chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Dysphagia, Feeling abnormal
Clinical narrative: Left arm was only sore for 36 hours; Within 1 minute throat got ice cold; Difficult to swallow; Fuzzy feeling over entire body; Numb face; Tingly feeling; Heavy arms and legs; Light headed, felt very woozy; Blood Pressure went up to 170/120; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Lot number: EN6205), via an unspecified route of administration in the left arm on 05Mar2021 at 11:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple (20 to 30) bilateral knee surgeries and total right knee joint replacement on 02May2020. Concomitant medications included oxycodone 5mg (MANUFACTURER UNKNOWN) as needed, aspirin 88mg/day (MANUFACTURER UNKNOWN) for unspecified indication. 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 4 weeks prior to the COVID-19 vaccination. On 05Mar2021 (within 1 minute of vaccination), the patients throat got ice cold and more difficult to swallow, fuzzy feeling over entire body, numb face, tingly feeling, heavy arms and legs. Light headed, felt very woozy. It felt exactly like patient had been administered general anaesthesia right before surgery. The patient blood pressure (BP) went up to 170/120 (unspecified unit). As symptoms started getting better after 1 hour, BP went down to 140/70. On an unknown date, the left arm was only sore for 36 hours. It was reported that, emergency medical technician (EMT) did multiple blood pressure checks and electrocardiogram (EKG) at the vaccine site. The patient did not received treatment for adverse events. The clinical outcome of events throat discomforts, swallowing difficult, fuzzy, numbness in face, tingling, heavy feeling in arms and legs, light headed and blood pressure increased was recovered on 05Mar2021 (symptoms were gone after 3 to 4 hours from onset of reaction) and the event pain in arm was recovered on an unknown date (left arm was sore for 36 hours).   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Limb discomfort, Oropharyngeal discomfort, Pain in extremity, Paraesthesia
Clinical narrative: Left arm was only sore for 36 hours; Within 1 minute throat got ice cold; Difficult to swallow; Fuzzy feeling over entire body; Numb face; Tingly feeling; Heavy arms and legs; Light headed, felt very woozy; Blood Pressure went up to 170/120; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Lot number: EN6205), via an unspecified route of administration in the left arm on 05Mar2021 at 11:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included multiple (20 to 30) bilateral knee surgeries and total right knee joint replacement on 02May2020. Concomitant medications included oxycodone 5mg (MANUFACTURER UNKNOWN) as needed, aspirin 88mg/day (MANUFACTURER UNKNOWN) for unspecified indication. 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 4 weeks prior to the COVID-19 vaccination. On 05Mar2021 (within 1 minute of vaccination), the patients throat got ice cold and more difficult to swallow, fuzzy feeling over entire body, numb face, tingly feeling, heavy arms and legs. Light headed, felt very woozy. It felt exactly like patient had been administered general anaesthesia right before surgery. The patient blood pressure (BP) went up to 170/120 (unspecified unit). As symptoms started getting better after 1 hour, BP went down to 140/70. On an unknown date, the left arm was only sore for 36 hours. It was reported that, emergency medical technician (EMT) did multiple blood pressure checks and electrocardiogram (EKG) at the vaccine site. The patient did not received treatment for adverse events. The clinical outcome of events throat discomforts, swallowing difficult, fuzzy, numbness in face, tingling, heavy feeling in arms and legs, light headed and blood pressure increased was recovered on 05Mar2021 (symptoms were gone after 3 to 4 hours from onset of reaction) and the event pain in arm was recovered on an unknown date (left arm was sore for 36 hours).   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Injection site pain
Clinical narrative: nausea added to all the symptoms above; Dizziness; chills; fever; severe ringing in ears; Burning under skin above both elbows throughoutback shoulders and down back torsobut not along spinal bones; overall weakness and tiredness throughout body/unable to get out of bed; overall weakness and tiredness throughout body; Slight headache begins; feeling unwell; pain in left and moving up arm from injection site, across backshoulders, and down right are above elbow; shaky; This is a spontaneous report from a contactable consumer (patient). A 59-years-old non-pregnant female patient received second dose of BNT162B2 (Pfizer BioNTech COVID-19 vaccine, solution for injection, Batch/Lot Number: EL3246), an unspecified route of administration, administered in arm left on 04Mar2021 (at the age of 59-year-old) as a single dose for covid-19 immunisation at CDR. The patient medical history was reported as none. The patient concomitant medications were not reported. The patient previously took compazine [prochlorperazine maleate] and Zoloft and experienced drug allergies. The patient received first dose of BNT162B2 (Pfizer BioNTech COVID-19 vaccine, solution for injection, Batch/Lot Number: EL3246) via unspecified route of administration in right arm on 11Feb2021at 02:00 PM as a single dose for covid-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other vaccine in four week and not received any other medications in two weeks. On 04Mar2021 at 6:00 PM, patient experienced pain in left and moving up arm from injection site, across back shoulders, and down right are above elbow. 05Mar2021 at 10:00 AM, patient experienced burning under skin above both elbows throughout back shoulders and down back torso but not along spinal bones, overall weakness and tiredness throughout body, slight headache begins and feeling unwell. On 06Mar2021 at 8:00 AM, patient had dizziness and weakness, tiredness, severe/excruciating headache, muscle pain, chills, fever, feeling unwell, severe ringing in ears, unable to get out of bed. 06Mar2021 at 5:00 PM, nausea added to all symptoms above last 2 hours. 07Mar2021 at 8:00 AM, patient was able to get out of bed. On an unspecified date in Mar2021, patient was shaky. No relief from Advil pain reliever. Headache was manageable, dizziness persists, weakness/minimal energy, shaky, burning under skin remained. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Nausea, Skin burning sensation, Tinnitus, Tremor
Clinical narrative: nausea added to all the symptoms above; Dizziness; chills; fever; severe ringing in ears; Burning under skin above both elbows throughoutback shoulders and down back torsobut not along spinal bones; overall weakness and tiredness throughout body/unable to get out of bed; overall weakness and tiredness throughout body; Slight headache begins; feeling unwell; pain in left and moving up arm from injection site, across backshoulders, and down right are above elbow; shaky; This is a spontaneous report from a contactable consumer (patient). A 59-years-old non-pregnant female patient received second dose of BNT162B2 (Pfizer BioNTech COVID-19 vaccine, solution for injection, Batch/Lot Number: EL3246), an unspecified route of administration, administered in arm left on 04Mar2021 (at the age of 59-year-old) as a single dose for covid-19 immunisation at CDR. The patient medical history was reported as none. The patient concomitant medications were not reported. The patient previously took compazine [prochlorperazine maleate] and Zoloft and experienced drug allergies. The patient received first dose of BNT162B2 (Pfizer BioNTech COVID-19 vaccine, solution for injection, Batch/Lot Number: EL3246) via unspecified route of administration in right arm on 11Feb2021at 02:00 PM as a single dose for covid-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other vaccine in four week and not received any other medications in two weeks. On 04Mar2021 at 6:00 PM, patient experienced pain in left and moving up arm from injection site, across back shoulders, and down right are above elbow. 05Mar2021 at 10:00 AM, patient experienced burning under skin above both elbows throughout back shoulders and down back torso but not along spinal bones, overall weakness and tiredness throughout body, slight headache begins and feeling unwell. On 06Mar2021 at 8:00 AM, patient had dizziness and weakness, tiredness, severe/excruciating headache, muscle pain, chills, fever, feeling unwell, severe ringing in ears, unable to get out of bed. 06Mar2021 at 5:00 PM, nausea added to all symptoms above last 2 hours. 07Mar2021 at 8:00 AM, patient was able to get out of bed. On an unspecified date in Mar2021, patient was shaky. No relief from Advil pain reliever. Headache was manageable, dizziness persists, weakness/minimal energy, shaky, burning under skin remained. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: nausea added to all the symptoms above; Dizziness; chills; fever; severe ringing in ears; Burning under skin above both elbows throughoutback shoulders and down back torsobut not along spinal bones; overall weakness and tiredness throughout body/unable to get out of bed; overall weakness and tiredness throughout body; Slight headache begins; feeling unwell; pain in left and moving up arm from injection site, across backshoulders, and down right are above elbow; shaky; This is a spontaneous report from a contactable consumer (patient). A 59-years-old non-pregnant female patient received second dose of BNT162B2 (Pfizer BioNTech COVID-19 vaccine, solution for injection, Batch/Lot Number: EL3246), an unspecified route of administration, administered in arm left on 04Mar2021 (at the age of 59-year-old) as a single dose for covid-19 immunisation at CDR. The patient medical history was reported as none. The patient concomitant medications were not reported. The patient previously took compazine [prochlorperazine maleate] and Zoloft and experienced drug allergies. The patient received first dose of BNT162B2 (Pfizer BioNTech COVID-19 vaccine, solution for injection, Batch/Lot Number: EL3246) via unspecified route of administration in right arm on 11Feb2021at 02:00 PM as a single dose for covid-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other vaccine in four week and not received any other medications in two weeks. On 04Mar2021 at 6:00 PM, patient experienced pain in left and moving up arm from injection site, across back shoulders, and down right are above elbow. 05Mar2021 at 10:00 AM, patient experienced burning under skin above both elbows throughout back shoulders and down back torso but not along spinal bones, overall weakness and tiredness throughout body, slight headache begins and feeling unwell. On 06Mar2021 at 8:00 AM, patient had dizziness and weakness, tiredness, severe/excruciating headache, muscle pain, chills, fever, feeling unwell, severe ringing in ears, unable to get out of bed. 06Mar2021 at 5:00 PM, nausea added to all symptoms above last 2 hours. 07Mar2021 at 8:00 AM, patient was able to get out of bed. On an unspecified date in Mar2021, patient was shaky. No relief from Advil pain reliever. Headache was manageable, dizziness persists, weakness/minimal energy, shaky, burning under skin remained. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Nausea, Pain in extremity, Pyrexia, Skin burning sensation
Clinical narrative: nausea added to all the symptoms above; Dizziness; chills; fever; severe ringing in ears; Burning under skin above both elbows throughoutback shoulders and down back torsobut not along spinal bones; overall weakness and tiredness throughout body/unable to get out of bed; overall weakness and tiredness throughout body; Slight headache begins; feeling unwell; pain in left and moving up arm from injection site, across backshoulders, and down right are above elbow; shaky; This is a spontaneous report from a contactable consumer (patient). A 59-years-old non-pregnant female patient received second dose of BNT162B2 (Pfizer BioNTech COVID-19 vaccine, solution for injection, Batch/Lot Number: EL3246), an unspecified route of administration, administered in arm left on 04Mar2021 (at the age of 59-year-old) as a single dose for covid-19 immunisation at CDR. The patient medical history was reported as none. The patient concomitant medications were not reported. The patient previously took compazine [prochlorperazine maleate] and Zoloft and experienced drug allergies. The patient received first dose of BNT162B2 (Pfizer BioNTech COVID-19 vaccine, solution for injection, Batch/Lot Number: EL3246) via unspecified route of administration in right arm on 11Feb2021at 02:00 PM as a single dose for covid-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other vaccine in four week and not received any other medications in two weeks. On 04Mar2021 at 6:00 PM, patient experienced pain in left and moving up arm from injection site, across back shoulders, and down right are above elbow. 05Mar2021 at 10:00 AM, patient experienced burning under skin above both elbows throughout back shoulders and down back torso but not along spinal bones, overall weakness and tiredness throughout body, slight headache begins and feeling unwell. On 06Mar2021 at 8:00 AM, patient had dizziness and weakness, tiredness, severe/excruciating headache, muscle pain, chills, fever, feeling unwell, severe ringing in ears, unable to get out of bed. 06Mar2021 at 5:00 PM, nausea added to all symptoms above last 2 hours. 07Mar2021 at 8:00 AM, patient was able to get out of bed. On an unspecified date in Mar2021, patient was shaky. No relief from Advil pain reliever. Headache was manageable, dizziness persists, weakness/minimal energy, shaky, burning under skin remained. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus, Tremor
Clinical narrative: nausea added to all the symptoms above; Dizziness; chills; fever; severe ringing in ears; Burning under skin above both elbows throughoutback shoulders and down back torsobut not along spinal bones; overall weakness and tiredness throughout body/unable to get out of bed; overall weakness and tiredness throughout body; Slight headache begins; feeling unwell; pain in left and moving up arm from injection site, across backshoulders, and down right are above elbow; shaky; This is a spontaneous report from a contactable consumer (patient). A 59-years-old non-pregnant female patient received second dose of BNT162B2 (Pfizer BioNTech COVID-19 vaccine, solution for injection, Batch/Lot Number: EL3246), an unspecified route of administration, administered in arm left on 04Mar2021 (at the age of 59-year-old) as a single dose for covid-19 immunisation at CDR. The patient medical history was reported as none. The patient concomitant medications were not reported. The patient previously took compazine [prochlorperazine maleate] and Zoloft and experienced drug allergies. The patient received first dose of BNT162B2 (Pfizer BioNTech COVID-19 vaccine, solution for injection, Batch/Lot Number: EL3246) via unspecified route of administration in right arm on 11Feb2021at 02:00 PM as a single dose for covid-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive any other vaccine in four week and not received any other medications in two weeks. On 04Mar2021 at 6:00 PM, patient experienced pain in left and moving up arm from injection site, across back shoulders, and down right are above elbow. 05Mar2021 at 10:00 AM, patient experienced burning under skin above both elbows throughout back shoulders and down back torso but not along spinal bones, overall weakness and tiredness throughout body, slight headache begins and feeling unwell. On 06Mar2021 at 8:00 AM, patient had dizziness and weakness, tiredness, severe/excruciating headache, muscle pain, chills, fever, feeling unwell, severe ringing in ears, unable to get out of bed. 06Mar2021 at 5:00 PM, nausea added to all symptoms above last 2 hours. 07Mar2021 at 8:00 AM, patient was able to get out of bed. On an unspecified date in Mar2021, patient was shaky. No relief from Advil pain reliever. Headache was manageable, dizziness persists, weakness/minimal energy, shaky, burning under skin remained. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache
Clinical narrative: Fatigue; Chills; Headaches; Joint pain in shoulders; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6202), via an unspecified route of administration, administered in left arm on 02Mar2021 (at the age of 50-year-old) as unknown, single dose for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history included known allergies: shellfish. The concomitant medications for patient included men's multi vitamins (unspecified). The patient did not receive any other vaccine in 4 weeks. The patient did not have COVID prior to vaccination. On 02Mar2021, the patient experienced fatigue, chills, headaches, and joint pain in shoulders. No treatment was received for the events. The patient was tested with nasal swab (rapid test) for COVID, post vaccination, the test result was negative on 02Mar2021. The outcome of the events was reported as not resolved.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, SARS-CoV-2 test
Clinical narrative: Fatigue; Chills; Headaches; Joint pain in shoulders; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6202), via an unspecified route of administration, administered in left arm on 02Mar2021 (at the age of 50-year-old) as unknown, single dose for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history included known allergies: shellfish. The concomitant medications for patient included men's multi vitamins (unspecified). The patient did not receive any other vaccine in 4 weeks. The patient did not have COVID prior to vaccination. On 02Mar2021, the patient experienced fatigue, chills, headaches, and joint pain in shoulders. No treatment was received for the events. The patient was tested with nasal swab (rapid test) for COVID, post vaccination, the test result was negative on 02Mar2021. The outcome of the events was reported as not resolved.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal discomfort, Fatigue, Headache, Pain in extremity
Clinical narrative: Upset stomach; Sore arm; Headache; Tired; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 16Mar2021 at 11:15 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the left arm on 23Feb2021 at 11.45 as a single dose for COVID-19 immunisation. Concomitant medication included Celebrex for an unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. The patient was not diagnosed with covid-19 prior to vaccination. Since the vaccination, patient had not tested positive for COVID-19. On 16Mar2021 at 19.00, patient experienced sore arm, headache, tired, upset stomach. Clinical outcome of the events sore arm, headache, tired, upset stomach was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Pharyngeal swelling
Clinical narrative: WITHIN 5 MINUTES FELT THROAT SLIGHTLY SWELL.; FELT BODY CHILLS FIRST; This is a spontaneous report received from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 17Mar2021 at 13:00 (At the age of 28-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included ACID REDUCER PLUS ANTACID chewable tablet initiated on an unknown date for an unknown indication. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to vaccination patient had not tested positive for COVID-19. Since the vaccination, patient has not tested positive for COVID-19. On 17March2021 at 13:15, patient felt body chills first and within 5 minutes felt throat slightly swell, patient felt her throat less swollen 10 minutes later but still felt it a "tad bit" for the following two and a half hour. Therapeutic measures were reported as unknown. The clinical outcome of the events chills and throat swelling were recovered in Mar2021 with sequelae.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood creatine phosphokinase, C-reactive protein, Computerised tomogram head, Electrocardiogram, Full blood count
Clinical narrative: Severe joint and muscle pain and weakness throughout the body, especially in the right leg and right knee.; Severe joint and muscle pain and weakness throughout the body, especially in the right leg and right knee.; Weakness throughout the body, especially in the right leg and right knee. Unable to lift right foot from floor; Unable to sit and stand back up; Unable to sit and stand back up; Severe pain in the neck starting at the base of the skull and lower back; Weakness throughout the body, especially in the right leg and right knee. Unable to lift right foot from floor; dose number=1/administration date=03Feb2021,dose number=2,administration date=17Feb2021; dose number=1/administration date=03Feb2021,dose number=2,administration date=17Feb2021; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9267), via an unspecified route of administration in left arm on 17Feb2021 at 04:00 PM as 2nd dose, single for COVID-19 immunization. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN5318), via an unspecified route of administration in left arm on 03Feb2021 at 04:00 PM as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had no known allergies. Patient did not receive any other vaccine in four weeks. Patient did not receive any other medications in two weeks. Patient was not pregnant. On 20Feb2021 at 03:00 AM, patient experienced severe joint and muscle pain and weakness throughout the body, especially in the right leg and right knee. Unable to lift right foot from floor. Unable to sit and stand back up. Severe pain in the neck starting at the base of the skull and lower back. Symptoms have been persistent for close to 3 weeks. No treatment was received. The outcome of the events off label use and inappropriate schedule of vaccine administered was unknown and outcome of the other events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Muscular weakness, Pain in extremity, Troponin, Urine analysis
Clinical narrative: Severe joint and muscle pain and weakness throughout the body, especially in the right leg and right knee.; Severe joint and muscle pain and weakness throughout the body, especially in the right leg and right knee.; Weakness throughout the body, especially in the right leg and right knee. Unable to lift right foot from floor; Unable to sit and stand back up; Unable to sit and stand back up; Severe pain in the neck starting at the base of the skull and lower back; Weakness throughout the body, especially in the right leg and right knee. Unable to lift right foot from floor; dose number=1/administration date=03Feb2021,dose number=2,administration date=17Feb2021; dose number=1/administration date=03Feb2021,dose number=2,administration date=17Feb2021; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9267), via an unspecified route of administration in left arm on 17Feb2021 at 04:00 PM as 2nd dose, single for COVID-19 immunization. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN5318), via an unspecified route of administration in left arm on 03Feb2021 at 04:00 PM as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had no known allergies. Patient did not receive any other vaccine in four weeks. Patient did not receive any other medications in two weeks. Patient was not pregnant. On 20Feb2021 at 03:00 AM, patient experienced severe joint and muscle pain and weakness throughout the body, especially in the right leg and right knee. Unable to lift right foot from floor. Unable to sit and stand back up. Severe pain in the neck starting at the base of the skull and lower back. Symptoms have been persistent for close to 3 weeks. No treatment was received. The outcome of the events off label use and inappropriate schedule of vaccine administered was unknown and outcome of the other events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Dysstasia, Inappropriate schedule of product administration, Movement disorder, Muscular weakness
Clinical narrative: Severe joint and muscle pain and weakness throughout the body, especially in the right leg and right knee.; Severe joint and muscle pain and weakness throughout the body, especially in the right leg and right knee.; Weakness throughout the body, especially in the right leg and right knee. Unable to lift right foot from floor; Unable to sit and stand back up; Unable to sit and stand back up; Severe pain in the neck starting at the base of the skull and lower back; Weakness throughout the body, especially in the right leg and right knee. Unable to lift right foot from floor; dose number=1/administration date=03Feb2021,dose number=2,administration date=17Feb2021; dose number=1/administration date=03Feb2021,dose number=2,administration date=17Feb2021; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9267), via an unspecified route of administration in left arm on 17Feb2021 at 04:00 PM as 2nd dose, single for COVID-19 immunization. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN5318), via an unspecified route of administration in left arm on 03Feb2021 at 04:00 PM as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had no known allergies. Patient did not receive any other vaccine in four weeks. Patient did not receive any other medications in two weeks. Patient was not pregnant. On 20Feb2021 at 03:00 AM, patient experienced severe joint and muscle pain and weakness throughout the body, especially in the right leg and right knee. Unable to lift right foot from floor. Unable to sit and stand back up. Severe pain in the neck starting at the base of the skull and lower back. Symptoms have been persistent for close to 3 weeks. No treatment was received. The outcome of the events off label use and inappropriate schedule of vaccine administered was unknown and outcome of the other events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Neck pain, Off label use, Sitting disability
Clinical narrative: Severe joint and muscle pain and weakness throughout the body, especially in the right leg and right knee.; Severe joint and muscle pain and weakness throughout the body, especially in the right leg and right knee.; Weakness throughout the body, especially in the right leg and right knee. Unable to lift right foot from floor; Unable to sit and stand back up; Unable to sit and stand back up; Severe pain in the neck starting at the base of the skull and lower back; Weakness throughout the body, especially in the right leg and right knee. Unable to lift right foot from floor; dose number=1/administration date=03Feb2021,dose number=2,administration date=17Feb2021; dose number=1/administration date=03Feb2021,dose number=2,administration date=17Feb2021; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9267), via an unspecified route of administration in left arm on 17Feb2021 at 04:00 PM as 2nd dose, single for COVID-19 immunization. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN5318), via an unspecified route of administration in left arm on 03Feb2021 at 04:00 PM as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had no known allergies. Patient did not receive any other vaccine in four weeks. Patient did not receive any other medications in two weeks. Patient was not pregnant. On 20Feb2021 at 03:00 AM, patient experienced severe joint and muscle pain and weakness throughout the body, especially in the right leg and right knee. Unable to lift right foot from floor. Unable to sit and stand back up. Severe pain in the neck starting at the base of the skull and lower back. Symptoms have been persistent for close to 3 weeks. No treatment was received. The outcome of the events off label use and inappropriate schedule of vaccine administered was unknown and outcome of the other events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chest pain, Headache, Injection site pain, Limb discomfort
Clinical narrative: Patient has been suffering from headaches, rashes, chest pain, and numbness to her hands and fingers.  Patient was order a CT scan of the chest. CT scan indicates mild pericarditis as well as post inflammatory lung changes. Echocardiogram is pending to confirm the diagnoses of pericarditis. Patient had MRI of the head and brain and that showed up as unremarkable.  Patient continues to have these symptoms and denies having any of these symptoms before the COVID-19 vaccine.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nausea, Neck pain, Pain, Paraesthesia
Clinical narrative: Patient has been suffering from headaches, rashes, chest pain, and numbness to her hands and fingers.  Patient was order a CT scan of the chest. CT scan indicates mild pericarditis as well as post inflammatory lung changes. Echocardiogram is pending to confirm the diagnoses of pericarditis. Patient had MRI of the head and brain and that showed up as unremarkable.  Patient continues to have these symptoms and denies having any of these symptoms before the COVID-19 vaccine.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Computerised tomogram thorax, Headache, Hypoaesthesia, Magnetic resonance imaging head
Clinical narrative: Patient has been suffering from headaches, rashes, chest pain, and numbness to her hands and fingers.  Patient was order a CT scan of the chest. CT scan indicates mild pericarditis as well as post inflammatory lung changes. Echocardiogram is pending to confirm the diagnoses of pericarditis. Patient had MRI of the head and brain and that showed up as unremarkable.  Patient continues to have these symptoms and denies having any of these symptoms before the COVID-19 vaccine.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pericarditis, Rash
Clinical narrative: Patient has been suffering from headaches, rashes, chest pain, and numbness to her hands and fingers.  Patient was order a CT scan of the chest. CT scan indicates mild pericarditis as well as post inflammatory lung changes. Echocardiogram is pending to confirm the diagnoses of pericarditis. Patient had MRI of the head and brain and that showed up as unremarkable.  Patient continues to have these symptoms and denies having any of these symptoms before the COVID-19 vaccine.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cyanosis, Death, Pulse absent, Unresponsive to stimuli, Wheelchair user
Clinical narrative: Pt. is a 74 Y female with dementia who was brought to the hospital due to altered mental status and then died shortly after receiving vaccine.  She presented to ER from her facility on 3/23/21 due to urinary incontinence and worsening of mental status. She was tachycardic, O2 sat 94% on room air, found to be in urosepsis and was started on Rocephin. Patient had been stable clinically, and on day of discharge was given second dose of Pfizer vaccine at 1320.  Patient then was found to be too weak to go home by means of friend's private transportation. Patient was then scheduled to leave by medical transport, but then became non-responsive and pulseless.  Patient was DNR and she was pronounced dead at 5:22pm.  No note of any fevers, tachycardia, rash, or new hypoxemia after the vaccine.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Death, Mental status changes, Pulse absent, Tachycardia
Clinical narrative: Pt. is a 74 Y female with dementia who was brought to the hospital due to altered mental status and then died shortly after receiving vaccine.  She presented to ER from her facility on 3/23/21 due to urinary incontinence and worsening of mental status. She was tachycardic, O2 sat 94% on room air, found to be in urosepsis and was started on Rocephin. Patient had been stable clinically, and on day of discharge was given second dose of Pfizer vaccine at 1320.  Patient then was found to be too weak to go home by means of friend's private transportation. Patient was then scheduled to leave by medical transport, but then became non-responsive and pulseless.  Patient was DNR and she was pronounced dead at 5:22pm.  No note of any fevers, tachycardia, rash, or new hypoxemia after the vaccine.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unresponsive to stimuli, Urinary incontinence, Urosepsis
Clinical narrative: Pt. is a 74 Y female with dementia who was brought to the hospital due to altered mental status and then died shortly after receiving vaccine.  She presented to ER from her facility on 3/23/21 due to urinary incontinence and worsening of mental status. She was tachycardic, O2 sat 94% on room air, found to be in urosepsis and was started on Rocephin. Patient had been stable clinically, and on day of discharge was given second dose of Pfizer vaccine at 1320.  Patient then was found to be too weak to go home by means of friend's private transportation. Patient was then scheduled to leave by medical transport, but then became non-responsive and pulseless.  Patient was DNR and she was pronounced dead at 5:22pm.  No note of any fevers, tachycardia, rash, or new hypoxemia after the vaccine.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haemorrhage, Subdural haematoma
Clinical narrative: This is a 42 year old female w a PMH of reynauds syndrome who presented to an outside ED for evaluation of episodes of dizziness and unsteadiness. She also reported intermittent occipital headaches. She was found to have a subdural fluid collection on CT so she was transferred to AGH for further evaluation and management. She was neurologically intact, denied any other complaints. She had repeat CT scans that showed stable subdural collection. She had an angiogram that was negative for vascular abnormalities. She had a CT scan of the skull base showing no evidence of CSF leak or dehiscence of bone. She was stable for discharge on 4/13/21 to follow with hematology for further coagulopathy and with neurosurgery in clinic with follow up CT scans.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time, Angiogram normal, Balance disorder, Computerised tomogram head abnormal, Dizziness
Clinical narrative: This is a 42 year old female w a PMH of reynauds syndrome who presented to an outside ED for evaluation of episodes of dizziness and unsteadiness. She also reported intermittent occipital headaches. She was found to have a subdural fluid collection on CT so she was transferred to AGH for further evaluation and management. She was neurologically intact, denied any other complaints. She had repeat CT scans that showed stable subdural collection. She had an angiogram that was negative for vascular abnormalities. She had a CT scan of the skull base showing no evidence of CSF leak or dehiscence of bone. She was stable for discharge on 4/13/21 to follow with hematology for further coagulopathy and with neurosurgery in clinic with follow up CT scans.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haematocrit normal, Haemoglobin normal, Headache, International normalised ratio normal, Lacunar infarction
Clinical narrative: This is a 42 year old female w a PMH of reynauds syndrome who presented to an outside ED for evaluation of episodes of dizziness and unsteadiness. She also reported intermittent occipital headaches. She was found to have a subdural fluid collection on CT so she was transferred to AGH for further evaluation and management. She was neurologically intact, denied any other complaints. She had repeat CT scans that showed stable subdural collection. She had an angiogram that was negative for vascular abnormalities. She had a CT scan of the skull base showing no evidence of CSF leak or dehiscence of bone. She was stable for discharge on 4/13/21 to follow with hematology for further coagulopathy and with neurosurgery in clinic with follow up CT scans.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head abnormal, Platelet count normal, Red blood cell count normal, Scan with contrast abnormal, Subdural haematoma
Clinical narrative: This is a 42 year old female w a PMH of reynauds syndrome who presented to an outside ED for evaluation of episodes of dizziness and unsteadiness. She also reported intermittent occipital headaches. She was found to have a subdural fluid collection on CT so she was transferred to AGH for further evaluation and management. She was neurologically intact, denied any other complaints. She had repeat CT scans that showed stable subdural collection. She had an angiogram that was negative for vascular abnormalities. She had a CT scan of the skull base showing no evidence of CSF leak or dehiscence of bone. She was stable for discharge on 4/13/21 to follow with hematology for further coagulopathy and with neurosurgery in clinic with follow up CT scans.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Subdural haemorrhage, Venogram normal
Clinical narrative: This is a 42 year old female w a PMH of reynauds syndrome who presented to an outside ED for evaluation of episodes of dizziness and unsteadiness. She also reported intermittent occipital headaches. She was found to have a subdural fluid collection on CT so she was transferred to AGH for further evaluation and management. She was neurologically intact, denied any other complaints. She had repeat CT scans that showed stable subdural collection. She had an angiogram that was negative for vascular abnormalities. She had a CT scan of the skull base showing no evidence of CSF leak or dehiscence of bone. She was stable for discharge on 4/13/21 to follow with hematology for further coagulopathy and with neurosurgery in clinic with follow up CT scans.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Sinus arrest, Syncope
Clinical narrative: Syncopal Episode with sinus pauses.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sinus arrest, Syncope
Clinical narrative: Syncopal Episode with sinus pauses.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site pain, Injection site swelling, Neck pain, Pruritus
Clinical narrative: developed severe prolonged pain shoulder; severe prolonged pain shoulder/arm; developed severe prolonged pain shoulder/arm and joint mobility restriction; This is a spontaneous report from a contactable consumer (patient) reported to Pfizer sponsored program. A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 29Mar2021 as 2nd dose, single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on unspecified date as 1st dose, single dose for COVID-19 immunization. On unspecified date in 2021, after shot patient developed severe prolonged pain shoulder/arm and joint mobility restriction. The clinical outcome of event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Joint range of motion decreased, Pain in extremity
Clinical narrative: developed severe prolonged pain shoulder; severe prolonged pain shoulder/arm; developed severe prolonged pain shoulder/arm and joint mobility restriction; This is a spontaneous report from a contactable consumer (patient) reported to Pfizer sponsored program. A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 29Mar2021 as 2nd dose, single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on unspecified date as 1st dose, single dose for COVID-19 immunization. On unspecified date in 2021, after shot patient developed severe prolonged pain shoulder/arm and joint mobility restriction. The clinical outcome of event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Joint stiffness, Pain in extremity
Clinical narrative: developed severe prolonged pain shoulder; severe prolonged pain shoulder/arm; developed severe prolonged pain shoulder/arm and joint mobility restriction; This is a spontaneous report from a contactable consumer (patient) reported to Pfizer sponsored program. A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 29Mar2021 as 2nd dose, single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on unspecified date as 1st dose, single dose for COVID-19 immunization. On unspecified date in 2021, after shot patient developed severe prolonged pain shoulder/arm and joint mobility restriction. The clinical outcome of event was unknown.  Information about lot/batch number has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy, Blood test, Computerised tomogram, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: Guillain Barre Syndrome Bilateral Bell's Palsy  He was a hiker prior to injection. Now he is unable to walk. He needs assist x3 to be able to stand and take only a few steps. Face paralyzed (upper motor neuron weakness). He had 5 days of IVig and then transferred to a higher level care as he developed the UMN weakness after the IVIg was completed. He is now in outpatient rehabilitation.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lumbar puncture abnormal, Magnetic resonance imaging, Nerve conduction studies abnormal
Clinical narrative: Guillain Barre Syndrome Bilateral Bell's Palsy  He was a hiker prior to injection. Now he is unable to walk. He needs assist x3 to be able to stand and take only a few steps. Face paralyzed (upper motor neuron weakness). He had 5 days of IVig and then transferred to a higher level care as he developed the UMN weakness after the IVIg was completed. He is now in outpatient rehabilitation.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Bell's palsy, Dysstasia, Electromyogram abnormal, Facial paralysis
Clinical narrative: Guillain Barre Syndrome Bilateral Bell's Palsy  He was a hiker prior to injection. Now he is unable to walk. He needs assist x3 to be able to stand and take only a few steps. Face paralyzed (upper motor neuron weakness). He had 5 days of IVig and then transferred to a higher level care as he developed the UMN weakness after the IVIg was completed. He is now in outpatient rehabilitation.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gait inability, Guillain-Barre syndrome, Immunoglobulin therapy, Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal abnormal
Clinical narrative: Guillain Barre Syndrome Bilateral Bell's Palsy  He was a hiker prior to injection. Now he is unable to walk. He needs assist x3 to be able to stand and take only a few steps. Face paralyzed (upper motor neuron weakness). He had 5 days of IVig and then transferred to a higher level care as he developed the UMN weakness after the IVIg was completed. He is now in outpatient rehabilitation.