chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Illness, Pleurisy
Clinical narrative: I have the problem in my lungs, I got inflammation inner lining of my lungs; I am sick and having big problem after getting the vaccine; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, as dose number unknown, single, for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. It was reported that, the patient had big problem after getting the vaccine. The patient was getting very sick from the Pfizer Covid-19 Vaccine and patient had problem in lungs, got inflammation in inner lining of lungs. The outcome for the events was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: felt like throat was closing; This is a spontaneous report from a non-contactable pharmacist. A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular route administered in right arm on 30Mar2021 (Batch/Lot Number: er8727) at the age of 63 years, as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was unknown if patient had COVID prior to vaccination. The patient stated she felt like throat was closing on an unspecified date. Dexamethasone was administered and symptoms resolved. Outcome of the event was recovered on an unspecified date. It was unknown if patient was tested for COVID post vaccination.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported event Throat tightness and suspect drug BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Malaise
Clinical narrative: BP 203/105. pt was admitted to ED for high level of care; patient stated she was "not feeling well"; This is a spontaneous report from a non-contactable pharmacist (patient).  A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in Arm Left on 29Mar2021 (Lot Number: ER8727) as dose number unknown, single (at the age of 76-years-old) for COVID-19 immunization. Facility type Vaccine was the Hospital. The patient's medical history and concomitant medications were not reported. It was unknown if the patient experienced Covid prior vaccination. On 29Mar2021, the patient stated she was "not feeling well", BP 203/105. Pt was admitted to ED for high level of care. Adverse events resulted in Emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood pressure measurement: 203/105 on 29Mar2021. Unknown if the patient received treatment. The outcome of the events was unknown. Unknown if the patient was Covid tested post vaccination. The case was considered as serious (medically significant).  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known temporal relationship there is reasonable possibility of causal association between the reported events Blood Pressure high, malaise and the suspect drug BNT162B2.  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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye movement disorder
Clinical narrative: patient felt faint and eyes rolled back. patient given water and symptoms resolved in 20 minutes; patient felt faint and eyes rolled back. patient given water and symptoms resolved in 20 minutes; This is a spontaneous report from a non-contactable pharmacist.   A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 13May2021 (Batch/Lot Number: ew0151) (at the age of 38-years-old) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient was not pregnant at time of vaccination. The vaccine was administered in a hospital. There were no other vaccines received in four weeks. It was unknown if the patient had COVID-19 prior to vaccination. On 13May2021, the patient felt faint and eyes rolled back. Patient given water and symptoms resolved in 20 minutes. The events did not require treatment. The outcome of the events was recovered on 13May2021. It was unknown if patient was tested for COVID-19 post vaccination.  No follow up attempts are possible; Information about lot/batch number cannot be requested. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Blood test, Cerebrovascular accident, Cognitive disorder, Coordination abnormal
Clinical narrative: rapid heart beat; having stroke like symptoms; My left eye developed a blind spot; my balance and coordination are compromised; my balance and coordination are compromised; my speech and cognitive thinking is impaired; my speech and cognitive thinking is impaired; I am now acutely light sensitive; sometimes there is numbness in my hands; chronic fatigue; 1st dose 08May2021 / 2nd dose 22May2021; 1st dose 08May2021 / 2nd dose 22May2021; This is a spontaneous report received from a contactable consumer (patient). A 48-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 22May2021 11:00 (Batch/Lot Number: Unknown) (at the age of 48 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 administered in Arm Left on 08May2021 11:00 for covid-19 immunisation. Concomitant medications included multivitamins; ethinylestradiol, etonogestrel (NUVARING); both taken for an unspecified indication, start and stop date were not reported. The day after the second vaccine injection at 23May2021 08:00, patient had rapid heartbeat for 7 days. Upon an urgent care visit and an ekg (electrocardiogram), heart rate levels had returned to normal. After the heart episode, patient began having stroke like symptoms which she still has today. Patient's left eye has developed a blind spot, balance and coordination were compromised, speech and cognitive thinking was impaired, patient was now acutely light sensitive, sometimes there was numbness in hands and has chronic fatigue. Patient had an MRI (Magnetic resonance imaging) and several blood tests (unknown results). Patient's symptoms showed up the days after the 2nd Pfizer vaccine. No treatment was received for the events. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The events were reported as serious for disability. The outcome of event rapid heart beat was recovered on 30May2021, event 1st dose 08May2021 / 2nd dose 22May2021 was unknown, while for other events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Results of tests and procedures for investigation of the patient: Test: Nasal Swab, Result: Negative, Date: 11Sep2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Heart rate increased, Hypoaesthesia, Inappropriate schedule of product administration
Clinical narrative: rapid heart beat; having stroke like symptoms; My left eye developed a blind spot; my balance and coordination are compromised; my balance and coordination are compromised; my speech and cognitive thinking is impaired; my speech and cognitive thinking is impaired; I am now acutely light sensitive; sometimes there is numbness in my hands; chronic fatigue; 1st dose 08May2021 / 2nd dose 22May2021; 1st dose 08May2021 / 2nd dose 22May2021; This is a spontaneous report received from a contactable consumer (patient). A 48-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 22May2021 11:00 (Batch/Lot Number: Unknown) (at the age of 48 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 administered in Arm Left on 08May2021 11:00 for covid-19 immunisation. Concomitant medications included multivitamins; ethinylestradiol, etonogestrel (NUVARING); both taken for an unspecified indication, start and stop date were not reported. The day after the second vaccine injection at 23May2021 08:00, patient had rapid heartbeat for 7 days. Upon an urgent care visit and an ekg (electrocardiogram), heart rate levels had returned to normal. After the heart episode, patient began having stroke like symptoms which she still has today. Patient's left eye has developed a blind spot, balance and coordination were compromised, speech and cognitive thinking was impaired, patient was now acutely light sensitive, sometimes there was numbness in hands and has chronic fatigue. Patient had an MRI (Magnetic resonance imaging) and several blood tests (unknown results). Patient's symptoms showed up the days after the 2nd Pfizer vaccine. No treatment was received for the events. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The events were reported as serious for disability. The outcome of event rapid heart beat was recovered on 30May2021, event 1st dose 08May2021 / 2nd dose 22May2021 was unknown, while for other events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Results of tests and procedures for investigation of the patient: Test: Nasal Swab, Result: Negative, Date: 11Sep2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Off label use, Photophobia, SARS-CoV-2 test, Speech disorder
Clinical narrative: rapid heart beat; having stroke like symptoms; My left eye developed a blind spot; my balance and coordination are compromised; my balance and coordination are compromised; my speech and cognitive thinking is impaired; my speech and cognitive thinking is impaired; I am now acutely light sensitive; sometimes there is numbness in my hands; chronic fatigue; 1st dose 08May2021 / 2nd dose 22May2021; 1st dose 08May2021 / 2nd dose 22May2021; This is a spontaneous report received from a contactable consumer (patient). A 48-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 22May2021 11:00 (Batch/Lot Number: Unknown) (at the age of 48 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 administered in Arm Left on 08May2021 11:00 for covid-19 immunisation. Concomitant medications included multivitamins; ethinylestradiol, etonogestrel (NUVARING); both taken for an unspecified indication, start and stop date were not reported. The day after the second vaccine injection at 23May2021 08:00, patient had rapid heartbeat for 7 days. Upon an urgent care visit and an ekg (electrocardiogram), heart rate levels had returned to normal. After the heart episode, patient began having stroke like symptoms which she still has today. Patient's left eye has developed a blind spot, balance and coordination were compromised, speech and cognitive thinking was impaired, patient was now acutely light sensitive, sometimes there was numbness in hands and has chronic fatigue. Patient had an MRI (Magnetic resonance imaging) and several blood tests (unknown results). Patient's symptoms showed up the days after the 2nd Pfizer vaccine. No treatment was received for the events. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The events were reported as serious for disability. The outcome of event rapid heart beat was recovered on 30May2021, event 1st dose 08May2021 / 2nd dose 22May2021 was unknown, while for other events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Results of tests and procedures for investigation of the patient: Test: Nasal Swab, Result: Negative, Date: 11Sep2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Visual field defect
Clinical narrative: rapid heart beat; having stroke like symptoms; My left eye developed a blind spot; my balance and coordination are compromised; my balance and coordination are compromised; my speech and cognitive thinking is impaired; my speech and cognitive thinking is impaired; I am now acutely light sensitive; sometimes there is numbness in my hands; chronic fatigue; 1st dose 08May2021 / 2nd dose 22May2021; 1st dose 08May2021 / 2nd dose 22May2021; This is a spontaneous report received from a contactable consumer (patient). A 48-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 22May2021 11:00 (Batch/Lot Number: Unknown) (at the age of 48 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 administered in Arm Left on 08May2021 11:00 for covid-19 immunisation. Concomitant medications included multivitamins; ethinylestradiol, etonogestrel (NUVARING); both taken for an unspecified indication, start and stop date were not reported. The day after the second vaccine injection at 23May2021 08:00, patient had rapid heartbeat for 7 days. Upon an urgent care visit and an ekg (electrocardiogram), heart rate levels had returned to normal. After the heart episode, patient began having stroke like symptoms which she still has today. Patient's left eye has developed a blind spot, balance and coordination were compromised, speech and cognitive thinking was impaired, patient was now acutely light sensitive, sometimes there was numbness in hands and has chronic fatigue. Patient had an MRI (Magnetic resonance imaging) and several blood tests (unknown results). Patient's symptoms showed up the days after the 2nd Pfizer vaccine. No treatment was received for the events. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The events were reported as serious for disability. The outcome of event rapid heart beat was recovered on 30May2021, event 1st dose 08May2021 / 2nd dose 22May2021 was unknown, while for other events was not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Results of tests and procedures for investigation of the patient: Test: Nasal Swab, Result: Negative, Date: 11Sep2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Lymphadenopathy, Pain
Clinical narrative: she experienced achiness; glands are swelling and achy; I just feel achy; I have this achiness, weakness; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FC3183) via an unspecified route of administration on 25Aug2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced as, she experienced achiness, glands are swelling and achy, i just feel achy; i have this achiness, weakness on 2021. Reported as, patient stated that after her first shot on 25Aug2021, she experienced achiness and her glands was swelling and achy. Patient stated that it will be two weeks tomorrow, that this started the day before she was to receive the second dose. Patient have achiness severe achiness. That could only last for one day, ok two weeks later, she got it was not severe but her glands were swollen and she just feel achy. Her glands was swollen like his ears and under his jaw. Outcome of all the events were not recovered.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Arrhythmia, Arthralgia, Brain natriuretic peptide, Full blood count, Pulmonary function test
Clinical narrative: I am experiencing some issue with arrhythmia; I sustained significant changes in my arrhythmia; Shoulder pain; local injection discomfort, have pain for couple of days; shoulder pain; This is a spontaneous report from a contactable physician. A 73-years-old patient of an unspecified gender received bnt162b2 (BNT162B2), via an unspecified route of administration at the age of 73 years old on 23Sep2021 (Batch/Lot Number: 301458A) as DOSE 3, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 01Feb2021 (lot number: EL9265) for COVID-19 immunization and second dose of BNT162B2 on 11Feb2021 (lot number: EN6700) for COVID-19 immunization. On an unspecified date, the patient experienced local injection discomfort, have pain for couple of days, shoulder pain. Also, the patient was experiencing some issue with arrhythmia. The patient sustained significant changes in my arrhythmia. The patient underwent lab tests and procedures which included EKG that showed little bit more vigorous; have a high PVC load and significant increase in the PVC load for 2 to 3 days after the injection. The patient also had BNP, CBC and pulmonary function test but results were unknown. The outcome of the events was unknown.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported event Arrhythmia and suspect drug BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101340544 Same patient and drug, different event separated in time
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I am experiencing some issue with arrhythmia; I sustained significant changes in my arrhythmia; Shoulder pain; local injection discomfort, have pain for couple of days; shoulder pain; This is a spontaneous report from a contactable physician. A 73-years-old patient of an unspecified gender received bnt162b2 (BNT162B2), via an unspecified route of administration at the age of 73 years old on 23Sep2021 (Batch/Lot Number: 301458A) as DOSE 3, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 01Feb2021 (lot number: EL9265) for COVID-19 immunization and second dose of BNT162B2 on 11Feb2021 (lot number: EN6700) for COVID-19 immunization. On an unspecified date, the patient experienced local injection discomfort, have pain for couple of days, shoulder pain. Also, the patient was experiencing some issue with arrhythmia. The patient sustained significant changes in my arrhythmia. The patient underwent lab tests and procedures which included EKG that showed little bit more vigorous; have a high PVC load and significant increase in the PVC load for 2 to 3 days after the injection. The patient also had BNP, CBC and pulmonary function test but results were unknown. The outcome of the events was unknown.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported event Arrhythmia and suspect drug BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202101340544 Same patient and drug, different event separated in time
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report from a contactable consumer (patient), from a sponsored program.  A 71-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single, and dose 2 via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as dose 2, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced covid-19 on an unspecified date with outcome of unknown. Caller is asking for recommendations on the booster vaccine. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Malaise, Pain, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; Feeling unwell; Pain; This is a solicited report from a Non-interventional Study based on information by Pfizer from the Regulatory Authority, Manufacturer control number: 21K-163-4086850-00.  A currently 76-year-old male patient received bnt162b2 (BNT162B2), intramuscular on 21Jan2021 (at the age of 75-years-old) (Batch/Lot number was not reported) as dose 1, single, then intramuscular on 11Feb2021 (at the age of 75-years-old) (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation; and adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at an unknown dose and frequency (Citrate free) for moderate to severe ulcerative colitis. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced COVID-19, feeling unwell and pain. The patient had underwent lab tests and procedures which included Covid positive on an unspecified date. The action taken in response to the events for adalimumab was unknown. The outcome of the events was unknown.   Solicited report from the Regulatory Authority by a consumer of an elderly male with events of non-serious not feeling well, COVID 19 and pain with HUMIRA (ADALIMUMAB). There was no reported medical history. On unknown dates, the patient experienced not feeling well, COVID 19 and pain. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. It was unknown if patient was enrolled in a covid 19 vaccine trial. On 21Jan2021, he received 1st dose covid 19 vaccine manufactured by Pfizer, biontech. On 11Feb2021, he received 2nd dose covid 19 vaccine manufactured by Pfizer, biontech.  The reporter's causality for adalimumab for the events of not feeling well and pain was not provided. The reporter's causality for the event COVID-19 with adalimumab was no reasonable possibility. The reporter's causality for BNT162B2 for the events malaise, pain and COVID-19 was possible.  The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on possible dose- event relationship post-vaccination  the causal role of BNT162B2 vaccine cannot be excluded for the reported events  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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Heart rate, Heart rate irregular, Nausea, SARS-CoV-2 test
Clinical narrative: Nausea; vomiting; diarrhea; excessive sweating; irregular heart rate; long QT; Elevated WBC 19; This is a spontaneous report from a contactable nurse (patient). A 55-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm right on 14Sep2021 at 17:30 (Batch/Lot number was not reported) as dose 1, single (at the age of 55 years old) for COVID-19 immunization. Medical history included depression, thyroidectomy and hysterectomy from an unknown date. Concomitant medications included fluoxetine hydrochloride (PROZAC) taken for an unspecified indication, start and stop date were not reported. No other vaccine in fourweeks. On 15Sep2021 at 15:00, the patient experienced nausea, vomiting, diarrhea with excessive sweating irregular heart rate, long QT wave never had before. Stated "Coincidence or an issue caused by the vaccine AAA (as reported)". Elevated WBC 19. Adverse events (AE) resulted in hospitalization for 4 days. Therapeutic measures were taken as result of the events, treatment included IV fluids, IV antibiotics heart monitoring continue. No covid prior vaccination. Covid tested post vaccination. The patient underwent lab tests and procedures which included QT: long QT wave never had before, heart rate: irregular, WBC 19: elevated on unspecified date; Nasal Swab: negative on 19Sep2021. The outcome of the events was not resolved.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.; Sender's Comments: Based on the currently available information the possibility of causal association between the reported events and the suspect drug BNT162B2  cannot be ruled out. 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Nausea; vomiting; diarrhea; excessive sweating; irregular heart rate; long QT; Elevated WBC 19; This is a spontaneous report from a contactable nurse (patient). A 55-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm right on 14Sep2021 at 17:30 (Batch/Lot number was not reported) as dose 1, single (at the age of 55 years old) for COVID-19 immunization. Medical history included depression, thyroidectomy and hysterectomy from an unknown date. Concomitant medications included fluoxetine hydrochloride (PROZAC) taken for an unspecified indication, start and stop date were not reported. No other vaccine in fourweeks. On 15Sep2021 at 15:00, the patient experienced nausea, vomiting, diarrhea with excessive sweating irregular heart rate, long QT wave never had before. Stated "Coincidence or an issue caused by the vaccine AAA (as reported)". Elevated WBC 19. Adverse events (AE) resulted in hospitalization for 4 days. Therapeutic measures were taken as result of the events, treatment included IV fluids, IV antibiotics heart monitoring continue. No covid prior vaccination. Covid tested post vaccination. The patient underwent lab tests and procedures which included QT: long QT wave never had before, heart rate: irregular, WBC 19: elevated on unspecified date; Nasal Swab: negative on 19Sep2021. The outcome of the events was not resolved.  The lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.; Sender's Comments: Based on the currently available information the possibility of causal association between the reported events and the suspect drug BNT162B2  cannot be ruled out. 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.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Back pain, Coronavirus infection, Dyspnoea, Pain in extremity, Pyrexia
Clinical narrative: shortness of breath; She had back pain; Coronavirus 224; pain in arm; fever; This is a solicited report (manufacturer control number: 21K-163-4089904-00). A contactable consumer (patient herself) reported that a 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via intramuscular, on an unspecified date, as dose number unknown, single for COVID-19 immunisation; and, upadacitinib (RINVOQ), via oral, from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at an unknown dose and frequency for moderate to severe rheumatoid arthritis. The patient's medical history included ongoing moderate to severe rheumatoid arthritis. The patient's concomitant medications were not reported. On unspecified date in Sep2021, it was reported that the patient experienced back pain, pain in arm after the COVID-19 vaccine with updacitinib. It was also reported that the patient had been recently hospitalized for shortness of breath. She had fever, and on Sep2021 she had Coronavirus 224. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken in response to the events for upadacitinib was unknown. The outcome of the events of shortness of breath, fever and coronavirus 224 was recovering; for the event pain in arm was recovered on unspecified date in 2021, while for the other event was not recovered. The reported causality for the events pain in arm, back pain and coronavirus 224 as per reporter was possible, while for the other events was on reasonable possibility. Opinion was that there is no reasonable possibility that the events of coronavirus 224, back pain and pain in arm after covid vaccine were related to rinvoq (upadacitinib).  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Coronavirus infection, Dyspnoea, Back pain, Pain in extremity, and Pyrexia and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Pruritus, Swollen tongue
Clinical narrative: swollen throat and tongue; swollen throat and tongue; itching; This is a spontaneous report from a non-contactable pharmacist. A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the left arm, on 07Apr2021 (lot number: ew0151), at age 27 years old, as dose number unknown, single, for COVID-19 immunisation, at a hospital. Relevant medical history and concomitant medications were not reported. Relevant medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination, and it was unknown if he has been tested for COVID-19 post vaccination. The patient had no other medications in four weeks. On an unspecified date in 2021, the patient experienced swollen throat and tongue, and itching. Treatment for the events included Benadryl. The patient recovered from the events on an unspecified date in 2021. The reporting pharmacist assessed this report as non-serious.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis; This is a spontaneous report from a contactable physician and a contactable consumer.  A 19-year-old female patient (reporter's niece) received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in Jul2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced myocarditis on an unspecified date with outcome of unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the event Myocarditis and the suspect drug BNT162B2. 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.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Malaise, Myalgia
Clinical narrative: Tiredness; Muscle pain; kind of Joint pain; generally feeling unwell; feeling no energy at all; This is a spontaneous report from a contactable consumer reported for himself/herself. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 3 via an unspecified route of administration on 24Sep2021 as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. Reason for no lot number: of COVID-19 Vaccine: Other: LOT#: Consumer stated, sorry but I got another call coming in and I can't answer. The patient medical and concomitant medication history were reported. On Sep2021, patient had the booster shot on Friday and patient did not have serious side effect, but patient had like tiredness, muscle pain, kind of joint pain and generally feeling unwell. Patient was just feeling no energy at all. How long is this last?" Patient, just wanted to know how long it lasted. Its been 24, you know its been more than 1 day. Consumer was unwilling to complete the report. Further probing could not be done. Hence, limited information available over the call. The outcome of the events were unknown.  The lot number was not provided. Information on lot number has been requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; This is a spontaneous report from a non-contactable other hcp  A female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (at an unspecified age) (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation.   The patient medical history and concomitant medications were not reported.  The patient experienced stroke (medically significant) on an unspecified date within 48 hours of her vaccine with outcome of unknown. Therapeutic measures were taken as a result of stroke: fully on anticoagulation. (as reported)  The lot number for [BNT162B2], was not provided and will be requested during follow up; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the event cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Rash
Clinical narrative: had a rash again and had to get intramuscular steroid injections in her butt again after the second dose; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: 041C21A, Expiration date: Not reported), via an unspecified route of administration on 08Sep2021 as dose 2, single for COVID-19 immunization. Medical history included infertility issues. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: 041C2A, Expiration date: Not reported), via an unspecified route of administration on 11Aug2021 as dose 1, single for COVID-19 immunization and experienced terrible rash/rash was blistering, heart palpitations, migraine, open sores on her body and had scar tissues on her arms. She had been in and out of emergency rooms (ER) getting steroid injections in her butt and had to be on high doses of steroid pills. The patient had to get her second dose on 08Sep2021 to be compliant for school. She had just been tapered off the her steroids prior to the second dose and then she erupted everywhere and had a rash again in Sep2021 and had to get intramuscular steroid injections in her butt again after the second dose. This is the most severe reaction that her doctor has seen until now. She was put on a higher dose of steroids, oral diphenhydramine (BENADRYL) and an oral histamine receptor blocker called famotidine (PEPCID). She wants to go through invetro and she cannot proceed with invetro due to the high dose of steroids, she had infertility issues and she cannot continue with stemming procedure for infertility issues since the vaccine messed her up so bad. She's concerned that it's going to affect her fertility. She wants to have a baby and she cannot try to have a baby due to her high dose of steroids. On an unspecified date, the patient shingle's test was negative. The patient wanted to know that how long these events last. The outcome of event was unknown at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cataract, Fall, Headache, Poor peripheral circulation
Clinical narrative: Cataract on left eye; Poor circulation in legs; Fell; Headache; This is a solicited report from a contactable consumer (patient) via a non-Pfizer-sponsored program (Other Manufacturer Control Number: 21K-163-4088265-00).   Solicited report by a consumer of an adult (64-year-old) female with events of cataract on left eye and non-serious poor circulation in legs and fell four times and headache when getting bangs cut/attributed to a mineral allergy with Rinvoq (Upadacitinib). There was no reported medical history. On unknown dates, the patient experienced Cataract on left eye, poor circulation in legs and fell four times and headache when getting bangs cut/attributed to a mineral allergy. PFIZER BIONTECH COVID-19 Vaccine (Tozinameran) was also considered suspect. The patient had cataract surgery on her left eye. She had poor circulation in her legs, and she fell four times. She got a headache when getting her bangs cut, attributed to a mineral allergy. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 15Feb2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. On 19Mar2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer. The action taken in response to the events for upadacitinib was unknown. The patient had not recovered from the events.  Causality for Rinvoq (Upadacitinib): The reporter's causality for the event(s) of cataract on left eye, poor circulation in legs and fell four times unknown onset, poor circulation in legs and fell four times unknown onset, headache when getting bangs cut/attributed to a mineral allergy unknown onset and headache when getting bangs cut/attributed to a mineral allergy unknown onset was not provided. Opinion is that there is no reasonable possibility that the events of cataract on left eye, poor circulation in legs and fell four times unknown onset, headache when getting bangs cut/attributed to a mineral allergy unknown onset and headache when getting bangs cut/attributed to a mineral allergy unknown onset are related to Rinvoq (Upadacitinib). Opinion is that the event of poor circulation in legs and fell four times unknown onset is not assessable.  The reporter's assessment of the causal relationship of the events with BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on current information available, the event cataract mostly represented intercurrent condition in this patient with advanced age, unrelated to Bnt162b2. non-serious event headache was considered related.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Constipation, Functional gastrointestinal disorder, SARS-CoV-2 test
Clinical narrative: Bowel stopped producing stools; Bowel stopped producing stools; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 11Apr2021 11:00 (Lot number: EW0153) as dose 1, single for COVID-19 immunisation. Medical history included gastritis, and back pain. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications received within 2 weeks of vaccination included zolpidem tartrate (AMBIEN); alprazolam (XANAX); and phentermine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took levofloxacin (LEVAQUIN), naproxen and pethidine hydrochloride (DEMEROL), and experienced drug allergies. The patient experienced bowel stopped producing stools on 11May2021 when patient noticed it. The AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (days of hospitalization: 5), Life threatening illness (immediate risk of death from the event), and Disability or permanent damage. No treatment was received for the reported event. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab test which included COVID test: negative nasal swab on 03Jun2021. The outcome of the event was not recovered.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Constipation
Clinical narrative: Bowel stopped producing stools; Bowel stopped producing stools; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 11Apr2021 11:00 (Lot number: EW0153) as dose 1, single for COVID-19 immunisation. Medical history included gastritis, and back pain. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications received within 2 weeks of vaccination included zolpidem tartrate (AMBIEN); alprazolam (XANAX); and phentermine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took levofloxacin (LEVAQUIN), naproxen and pethidine hydrochloride (DEMEROL), and experienced drug allergies. The patient experienced bowel stopped producing stools on 11May2021 when patient noticed it. The AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization (days of hospitalization: 5), Life threatening illness (immediate risk of death from the event), and Disability or permanent damage. No treatment was received for the reported event. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab test which included COVID test: negative nasal swab on 03Jun2021. The outcome of the event was not recovered.