave him steroids, did an MRI of his neck and a CT of head. After discharged, in Apr2021, patient felt intense tingling sensations throughout the day making him dizzy, nauseous, and loss of control of his right arm and leg.  Patient has had regular visits with the recommended neurologist where they did an EKG test, and patient is now waiting on a lumbar puncture test. Event numbness resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for three days. Since the vaccination, the patient had not been tested for COVID-19. Treatment received for the adverse event numbness as steroids. Outcome of the events was not recovered.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immune reconstitution inflammatory syndrome, Paraesthesia, Small fibre neuropathy, Vasculitis
Clinical narrative: Inflammatory immune response; Vasculitis; Suffering paresthesia since 2 days after my 1st dose of COVID-19 vaccine.; Small fiber neuropathy; This is a spontaneous report received from a contactable consumer (patient). A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 administered in Arm Left on 25May2021 (Lot Number: EW0183) at age of 51-year-old as 1ST DOSE,SINGLE for covid-19 immunisation. Medical history included known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications received within 2 weeks of vaccination was fexofenadine. The patient suffering paresthesia since 2 days after her 1st dose of COVID-19 vaccine -now on day 12. A neurologist has diagnosed her with an inflammatory immune response causing small fiber neuropathy and possible vasculitis.  Events onset date was 26May2021. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received. The outcome was Not recovered. No COVID prior vaccination. No COVID tested post vaccination.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood test, Electromyogram, Neurological examination, Paraesthesia
Clinical narrative: Inflammatory immune response; Vasculitis; Suffering paresthesia since 2 days after my 1st dose of COVID-19 vaccine.; Small fiber neuropathy; This is a spontaneous report received from a contactable consumer (patient). A 51-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 administered in Arm Left on 25May2021 (Lot Number: EW0183) at age of 51-year-old as 1ST DOSE,SINGLE for covid-19 immunisation. Medical history included known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications received within 2 weeks of vaccination was fexofenadine. The patient suffering paresthesia since 2 days after her 1st dose of COVID-19 vaccine -now on day 12. A neurologist has diagnosed her with an inflammatory immune response causing small fiber neuropathy and possible vasculitis.  Events onset date was 26May2021. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received. The outcome was Not recovered. No COVID prior vaccination. No COVID tested post vaccination.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives all over torso/back, arms/under arms, legs/behind the knees, neck and chin. NO wheezing or shortness of breath.; itching; This is a spontaneous report from a contactable consumer (patient). A 13-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 04Jun2021 at 08:00 (Batch/Lot number was not reported) (at the age of 13-year-old) as single dose for COVID-19 immunisation. The patient medical history included COVID-19 from an unknown date to an unknown date. No known allergies. Since the vaccination the patient has not been tested for COVID-19. The patient's concomitant medications were not reported.  On 04Jun2021 at 10:00, the patient experienced hives all over torso/back, arms/under arms, legs/behind the knees, neck and chin with itching. No wheezing or shortness of breath. The events were serious, medically significant. The events required doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with BENADRYL. The patient outcome of the events was recovering.  Information about lot/batch number has been requested.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Loss of consciousness, Seizure
Clinical narrative: My daughter lost consciousness either from passing out or seizure; My daughter lost consciousness either from passing out or seizure; This is a spontaneous report from a non-contactable consumer (patient's mother). A 14-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right at the age of 14-year-old on 04Jun2021 12:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant. The patient previously took first dose bnt162b2 for COVID-19 Immunization. The reporter stated that 'my daughter lost consciousness either from passing out or seizure'. Event start on 05Jun2021 08:00. AE resulted in: Emergency room/department or urgent care.  Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included investigation: unknown results in Jun2021. Therapeutic measures were taken as a result of events (Testing and pain meds /IV fluids). The outcome of event was recovering.  Information on lot/batch number has been requested.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Body temperature, Pyrexia
Clinical narrative: major asthma attack; temp of 102; This is a spontaneous report from a consumer (patient parent) reported for son. A 12-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number Ew0177, on 14May2021 16:00 at single dose in left arm (at the age of 12-year-old) for COVID-19 immunization. Medical history included asthma. The patient had no Known allergies. The patient had no covid prior vaccination. The patient had no covid tested post vaccination. Concomitant medication was not reported. The patient had seen his pulmonologist the day before and had a really good check up for his asthma. He had his shot on 14May2021. On 16May2021 he had temp of 102. On early hours of 17May2021 he had major asthma attack. Reporter was very well educated in how to help with an asthma attack. So didnt need to seek medical attention. But it took several nebulizer treatments, couple days a prednisone to get him back to his base line. His temperature lasted a total for 4 days and missed 5 days of school. Reporter did call his pulmonologist for directions on what to do. The outcome of major asthma attack was resolved in 2021. The outcome of temp of 102 was resolved on 20May2021.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Cervical polyp, Paraesthesia, Pelvic pain, Vaccination site pain
Clinical narrative: reproductive organs, bleeding that consisted for 2 weeks straight and now spotting 3 weeks out of 4 weeks; intense pain in reproductive organs; Bloating; now growths (possibly cervical polyps); dull achy sore pain where the shot was administered; tingliess in her fingers on that arm; This is a spontaneous report received from a contactable consumer (patient). A 40-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown, NDC 59267100002) via an unspecified route of administration at left arm on 13Apr2021 12:00 (40-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included depression and ADHD. Concomitant medications in two weeks included dextroamphetamine hydrochloride; alprazolam; sertraline hydrochloride (ZOLOFT); hydroxyzine hydrochloride (VISTARIL). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) at left arm on 23Mar2021 11:00 (40-year-old at time of vaccination) for COVID-19 immunization. Patient did not receive any other vaccines within 4weeks prior to the COVID vaccine. Event start date was reported as 14Apr2021 15:00. Patient has had a dull achy sore pain where the shot was administered ever since she received the last shot. She also has tingliess in her fingers on that arm. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for these adverse events. The patient also reported intense pain in reproductive organs, bleeding that consisted for 2 weeks straight and now spotting 3 weeks out of 4 weeks. Bloating and now growths (possibly cervical polyps)- visting OBGYN for follow up. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The case was serious, medically significant. No therapeutic measures were taken as a result of the event "dull achy sore pain where the shot was administered" and "tingliess in her fingers on that arm". The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: reproductive organs, bleeding that consisted for 2 weeks straight and now spotting 3 weeks out of 4 weeks; intense pain in reproductive organs; Bloating; now growths (possibly cervical polyps); dull achy sore pain where the shot was administered; tingliess in her fingers on that arm; This is a spontaneous report received from a contactable consumer (patient). A 40-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown, NDC 59267100002) via an unspecified route of administration at left arm on 13Apr2021 12:00 (40-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included depression and ADHD. Concomitant medications in two weeks included dextroamphetamine hydrochloride; alprazolam; sertraline hydrochloride (ZOLOFT); hydroxyzine hydrochloride (VISTARIL). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) at left arm on 23Mar2021 11:00 (40-year-old at time of vaccination) for COVID-19 immunization. Patient did not receive any other vaccines within 4weeks prior to the COVID vaccine. Event start date was reported as 14Apr2021 15:00. Patient has had a dull achy sore pain where the shot was administered ever since she received the last shot. She also has tingliess in her fingers on that arm. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for these adverse events. The patient also reported intense pain in reproductive organs, bleeding that consisted for 2 weeks straight and now spotting 3 weeks out of 4 weeks. Bloating and now growths (possibly cervical polyps)- visting OBGYN for follow up. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The case was serious, medically significant. No therapeutic measures were taken as a result of the event "dull achy sore pain where the shot was administered" and "tingliess in her fingers on that arm". The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Intermenstrual bleeding, Menstrual disorder, Polymenorrhoea
Clinical narrative: reproductive organs, bleeding that consisted for 2 weeks straight and now spotting 3 weeks out of 4 weeks; intense pain in reproductive organs; Bloating; now growths (possibly cervical polyps); dull achy sore pain where the shot was administered; tingliess in her fingers on that arm; This is a spontaneous report received from a contactable consumer (patient). A 40-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown, NDC 59267100002) via an unspecified route of administration at left arm on 13Apr2021 12:00 (40-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included depression and ADHD. Concomitant medications in two weeks included dextroamphetamine hydrochloride; alprazolam; sertraline hydrochloride (ZOLOFT); hydroxyzine hydrochloride (VISTARIL). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) at left arm on 23Mar2021 11:00 (40-year-old at time of vaccination) for COVID-19 immunization. Patient did not receive any other vaccines within 4weeks prior to the COVID vaccine. Event start date was reported as 14Apr2021 15:00. Patient has had a dull achy sore pain where the shot was administered ever since she received the last shot. She also has tingliess in her fingers on that arm. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for these adverse events. The patient also reported intense pain in reproductive organs, bleeding that consisted for 2 weeks straight and now spotting 3 weeks out of 4 weeks. Bloating and now growths (possibly cervical polyps)- visting OBGYN for follow up. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The case was serious, medically significant. No therapeutic measures were taken as a result of the event "dull achy sore pain where the shot was administered" and "tingliess in her fingers on that arm". The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: reproductive organs, bleeding that consisted for 2 weeks straight and now spotting 3 weeks out of 4 weeks; intense pain in reproductive organs; Bloating; now growths (possibly cervical polyps); dull achy sore pain where the shot was administered; tingliess in her fingers on that arm; This is a spontaneous report received from a contactable consumer (patient). A 40-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown, NDC 59267100002) via an unspecified route of administration at left arm on 13Apr2021 12:00 (40-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included depression and ADHD. Concomitant medications in two weeks included dextroamphetamine hydrochloride; alprazolam; sertraline hydrochloride (ZOLOFT); hydroxyzine hydrochloride (VISTARIL). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) at left arm on 23Mar2021 11:00 (40-year-old at time of vaccination) for COVID-19 immunization. Patient did not receive any other vaccines within 4weeks prior to the COVID vaccine. Event start date was reported as 14Apr2021 15:00. Patient has had a dull achy sore pain where the shot was administered ever since she received the last shot. She also has tingliess in her fingers on that arm. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for these adverse events. The patient also reported intense pain in reproductive organs, bleeding that consisted for 2 weeks straight and now spotting 3 weeks out of 4 weeks. Bloating and now growths (possibly cervical polyps)- visting OBGYN for follow up. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The case was serious, medically significant. No therapeutic measures were taken as a result of the event "dull achy sore pain where the shot was administered" and "tingliess in her fingers on that arm". The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pityriasis rosea, SARS-CoV-2 test
Clinical narrative: Pityriasis rosea; This is a spontaneous report from a non-contactable consumer (patient). A 17-year-old female patient received second dose of BNT162B2 on 21May2021 05:00 PM (at age of 17-year-old) at single dose on left arm for Covid-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 on 30Apr2021 05:00 PM (at age of 17-year-old) for Covid-19 immunization. No other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced Pityriasis rosea on 23May2021. Patient received Mometasone cream as treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Patient had Nasal Swab on 04Jun2021 with result of negative. The outcome of the event was unknown. The event reported serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Joint swelling, Pain, Peripheral swelling, SARS-CoV-2 test
Clinical narrative: body began to swell; Swelling in her feet; had a lot of swelling in her joints; could not walk or pick up her arms and feet.; screamed in pain; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose via intramuscular in left arm on 19Jan2021 at 18:00 for COVID-19 immunization. The relevant medical history included high blood pressure & diabetes from unspecified date, allergy to penicillin from unspecified date. Concomitant medications included unspecified medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received medications within 2 weeks of vaccination. The patient took the vaccine on 19Jan2021 and she started feeling very still on Friday, by Monday she could not walk or pick up her arms and feet. She screamed in pain and her body began to swell so she went to urgent care and had to be placed on steroids. She could not wear shoes for 3 months due to swelling in her feel and they continue to swell, so she was forced to wear compression stockings. She continued to see a rheumatologist and had to take therapy for 3 months. She was healthy before the shot, but after her body was not the same and she had a lot of swelling in her joints after the first vaccine. The events onset date was reported as 22Jan2021 at 08:00 AM. The events resulted in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab test included nasal swab showed negative in Jan2021. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering.  Information on lot number/batch number was requested.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events swelling, peripheral swelling, joint swelling, gait disturbance and pain cannot be completely excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: body began to swell; Swelling in her feet; had a lot of swelling in her joints; could not walk or pick up her arms and feet.; screamed in pain; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose via intramuscular in left arm on 19Jan2021 at 18:00 for COVID-19 immunization. The relevant medical history included high blood pressure & diabetes from unspecified date, allergy to penicillin from unspecified date. Concomitant medications included unspecified medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received medications within 2 weeks of vaccination. The patient took the vaccine on 19Jan2021 and she started feeling very still on Friday, by Monday she could not walk or pick up her arms and feet. She screamed in pain and her body began to swell so she went to urgent care and had to be placed on steroids. She could not wear shoes for 3 months due to swelling in her feel and they continue to swell, so she was forced to wear compression stockings. She continued to see a rheumatologist and had to take therapy for 3 months. She was healthy before the shot, but after her body was not the same and she had a lot of swelling in her joints after the first vaccine. The events onset date was reported as 22Jan2021 at 08:00 AM. The events resulted in Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab test included nasal swab showed negative in Jan2021. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering.  Information on lot number/batch number was requested.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events swelling, peripheral swelling, joint swelling, gait disturbance and pain cannot be completely excluded.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Myocarditis, SARS-CoV-2 test
Clinical narrative: Woken up by a sharp pain in my chest; Myocarditis; This is a spontaneous report reported by a contactable consumer. A  23 years old male consumer (patient) reported for himself that he received the second dose of (Pfizer-BioNTech COVID-19 Vaccine, Batch/lot number ER8727) at single dose for COVID-19 immunisation on 19Apr2021 at 01:00 PM. Relevant history included Anxiety, Depression and Other mental health related illnesses. The medications that patient received within 2 weeks of vaccination included: fluoxetine hydrochloride (PROZAC), bupropion, nortriptyline. The patient previously received the first dose of Batch/lot number: ER8727, for COVID-19 immunisation on 29Mar2021 at 01:00 PM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Several days after receiving the second dose, the patient was woken up by a sharp pain in chest on 28Apr2021. After two days in the hospital he was told he had Myocarditis and was prescribed Colcrys and a large dose of Ibuprofen. The patient was still being seen for follow ups in regards to this. Outcome of event was unknown.  Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had Nasal Swab (COVID-19) test on 28Apr2021 and 12May2021, both negative result.