chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia, Peripheral swelling, SARS-CoV-2 test, Thrombosis, Ultrasound scan
Clinical narrative: 8 week paralysis of left arm; swelling of arm, fingers, legs; sinking of the eyes; loss of taste; headache; loss of breath; tingling/firing sensation down arm; nausea; diarrhea; nodule on left neck/shoulder; loss of concentration; unable to sleep; fatigue/exhaustion; suspected blood clot; unable to use arm, hand, fingers, etc. due to chronic pain; This is a spontaneous report from a contactable consumer (patient) received via COVID-19 Vaccine Adverse Event Reporting System (COVAES). A 40-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 05Apr2021 15:00 (Lot Number: ER2613; at the age of 40-years) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history included 3 Herniated discs; allergies: latex, pineapple, tamarind. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 05Apr2021 15:30, the patient had the following reactions: 8 week paralysis of left arm, swelling of arm, fingers, legs, "sinking of the eyes", loss of taste, headache, loss of breath, tingling/firing sensation down arm, nausea, diarrhea, nodule on left neck/shoulder, loss of concentration, unable to sleep, fatigue/exhaustion, suspected blood clot and unable to use arm, hand, fingers, etc. due to chronic pain. The events resulted in emergency room/department or urgent care and assessed as serious for disability or permanent damage. No treatment was received for the events (as reported). Patient has not work since 05May2021. The patient underwent lab tests and procedures which included blood test, Chest Xray, CT Scan and Ultrasound: all with unknown results and Covid test type post vaccination: Nasal Swab: negative in 2021; Covid test type post vaccination: Blood test: negative on 28Apr2021 and Covid test type post vaccination: PCR Rapid - Curative: negative on 03Jun2021. The outcome of the events was not recovered.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head, Head discomfort, Hypoaesthesia, Muscle tightness, Ultrasound Doppler
Clinical narrative: About 45 minutes later began feeling pressure on left side of neck behind ear. Later in evening feel pressure in rt side of neck down to rt uppershoulder.; Approx. 4 hours later started feeling tingling in left arm and hand.; Muscle Cramp in left jaw bone area; numbness/tingling in left foot; Rt arm injection area aggressively sore/tender.; Faint headache primarily rt side over eyebrow.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 14Apr2021 at 11:30 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as not applicable. The patient previously took Percocet and experienced an itchy reaction. Concomitant medications included vitamins (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing and ciprofloxacin hydrochloride (MANUFACTURER UNKNOWN) two doses two days before (the vaccine) on an unknown date in Apr2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 12:30, about 45 minutes later the patient began to feel pressure on left side of neck behind ear. Then approximately 4 hours later started feeling tingling in left arm and hand, Muscle Cramp in left jaw bone area and numbness/tingling in left foot. Later in evening felt pressure in right side of neck down to right upper shoulder and right arm injection area aggressively sore/tender. She also experienced faint headache primarily right side over eyebrow. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events feel pressure on left side of neck behind ear, feeling tingling in left arm and hand, Muscle Cramp in left jaw bone area, numbness/tingling in left foot, felt pressure in right side of neck down to right upper shoulder, right arm injection area aggressively sore/tender and faint headache primarily right side over eyebrow were unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: About 45 minutes later began feeling pressure on left side of neck behind ear. Later in evening feel pressure in rt side of neck down to rt uppershoulder.; Approx. 4 hours later started feeling tingling in left arm and hand.; Muscle Cramp in left jaw bone area; numbness/tingling in left foot; Rt arm injection area aggressively sore/tender.; Faint headache primarily rt side over eyebrow.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 14Apr2021 at 11:30 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as not applicable. The patient previously took Percocet and experienced an itchy reaction. Concomitant medications included vitamins (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing and ciprofloxacin hydrochloride (MANUFACTURER UNKNOWN) two doses two days before (the vaccine) on an unknown date in Apr2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 12:30, about 45 minutes later the patient began to feel pressure on left side of neck behind ear. Then approximately 4 hours later started feeling tingling in left arm and hand, Muscle Cramp in left jaw bone area and numbness/tingling in left foot. Later in evening felt pressure in right side of neck down to right upper shoulder and right arm injection area aggressively sore/tender. She also experienced faint headache primarily right side over eyebrow. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events feel pressure on left side of neck behind ear, feeling tingling in left arm and hand, Muscle Cramp in left jaw bone area, numbness/tingling in left foot, felt pressure in right side of neck down to right upper shoulder, right arm injection area aggressively sore/tender and faint headache primarily right side over eyebrow were unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypoaesthesia, Muscle spasms, Neck pain, Paraesthesia
Clinical narrative: About 45 minutes later began feeling pressure on left side of neck behind ear. Later in evening feel pressure in rt side of neck down to rt uppershoulder.; Approx. 4 hours later started feeling tingling in left arm and hand.; Muscle Cramp in left jaw bone area; numbness/tingling in left foot; Rt arm injection area aggressively sore/tender.; Faint headache primarily rt side over eyebrow.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 14Apr2021 at 11:30 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as not applicable. The patient previously took Percocet and experienced an itchy reaction. Concomitant medications included vitamins (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing and ciprofloxacin hydrochloride (MANUFACTURER UNKNOWN) two doses two days before (the vaccine) on an unknown date in Apr2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 12:30, about 45 minutes later the patient began to feel pressure on left side of neck behind ear. Then approximately 4 hours later started feeling tingling in left arm and hand, Muscle Cramp in left jaw bone area and numbness/tingling in left foot. Later in evening felt pressure in right side of neck down to right upper shoulder and right arm injection area aggressively sore/tender. She also experienced faint headache primarily right side over eyebrow. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events feel pressure on left side of neck behind ear, feeling tingling in left arm and hand, Muscle Cramp in left jaw bone area, numbness/tingling in left foot, felt pressure in right side of neck down to right upper shoulder, right arm injection area aggressively sore/tender and faint headache primarily right side over eyebrow were unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: About 45 minutes later began feeling pressure on left side of neck behind ear. Later in evening feel pressure in rt side of neck down to rt uppershoulder.; Approx. 4 hours later started feeling tingling in left arm and hand.; Muscle Cramp in left jaw bone area; numbness/tingling in left foot; Rt arm injection area aggressively sore/tender.; Faint headache primarily rt side over eyebrow.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 14Apr2021 at 11:30 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as not applicable. The patient previously took Percocet and experienced an itchy reaction. Concomitant medications included vitamins (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and unknown if ongoing and ciprofloxacin hydrochloride (MANUFACTURER UNKNOWN) two doses two days before (the vaccine) on an unknown date in Apr2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Apr2021 at 12:30, about 45 minutes later the patient began to feel pressure on left side of neck behind ear. Then approximately 4 hours later started feeling tingling in left arm and hand, Muscle Cramp in left jaw bone area and numbness/tingling in left foot. Later in evening felt pressure in right side of neck down to right upper shoulder and right arm injection area aggressively sore/tender. She also experienced faint headache primarily right side over eyebrow. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events feel pressure on left side of neck behind ear, feeling tingling in left arm and hand, Muscle Cramp in left jaw bone area, numbness/tingling in left foot, felt pressure in right side of neck down to right upper shoulder, right arm injection area aggressively sore/tender and faint headache primarily right side over eyebrow were unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dysphagia, Dyspnoea
Clinical narrative: Difficulty breathing; Tightness in chest; Difficulty swallowing; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 22Apr2021 at 11:30 AM (at the age of 40-year-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications included cetirizine hydrochloride (ZYRTEC) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within four weeks. Patient was not diagnosed with COVID prior vaccination. Patient was not COVID tested post vaccination. The patient previously took Biaxin and experienced drug allergy. On 22Apr2021 at 12:00 PM, the patient experienced difficulty breathing, tightness in chest, difficulty swallowing. Adverse events resulted in doctor or other healthcare professional office clinic visit. Adverse event: Difficulty breathing, Tightness in chest and difficulty swallowing; began 30 minutes after injection; subsided after taking antihistamine 3.5 hours after injection. The patient received antihistamine as treatment medication for the events difficulty breathing, tightness in chest, difficulty swallowing. Outcome of the events was recovered on 22Apr2021 at 15:00.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained, no further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction
Clinical narrative: SPONTANEOUS CORONARY ARTERY DISSECTION (SCAD); This spontaneous report received from a patient concerned a patient of unspecified age, sex, ethnic origin and race. The patient's height, and weight were not reported. The patient had no underlying health problems and no blockage anywhere. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 18-APR-2021 (reported as 11 days after vaccination), the patient had a heart attack. The patient believe that it was from the shot. After the shot, patient had heart palpitations and weird heart sensations. The patient was diagnosed with spontaneous coronary artery dissection (SCAD) after the heart attack, which was extremely rare and patient had no risk factors that are associated with this. The patient concluded that it was associated with the vaccine and the doctors could not rule that out. The patient would be on medication for the rest of life. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of spontaneous coronary artery dissection (SCAD) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210850480- covid-19 vaccine ad26.cov2.s-spontaneous coronary artery dissection (SCAD). This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Coronary artery dissection
Clinical narrative: SPONTANEOUS CORONARY ARTERY DISSECTION (SCAD); This spontaneous report received from a patient concerned a patient of unspecified age, sex, ethnic origin and race. The patient's height, and weight were not reported. The patient had no underlying health problems and no blockage anywhere. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 18-APR-2021 (reported as 11 days after vaccination), the patient had a heart attack. The patient believe that it was from the shot. After the shot, patient had heart palpitations and weird heart sensations. The patient was diagnosed with spontaneous coronary artery dissection (SCAD) after the heart attack, which was extremely rare and patient had no risk factors that are associated with this. The patient concluded that it was associated with the vaccine and the doctors could not rule that out. The patient would be on medication for the rest of life. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of spontaneous coronary artery dissection (SCAD) was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210850480- covid-19 vaccine ad26.cov2.s-spontaneous coronary artery dissection (SCAD). This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness, Heart rate increased
Clinical narrative: rapid heartbeat (120bmp); high blood pressure (165/85); dizziness; lightheaded; This is a spontaneous report from a contactable consumer or other non hcp. A 45-years-old non-pregnant female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0170) via an unspecified route of administration in Arm Right on 23Apr2021 12:30 (age at vaccination: 45 Years) as DOSE 1, SINGLE for covid-19 immunisation. Patient was not pregnant at the time of vaccination, Patient didn't receive other vaccines within 4 weeks prior to vaccination, patient had other medications Metoprolol, Lisinopril, Pepcid, Claritin, Melatonin within 2 weeks. Medical history included hypertension from an unknown date and unknown if ongoing, rubber sensitivity from an unknown date and unknown if ongoing. Concomitant medications included metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported; lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported; aluminium hydroxide gel, dried, magnesium carbonate (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]) taken for an unspecified indication, start and stop date were not reported; clarithromycin (CLARITIN [CLARITHROMYCIN]) taken for an unspecified indication, start and stop date were not reported; melatonin (MELATONIN) taken for an unspecified indication, start and stop date were not reported. Patient didn't had covid prior to vaccination. The patient previously took codeine and experienced drug hypersensitivity, avalox and experienced drug hypersensitivity and allergy to latex. On 23Apr2021 12:30 the patient experienced rapid heartbeat (120bmp), high blood pressure (165/85), dizziness, lightheaded. No treatment was received for the events. The patient underwent lab tests and procedures which included blood pressure measurement: 165/85 on 23Apr2021, blood pressure measurement: normal on 23Apr2021, heart rate: 120 bmp on 23Apr2021, heart rate: normal on 23Apr2021. Patient was not tested to covid to post vaccination. The outcome of the events heart rate increased, hypertension, dizziness was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Dizziness, Heart rate, Heart rate increased, Hypertension
Clinical narrative: rapid heartbeat (120bmp); high blood pressure (165/85); dizziness; lightheaded; This is a spontaneous report from a contactable consumer or other non hcp. A 45-years-old non-pregnant female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0170) via an unspecified route of administration in Arm Right on 23Apr2021 12:30 (age at vaccination: 45 Years) as DOSE 1, SINGLE for covid-19 immunisation. Patient was not pregnant at the time of vaccination, Patient didn't receive other vaccines within 4 weeks prior to vaccination, patient had other medications Metoprolol, Lisinopril, Pepcid, Claritin, Melatonin within 2 weeks. Medical history included hypertension from an unknown date and unknown if ongoing, rubber sensitivity from an unknown date and unknown if ongoing. Concomitant medications included metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported; lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported; aluminium hydroxide gel, dried, magnesium carbonate (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]) taken for an unspecified indication, start and stop date were not reported; clarithromycin (CLARITIN [CLARITHROMYCIN]) taken for an unspecified indication, start and stop date were not reported; melatonin (MELATONIN) taken for an unspecified indication, start and stop date were not reported. Patient didn't had covid prior to vaccination. The patient previously took codeine and experienced drug hypersensitivity, avalox and experienced drug hypersensitivity and allergy to latex. On 23Apr2021 12:30 the patient experienced rapid heartbeat (120bmp), high blood pressure (165/85), dizziness, lightheaded. No treatment was received for the events. The patient underwent lab tests and procedures which included blood pressure measurement: 165/85 on 23Apr2021, blood pressure measurement: normal on 23Apr2021, heart rate: 120 bmp on 23Apr2021, heart rate: normal on 23Apr2021. Patient was not tested to covid to post vaccination. The outcome of the events heart rate increased, hypertension, dizziness was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood lactic acid increased, Chest X-ray normal, Dizziness, Headache, Intensive care
Clinical narrative: Was hospital due to my lactic acid being 4 and not being able to get my heart rate down; Was hospital due to my lactic acid being 4 and not being able to get my heart rate down; This is a spontaneous report from a contactable other health care professional or nurse (patient). A female patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included diabetic on insulin that was not well controlled. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient had an adverse reaction to her second shot and was hospital due to lactic acid being 4 and not being able to get her heart rate down on an unspecified date. The patient wanted to know, she was an emergency room nurse and no one knew if she should get the booster shot or not due to her reaction. The patient underwent lab tests and procedures which included blood lactic acid was 4 and heart rate was down on an unspecified date. Seriousness of the case was considered as hospitalization. The clinical outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events blood lactic acid increased and heart rate irregular cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Pain, Pyrexia, Urine analysis, Vomiting
Clinical narrative: Was hospital due to my lactic acid being 4 and not being able to get my heart rate down; Was hospital due to my lactic acid being 4 and not being able to get my heart rate down; This is a spontaneous report from a contactable other health care professional or nurse (patient). A female patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included diabetic on insulin that was not well controlled. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient had an adverse reaction to her second shot and was hospital due to lactic acid being 4 and not being able to get her heart rate down on an unspecified date. The patient wanted to know, she was an emergency room nurse and no one knew if she should get the booster shot or not due to her reaction. The patient underwent lab tests and procedures which included blood lactic acid was 4 and heart rate was down on an unspecified date. Seriousness of the case was considered as hospitalization. The clinical outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events blood lactic acid increased and heart rate irregular cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: White blood cell count normal
Clinical narrative: Was hospital due to my lactic acid being 4 and not being able to get my heart rate down; Was hospital due to my lactic acid being 4 and not being able to get my heart rate down; This is a spontaneous report from a contactable other health care professional or nurse (patient). A female patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included diabetic on insulin that was not well controlled. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient had an adverse reaction to her second shot and was hospital due to lactic acid being 4 and not being able to get her heart rate down on an unspecified date. The patient wanted to know, she was an emergency room nurse and no one knew if she should get the booster shot or not due to her reaction. The patient underwent lab tests and procedures which included blood lactic acid was 4 and heart rate was down on an unspecified date. Seriousness of the case was considered as hospitalization. The clinical outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events blood lactic acid increased and heart rate irregular cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood lactic acid, Blood lactic acid increased, Heart rate, Heart rate irregular
Clinical narrative: Was hospital due to my lactic acid being 4 and not being able to get my heart rate down; Was hospital due to my lactic acid being 4 and not being able to get my heart rate down; This is a spontaneous report from a contactable other health care professional or nurse (patient). A female patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included diabetic on insulin that was not well controlled. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient had an adverse reaction to her second shot and was hospital due to lactic acid being 4 and not being able to get her heart rate down on an unspecified date. The patient wanted to know, she was an emergency room nurse and no one knew if she should get the booster shot or not due to her reaction. The patient underwent lab tests and procedures which included blood lactic acid was 4 and heart rate was down on an unspecified date. Seriousness of the case was considered as hospitalization. The clinical outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events blood lactic acid increased and heart rate irregular cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood lactic acid, Blood lactic acid decreased
Clinical narrative: Was hospital due to my lactic acid being 4 and not being able to get my heart rate down; Was hospital due to my lactic acid being 4 and not being able to get my heart rate down; This is a spontaneous report from a contactable other health care professional or nurse (patient). A female patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included diabetic on insulin that was not well controlled. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient had an adverse reaction to her second shot and was hospital due to lactic acid being 4 and not being able to get her heart rate down on an unspecified date. The patient wanted to know, she was an emergency room nurse and no one knew if she should get the booster shot or not due to her reaction. The patient underwent lab tests and procedures which included blood lactic acid was 4 and heart rate was down on an unspecified date. Seriousness of the case was considered as hospitalization. The clinical outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of events blood lactic acid increased and heart rate irregular cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Injection site hypoaesthesia, Vaccine positive rechallenge
Clinical narrative: Numbness in left arm; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6205) via an unspecified route of administration in the left arm on 28Feb2021 at 08:00 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. The patient had not reported any other health issues. The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El9262) via an unspecified route of administration in the left arm on 02Feb2021 at 08:00 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Feb2021 at 08:00, the patient experienced numbness in left arm. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the reported events. The clinical outcome of numbness in left arm was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Eye contusion, Fatigue, Hypoaesthesia, Nerve injury
Clinical narrative: Numbness in left arm; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6205) via an unspecified route of administration in the left arm on 28Feb2021 at 08:00 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. The patient had not reported any other health issues. The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El9262) via an unspecified route of administration in the left arm on 02Feb2021 at 08:00 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Feb2021 at 08:00, the patient experienced numbness in left arm. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the reported events. The clinical outcome of numbness in left arm was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, X-ray
Clinical narrative: Numbness in left arm; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6205) via an unspecified route of administration in the left arm on 28Feb2021 at 08:00 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. The patient had not reported any other health issues. The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El9262) via an unspecified route of administration in the left arm on 02Feb2021 at 08:00 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Feb2021 at 08:00, the patient experienced numbness in left arm. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the reported events. The clinical outcome of numbness in left arm was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in left arm; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6205) via an unspecified route of administration in the left arm on 28Feb2021 at 08:00 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. The patient had not reported any other health issues. The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: El9262) via an unspecified route of administration in the left arm on 02Feb2021 at 08:00 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Feb2021 at 08:00, the patient experienced numbness in left arm. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the reported events. The clinical outcome of numbness in left arm was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray normal, Computerised tomogram thorax normal, Cough, Dyspnoea
Clinical narrative: BLOOD CLOT; DEEP VEIN THROMBOSIS; This spontaneous report received from a patient concerned a unspecified age and sex and unspecified race & ethnicity  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 Total dose was administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  The patient was vaccinated on 02-APR-2021 and after many blood tests, hematologist confirmed blood clot from the vaccine. On APR-2021, Laboratory data included: Blood test (NR: not provided) blood clot from the vaccine. On 20-APR-2021, the patient experienced blood clot. On 20-APR-2021, the patient experienced deep vein thrombosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot and deep vein thrombosis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210852202-COVID-19 VACCINE AD26.COV2.S - BLOOD CLOT, DEEP VEIN THROMBOSIS . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Thrombosis, Ultrasound Doppler abnormal
Clinical narrative: BLOOD CLOT; DEEP VEIN THROMBOSIS; This spontaneous report received from a patient concerned a unspecified age and sex and unspecified race & ethnicity  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 Total dose was administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  The patient was vaccinated on 02-APR-2021 and after many blood tests, hematologist confirmed blood clot from the vaccine. On APR-2021, Laboratory data included: Blood test (NR: not provided) blood clot from the vaccine. On 20-APR-2021, the patient experienced blood clot. On 20-APR-2021, the patient experienced deep vein thrombosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot and deep vein thrombosis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210852202-COVID-19 VACCINE AD26.COV2.S - BLOOD CLOT, DEEP VEIN THROMBOSIS . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood test, Deep vein thrombosis, Thrombosis
Clinical narrative: BLOOD CLOT; DEEP VEIN THROMBOSIS; This spontaneous report received from a patient concerned a unspecified age and sex and unspecified race & ethnicity  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 Total dose was administered on 02-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  The patient was vaccinated on 02-APR-2021 and after many blood tests, hematologist confirmed blood clot from the vaccine. On APR-2021, Laboratory data included: Blood test (NR: not provided) blood clot from the vaccine. On 20-APR-2021, the patient experienced blood clot. On 20-APR-2021, the patient experienced deep vein thrombosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot and deep vein thrombosis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210852202-COVID-19 VACCINE AD26.COV2.S - BLOOD CLOT, DEEP VEIN THROMBOSIS . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 64.0
Sex: F
Vaccine: COVID19, UNK, UNK, VARZOS, VARZOS, COVID19, VARZOS, VARZOS, COVID19
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Mild Shingles symptoms on left side of abdomen and left side of back; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613), via an unspecified route of administration in the left arm on 16Apr2021 at 11:45 (at the age of 64-years-old), as a single dose for COVID-19 immunisation. Medical history included acid reflux (GERD), shingles, allergy to fresh pineapple and raw shrimp. 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 COVID vaccine. Concomitant medications included estradiol (MANUFACTURER UNKNOWN) 10 mcg, estradiol/norethisterone acetate (COMBIPATCH) 0.05-0.14 mg; both from unknown dates for unspecified indications. The patient previously received varicella zoster vaccine live (ZOSTAVAX) on 01Sep2015 (at the age of 59-years-old) and varicella zoster vaccine (SHINGRIX) on 12Jan2018 and 07Feb2018 (at the age of 61-years-old); both taken for shingles. The patient previously received sulfamethoxazole TMP DS 800-160 (MANUFACTURER UNKNOWN) and rofecoxib (VIOXX); both on unknown dates for unspecified indications and experienced drug allergy. The patient had no shingles side effects until 8 hours after the first COVID vaccine. On 16Apr2021 at 20:00, the patient experienced mild shingles symptoms on left side of abdomen and left side of back. Ten years ago, the patient experienced one severe case of shingles and one mild case of shingles when the patient was in mid-50s.The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event mild shingles symptoms on left side of abdomen and left side of back was not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.