chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Appendicitis, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Swollen underarm and collar bone lymph node; appendicitis; This is a spontaneous report from a contactable consumer reporting for himself. A 36-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EW0161/expiration date: not provided), via an unspecified route of administration, on 31Mar2021 (at the age of 36 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number ER8734/expiration date: not provided), via an unspecified route of administration, on 31Mar2021 at 1:30pm (at the age of 36 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. Relevant medical history was not provided. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication (other medications taken in two weeks) were none.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Apr2021 at 3:00pm, the patient experienced swollen underarm and collar bone lymph node and appendicitis. The events required an emergency room visit and the patient was admitted to the hospital. The patient received treatment for these events swollen underarm and collar bone lymph node and appendicitis which included an appendectomy. The outcome of the events swollen underarm and collar bone lymph node and appendicitis was recovering. Since the vaccination, the patient has been tested for COVID-19, test type nasal swab on 24Apr2021 with result negative.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Decreased appetite, Dehydration, Dyspnoea, Headache
Clinical narrative: sinus infection; couldn't breathe; extreme high anxiety; couldn't sleep; lack of appetite; nervous about everything; dehydrated; kidney levels numbers raised; headache; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), single dose, dose 2 via an unspecified route of administration, administered in the right arm on 12Apr2021 at 11:15 (at the age of 61 years-old) for COVID-19  immunization. Medical history included blood glucose abnormal from an unknown date and unknown if ongoing other medical history: sugar, kidney problems, coronary artery disease (CAD), high blood pressure  and renal disorder from an unknown date and unknown if ongoing. The patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1 in the right arm on 22Mar2021 at 11:15 AM. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified medication for high blood pressure and "sugar medicine." The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. On 14Apr2021 at 06:00 AM, the patient experienced sinus infection, couldn't breathe, extreme high anxiety, couldn't sleep, lack of appetite, nervous about everything, dehydrated, kidney levels numbers raised and headache. The patient was hospitalized for sinus infection for 1 days. The patient was hospitalized for couldn't breathe for 1 day. The patient was hospitalized for extreme high anxiety, couldn't sleep and lack of appetite for 1 day. The events sinus infection, couldn't breathe which led to extreme high anxiety, couldn't sleep, lack of appetite, nervous about everything, dehydrated, kidney levels numbers raised and headache  required an emergency room and physician's office visit. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 20Apr2021. Therapeutic measures were taken as a result of sinus infection, couldn't breathe, extreme high anxiety, couldn't sleep, lack of appetite, nervous about everything, dehydrated, kidney levels numbers raised and headache and included antibiotics and medicine to help sleep. The clinical outcome of sinus infection, couldn't breathe, extreme high anxiety, couldn't sleep, lack of appetite, nervous about everything, dehydrated, kidney levels numbers raised and headache were recovering. It was also reported that since the vaccination, the patient was tested for COVID-19.   Information on the lot/batch number has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Nervousness, Renal disorder, SARS-CoV-2 test, Sinusitis
Clinical narrative: sinus infection; couldn't breathe; extreme high anxiety; couldn't sleep; lack of appetite; nervous about everything; dehydrated; kidney levels numbers raised; headache; This is a spontaneous report from a contactable consumer (patient). A 61-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), single dose, dose 2 via an unspecified route of administration, administered in the right arm on 12Apr2021 at 11:15 (at the age of 61 years-old) for COVID-19  immunization. Medical history included blood glucose abnormal from an unknown date and unknown if ongoing other medical history: sugar, kidney problems, coronary artery disease (CAD), high blood pressure  and renal disorder from an unknown date and unknown if ongoing. The patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown), dose 1 in the right arm on 22Mar2021 at 11:15 AM. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified medication for high blood pressure and "sugar medicine." The patient did not receive  any other vaccine within 4 weeks prior to the vaccine. On 14Apr2021 at 06:00 AM, the patient experienced sinus infection, couldn't breathe, extreme high anxiety, couldn't sleep, lack of appetite, nervous about everything, dehydrated, kidney levels numbers raised and headache. The patient was hospitalized for sinus infection for 1 days. The patient was hospitalized for couldn't breathe for 1 day. The patient was hospitalized for extreme high anxiety, couldn't sleep and lack of appetite for 1 day. The events sinus infection, couldn't breathe which led to extreme high anxiety, couldn't sleep, lack of appetite, nervous about everything, dehydrated, kidney levels numbers raised and headache  required an emergency room and physician's office visit. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 20Apr2021. Therapeutic measures were taken as a result of sinus infection, couldn't breathe, extreme high anxiety, couldn't sleep, lack of appetite, nervous about everything, dehydrated, kidney levels numbers raised and headache and included antibiotics and medicine to help sleep. The clinical outcome of sinus infection, couldn't breathe, extreme high anxiety, couldn't sleep, lack of appetite, nervous about everything, dehydrated, kidney levels numbers raised and headache were recovering. It was also reported that since the vaccination, the patient was tested for COVID-19.   Information on the lot/batch number has been requested.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Coronary artery thrombosis, Cough, Dyspnoea, Pulmonary thrombosis, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). An 83-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE),  via an unspecified route of administration on 03Feb2021 (Batch/Lot number was not reported) as a single dose (at the age of 83-years old) for COVID-19 immunisation.  Medical history included the patient had known allergies (unspecified) and unspecified chronic health conditions from an unknown date.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient was not pregnant. The patient received unspecified concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 15Feb2021 at 13:00 the patient experienced getting out of breath, three blood clots/clots were in my leg heart and lung, and cough. The events resulted in emergency room visit and the patient was hospitalized (from an unknown date) for the events getting out of breath, three blood clots/clots were in my leg heart and lung, and cough for 6 days. The clinical course is as follows: 2 or 3 weeks after the patient got the vaccine she started getting out of breath when she walked. Each day she got worse. Then the patient was taken to the hospital where they discovered the patient had three blood clots. The clots were in the patient's leg, heart and lung. The patient stated the Doctors do not understand where the clots came from. The patient was in the hospital 6 days. The patient stated they are still having breathing problem and still on oxygen as needed and they still cough at night. The patient asked if there have been any other reports of this happening to other people who got the vaccine as the patient never had blood clots before this. The patient underwent lab tests and procedures which included COVID test (nasal swab): negative on 15Mar2021.  Therapeutic measures were taken as a result of getting out of breath, three blood clots/clots were in my leg heart and lung, and cough and included blood thinners and oxygen therapy and complete bed rest. The clinical outcome of the events getting out of breath, three blood clots/clots were in my leg heart and lung, and cough was not recovered.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). An 83-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE),  via an unspecified route of administration on 03Feb2021 (Batch/Lot number was not reported) as a single dose (at the age of 83-years old) for COVID-19 immunisation.  Medical history included the patient had known allergies (unspecified) and unspecified chronic health conditions from an unknown date.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient was not pregnant. The patient received unspecified concomitant medications. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 15Feb2021 at 13:00 the patient experienced getting out of breath, three blood clots/clots were in my leg heart and lung, and cough. The events resulted in emergency room visit and the patient was hospitalized (from an unknown date) for the events getting out of breath, three blood clots/clots were in my leg heart and lung, and cough for 6 days. The clinical course is as follows: 2 or 3 weeks after the patient got the vaccine she started getting out of breath when she walked. Each day she got worse. Then the patient was taken to the hospital where they discovered the patient had three blood clots. The clots were in the patient's leg, heart and lung. The patient stated the Doctors do not understand where the clots came from. The patient was in the hospital 6 days. The patient stated they are still having breathing problem and still on oxygen as needed and they still cough at night. The patient asked if there have been any other reports of this happening to other people who got the vaccine as the patient never had blood clots before this. The patient underwent lab tests and procedures which included COVID test (nasal swab): negative on 15Mar2021.  Therapeutic measures were taken as a result of getting out of breath, three blood clots/clots were in my leg heart and lung, and cough and included blood thinners and oxygen therapy and complete bed rest. The clinical outcome of the events getting out of breath, three blood clots/clots were in my leg heart and lung, and cough was not recovered.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Cold sweat, Dyspnoea, Investigation, Muscle spasms
Clinical narrative: nearly fainted twice; I've been having weird pains in several spots inside my muscles all over the place in my legs, feet, arms, neck, chest, face and even my left hand ring finger tip. It's pain that is in spots, it feels; I've been having weird pains in several spots inside my muscles all over the place in my legs, feet, arms, neck, chest, face and even my left hand ring finger tip. It's pain that is in spots, it feels; pains in chest; catching my breath; very cold and clammy; This is a spontaneous report from a contactable consumer (the patient).   A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EW0169), via an unspecified route of administration, on 14Apr2021 at 11:30 (at the age of 45-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included cardiac disorder from an unknown date and unknown if ongoing,  irregular heart beat  and depression from an unknown date and unknown if ongoing. Concomitant medication included metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported. The patient did not have any other vaccines within four weeks prior to the vaccination.  The patient stated that  when he first got the shot he actually nearly fainted twice and had to lay on the floor for a while. It was very scary, he thought he was going to die.  He got very cold and clammy and had pains in chest and had a hard time catching his breath. They checked his vital signs a couple times and said they looked good. But he still felt sick and they said if he did not  feel better soon they may have to call for an ambulance for him. Eventually he felt better enough to where he was able to get up off the floor and on handicap cart to drive out of there. Also, he's been having weird pains in several spots inside his muscles all over the place in his legs, feet, arms, neck, chest, face and even his left hand ring finger tip. It's pain that is in spots, it feels like mini-charley-horses that lasts anywhere from 20 something to 30 something seconds. Now it's mostly continuous pains in his thigh muscles between his legs. And a pain in one spot in his left arm bicep. This has been happening for days."  The patient experienced "nearly fainted twice"  on 15Apr2021 with outcome of not recovered, chest pain, got very cold and clammy and had a hard time catching his breath on 15Apr2021 with outcome of not recovered. He also reported that he has been having weird pains in several spots inside his muscles all over the place in his legs, feet, arms, neck, chest, face and even his  left hand ring finger tip. it's pain that is in spots, it feels starting on 15Apr2021 with outcome of not recovered.  The patient underwent lab tests and procedures which included unspecified investigation: myalgias  on an unspecified date . Therapeutic measures (unspecified) were taken as a result of the events.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Syncope
Clinical narrative: nearly fainted twice; I've been having weird pains in several spots inside my muscles all over the place in my legs, feet, arms, neck, chest, face and even my left hand ring finger tip. It's pain that is in spots, it feels; I've been having weird pains in several spots inside my muscles all over the place in my legs, feet, arms, neck, chest, face and even my left hand ring finger tip. It's pain that is in spots, it feels; pains in chest; catching my breath; very cold and clammy; This is a spontaneous report from a contactable consumer (the patient).   A 45-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EW0169), via an unspecified route of administration, on 14Apr2021 at 11:30 (at the age of 45-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included cardiac disorder from an unknown date and unknown if ongoing,  irregular heart beat  and depression from an unknown date and unknown if ongoing. Concomitant medication included metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported. The patient did not have any other vaccines within four weeks prior to the vaccination.  The patient stated that  when he first got the shot he actually nearly fainted twice and had to lay on the floor for a while. It was very scary, he thought he was going to die.  He got very cold and clammy and had pains in chest and had a hard time catching his breath. They checked his vital signs a couple times and said they looked good. But he still felt sick and they said if he did not  feel better soon they may have to call for an ambulance for him. Eventually he felt better enough to where he was able to get up off the floor and on handicap cart to drive out of there. Also, he's been having weird pains in several spots inside his muscles all over the place in his legs, feet, arms, neck, chest, face and even his left hand ring finger tip. It's pain that is in spots, it feels like mini-charley-horses that lasts anywhere from 20 something to 30 something seconds. Now it's mostly continuous pains in his thigh muscles between his legs. And a pain in one spot in his left arm bicep. This has been happening for days."  The patient experienced "nearly fainted twice"  on 15Apr2021 with outcome of not recovered, chest pain, got very cold and clammy and had a hard time catching his breath on 15Apr2021 with outcome of not recovered. He also reported that he has been having weird pains in several spots inside his muscles all over the place in his legs, feet, arms, neck, chest, face and even his  left hand ring finger tip. it's pain that is in spots, it feels starting on 15Apr2021 with outcome of not recovered.  The patient underwent lab tests and procedures which included unspecified investigation: myalgias  on an unspecified date . Therapeutic measures (unspecified) were taken as a result of the events.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Blood pressure measurement, Dizziness, Headache, Hypotension
Clinical narrative: acute heart pain; low blood pressure (80/50); fever; dizziness; nausea; strong headache; This is a spontaneous report from a contactable consumer (the patient). This 40-year-old (non-pregnant) female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 02Apr2021 at 09:00 (at the age of 40-year-old) as single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19 and had tested negative for COVID-19 with the Nasal Swab Real-time PCR tests on 17Oct2020 and again on 02Feb2021. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did have an allergy to eggs and having no other medical history. The patient stated that she is completely healthy. The patient's concomitant medications were not reported. The patient did not receive any medications within 2 weeks of vaccination. On 02Apr2021 at 10:00 AM, the patient experienced strong headache, dizziness, nausea, low blood pressure (80/50), acute heart pain and fever. No treatment was received for the adverse events. The patient had a low blood pressure measured 80/50 mmHg on 02Apr2021. The clinical outcomes of the strong headache, dizziness, nausea, low blood pressure (80/50), acute heart pain and fever were resolved in Apr2021.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: acute heart pain; low blood pressure (80/50); fever; dizziness; nausea; strong headache; This is a spontaneous report from a contactable consumer (the patient). This 40-year-old (non-pregnant) female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 02Apr2021 at 09:00 (at the age of 40-year-old) as single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19 and had tested negative for COVID-19 with the Nasal Swab Real-time PCR tests on 17Oct2020 and again on 02Feb2021. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did have an allergy to eggs and having no other medical history. The patient stated that she is completely healthy. The patient's concomitant medications were not reported. The patient did not receive any medications within 2 weeks of vaccination. On 02Apr2021 at 10:00 AM, the patient experienced strong headache, dizziness, nausea, low blood pressure (80/50), acute heart pain and fever. No treatment was received for the adverse events. The patient had a low blood pressure measured 80/50 mmHg on 02Apr2021. The clinical outcomes of the strong headache, dizziness, nausea, low blood pressure (80/50), acute heart pain and fever were resolved in Apr2021.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dyspnoea, Heart rate, Heart rate increased, Hypertension
Clinical narrative: high heart rate; high blood pressure; shortness of breath; bilateral pulmonary emboli; This is a spontaneous report from the patient. This 49-year-old non-pregnant female patient reported that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL9269) via an unspecified route of administration in the right arm on 04Feb2021 at 08:30 (at the age of 48-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient's known allergies included morphine, hydromorphone (DILAUDID), sulfas, and coconut. The patient did not have COVID prior to vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL9269) via unspecified route in the right arm on 14Jan2021 as a single dose for COVID-19 immunization. Concomitant medications were not reported. On 19Apr2021, the patient was having high heart rate, high blood pressure and shortness of breath. She was hospitalized and diagnosed with bilateral pulmonary emboli. The events resulted in emergency room/department or urgent care and hospitalization for 3 days. The patient stated that she doubts this was vaccine related but wanted to report it. The patient was treated with intravenous heparin, then oral rivaroxaban (XARELTO). The clinical outcome of the events high heart rate, high blood pressure and shortness of breath, and bilateral pulmonary emboli was recovering. The patient was tested for COVID post vaccination via nasal swab on 19Apr2021 with result of negative.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be totally excluded.  The case will be reassessed if additional information becomes 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 Investigators, as appropriate.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, SARS-CoV-2 test
Clinical narrative: high heart rate; high blood pressure; shortness of breath; bilateral pulmonary emboli; This is a spontaneous report from the patient. This 49-year-old non-pregnant female patient reported that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL9269) via an unspecified route of administration in the right arm on 04Feb2021 at 08:30 (at the age of 48-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient's known allergies included morphine, hydromorphone (DILAUDID), sulfas, and coconut. The patient did not have COVID prior to vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL9269) via unspecified route in the right arm on 14Jan2021 as a single dose for COVID-19 immunization. Concomitant medications were not reported. On 19Apr2021, the patient was having high heart rate, high blood pressure and shortness of breath. She was hospitalized and diagnosed with bilateral pulmonary emboli. The events resulted in emergency room/department or urgent care and hospitalization for 3 days. The patient stated that she doubts this was vaccine related but wanted to report it. The patient was treated with intravenous heparin, then oral rivaroxaban (XARELTO). The clinical outcome of the events high heart rate, high blood pressure and shortness of breath, and bilateral pulmonary emboli was recovering. The patient was tested for COVID post vaccination via nasal swab on 19Apr2021 with result of negative.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information, a possible contributory role of the suspect product BNT162B2 to the development of reported events cannot be totally excluded.  The case will be reassessed if additional information becomes 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 Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Heart rate, Heart rate irregular, Myocardial infarction, Tinnitus
Clinical narrative: stroke; heart attack; ringing in her ears; irregular heartbeat; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 22Apr2021 09:00 (Batch/Lot Number: EW0172) as a single dose for COVID-19 immunisation. Medical history included asthma and autoimmune diseases. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) taken for an unspecified indication, start and stop date were not reported. The patient previously took codeine and experienced allergy to codeine. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior vaccination and the patient did not test for COVID post vaccination. The patient received the vaccine on 22Apr2021 at 09:00 and by 20:00 on 22Apr2021, the patient was already having symptoms the one that scared her was the ringing in her ears which lasted a good hour. She was afraid that it was going to be permanent and then she shattered having irregular heartbeat and she didn't know if she was going to have a heart attack or stroke as it was beating very slow. The patient did not receive treatment for the events. The patient underwent lab tests and procedures which included heart beat: irregular on 22Apr2021 20:00. The outcome of event, ringing in her ears, was recovered on an unspecified date and the outcome of events, irregular heartbeat, heart attack and stroke, was unknown.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Bell's palsy
Clinical narrative: Bells palsy; miscarriage; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 08Apr2021 at 17:00 (Lot Number: ER8729) (at the age of 30-year-old) as single dose for COVID-19 immunisation. The patient was pregnant at time of vaccination, last menstrual date was 20Feb2021, due date was 27Nov2021, the patient was 6 weeks pregnant at the onset of the events. The patient did not test positive to COVID-19, pre or post vaccination. Medical history was none. No known allergies. There were no concomitant medications.  On 15Apr2021 at 07:00, the patient experienced Bell's palsy and miscarriage.  the events required emergency room visit and physician office visit, the patient was hospitalized for one day due to the events.  Therapeutic measures were taken as a result of the events and included ultrasound. The patient outcome of the events  not recovered.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Pain in extremity
Clinical narrative: right foot is in a lot of pain feels like its broken, barely can walk; right foot is in a lot of pain feels like its broken, barely can walk; This is a spontaneous report from a contactable consumer (the patient). This 62-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in in the right arm in Mar2021 (at the age of 62-year-old) as single dose for COVID-19 immunization. The patient did not have any allergies to medications, food, or other products. The patient's medical history and concomitant medications were not reported. The patient previously had blisters on the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP 7533) via an unspecified route of administration in in the right arm in Mar2021 at 14:30 (at the age of 62-year-old) as single dose for COVID-19 immunization. Prior to the 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 receive any other vaccines within four weeks prior to the vaccination. On 24Apr2021 03:00 AM the patient experienced her right foot is in a lot of pain feels like its broken, barely can walk. She considered these events resulted in disability. No treatment was received for the adverse events. The clinical outcomes of the "right foot is in a lot of pain feels like its broken, barely can walk" were resolving as of 24Apr2021.   The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Tardive dyskinesia
Clinical narrative: Mild tar dive dyskinesia for 24 hours; This is a spontaneous report from a contactable consumer (reported for herself). A 65-years-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: Pfizer EM 6199) administered at left arm via an unknown route of administration on 03Mar2021 13:30 as single dose for COVID-19 immunization. Medical history included Major unipolar depression. The patient was previously administered first dose of the vaccine (lot number: Pfizer EM 9809) on 10Feb2021 13:00, administered on left arm as single dose and experienced no adverse event. Concomitant medications included phenelzine sulfate (NARDIL) within 2 weeks of vaccination (15mg) 4 times daily and other vaccines on 03Mar2021. On 03Mar2021 at 15:00pm, the patient experienced mild tar dive dyskinesia for 24 hours. The outcome of the event was recovered with sequelae. Device date reported as 25Apr2021. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient has not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Additional Information has been requested.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Energy increased, Haemorrhage, Menstruation irregular, Pain in extremity
Clinical narrative: Currently 4 days of bleeding; increased energy; sore left arm; overly emotional cry ie for a couple/few days; menstruating when I had my period only 14 days before; This is a spontaneous report from contactable consumer, patient. A 43-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration, in the left arm on 09Apr2021 at 11:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis from an unknown date and unknown if ongoing, and thyroid issues. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant drugs included ofatumumab (KESIMPTA) from 30Mar2020. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously took ocrelizumab and experienced hypersensitivity.  On  21Apr2021 at 12:00, the patient experienced currently 4 days of bleeding, increased energy, sore left arm, overly emotional cry ie for a couple/few days, menstruating when I had my period only 14 days before.  The outcome of the events, currently 4 days of bleeding, increased energy, sore left arm, overly emotional cry ie for a couple/few days, menstruating when I had my period only 14 days before was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Menstruation delayed, Nausea
Clinical narrative: dizziness; headache; pain; fatigue; nausea; vomiting; Menstruation delayed; Urinate every 5 to 10 min; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 20Apr2021 at 14:45, at single dose, for COVID-19 immunisation. Medical history was none. Patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. The patient previously took hydrocodone (unknown manufacturer) and the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced dizziness (hospitalization for 1 day) in 2021 with outcome of recovering, headache (hospitalization for 1 day) in 2021 with outcome of recovering, pain (hospitalization for 1 day) in 2021 with outcome of recovering, fatigue (hospitalization for 1 day) in 2021 with outcome of recovering, nausea (hospitalization for 1 day) in 2021 with outcome of recovering, vomiting (hospitalization for 1 day) in 2021 with outcome of recovering, menstruation delayed (hospitalization for 1 day) in 2021 with outcome of recovering, urinate every 5 to 10 min (hospitalization for 1 day) in 2021 with outcome of recovering. The patient has not been tested for COVID-19 since vaccination.    The information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pollakiuria, Vomiting
Clinical narrative: dizziness; headache; pain; fatigue; nausea; vomiting; Menstruation delayed; Urinate every 5 to 10 min; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 20Apr2021 at 14:45, at single dose, for COVID-19 immunisation. Medical history was none. Patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. The patient previously took hydrocodone (unknown manufacturer) and the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced dizziness (hospitalization for 1 day) in 2021 with outcome of recovering, headache (hospitalization for 1 day) in 2021 with outcome of recovering, pain (hospitalization for 1 day) in 2021 with outcome of recovering, fatigue (hospitalization for 1 day) in 2021 with outcome of recovering, nausea (hospitalization for 1 day) in 2021 with outcome of recovering, vomiting (hospitalization for 1 day) in 2021 with outcome of recovering, menstruation delayed (hospitalization for 1 day) in 2021 with outcome of recovering, urinate every 5 to 10 min (hospitalization for 1 day) in 2021 with outcome of recovering. The patient has not been tested for COVID-19 since vaccination.    The information on the lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Fibrin D dimer, Fibrin D dimer increased
Clinical narrative: Episodes of shortness of breadth/ difficulty breathing; Chest Pain; Elevated d-dimer values; This is a spontaneous report from a contactable consumer (patient). This 38-year-old, nonpregnant, female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 at a hospital facility, via an unspecified route of administration, administered in left arm on 13Apr2021 09:30 AM (age at the time of vaccination: 38 years; Batch/Lot Number: EW0151) as single dose for COVID-19 immunization. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination patient had not been tested for COVID-19. Patient had no known allergies and no medical history. The patient's concomitant medications were not reported. The patient experienced episodes of shortness of breath, chest pain, elevated D-dimer values, difficulty breathing, multiple ER visits starting "23Mar2021" at 09:45 AM. The adverse events did result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient reported her events were not serious, did not have hospitalization, and were not disabling/incapacitating. No treatment was given for the events. Patient was not recovered from shortness of breath, chest pain, elevated D-dimer values, and difficulty breathing.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Burning sensation, Hypoaesthesia, Hypotension
Clinical narrative: I fainted( the day after 1st dose); When I regained conscious I started to feel numbness and tingling in both arms and hands and few minutes later on both legs and feet.; My blood pressure was 89; When I regained conscious I started to feel numbness and tingling in both arms and hands and few minutes later on both legs and feet.; pain in joint; I have been feeling burn; This is a spontaneous report from a contactable consumer. A 52-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EN6204) via an unspecified route of administration, administered on left arm on 19Mar2021 08:45 (Batch/Lot Number: EN6204) and second dose via an unspecified route of administration, administered on left arm on 09Apr2021 09:15 (Lot Number: EP7533) as single dose, for covid-19 immunization. The patient Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.The patient concomitant medications were not reported. On 20Mar2021 02:00 PM, the patient fainted after the 1st dose. Her blood pressure was 89. When she regained conscious, she started to feel numbness and tingling in both arms and hands and few minutes later on both legs and feet. Since then, she had been feeling burn and tingling in her hands and feet. Some pain in her joint. The paramedic asked her to walk and then It went away on that moment. The patient underwent lab tests and procedures which included blood pressure measurement was 89. The patient did not receive any treatment for the events. The outcome of the events was reported was recovered /Recovered with lasting effects.   Information about Lot/Batch number is obtained. Additional information has been requested
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Syncope
Clinical narrative: I fainted( the day after 1st dose); When I regained conscious I started to feel numbness and tingling in both arms and hands and few minutes later on both legs and feet.; My blood pressure was 89; When I regained conscious I started to feel numbness and tingling in both arms and hands and few minutes later on both legs and feet.; pain in joint; I have been feeling burn; This is a spontaneous report from a contactable consumer. A 52-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EN6204) via an unspecified route of administration, administered on left arm on 19Mar2021 08:45 (Batch/Lot Number: EN6204) and second dose via an unspecified route of administration, administered on left arm on 09Apr2021 09:15 (Lot Number: EP7533) as single dose, for covid-19 immunization. The patient Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.The patient concomitant medications were not reported. On 20Mar2021 02:00 PM, the patient fainted after the 1st dose. Her blood pressure was 89. When she regained conscious, she started to feel numbness and tingling in both arms and hands and few minutes later on both legs and feet. Since then, she had been feeling burn and tingling in her hands and feet. Some pain in her joint. The paramedic asked her to walk and then It went away on that moment. The patient underwent lab tests and procedures which included blood pressure measurement was 89. The patient did not receive any treatment for the events. The outcome of the events was reported was recovered /Recovered with lasting effects.   Information about Lot/Batch number is obtained. Additional information has been requested
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Oxygen saturation decreased, Syncope
Clinical narrative: Fainted; low pulse oxygen level; Fainted; low pulse oxygen level; This is a spontaneous report from a contactable consumer. A 54-year-old, nonpregnant, female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 at a health clinic facility, via an unspecified route of administration, administered in left arm on 25Apr2021 11:45 AM (age at vaccination: 54 years; Batch/Lot Number: ER8736) as single dose for COVID-19 immunization. Medical history was reported as none and patient had no known allergies. The patient's concomitant medications were not reported. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination patient had not been tested for COVID-19. The patient experienced fainted; low pulse oxygen level on 25Apr2021 11:45 am. No treatment was given. Patient recovered on an unspecified date from fainted; low pulse oxygen level.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicectomy, Appendicitis, SARS-CoV-2 test
Clinical narrative: Appendicitis; This is a spontaneous report from a contactable consumer (Patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), via an unspecified route of administration, administered in left arm on 20Apr2021 at 16:15 (at the age of 53-years) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No known allergies reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Apr2021 administered in left arm. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any medications within two weeks of vaccination. On 20Apr2021 at 16:45 (30-minutes after vaccination), patient experienced appendicitis. The patient was hospitalized for appendicitis on an unspecified date in Apr2021. Therapeutic measures taken as result of appendicitis included appendectomy. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Nasal swab): Negative on 20Apr2021 and appendectomy on an unspecified date. The outcome of event appendicitis was recovering.   Information on the lot/batch number has been requested.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Inappropriate schedule of product administration, Off label use, Product administered at inappropriate site
Clinical narrative: Respiratory distress on exertion; Chills; Joint pain; first dose of BNT162B2 administered in left leg; first dose and second dose received on same day (08Mar2021); first dose and second dose received on same day (08Mar2021); This is a spontaneous report received from a contactable Other Health Professional (patient). A 69-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6204) via an unspecified route of administration in the left leg and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: 8732) via an unspecified route of administration in the right arm on 08Mar2021 (at the age of 69-year-old) at 11:00 as a single dose for Covid-19 immunization in hospital. The patient had no allergies and medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included an unspecified blood pressure medication (within 2 weeks of vaccination). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021, the patient experienced respiratory distress on exertion, chills and Joint pain. Patient did not receive any treatment for the events. The outcome of the events was recovering.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine 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 Committees, and Investigators, as appropriate.