chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Chills, Dizziness, Fatigue
Clinical narrative: blood clot; high levels of d dimer in blood; very dizzy; can barely walk; migraine; fatigue; chills; temperature changes; pain in body switching from left to right and vice verse; chest pain; shallow breathing; This is a spontaneous report from a non-contactable consumer. This consumer (patient) reported that a 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 29-years, via an unspecified route of administration on 20May2021 at single dose for COVID-19 immunization, in hospital. Medical history was 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 was not pregnant at time of vaccination. Concomitant medications included gabapentin, lorazepam (ATIVAN), norethisterone (NORETHINDRONE), omeprazole. The patient previously received all antibiotics except for doxycycline. The patient went to hospital to check for blood clot; high levels of d dimer in blood; very dizzy, can barely walk; migraine; fatigue; chills and temperature changes; pain in body switching from left to right and vice verse; chest pain and shallow breathing; serious side effects 1 week later. The events occurred on 27May2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit, resulted in emergency room/department or urgent care. Outcome of the events was not recovered/not resolved. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Fibrin D dimer, Fibrin D dimer increased, Gait disturbance, Hypopnoea
Clinical narrative: blood clot; high levels of d dimer in blood; very dizzy; can barely walk; migraine; fatigue; chills; temperature changes; pain in body switching from left to right and vice verse; chest pain; shallow breathing; This is a spontaneous report from a non-contactable consumer. This consumer (patient) reported that a 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 29-years, via an unspecified route of administration on 20May2021 at single dose for COVID-19 immunization, in hospital. Medical history was 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 was not pregnant at time of vaccination. Concomitant medications included gabapentin, lorazepam (ATIVAN), norethisterone (NORETHINDRONE), omeprazole. The patient previously received all antibiotics except for doxycycline. The patient went to hospital to check for blood clot; high levels of d dimer in blood; very dizzy, can barely walk; migraine; fatigue; chills and temperature changes; pain in body switching from left to right and vice verse; chest pain and shallow breathing; serious side effects 1 week later. The events occurred on 27May2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit, resulted in emergency room/department or urgent care. Outcome of the events was not recovered/not resolved. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain, Thrombosis
Clinical narrative: blood clot; high levels of d dimer in blood; very dizzy; can barely walk; migraine; fatigue; chills; temperature changes; pain in body switching from left to right and vice verse; chest pain; shallow breathing; This is a spontaneous report from a non-contactable consumer. This consumer (patient) reported that a 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 29-years, via an unspecified route of administration on 20May2021 at single dose for COVID-19 immunization, in hospital. Medical history was 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 was not pregnant at time of vaccination. Concomitant medications included gabapentin, lorazepam (ATIVAN), norethisterone (NORETHINDRONE), omeprazole. The patient previously received all antibiotics except for doxycycline. The patient went to hospital to check for blood clot; high levels of d dimer in blood; very dizzy, can barely walk; migraine; fatigue; chills and temperature changes; pain in body switching from left to right and vice verse; chest pain and shallow breathing; serious side effects 1 week later. The events occurred on 27May2021. The adverse events resulted in doctor or other healthcare professional office/clinic visit, resulted in emergency room/department or urgent care. Outcome of the events was not recovered/not resolved. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immune thrombocytopenia
Clinical narrative: ITP (immune-mediated thrombocytopenia); This is a spontaneous report from a contactable other HCP (patient). A 49-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 15Apr2021 13:15 (Batch/Lot Number: ER8729) as 1st dose, single for covid-19 immunisation; paracetamol (TYLENOL), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included premature menopause. Patient not diagnosed with COVID-19 Prior to vaccination. The patient previously took penicilline and sulfa drugs and experienced allergy. Concomitant medications within 2 weeks of vaccination include Multivitamin and paracetamol (TYLENOL). No other vaccines within 4 weeks prior to the COVID. The patient experienced ITP (immune-mediated thrombocytopenia) on 23Apr2021. Patient received immunosuppression with steroids for the event. The outcome of event was not recovered. Patient received dose 2 administered in left arm on 06May2021 13:15 (Batch/Lot Number: EW0175). Patient has not been tested for COVID-19 Since the vaccination.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event of Immune-mediated thrombocytopenia cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes available.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Contusion, Ehrlichia test, HIV test negative, Helicobacter test negative
Clinical narrative: ITP (immune-mediated thrombocytopenia); This is a spontaneous report from a contactable other HCP (patient). A 49-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 15Apr2021 13:15 (Batch/Lot Number: ER8729) as 1st dose, single for covid-19 immunisation; paracetamol (TYLENOL), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included premature menopause. Patient not diagnosed with COVID-19 Prior to vaccination. The patient previously took penicilline and sulfa drugs and experienced allergy. Concomitant medications within 2 weeks of vaccination include Multivitamin and paracetamol (TYLENOL). No other vaccines within 4 weeks prior to the COVID. The patient experienced ITP (immune-mediated thrombocytopenia) on 23Apr2021. Patient received immunosuppression with steroids for the event. The outcome of event was not recovered. Patient received dose 2 administered in left arm on 06May2021 13:15 (Batch/Lot Number: EW0175). Patient has not been tested for COVID-19 Since the vaccination.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event of Immune-mediated thrombocytopenia cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes available.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hepatitis C test negative, Immune thrombocytopenia, Immunology test, Myalgia, Platelet count decreased
Clinical narrative: ITP (immune-mediated thrombocytopenia); This is a spontaneous report from a contactable other HCP (patient). A 49-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 15Apr2021 13:15 (Batch/Lot Number: ER8729) as 1st dose, single for covid-19 immunisation; paracetamol (TYLENOL), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included premature menopause. Patient not diagnosed with COVID-19 Prior to vaccination. The patient previously took penicilline and sulfa drugs and experienced allergy. Concomitant medications within 2 weeks of vaccination include Multivitamin and paracetamol (TYLENOL). No other vaccines within 4 weeks prior to the COVID. The patient experienced ITP (immune-mediated thrombocytopenia) on 23Apr2021. Patient received immunosuppression with steroids for the event. The outcome of event was not recovered. Patient received dose 2 administered in left arm on 06May2021 13:15 (Batch/Lot Number: EW0175). Patient has not been tested for COVID-19 Since the vaccination.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event of Immune-mediated thrombocytopenia cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes available.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombocytopenia
Clinical narrative: ITP (immune-mediated thrombocytopenia); This is a spontaneous report from a contactable other HCP (patient). A 49-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 15Apr2021 13:15 (Batch/Lot Number: ER8729) as 1st dose, single for covid-19 immunisation; paracetamol (TYLENOL), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included premature menopause. Patient not diagnosed with COVID-19 Prior to vaccination. The patient previously took penicilline and sulfa drugs and experienced allergy. Concomitant medications within 2 weeks of vaccination include Multivitamin and paracetamol (TYLENOL). No other vaccines within 4 weeks prior to the COVID. The patient experienced ITP (immune-mediated thrombocytopenia) on 23Apr2021. Patient received immunosuppression with steroids for the event. The outcome of event was not recovered. Patient received dose 2 administered in left arm on 06May2021 13:15 (Batch/Lot Number: EW0175). Patient has not been tested for COVID-19 Since the vaccination.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event of Immune-mediated thrombocytopenia cannot be totally excluded/assessed.  The case will be reassessed if additional information becomes available.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immune thrombocytopenia
Clinical narrative: Muscle soreness, arthralgia, bruising. Significant thrombocytopenia noted on blood work within weeks of vaccination - diagnosed with ITP. Currently being treated with immunosuppressive doses of steroids as well as platelet production medication. Counts are still very low.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Contusion, Ehrlichia test, HIV test negative, Helicobacter test negative
Clinical narrative: Muscle soreness, arthralgia, bruising. Significant thrombocytopenia noted on blood work within weeks of vaccination - diagnosed with ITP. Currently being treated with immunosuppressive doses of steroids as well as platelet production medication. Counts are still very low.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hepatitis C test negative, Immune thrombocytopenia, Immunology test, Myalgia, Platelet count decreased
Clinical narrative: Muscle soreness, arthralgia, bruising. Significant thrombocytopenia noted on blood work within weeks of vaccination - diagnosed with ITP. Currently being treated with immunosuppressive doses of steroids as well as platelet production medication. Counts are still very low.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombocytopenia
Clinical narrative: Muscle soreness, arthralgia, bruising. Significant thrombocytopenia noted on blood work within weeks of vaccination - diagnosed with ITP. Currently being treated with immunosuppressive doses of steroids as well as platelet production medication. Counts are still very low.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Fall, Intracardiac thrombus, Thrombosis
Clinical narrative: hospital with AFib; Has clots in both legs/Developed one blood clot in arm; fell; Has clots in heart, in multiple areas of heart; This is a spontaneous report from a contactable consumer (patient's daughter). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 07Apr2021 (Batch/Lot Number: ER8733) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in arm on 10Mar2021 (Lot Number: EN6204) for covid-19 immunisation. The patient in hospital with AFib on 21May2021. The patient fell on 17May2021, it was unsure if the patient fell on 17May2021 from the AFib. The patient had been hospitalized since 21May2021. It was unknow if the reason the patient fell was because the patient went into a different rhythm. The patient got sick and got AFib. The AFib was still ongoing and the patient was still hospitalized. The patient had clots in both legs, it began when the patient was hospitalized on 21May2021. The patient had no history of blood clots. The patient had clots in heart, in multiple areas of heart. All the blood clots were acquired while the patient was in the hospital. The patient developed one blood clot in arm on 31May2021 after being on apixaban (ELIQUIS), the patient acquired a clot in one arm. The other clots started on 28May2021 and 29May2021. In past weekend the patient went in to get a TEE and they could not perform the TEE because the callers mother had blood clots in her heart. Reporter seriousness for events hospital with AFib and clots in both legs/clots in heart, in multiple areas of heart/developed one blood clot in arm was unspecified. The outcome of events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Choking, Dyspnoea, Fall, Loss of consciousness
Clinical narrative: fell on the floor and she lose all the conscious; she got a kind of choke; fell on the floor and she lose all the conscious; lose all the energy; cannot breathe; This is a spontaneous report from a contactable consumer (patient's mother). A 19-year-old female patient received bnt162b2 (Pfizer product, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on May2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Last Friday (unspecified May2021) she was vaccinated with the Pfizer and she got a lot of symptoms of the vaccine,  after 20 seconds she fell on the floor and she lose all the conscious and took that it was minute and half to come up and she got a kind of choke, cannot breathe and lose all the energy, it took almost 2 days to become normal again. The patient's mother did not want her to get another shot. The outcome of events was recovered.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, International normalised ratio, International normalised ratio decreased, Nausea
Clinical narrative: INR was only 1.5 it was below therapeutic range; Dizzy/light headed; she is very upset; Nausea; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included diabetes type 1. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for an unspecified indication, start and stop date were not reported. The patient experienced INR was only 1.5 it was below therapeutic range, dizzy/light headed, nausea, she was very upset on an unspecified date. Event details: The consumer reported that she received the first dose of the vaccine. Two days after the shot her INR have dropped below therapeutic range she did have the blood disorder (Further not clarified hence not captured in tab) and she was upset that all three of her doctor's told her to get the shot and she have blood disorder so she was very upset about that and like to speak to somebody. She felt like little bit light headed, she felt dizzy and a little bit nausea after the first dose. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in left arm lasting for about 24 hours; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 19Apr2021 18:30 (Lot Number: EW0161), at the age of 45-year-old, as single dose for COVID-19 immunisation. The medical history included multiple chemical sensitivities and polyneuropathy. The concomitant medication was not reported. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. After Vaccine #1 the patient experienced pain in his left arm lasting for about 24 hours in Apr2021. The outcome of the event was recovered in Apr2021.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Nasal congestion, Pain, Pain in extremity, Rhinorrhoea
Clinical narrative: pain in my left arm lasting for about 24 hours; After Vaccine #2 also experienced flu/cold-like symptoms; Body aches/pain; sneezing; running/stuffy nose; running/stuffy nose; This is a spontaneous report from a contactable consumer (patient).  A 45-year-old male patient received bnt162b2  (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in arm left on 10May2021 11:30 (Lot Number: EW0173) at age of 45-year-old at single dose for COVID-19 immunization at facility of Health Clinic. Medical history included multiple Chemical Sensitivities, polyneuropathy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine or any other medications the patient received within 2 weeks of vaccination. The patient previously took first dose of bnt162b2 (Lot number: EW0161) on 19Apr2021 18:30 in left arm and experienced pain in left arm and lasting for about 24 hours. After second dose, the patient experienced pain in his left arm, flu/cold-like symptoms , body aches/pain, sneezing, running/stuffy nose, all on 10May2021 23:00. The events were serious for disability. There was no treatment for the events. Body aches slowly started to disappear on 11May2021. Other symptoms lessened over the course of next 10 days but never really gone away. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the body aches/pain was resolved on 11May2021, the rest events was resolving.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: pain in my left arm lasting for about 24 hours; After Vaccine #2 also experienced flu/cold-like symptoms; Body aches/pain; sneezing; running/stuffy nose; running/stuffy nose; This is a spontaneous report from a contactable consumer (patient).  A 45-year-old male patient received bnt162b2  (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in arm left on 10May2021 11:30 (Lot Number: EW0173) at age of 45-year-old at single dose for COVID-19 immunization at facility of Health Clinic. Medical history included multiple Chemical Sensitivities, polyneuropathy. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine or any other medications the patient received within 2 weeks of vaccination. The patient previously took first dose of bnt162b2 (Lot number: EW0161) on 19Apr2021 18:30 in left arm and experienced pain in left arm and lasting for about 24 hours. After second dose, the patient experienced pain in his left arm, flu/cold-like symptoms , body aches/pain, sneezing, running/stuffy nose, all on 10May2021 23:00. The events were serious for disability. There was no treatment for the events. Body aches slowly started to disappear on 11May2021. Other symptoms lessened over the course of next 10 days but never really gone away. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the body aches/pain was resolved on 11May2021, the rest events was resolving.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hallucination, visual, Pain
Clinical narrative: I have been seeing like, like when I see a cord it seems like it moves like a snake; I was laying down and I was looking at my rug, my rug looked like it was moving like a snake; little achy right; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0191) via unspecified route in left arm single dose for COVID-19 immunization on 02Jun2021 09:50 at 53-year-old. Medical history included: blood pressure high. Concomitant medication included lisinopril for blood pressure high. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0176) via unspecified route in left arm single dose for COVID-19 immunization on 11May2021 10:00 at 53-year-old. The patient felt just a little, like little achy right if I have a little small virus but then she took the Ibuprofen (treatment) and was okay but she had been seeing like, like when she saw a cord, like one way you plugged in, it seemed like it moved like a snake and then she was looking, she was laying down and was looking at her rug, her rug looked like it was moving like a snake, like a wave and then she came to see therapist because she had an appointment and when she was driving, it seemed like the road would move like snake also and then the birds were flying, it seemed like, when you see a jet when it flied and it had like a smoke coming from the back, it seemed like the birds had smoke coming from their back and then when shewent to tell her therapist, she thought maybe it's the medicine that was making her, she meant the vaccine was making her that way and she was like talking to her and she had like curtains behind her and it seemed like the curtains are moving around like snake. The patient never had anything like that, ever happened to her. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, SARS-CoV-2 test
Clinical narrative: Hip pain that turned into extreme pain that left me unable to sit, stand or put pressure on hip; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at 48-year-old, dose 2 via an unspecified route of administration, administered in Arm Right on 04May2021 17:30 (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunisation in Public Health Clinic facility. The patient medical history was not reported. Patient is not Pregnant at the time of vaccination. Patient received other medications within 2 weeks of vaccination (unspecified).  the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received the first dose of BNT162B2 (Pfizer, Batch/lot number: Unknown) at 48 years old into right arm on 12Apr2021 04:00 PM for COVID-19 Immunization. The patient experienced hip pain that turned into extreme pain that left her unable to sit, stand or put pressure on hip (hospitalization for 4 days) on 06May2021 08:00.  AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. no covid prior vaccination. The patient underwent lab tests and procedures which included Nasal Swab post vaccination on 15May2021: negative. It was unknown if treatment received for the event. Outcome of the event was recovering. It was serious report. Seriousness criteria of Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect were all No.  Follow attempts are needed; further information has been expected.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Menstrual disorder, Polymenorrhoea, Pruritus, Rash
Clinical narrative: I started my menstrual cycle 2 weeks sooner; the menstrual cycle had a lot of blood clots, clots coming out.; I started my menstrual cycle 2 weeks sooner; the menstrual cycle had a lot of blood clots, clots coming out.; extremely itchy from head to toe; Rash almost like I don't know if it's hive or rash on my body and on my face; when I scratch to itch.; Rash almost like I don't know if it's hive or rash on my body and on my face; when I scratch to itch.; This is a spontaneous report from a contactable consumer (patient). A 34-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 18May2021 (Batch/Lot Number: EW0161) as single dose for COVID-19 immunisation. The patient medical history was none. No family medical history. Concomitant medication included escitalopram oxalate (LEXAPRO). No prior vaccinations within 4 weeks. On an unspecified date in May2021, the patient experienced extremely itchy from head to toe and rash almost like, patient didn't know if it's hive or as rash on body and on face which patient never gotten in life especially where patient scratch to itch. And patient started menstrual cycle 2 weeks sooner than it should started and the menstrual cycle had a lot of blood clots, clots coming out. Treatment in response to event included diphenhydramine hydrochloride (BENADRYL). The patient had a blood test (Jun2021) done just to check level of like vitamin D, vitamin b, full blood panel. Just a regular full blood panel. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I started my menstrual cycle 2 weeks sooner; the menstrual cycle had a lot of blood clots, clots coming out.; I started my menstrual cycle 2 weeks sooner; the menstrual cycle had a lot of blood clots, clots coming out.; extremely itchy from head to toe; Rash almost like I don't know if it's hive or rash on my body and on my face; when I scratch to itch.; Rash almost like I don't know if it's hive or rash on my body and on my face; when I scratch to itch.; This is a spontaneous report from a contactable consumer (patient). A 34-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 18May2021 (Batch/Lot Number: EW0161) as single dose for COVID-19 immunisation. The patient medical history was none. No family medical history. Concomitant medication included escitalopram oxalate (LEXAPRO). No prior vaccinations within 4 weeks. On an unspecified date in May2021, the patient experienced extremely itchy from head to toe and rash almost like, patient didn't know if it's hive or as rash on body and on face which patient never gotten in life especially where patient scratch to itch. And patient started menstrual cycle 2 weeks sooner than it should started and the menstrual cycle had a lot of blood clots, clots coming out. Treatment in response to event included diphenhydramine hydrochloride (BENADRYL). The patient had a blood test (Jun2021) done just to check level of like vitamin D, vitamin b, full blood panel. Just a regular full blood panel. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Thrombosis, X-ray
Clinical narrative: Did Xray found a big black spot on top of left side of stomach.  dr said it was blood clot from the vaccine.; Severe stomach pain; This is a spontaneous report received from a contactable consumer (patient). This 68-year-old male patient received bnt162b2, dose 2 via an unspecified route of administration on 19Mar2021 (Batch/Lot number was not reported) as 2nd dose, single at the age of 68-year-old for covid-19 immunisation. The patient received the 1st dose of bnt162b2 on unknown date for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced severe stomach pain. Did Xray found a big black spot on top of left side of stomach. Dr said it was blood clot from the vaccine. Happened week after taking shot. The product was used by the patient. The outcome of event was unknown. Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: was reported that patient experienced:confirmed covid.; was reported that patient experienced:confirmed covid.; This is a spontaneous report from a non-contactable other healthcare professional (HCP). This non-contactable other HCP was reporting same events under the same suspect product for two patients. This is one of two reports.  An around 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date were unknown) as the 2nd dose, single dose for COVID-19 immunization. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. Relevant medical history included that the patient was obese and had multiple sclerosis (MS), both from an unknown date and unknown if ongoing. Concomitant medication included ocrelizumab (OCREVUS) taken for an unspecified indication, start and stop date were not reported. It was reported that patient experienced: confirmed covid on an unspecified date. It was further reported that there were two MS patients currently more than (>) 1 month post second vaccine (both Pfizer) with lab confirmed covid (positive); both with medically significant illness, neither required hospitalization. The outcome of the event was unknown.  No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported "experienced: confirmed covid".,Linked Report(s) : US-PFIZER INC-2021641519 same reporter, drug, and event; different patient
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain in extremity, Tremor
Clinical narrative: Blister-like hives appeared on tops of ears, then upper back and back of hand; Sore arm; Nausea; Fatigue; Tremors; Headache; Vomiting; This is a spontaneous report from a contactable consumer (patient). A 12-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration Date: unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 14May2021 09:00 as single dose for COVID-19 immunization. The patient medical history and concomitant medication was not reported. The patient previously had the known allergies included hives developed after 1 dose of amoxicillin and Azithromycin, hives present after several doses of m (as reported). The patient did not have the COVID prior vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. The patient received Multivitamin and Probiotic in two weeks. On 14May2021 at 01:00 PM, after the 4 hours of dose the patient experienced blister-like hives appeared on tops of ears, then upper back and back of hand. Then, sore arm, nausea, fatigue, tremors, headache through night. Following day continued with hives, headache, fatigue, sore arm, plus vomiting. Felt much better by the second day post shot. Just hives and arm soreness continued. The patient did not receive treatment for the events. On an unspecified date, the events nausea, fatigue, vomiting, tremors and headache were resolved. The outcome of blister-like hives appeared on tops of ears, then upper back and back of hand and sore arm were not resolved.  Information on lot/batch number has been requested.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria, Vomiting
Clinical narrative: Blister-like hives appeared on tops of ears, then upper back and back of hand; Sore arm; Nausea; Fatigue; Tremors; Headache; Vomiting; This is a spontaneous report from a contactable consumer (patient). A 12-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration Date: unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 14May2021 09:00 as single dose for COVID-19 immunization. The patient medical history and concomitant medication was not reported. The patient previously had the known allergies included hives developed after 1 dose of amoxicillin and Azithromycin, hives present after several doses of m (as reported). The patient did not have the COVID prior vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks. The patient received Multivitamin and Probiotic in two weeks. On 14May2021 at 01:00 PM, after the 4 hours of dose the patient experienced blister-like hives appeared on tops of ears, then upper back and back of hand. Then, sore arm, nausea, fatigue, tremors, headache through night. Following day continued with hives, headache, fatigue, sore arm, plus vomiting. Felt much better by the second day post shot. Just hives and arm soreness continued. The patient did not receive treatment for the events. On an unspecified date, the events nausea, fatigue, vomiting, tremors and headache were resolved. The outcome of blister-like hives appeared on tops of ears, then upper back and back of hand and sore arm were not resolved.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis, Migraine
Clinical narrative: face droops; Migraines; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Program. A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation.  The patient medical history was not reported. Concomitant medication included testosterone taken for an unspecified indication from an unspecified start date and ongoing.  The patient experienced side effects, migraines and face droops. The outcome of the events was unknown.  Information regarding the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Dyspnoea, Oxygen consumption decreased, SARS-CoV-2 test
Clinical narrative: was reported that patient experienced:confirmed covid.; was reported that patient experienced:confirmed covid; low O2; Shortness of breath; This is a Spontaneous report from a non-contactable health care professional based on the information received by Pfizer(Manufacturer Control No: LRN4341875). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; ), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunization. Medical history included multiple sclerosis from an unknown date and unknown if ongoing.. Concomitant medication included ocrelizumab (OCREVUS). On an unspecified date, The patient experienced :confirmed Covid, low o2,  shortness of breath. The event were considered medically significant. Events of low 02 and shortness of breath required an emergency room visit.. The reporter states 'two MS patient now greater than 1 month post second vaccine (both Pfizer) with lab confirmed Covid. Both with medically significant illness, neither required hospitalization. The patient underwent lab tests and procedures which included sars-cov-2 test: lab confirmed covid on an unknown date. The clinical outcome of the events was unknown,   No follow-up attempts are possible; information about lot batch number cannot be obtained. .
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Malaise, Pyrexia
Clinical narrative: not feeling good today at all; extreme fever reaching 100.4 F; This is a spontaneous report from a contactable consumer (friend). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient went and got the shot yesterday he was not feeling good today at all. He has a temperature of 100.4. He had an extreme fever reaching 100.4 F. He took ibuprofen instead of Tylenol. The reporter was told to take Tylenol and asking if him taking Ibuprofen did that to him. He just went to eat. He should not have taken ibuprofen and was supposed to take Tylenol. The report was considered as non-serious by reporter. The outcome of events was unknown.  Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: she doesn't want to since she got very ill; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 13May2021 as single dose for COVID-19 immunization. Medical history included COVID from Feb2021 to an unknown date. The patient's concomitant medications were not reported. Patient stated she received the first dose of a Covid 19 vaccine on 13May2021, she was scheduled to get the second dose on 03Jun2021. She stated she heard she needs to quarantine for 14 days after receiving the second dose, but she needs to travel out of town on the 07Jun2021; and she was told that if she misses her appointment she should restart the series, which she doesn't want to since she got very ill on an unspecified date in 2021 and she also had Covid and was hospitalized for 10 days on February. She wanted to know if this information was true. Patient confirmed yesterday that she actually got the Pfizer vaccine. Before the vaccine, she had COVID and almost died. The outcome of event was unknown.  Information related to batch/Lot no. was requested.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest discomfort, Chest pain, Dyspnoea, Magnetic resonance imaging head
Clinical narrative: Periodic chest pain/heaviness as well as occasional shortness of breathe; Periodic chest pain/heaviness as well as occasional shortness of breathe; periodic chest pain/heaviness as well as occasional shortness of breathe; Tingly sensations in my left arm; This is a spontaneous report from a contactable consumer (patient). A 39-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Mar2021 09:00 at the age of 39-years-old (Batch/Lot Number: EP7533) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation.  Medical history was None.  There were no concomitant medications.  The patient previously took cefalexin monohydrate (KEFLEXIN) and experienced allergies. There was no other vaccine in four weeks. There were no other medications in two weeks. The patient did not get covid prior vaccination. covid was not tested post vaccination. The patient stated she began to have tingly sensations in her left arm like it was 'asleep' from 02Apr2021. The tingly sensations started to move to her other limbs, and she went to see her neurologist (Name). He ran some test, blood work and an MRI of the Brain and no issues were found. In the last two to three weeks, she had been having periodic chest pain/heaviness as well as occasional shortness of breath from 02Apr2021. She went to the local urgent care; they did some blood test and again no issues found.Today she went to her neurologist to report her symptoms and he had made her an urgent cardiologist appointment for 3Jun2021. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood test: no issues were found, MRI Brain WO: no issues were found, nerve tests: unknown results, all on an unspecified date.  The outcome of the events was not resolved.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neurological examination, Paraesthesia
Clinical narrative: Periodic chest pain/heaviness as well as occasional shortness of breathe; Periodic chest pain/heaviness as well as occasional shortness of breathe; periodic chest pain/heaviness as well as occasional shortness of breathe; Tingly sensations in my left arm; This is a spontaneous report from a contactable consumer (patient). A 39-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Mar2021 09:00 at the age of 39-years-old (Batch/Lot Number: EP7533) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation.  Medical history was None.  There were no concomitant medications.  The patient previously took cefalexin monohydrate (KEFLEXIN) and experienced allergies. There was no other vaccine in four weeks. There were no other medications in two weeks. The patient did not get covid prior vaccination. covid was not tested post vaccination. The patient stated she began to have tingly sensations in her left arm like it was 'asleep' from 02Apr2021. The tingly sensations started to move to her other limbs, and she went to see her neurologist (Name). He ran some test, blood work and an MRI of the Brain and no issues were found. In the last two to three weeks, she had been having periodic chest pain/heaviness as well as occasional shortness of breath from 02Apr2021. She went to the local urgent care; they did some blood test and again no issues found.Today she went to her neurologist to report her symptoms and he had made her an urgent cardiologist appointment for 3Jun2021. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood test: no issues were found, MRI Brain WO: no issues were found, nerve tests: unknown results, all on an unspecified date.  The outcome of the events was not resolved.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Blood test normal, Cardiac monitoring, Chest X-ray, Dyspnoea
Clinical narrative: Periodic chest pain/heaviness as well as occasional shortness of breathe; Periodic chest pain/heaviness as well as occasional shortness of breathe; periodic chest pain/heaviness as well as occasional shortness of breathe; Tingly sensations in my left arm; This is a spontaneous report from a contactable consumer (patient). A 39-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Mar2021 09:00 at the age of 39-years-old (Batch/Lot Number: EP7533) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation.  Medical history was None.  There were no concomitant medications.  The patient previously took cefalexin monohydrate (KEFLEXIN) and experienced allergies. There was no other vaccine in four weeks. There were no other medications in two weeks. The patient did not get covid prior vaccination. covid was not tested post vaccination. The patient stated she began to have tingly sensations in her left arm like it was 'asleep' from 02Apr2021. The tingly sensations started to move to her other limbs, and she went to see her neurologist (Name). He ran some test, blood work and an MRI of the Brain and no issues were found. In the last two to three weeks, she had been having periodic chest pain/heaviness as well as occasional shortness of breath from 02Apr2021. She went to the local urgent care; they did some blood test and again no issues found.Today she went to her neurologist to report her symptoms and he had made her an urgent cardiologist appointment for 3Jun2021. The events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood test: no issues were found, MRI Brain WO: no issues were found, nerve tests: unknown results, all on an unspecified date.  The outcome of the events was not resolved.