chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, SARS-CoV-2 test negative
Clinical narrative: Heart Palpitations; This is a spontaneous report from a contactable nurse (patient reported for herself). A 28-year-old non-pregnant female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EK5730), via an intramuscular route of administration, administered in Arm Right on 16Jan2021 (at the age of 28-year-old), as single for covid-19 immunisation. The patient was non-pregnant at the time of vaccination. The patient had no other medical history. The patient had no known allergies. Concomitant medication included Ethinylestradiol, norgestimate (SPRINTEC) taken for birth control, start and stop date were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection,Lot Number: EL3246), via an intramuscular route of administration, administered in Arm Right on 26Dec2020 (at the age of 28-year-old), as single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19Prior to vaccination. No other vaccine received in four weeks. On 17Jan2021, 1 day post second injection, the patient experienced heart palpitations. It was Intermittent that day and on and off since then. On 09Jun2021, the patient underwent Rapid, Nasal Swab test, which was Negative for covid-19. No treatment was received to treat the event. The event assessed as medically significant. The outcome of the event was unknown at the time of this report.  Follow-Up (28Jun2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of  palpitations. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chills, Deep vein thrombosis, Hypoaesthesia, Magnetic resonance imaging
Clinical narrative: Chills; Numbness/tingling; Numbness/tingling; Knees also started making a tearing sound and are achy; Knees also started making a tearing; DVT blood clot; This is a spontaneous report received from a contactable consumer (patient). A 36-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm at the age of 36-years-old on 16Jun2021 11:15 (Lot Number: EW0196) as single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm at the age of 36-years-old on 26May2021 11:15 (Lot Number: EW0178) as single dose for covid-19 immunisation. After her second shot ,she woke up with chills and numbness/tingling on her right side on 17Jun2021 1:30. She went to the hospital and they found a DVT blood clot in Jun2021.  1 week later and she had numbness/tingling on both sides. Her knees also started making a tearing sound and were achy in Jun2021. The adverse event DVT blood clot resulted in any of the following doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse event DVT blood clot  included Eliquis and no treatment received for the other events. The case was reported as non-serious by reporter.  The outcome of the events was not recovered.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Thrombosis, Ultrasound scan
Clinical narrative: Chills; Numbness/tingling; Numbness/tingling; Knees also started making a tearing sound and are achy; Knees also started making a tearing; DVT blood clot; This is a spontaneous report received from a contactable consumer (patient). A 36-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm at the age of 36-years-old on 16Jun2021 11:15 (Lot Number: EW0196) as single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm at the age of 36-years-old on 26May2021 11:15 (Lot Number: EW0178) as single dose for covid-19 immunisation. After her second shot ,she woke up with chills and numbness/tingling on her right side on 17Jun2021 1:30. She went to the hospital and they found a DVT blood clot in Jun2021.  1 week later and she had numbness/tingling on both sides. Her knees also started making a tearing sound and were achy in Jun2021. The adverse event DVT blood clot resulted in any of the following doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse event DVT blood clot  included Eliquis and no treatment received for the other events. The case was reported as non-serious by reporter.  The outcome of the events was not recovered.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Deep vein thrombosis, Hypoaesthesia, Joint injury
Clinical narrative: Chills; Numbness/tingling; Numbness/tingling; Knees also started making a tearing sound and are achy; Knees also started making a tearing; DVT blood clot; This is a spontaneous report received from a contactable consumer (patient). A 36-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm at the age of 36-years-old on 16Jun2021 11:15 (Lot Number: EW0196) as single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm at the age of 36-years-old on 26May2021 11:15 (Lot Number: EW0178) as single dose for covid-19 immunisation. After her second shot ,she woke up with chills and numbness/tingling on her right side on 17Jun2021 1:30. She went to the hospital and they found a DVT blood clot in Jun2021.  1 week later and she had numbness/tingling on both sides. Her knees also started making a tearing sound and were achy in Jun2021. The adverse event DVT blood clot resulted in any of the following doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse event DVT blood clot  included Eliquis and no treatment received for the other events. The case was reported as non-serious by reporter.  The outcome of the events was not recovered.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Chills; Numbness/tingling; Numbness/tingling; Knees also started making a tearing sound and are achy; Knees also started making a tearing; DVT blood clot; This is a spontaneous report received from a contactable consumer (patient). A 36-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm at the age of 36-years-old on 16Jun2021 11:15 (Lot Number: EW0196) as single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm at the age of 36-years-old on 26May2021 11:15 (Lot Number: EW0178) as single dose for covid-19 immunisation. After her second shot ,she woke up with chills and numbness/tingling on her right side on 17Jun2021 1:30. She went to the hospital and they found a DVT blood clot in Jun2021.  1 week later and she had numbness/tingling on both sides. Her knees also started making a tearing sound and were achy in Jun2021. The adverse event DVT blood clot resulted in any of the following doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse event DVT blood clot  included Eliquis and no treatment received for the other events. The case was reported as non-serious by reporter.  The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diplopia, Strabismus
Clinical narrative: thyroid eye disease; intermittent vertigo.; having double vision and swelling of my right eye.; began having double vision and swelling of my right eye.; This is a spontaneous report from a contactable consumer (Patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EP7534, Expiration Date: not reported), via an unspecified route of administration in left arm on 18Mar2021 14:00 as dose 2, single for COVID-19 immunization. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL9266, Expiration Date: not reported), via an unspecified route of administration in left arm on 26Feb2021 14:00 as dose 1, single for COVID-19 immunization. Medical history included Graves hypothyroid after radiation 35 years ago, Graves disease and thyroid hormone replacement therapy. No known allergies. Concomitant medication(s) included metoprolol tartrate, amitriptyline, cl. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not received other vaccine in four weeks. About 3 weeks after second dose the patient experienced thyroid eye disease, intermittent vertigo, began having double vision and swelling of my right eye on an unspecified date in Apr2021. Patient had graves disease 40 years ago, so had auto-immune issues. In this case, thyroid eye disease, which was a separate auto-immune condition from Graves. She had an appointmentz with a neuro-ophthalmologist on 29July. Adverse events resulted in Doctor or other healthcare professional office/clinic visit/Disability or permanent damage. The patient did not received any treatment for the events. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diplopia, Endocrine ophthalmopathy, Eye swelling, Vertigo
Clinical narrative: thyroid eye disease; intermittent vertigo.; having double vision and swelling of my right eye.; began having double vision and swelling of my right eye.; This is a spontaneous report from a contactable consumer (Patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EP7534, Expiration Date: not reported), via an unspecified route of administration in left arm on 18Mar2021 14:00 as dose 2, single for COVID-19 immunization. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL9266, Expiration Date: not reported), via an unspecified route of administration in left arm on 26Feb2021 14:00 as dose 1, single for COVID-19 immunization. Medical history included Graves hypothyroid after radiation 35 years ago, Graves disease and thyroid hormone replacement therapy. No known allergies. Concomitant medication(s) included metoprolol tartrate, amitriptyline, cl. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not received other vaccine in four weeks. About 3 weeks after second dose the patient experienced thyroid eye disease, intermittent vertigo, began having double vision and swelling of my right eye on an unspecified date in Apr2021. Patient had graves disease 40 years ago, so had auto-immune issues. In this case, thyroid eye disease, which was a separate auto-immune condition from Graves. She had an appointmentz with a neuro-ophthalmologist on 29July. Adverse events resulted in Doctor or other healthcare professional office/clinic visit/Disability or permanent damage. The patient did not received any treatment for the events. The outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram normal, Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer (patient). This consumer reported for himself that a 62-years-old male patient received second dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: EW0173, NDC number/ expiry date: unknown), (at the age of 62-years-old) via an unspecified route of administration in right arm on 07May2021 as single dose for COVID-19 immunisation. The patient's medication history was not reported. Concomitant medications included Nexium (Esomeprazole Magnesium) for an unknown indication from an unknown date. The patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Batch/Lot Number: EW0162, NDC number: unknown), (at the age of 62-years-old) via an unspecified route of administration in right arm on 09Apr2021 as historical vaccine as single dose for COVID-19 immunisation and no reaction on previous exposure to drug. The patient taking Covid vaccine because he did not want to get Covid 19. Vaccination facilitated in stadium. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. Starting around 14May2021, the patient got a headache. Stated that headache was still there today. It would go away. Sometimes it hurts less or more or was on the left or the right side; but it was always there. The headache was always there but fluctuates and it was not serious. On a pain scale of one to ten he would give it a three or sometimes a two. He has never had a problem with headaches before. The patient visited physician office for headache. He had a computerized tomography (CT) scan recently (in 2021) that was normal, they did not find anything on it. The patient did not receive any treatment for adverse event. The outcome of the adverse event was not recovered.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer (patient). This consumer reported for himself that a 62-years-old male patient received second dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: EW0173, NDC number/ expiry date: unknown), (at the age of 62-years-old) via an unspecified route of administration in right arm on 07May2021 as single dose for COVID-19 immunisation. The patient's medication history was not reported. Concomitant medications included Nexium (Esomeprazole Magnesium) for an unknown indication from an unknown date. The patient received first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Batch/Lot Number: EW0162, NDC number: unknown), (at the age of 62-years-old) via an unspecified route of administration in right arm on 09Apr2021 as historical vaccine as single dose for COVID-19 immunisation and no reaction on previous exposure to drug. The patient taking Covid vaccine because he did not want to get Covid 19. Vaccination facilitated in stadium. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. Starting around 14May2021, the patient got a headache. Stated that headache was still there today. It would go away. Sometimes it hurts less or more or was on the left or the right side; but it was always there. The headache was always there but fluctuates and it was not serious. On a pain scale of one to ten he would give it a three or sometimes a two. He has never had a problem with headaches before. The patient visited physician office for headache. He had a computerized tomography (CT) scan recently (in 2021) that was normal, they did not find anything on it. The patient did not receive any treatment for adverse event. The outcome of the adverse event was not recovered.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Believed to be pericarditis; Believed to be inflammation of/around the heart, as evidenced with pain in chest similar to when I was sick with Covid-19 in 2020.; Believed to be inflammation of/around the heart, as evidenced with pain in chest similar to when I was sick with Covid-19 in 2020.; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 35-year-old male patient received first dose of BNT162B2 (PFIZER/BIONTECH Covid-19 Vaccine, Solution for Injection, Batch/Lot number: Ew0178), via an unspecified route in the left arm on 09Jun2021 at 16:30 (age at vaccination: 35-year-old), as a dose 1, single for covid-19 immunization. Patient medical history included covid-19 in 2020. The patient concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 15Jun2021, patient experienced inflammation of/around the heart, as evidenced with pain in chest similar to when he was sick with Covid-19 in 2020. Believed to be pericarditis, as diagnosed before. Patient did not receive any treatment for the events. The patient underwent lab test and procedure which included SARS-CoV-2 test positive in 2020. The clinical outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Inflammation, Pericarditis, SARS-CoV-2 test
Clinical narrative: Believed to be pericarditis; Believed to be inflammation of/around the heart, as evidenced with pain in chest similar to when I was sick with Covid-19 in 2020.; Believed to be inflammation of/around the heart, as evidenced with pain in chest similar to when I was sick with Covid-19 in 2020.; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 35-year-old male patient received first dose of BNT162B2 (PFIZER/BIONTECH Covid-19 Vaccine, Solution for Injection, Batch/Lot number: Ew0178), via an unspecified route in the left arm on 09Jun2021 at 16:30 (age at vaccination: 35-year-old), as a dose 1, single for covid-19 immunization. Patient medical history included covid-19 in 2020. The patient concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 15Jun2021, patient experienced inflammation of/around the heart, as evidenced with pain in chest similar to when he was sick with Covid-19 in 2020. Believed to be pericarditis, as diagnosed before. Patient did not receive any treatment for the events. The patient underwent lab test and procedure which included SARS-CoV-2 test positive in 2020. The clinical outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Bowel movement irregularity, Computerised tomogram abnormal, Constipation
Clinical narrative: no more bowel movements for weeks; cramping; bloating; intestines were extremely inflamed; This is a spontaneous report from a contactable consumer(patient). A 59-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration, administered in left arm at the age of 59-years-old on 13May2021 (Lot Number: EW0170) as single dose for covid-19 immunisation. Medical history included: didn't drink or smoke. Concomitant medications included levothyroxine sodium (THYROXINE); duloxetine hydrochloride (CYMBALTA). The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 59-years-old as single dose for covid-19 immunization and didn't have a bowel movement (BM) for 3 weeks, she finally had a normal BM the morning of 13May2021. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient  wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't  been tested for COVID-19. Later that morning she received her second vaccine and then no more bowel movements for weeks. She had never had any gastrointestinal issues in her life and her colonoscopy came back clean as a whistle a year prior to this. She finally went to the emergency room on 21Jun2021 for severe cramping and bloating. CT scan showed that her intestines were extremely inflamed. She didn't eat meat or dairy. She took very good care of herself. She had a normal BM every morning up until she got the vaccine. The events resulted in [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. Treatment received for the adverse events included: Enema, stool softener mag of citrate. The outcome of the events was not recovered.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inflammatory bowel disease
Clinical narrative: no more bowel movements for weeks; cramping; bloating; intestines were extremely inflamed; This is a spontaneous report from a contactable consumer(patient). A 59-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration, administered in left arm at the age of 59-years-old on 13May2021 (Lot Number: EW0170) as single dose for covid-19 immunisation. Medical history included: didn't drink or smoke. Concomitant medications included levothyroxine sodium (THYROXINE); duloxetine hydrochloride (CYMBALTA). The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 59-years-old as single dose for covid-19 immunization and didn't have a bowel movement (BM) for 3 weeks, she finally had a normal BM the morning of 13May2021. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient  wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't  been tested for COVID-19. Later that morning she received her second vaccine and then no more bowel movements for weeks. She had never had any gastrointestinal issues in her life and her colonoscopy came back clean as a whistle a year prior to this. She finally went to the emergency room on 21Jun2021 for severe cramping and bloating. CT scan showed that her intestines were extremely inflamed. She didn't eat meat or dairy. She took very good care of herself. She had a normal BM every morning up until she got the vaccine. The events resulted in [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. Treatment received for the adverse events included: Enema, stool softener mag of citrate. The outcome of the events was not recovered.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Colonoscopy, Computerised tomogram, Constipation, Enteritis
Clinical narrative: no more bowel movements for weeks; cramping; bloating; intestines were extremely inflamed; This is a spontaneous report from a contactable consumer(patient). A 59-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration, administered in left arm at the age of 59-years-old on 13May2021 (Lot Number: EW0170) as single dose for covid-19 immunisation. Medical history included: didn't drink or smoke. Concomitant medications included levothyroxine sodium (THYROXINE); duloxetine hydrochloride (CYMBALTA). The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 59-years-old as single dose for covid-19 immunization and didn't have a bowel movement (BM) for 3 weeks, she finally had a normal BM the morning of 13May2021. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient  wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't  been tested for COVID-19. Later that morning she received her second vaccine and then no more bowel movements for weeks. She had never had any gastrointestinal issues in her life and her colonoscopy came back clean as a whistle a year prior to this. She finally went to the emergency room on 21Jun2021 for severe cramping and bloating. CT scan showed that her intestines were extremely inflamed. She didn't eat meat or dairy. She took very good care of herself. She had a normal BM every morning up until she got the vaccine. The events resulted in [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. Treatment received for the adverse events included: Enema, stool softener mag of citrate. The outcome of the events was not recovered.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms
Clinical narrative: no more bowel movements for weeks; cramping; bloating; intestines were extremely inflamed; This is a spontaneous report from a contactable consumer(patient). A 59-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration, administered in left arm at the age of 59-years-old on 13May2021 (Lot Number: EW0170) as single dose for covid-19 immunisation. Medical history included: didn't drink or smoke. Concomitant medications included levothyroxine sodium (THYROXINE); duloxetine hydrochloride (CYMBALTA). The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 59-years-old as single dose for covid-19 immunization and didn't have a bowel movement (BM) for 3 weeks, she finally had a normal BM the morning of 13May2021. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient  wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't  been tested for COVID-19. Later that morning she received her second vaccine and then no more bowel movements for weeks. She had never had any gastrointestinal issues in her life and her colonoscopy came back clean as a whistle a year prior to this. She finally went to the emergency room on 21Jun2021 for severe cramping and bloating. CT scan showed that her intestines were extremely inflamed. She didn't eat meat or dairy. She took very good care of herself. She had a normal BM every morning up until she got the vaccine. The events resulted in [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. Treatment received for the adverse events included: Enema, stool softener mag of citrate. The outcome of the events was not recovered.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram thorax abnormal, Pulmonary embolism
Clinical narrative: DVT; Pulmonary embolism in right lung; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 39-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), dose 2 via an unspecified route of administration, administered in left arm on 02May2021 11:00 (at the age of 39-years-old) (Batch/Lot Number: ER8736, Expiry date was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hearing aid user. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), dose 1 via an unspecified route of administration, administered in right arm on 11Apr2021 11:00 (Batch/Lot Number: EW0162) for covid-19 immunisation. There was no relevant past drug history reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was tested for COVID-19 since the vaccination. On 27Jun2021 08:00, the patient experienced dvt (deep vein thrombosis) and pulmonary embolism in right lung. The patient was hospitalized for 2 days for the reported events. Laboratory tests on 27Jun2021 included sars-cov-2 test: negative (nasal swab). The patient received treatment with blood thinner shots, and eliquis after hospital. Device date was reported as 04Jul2021. The clinical outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: DVT; Pulmonary embolism in right lung; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 39-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), dose 2 via an unspecified route of administration, administered in left arm on 02May2021 11:00 (at the age of 39-years-old) (Batch/Lot Number: ER8736, Expiry date was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hearing aid user. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), dose 1 via an unspecified route of administration, administered in right arm on 11Apr2021 11:00 (Batch/Lot Number: EW0162) for covid-19 immunisation. There was no relevant past drug history reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was tested for COVID-19 since the vaccination. On 27Jun2021 08:00, the patient experienced dvt (deep vein thrombosis) and pulmonary embolism in right lung. The patient was hospitalized for 2 days for the reported events. Laboratory tests on 27Jun2021 included sars-cov-2 test: negative (nasal swab). The patient received treatment with blood thinner shots, and eliquis after hospital. Device date was reported as 04Jul2021. The clinical outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Dyspnoea, Feeling abnormal, Headache, Injection site pain
Clinical narrative: Dizzy; Heart palpitations; Difficulty breathing/ he couldn't breathe/his throat started closing up; Allergic reaction; Swollen throat and tongue/ his throat was swollen; Swollen throat and tongue/ his tongue was swollen; Hives all over his body; This is a spontaneous report from a contactable consumer (parent). A 14-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0187), via an unspecified route of administration on 29Jun2021 at 09:40 (at the age of 14-year- old), as dose 1, single in left arm for COVID-19 immunisation at pharmacy. The patient's medical history was reported as none and concomitant medications were not reported. The patient did not receive any other vaccine on the same date of the Pfizer vaccine and no other vaccines were taken within 4 weeks of COVID vaccine. On 29Jun2021 at 09:40, right after the first dose of vaccine, the patient experienced allergic reaction and had swollen throat and tongue/his throat was swollen, difficulty breathing/he couldn't breathe/his throat started closing up, hives all over his body, and heart palpitations; all for a duration of 1 day 14 hours and 20 minutes. On 30Jun2021, 14 hours and 20 minutes after the administration of first dose of vaccine, the patient was dizzy, for a duration of 2 days. Later, the patient felt better. Treatment received included Epi Pen. Reporter stated that the pharmacist called the ambulance and took him to the Emergency Room for Pediatrics where he received Benadryl and something else for his breathing. Adverse event resulted in visit to emergency room on 29Jun2021 and physician office for allergic reaction. The clinical outcome of the event dizzy was resolved on 02Jul2021 and clinical outcome of all other events was resolved on 01Jul2021.  Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Suffocation feeling, Tremor, Urticaria
Clinical narrative: Dizzy; Heart palpitations; Difficulty breathing/ he couldn't breathe/his throat started closing up; Allergic reaction; Swollen throat and tongue/ his throat was swollen; Swollen throat and tongue/ his tongue was swollen; Hives all over his body; This is a spontaneous report from a contactable consumer (parent). A 14-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0187), via an unspecified route of administration on 29Jun2021 at 09:40 (at the age of 14-year- old), as dose 1, single in left arm for COVID-19 immunisation at pharmacy. The patient's medical history was reported as none and concomitant medications were not reported. The patient did not receive any other vaccine on the same date of the Pfizer vaccine and no other vaccines were taken within 4 weeks of COVID vaccine. On 29Jun2021 at 09:40, right after the first dose of vaccine, the patient experienced allergic reaction and had swollen throat and tongue/his throat was swollen, difficulty breathing/he couldn't breathe/his throat started closing up, hives all over his body, and heart palpitations; all for a duration of 1 day 14 hours and 20 minutes. On 30Jun2021, 14 hours and 20 minutes after the administration of first dose of vaccine, the patient was dizzy, for a duration of 2 days. Later, the patient felt better. Treatment received included Epi Pen. Reporter stated that the pharmacist called the ambulance and took him to the Emergency Room for Pediatrics where he received Benadryl and something else for his breathing. Adverse event resulted in visit to emergency room on 29Jun2021 and physician office for allergic reaction. The clinical outcome of the event dizzy was resolved on 02Jul2021 and clinical outcome of all other events was resolved on 01Jul2021.  Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Hypersensitivity, Palpitations, Pharyngeal oedema
Clinical narrative: Dizzy; Heart palpitations; Difficulty breathing/ he couldn't breathe/his throat started closing up; Allergic reaction; Swollen throat and tongue/ his throat was swollen; Swollen throat and tongue/ his tongue was swollen; Hives all over his body; This is a spontaneous report from a contactable consumer (parent). A 14-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0187), via an unspecified route of administration on 29Jun2021 at 09:40 (at the age of 14-year- old), as dose 1, single in left arm for COVID-19 immunisation at pharmacy. The patient's medical history was reported as none and concomitant medications were not reported. The patient did not receive any other vaccine on the same date of the Pfizer vaccine and no other vaccines were taken within 4 weeks of COVID vaccine. On 29Jun2021 at 09:40, right after the first dose of vaccine, the patient experienced allergic reaction and had swollen throat and tongue/his throat was swollen, difficulty breathing/he couldn't breathe/his throat started closing up, hives all over his body, and heart palpitations; all for a duration of 1 day 14 hours and 20 minutes. On 30Jun2021, 14 hours and 20 minutes after the administration of first dose of vaccine, the patient was dizzy, for a duration of 2 days. Later, the patient felt better. Treatment received included Epi Pen. Reporter stated that the pharmacist called the ambulance and took him to the Emergency Room for Pediatrics where he received Benadryl and something else for his breathing. Adverse event resulted in visit to emergency room on 29Jun2021 and physician office for allergic reaction. The clinical outcome of the event dizzy was resolved on 02Jul2021 and clinical outcome of all other events was resolved on 01Jul2021.  Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue, Urticaria
Clinical narrative: Dizzy; Heart palpitations; Difficulty breathing/ he couldn't breathe/his throat started closing up; Allergic reaction; Swollen throat and tongue/ his throat was swollen; Swollen throat and tongue/ his tongue was swollen; Hives all over his body; This is a spontaneous report from a contactable consumer (parent). A 14-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0187), via an unspecified route of administration on 29Jun2021 at 09:40 (at the age of 14-year- old), as dose 1, single in left arm for COVID-19 immunisation at pharmacy. The patient's medical history was reported as none and concomitant medications were not reported. The patient did not receive any other vaccine on the same date of the Pfizer vaccine and no other vaccines were taken within 4 weeks of COVID vaccine. On 29Jun2021 at 09:40, right after the first dose of vaccine, the patient experienced allergic reaction and had swollen throat and tongue/his throat was swollen, difficulty breathing/he couldn't breathe/his throat started closing up, hives all over his body, and heart palpitations; all for a duration of 1 day 14 hours and 20 minutes. On 30Jun2021, 14 hours and 20 minutes after the administration of first dose of vaccine, the patient was dizzy, for a duration of 2 days. Later, the patient felt better. Treatment received included Epi Pen. Reporter stated that the pharmacist called the ambulance and took him to the Emergency Room for Pediatrics where he received Benadryl and something else for his breathing. Adverse event resulted in visit to emergency room on 29Jun2021 and physician office for allergic reaction. The clinical outcome of the event dizzy was resolved on 02Jul2021 and clinical outcome of all other events was resolved on 01Jul2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bowel movement irregularity, Chills, Lymphadenopathy, Pyrexia
Clinical narrative: Swollen lymph nodes-painful; Swollen lymph nodes-painful; Fever; Chills; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female non pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in Arm Left on unspecified date in Jun2021  (Lot Number: EW0181) as a single dose for covid-19 immunisation from a pharmacy/drug store.  Medical history included hypothyroidism, blood cholesterol abnormal, known allergies to penicillin, wild mushrooms, Iodine all from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in Arm Left on 07Jun2021 18:00 (Lot Number: WE0178) as a single dose at the age of 50-year-old for covid-19 immunisation. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism, start and stop date were not reported; atorvastatin (LIPITOR) taken for blood cholesterol abnormal, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. The patient experienced swollen lymph nodes-painful, fever and chills on 29Jun2021 12:00 which result in doctor or other healthcare professional office/clinic visit. The outcome of the event was not recovered, and no treatment was received for the event.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Lymph node pain, Lymphadenopathy, Pyrexia
Clinical narrative: Swollen lymph nodes-painful; Swollen lymph nodes-painful; Fever; Chills; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female non pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in Arm Left on unspecified date in Jun2021  (Lot Number: EW0181) as a single dose for covid-19 immunisation from a pharmacy/drug store.  Medical history included hypothyroidism, blood cholesterol abnormal, known allergies to penicillin, wild mushrooms, Iodine all from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in Arm Left on 07Jun2021 18:00 (Lot Number: WE0178) as a single dose at the age of 50-year-old for covid-19 immunisation. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism, start and stop date were not reported; atorvastatin (LIPITOR) taken for blood cholesterol abnormal, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. The patient experienced swollen lymph nodes-painful, fever and chills on 29Jun2021 12:00 which result in doctor or other healthcare professional office/clinic visit. The outcome of the event was not recovered, and no treatment was received for the event.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose normal, Hyperhidrosis, Muscle spasms, Pallor, Seizure
Clinical narrative: Fainting; slight seizure of the left hand; Loss color in face; sweating all over the body; This is a spontaneous report from a contactable consumer (patient).  A 17-year-old female patient received BNT162B2, via an unspecified route of administration, administered in left arm on 29Jun2021 12:15 (Batch/Lot number was not reported) at the age of 17 years old as dose 1, single for COVID-19 immunization. Medical history was none. Patient was not pregnancy at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. On 29Jun2021 12:15, the patient experienced fainting with a slight seizure of the left hand. Lasted about 45 seconds. Loss color in face and sweating all over the body. No treatment was provided for the events. Outcome of events fainting and slight seizure of the left hand was recovered on 29Jun2021, while other events were recovered on unspecified date on Jun2021. The report was assessed as not serious.  Information on the lot/batch number has been requested.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: Fainting; slight seizure of the left hand; Loss color in face; sweating all over the body; This is a spontaneous report from a contactable consumer (patient).  A 17-year-old female patient received BNT162B2, via an unspecified route of administration, administered in left arm on 29Jun2021 12:15 (Batch/Lot number was not reported) at the age of 17 years old as dose 1, single for COVID-19 immunization. Medical history was none. Patient was not pregnancy at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. On 29Jun2021 12:15, the patient experienced fainting with a slight seizure of the left hand. Lasted about 45 seconds. Loss color in face and sweating all over the body. No treatment was provided for the events. Outcome of events fainting and slight seizure of the left hand was recovered on 29Jun2021, while other events were recovered on unspecified date on Jun2021. The report was assessed as not serious.  Information on the lot/batch number has been requested.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Pallor, Seizure, Syncope
Clinical narrative: Fainting; slight seizure of the left hand; Loss color in face; sweating all over the body; This is a spontaneous report from a contactable consumer (patient).  A 17-year-old female patient received BNT162B2, via an unspecified route of administration, administered in left arm on 29Jun2021 12:15 (Batch/Lot number was not reported) at the age of 17 years old as dose 1, single for COVID-19 immunization. Medical history was none. Patient was not pregnancy at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. On 29Jun2021 12:15, the patient experienced fainting with a slight seizure of the left hand. Lasted about 45 seconds. Loss color in face and sweating all over the body. No treatment was provided for the events. Outcome of events fainting and slight seizure of the left hand was recovered on 29Jun2021, while other events were recovered on unspecified date on Jun2021. The report was assessed as not serious.  Information on the lot/batch number has been requested.