chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood test, Catheterisation cardiac normal, Chest discomfort
Clinical narrative: Monday, got 2nd Pfizer vaccine. Tuesday, sick with fever and chills. Wednesday 2am, Thursday 1pm, Friday 8am: 3-4 hour cramping in hands, arms, shoulders, neck, upper back, with chest tightness. Tylenol, ibuprofen, heating pad, showers to no effect. Friday morning (May 14) I visit Primary Care during episode. Abnormal EKG. I drive to emergency room. 2 abnormal EKGs. I get a Cardiac Cathedar operation, followed by an echo in outpatient. Blood draw shows troponin levels at 29k and 26k. Presumed myopericarditis. 2 days in hospital, released May 16. Heart rate stabilized the night of May 14. Aspirin 650mg (ended Monday May 31), colchicine 0.6mg, Lisinopril 5mg, Metoprolol 25mg. Omeprazole upped to two 20mg tablets instead of one. Getting a heart MRI Wednesday, May 9. Back at work on Wednesday, May 19.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Echocardiogram, Ejection fraction normal, Electrocardiogram abnormal, Laboratory test
Clinical narrative: Monday, got 2nd Pfizer vaccine. Tuesday, sick with fever and chills. Wednesday 2am, Thursday 1pm, Friday 8am: 3-4 hour cramping in hands, arms, shoulders, neck, upper back, with chest tightness. Tylenol, ibuprofen, heating pad, showers to no effect. Friday morning (May 14) I visit Primary Care during episode. Abnormal EKG. I drive to emergency room. 2 abnormal EKGs. I get a Cardiac Cathedar operation, followed by an echo in outpatient. Blood draw shows troponin levels at 29k and 26k. Presumed myopericarditis. 2 days in hospital, released May 16. Heart rate stabilized the night of May 14. Aspirin 650mg (ended Monday May 31), colchicine 0.6mg, Lisinopril 5mg, Metoprolol 25mg. Omeprazole upped to two 20mg tablets instead of one. Getting a heart MRI Wednesday, May 9. Back at work on Wednesday, May 19.
Age: 24.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Muscle spasms, Myocarditis, Pyrexia, Troponin increased
Clinical narrative: Monday, got 2nd Pfizer vaccine. Tuesday, sick with fever and chills. Wednesday 2am, Thursday 1pm, Friday 8am: 3-4 hour cramping in hands, arms, shoulders, neck, upper back, with chest tightness. Tylenol, ibuprofen, heating pad, showers to no effect. Friday morning (May 14) I visit Primary Care during episode. Abnormal EKG. I drive to emergency room. 2 abnormal EKGs. I get a Cardiac Cathedar operation, followed by an echo in outpatient. Blood draw shows troponin levels at 29k and 26k. Presumed myopericarditis. 2 days in hospital, released May 16. Heart rate stabilized the night of May 14. Aspirin 650mg (ended Monday May 31), colchicine 0.6mg, Lisinopril 5mg, Metoprolol 25mg. Omeprazole upped to two 20mg tablets instead of one. Getting a heart MRI Wednesday, May 9. Back at work on Wednesday, May 19.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chest pain, Diarrhoea, Hypoaesthesia, Injection site pain
Clinical narrative: ringing in ears; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain/ Pain in arm; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain.; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain.; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain; could not sleep for 2 nights.; diarreha; numbness in left hand; brain fog; neck is stiff; This is a spontaneous report from a contactable consumer (Patient). A 68-year-old non-pregnant female patient received first dose of BNT162B2 (BNT162B2, Lot Number: EW0183), via an unspecified route of administration, administered in left arm on 17May2021 at 11:45 at age of 68-year-old as single dose for covid-19 immunisation. Medical history included allergies with poly glycol in cosmetics and penicillin, no other medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included xantofyl (LUTEIN), ascorbic acid/ zinc citrate (ZINC + VITAMIN C), vitamin D. On 17May2021, at 11:45 AM, immediate reaction after shot was done, patient had left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain, patient stayed 30 min, and took a acetaminophen (TYLENOL) during this time. Patient came home drank lots of water, pain and burning increased all day took ibuprofin and kept icing. No relief. 4 hours after injection, numbness in left hand lasted 10 min. During night, patient was tried to get out of bed left foot number for 5 min. Patient had diarreha for 5 days. Pain in arm was extreme immediately, stayed sore for 5 days, could not sleep for 2 nights. Patient also had brain fog and ringing in ears starting 22May2021. Patient still had burning in left side of neck, shoulder and jaw and neck is stiff. Patient took benedryl, tylenol, ibuprofen, iced, and exercised stretched, no relief. The outcome of events was not recovered. The events were assessed as non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Pain, Pain in extremity, Pain in jaw, Skin discolouration
Clinical narrative: ringing in ears; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain/ Pain in arm; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain.; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain.; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain; could not sleep for 2 nights.; diarreha; numbness in left hand; brain fog; neck is stiff; This is a spontaneous report from a contactable consumer (Patient). A 68-year-old non-pregnant female patient received first dose of BNT162B2 (BNT162B2, Lot Number: EW0183), via an unspecified route of administration, administered in left arm on 17May2021 at 11:45 at age of 68-year-old as single dose for covid-19 immunisation. Medical history included allergies with poly glycol in cosmetics and penicillin, no other medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included xantofyl (LUTEIN), ascorbic acid/ zinc citrate (ZINC + VITAMIN C), vitamin D. On 17May2021, at 11:45 AM, immediate reaction after shot was done, patient had left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain, patient stayed 30 min, and took a acetaminophen (TYLENOL) during this time. Patient came home drank lots of water, pain and burning increased all day took ibuprofin and kept icing. No relief. 4 hours after injection, numbness in left hand lasted 10 min. During night, patient was tried to get out of bed left foot number for 5 min. Patient had diarreha for 5 days. Pain in arm was extreme immediately, stayed sore for 5 days, could not sleep for 2 nights. Patient also had brain fog and ringing in ears starting 22May2021. Patient still had burning in left side of neck, shoulder and jaw and neck is stiff. Patient took benedryl, tylenol, ibuprofen, iced, and exercised stretched, no relief. The outcome of events was not recovered. The events were assessed as non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder
Clinical narrative: ringing in ears; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain/ Pain in arm; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain.; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain.; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain; could not sleep for 2 nights.; diarreha; numbness in left hand; brain fog; neck is stiff; This is a spontaneous report from a contactable consumer (Patient). A 68-year-old non-pregnant female patient received first dose of BNT162B2 (BNT162B2, Lot Number: EW0183), via an unspecified route of administration, administered in left arm on 17May2021 at 11:45 at age of 68-year-old as single dose for covid-19 immunisation. Medical history included allergies with poly glycol in cosmetics and penicillin, no other medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included xantofyl (LUTEIN), ascorbic acid/ zinc citrate (ZINC + VITAMIN C), vitamin D. On 17May2021, at 11:45 AM, immediate reaction after shot was done, patient had left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain, patient stayed 30 min, and took a acetaminophen (TYLENOL) during this time. Patient came home drank lots of water, pain and burning increased all day took ibuprofin and kept icing. No relief. 4 hours after injection, numbness in left hand lasted 10 min. During night, patient was tried to get out of bed left foot number for 5 min. Patient had diarreha for 5 days. Pain in arm was extreme immediately, stayed sore for 5 days, could not sleep for 2 nights. Patient also had brain fog and ringing in ears starting 22May2021. Patient still had burning in left side of neck, shoulder and jaw and neck is stiff. Patient took benedryl, tylenol, ibuprofen, iced, and exercised stretched, no relief. The outcome of events was not recovered. The events were assessed as non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Bone pain, Burning sensation, Chest pain, Diarrhoea
Clinical narrative: ringing in ears; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain/ Pain in arm; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain.; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain.; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain; could not sleep for 2 nights.; diarreha; numbness in left hand; brain fog; neck is stiff; This is a spontaneous report from a contactable consumer (Patient). A 68-year-old non-pregnant female patient received first dose of BNT162B2 (BNT162B2, Lot Number: EW0183), via an unspecified route of administration, administered in left arm on 17May2021 at 11:45 at age of 68-year-old as single dose for covid-19 immunisation. Medical history included allergies with poly glycol in cosmetics and penicillin, no other medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included xantofyl (LUTEIN), ascorbic acid/ zinc citrate (ZINC + VITAMIN C), vitamin D. On 17May2021, at 11:45 AM, immediate reaction after shot was done, patient had left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain, patient stayed 30 min, and took a acetaminophen (TYLENOL) during this time. Patient came home drank lots of water, pain and burning increased all day took ibuprofin and kept icing. No relief. 4 hours after injection, numbness in left hand lasted 10 min. During night, patient was tried to get out of bed left foot number for 5 min. Patient had diarreha for 5 days. Pain in arm was extreme immediately, stayed sore for 5 days, could not sleep for 2 nights. Patient also had brain fog and ringing in ears starting 22May2021. Patient still had burning in left side of neck, shoulder and jaw and neck is stiff. Patient took benedryl, tylenol, ibuprofen, iced, and exercised stretched, no relief. The outcome of events was not recovered. The events were assessed as non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Insomnia, Musculoskeletal stiffness, Neck pain
Clinical narrative: ringing in ears; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain/ Pain in arm; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain.; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain.; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain; could not sleep for 2 nights.; diarreha; numbness in left hand; brain fog; neck is stiff; This is a spontaneous report from a contactable consumer (Patient). A 68-year-old non-pregnant female patient received first dose of BNT162B2 (BNT162B2, Lot Number: EW0183), via an unspecified route of administration, administered in left arm on 17May2021 at 11:45 at age of 68-year-old as single dose for covid-19 immunisation. Medical history included allergies with poly glycol in cosmetics and penicillin, no other medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included xantofyl (LUTEIN), ascorbic acid/ zinc citrate (ZINC + VITAMIN C), vitamin D. On 17May2021, at 11:45 AM, immediate reaction after shot was done, patient had left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain, patient stayed 30 min, and took a acetaminophen (TYLENOL) during this time. Patient came home drank lots of water, pain and burning increased all day took ibuprofin and kept icing. No relief. 4 hours after injection, numbness in left hand lasted 10 min. During night, patient was tried to get out of bed left foot number for 5 min. Patient had diarreha for 5 days. Pain in arm was extreme immediately, stayed sore for 5 days, could not sleep for 2 nights. Patient also had brain fog and ringing in ears starting 22May2021. Patient still had burning in left side of neck, shoulder and jaw and neck is stiff. Patient took benedryl, tylenol, ibuprofen, iced, and exercised stretched, no relief. The outcome of events was not recovered. The events were assessed as non-serious.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pain in jaw, Tinnitus
Clinical narrative: ringing in ears; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain/ Pain in arm; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain.; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain.; Left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain; could not sleep for 2 nights.; diarreha; numbness in left hand; brain fog; neck is stiff; This is a spontaneous report from a contactable consumer (Patient). A 68-year-old non-pregnant female patient received first dose of BNT162B2 (BNT162B2, Lot Number: EW0183), via an unspecified route of administration, administered in left arm on 17May2021 at 11:45 at age of 68-year-old as single dose for covid-19 immunisation. Medical history included allergies with poly glycol in cosmetics and penicillin, no other medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included xantofyl (LUTEIN), ascorbic acid/ zinc citrate (ZINC + VITAMIN C), vitamin D. On 17May2021, at 11:45 AM, immediate reaction after shot was done, patient had left arm, left side of neck, shoulder, chest, jaw and back of skull had intense burning and pain, patient stayed 30 min, and took a acetaminophen (TYLENOL) during this time. Patient came home drank lots of water, pain and burning increased all day took ibuprofin and kept icing. No relief. 4 hours after injection, numbness in left hand lasted 10 min. During night, patient was tried to get out of bed left foot number for 5 min. Patient had diarreha for 5 days. Pain in arm was extreme immediately, stayed sore for 5 days, could not sleep for 2 nights. Patient also had brain fog and ringing in ears starting 22May2021. Patient still had burning in left side of neck, shoulder and jaw and neck is stiff. Patient took benedryl, tylenol, ibuprofen, iced, and exercised stretched, no relief. The outcome of events was not recovered. The events were assessed as non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cardiac flutter
Clinical narrative: Within 4 hours i was experiencing heart flutters.; This is a spontaneous report from a contactable consumer (patient).  A 53-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 10May2021 09:00 (at the age of 53-year-old) as 2nd dose, single for covid-19 immunisation.  Medical history included sinus allergies (trees, dust mites), avoid foods for digestion: bananas. Concomitant medications included budesonide (RHINOCORT); cetirizine hydrochloride (ZYRTEC); probiotics; carbomer (TEAR DROPS), womens daily probiotic, Eye 50+. Within 4 hours the patient was experiencing heart flutters on 10May2021 13:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in Doctor or other healthcare professional office/clinic visit. The patient received treatment for the adverse event included Current Evaluation Occurring. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not resolved.    Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac flutter
Clinical narrative: Within 4 hours i was experiencing heart flutters.; This is a spontaneous report from a contactable consumer (patient).  A 53-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 10May2021 09:00 (at the age of 53-year-old) as 2nd dose, single for covid-19 immunisation.  Medical history included sinus allergies (trees, dust mites), avoid foods for digestion: bananas. Concomitant medications included budesonide (RHINOCORT); cetirizine hydrochloride (ZYRTEC); probiotics; carbomer (TEAR DROPS), womens daily probiotic, Eye 50+. Within 4 hours the patient was experiencing heart flutters on 10May2021 13:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in Doctor or other healthcare professional office/clinic visit. The patient received treatment for the adverse event included Current Evaluation Occurring. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not resolved.    Information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pericarditis
Clinical narrative: Pericarditis; Dose number 1: 05Jan2021, Dose number 2: 22Jan2021; This is a spontaneous report from a contactable nurse (patient). A 47-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 22Jan2021 (Batch/Lot number was not reported) at age of 47 years old as single dose for covid-19 immunisation. Medical history included no.  No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19.   The patient's concomitant medications were not reported. The patient previously took 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 05Jan2021 administered in arm left at age of 47 years old as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Feb2021, The patient experienced pericarditis. Hospitalization prolonged was reported as no. The event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient received medication as treatment. The outcome of event pericarditis was recovering. Since the vaccination, the patient had not been tested for COVID-19.  Information about batch number has been requested.; Sender's Comments: The event pericarditis most likely represents intercurrent medical condition that is assessed as unrelated to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Pericarditis
Clinical narrative: Pericarditis; Dose number 1: 05Jan2021, Dose number 2: 22Jan2021; This is a spontaneous report from a contactable nurse (patient). A 47-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 22Jan2021 (Batch/Lot number was not reported) at age of 47 years old as single dose for covid-19 immunisation. Medical history included no.  No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19.   The patient's concomitant medications were not reported. The patient previously took 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 05Jan2021 administered in arm left at age of 47 years old as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Feb2021, The patient experienced pericarditis. Hospitalization prolonged was reported as no. The event resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient received medication as treatment. The outcome of event pericarditis was recovering. Since the vaccination, the patient had not been tested for COVID-19.  Information about batch number has been requested.; Sender's Comments: The event pericarditis most likely represents intercurrent medical condition that is assessed as unrelated to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood thyroid stimulating hormone normal, Contusion, Cyanosis, Paraesthesia, Vasodilatation
Clinical narrative: Blurred vision; Thyroid inflamed; tingling all through out the whole body; blue hands/Black and blue mark swollen on calfs; Pain in right leg; Black and blue mark swollen on calfs; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on an unspecified date (at the age of 52-years-old) (Batch/Lot Number: 648543) as single dose for covid-19 immunisation. Medical history included hashimotos. Concomitant medications included ergocalciferol (VITAMIN D); cyanocobalamin (VITAMIN B12) received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was no pregnancy. The patient was no pregnancy at time of vaccination. Age at vaccination was 52 years. The patient experienced blurred vision, thyroid inflamed, tingling all through out the whole body, blue hands, pain in right leg and black and blue mark swollen on calfs on 15Apr2021. The events resulted in emergency room/department or urgent care. The patient was hospitalized for the events for 1 day. The report was serious with the seriousness criteria of hospitalization. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred, Vitamin B12 increased, Vitamin D increased
Clinical narrative: Blurred vision; Thyroid inflamed; tingling all through out the whole body; blue hands/Black and blue mark swollen on calfs; Pain in right leg; Black and blue mark swollen on calfs; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on an unspecified date (at the age of 52-years-old) (Batch/Lot Number: 648543) as single dose for covid-19 immunisation. Medical history included hashimotos. Concomitant medications included ergocalciferol (VITAMIN D); cyanocobalamin (VITAMIN B12) received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was no pregnancy. The patient was no pregnancy at time of vaccination. Age at vaccination was 52 years. The patient experienced blurred vision, thyroid inflamed, tingling all through out the whole body, blue hands, pain in right leg and black and blue mark swollen on calfs on 15Apr2021. The events resulted in emergency room/department or urgent care. The patient was hospitalized for the events for 1 day. The report was serious with the seriousness criteria of hospitalization. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia, Peripheral swelling, Skin discolouration, Thyroiditis
Clinical narrative: Blurred vision; Thyroid inflamed; tingling all through out the whole body; blue hands/Black and blue mark swollen on calfs; Pain in right leg; Black and blue mark swollen on calfs; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on an unspecified date (at the age of 52-years-old) (Batch/Lot Number: 648543) as single dose for covid-19 immunisation. Medical history included hashimotos. Concomitant medications included ergocalciferol (VITAMIN D); cyanocobalamin (VITAMIN B12) received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was no pregnancy. The patient was no pregnancy at time of vaccination. Age at vaccination was 52 years. The patient experienced blurred vision, thyroid inflamed, tingling all through out the whole body, blue hands, pain in right leg and black and blue mark swollen on calfs on 15Apr2021. The events resulted in emergency room/department or urgent care. The patient was hospitalized for the events for 1 day. The report was serious with the seriousness criteria of hospitalization. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: Blurred vision; Thyroid inflamed; tingling all through out the whole body; blue hands/Black and blue mark swollen on calfs; Pain in right leg; Black and blue mark swollen on calfs; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received BNT162B2 (COVID-19 MRNA VACCINE BIONTECH), via an unspecified route of administration on an unspecified date (at the age of 52-years-old) (Batch/Lot Number: 648543) as single dose for covid-19 immunisation. Medical history included hashimotos. Concomitant medications included ergocalciferol (VITAMIN D); cyanocobalamin (VITAMIN B12) received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was no pregnancy. The patient was no pregnancy at time of vaccination. Age at vaccination was 52 years. The patient experienced blurred vision, thyroid inflamed, tingling all through out the whole body, blue hands, pain in right leg and black and blue mark swollen on calfs on 15Apr2021. The events resulted in emergency room/department or urgent care. The patient was hospitalized for the events for 1 day. The report was serious with the seriousness criteria of hospitalization. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Fatigue
Clinical narrative: treatment received for the adverse event?: Yes: Advil; Started to feel fatigue; fatigue/fatigue intense that prevent me to do habitual physical activity; This is a spontaneous report from a contactable consumer or other non hcp (patient).     A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: Unknown), via an unspecified route of administration, administered in left arm on 09Mar2021 at 09:30 (age at the time of vaccination: 46-year-old) as unknown, single dose for covid-19 immunization. The patient also received ibuprofen (ADVIL [IBUPROFEN]), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication.    Medical history included hypertension and allergy with shellfish. Patient not administered other vaccine in four weeks. Patient not had Covid prior vaccination; Patient was tested Covid post vaccination. Concomitant medications included losartan potassium (COZAAR), cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), vitamin d (VITAMIN D [VITAMIN D NOS]). On 14Mar2021 at 13:00 after vaccination, the patient experienced fatigue and received Advil for the treatment of adverse event. It was reported that the patient started to feel fatigue on 14Mar2021 (D5) but on Mar162021 (D7) fatigue intense that prevent him to do habitual physical activity. (Patient was an athlete preparing for a triathlon but 16Mar2021 and he was not able to finish a 4mile run, which was very simple to his fitness level. The outcome of the events was resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Drug interaction, Fatigue, Loss of personal independence in daily activities
Clinical narrative: treatment received for the adverse event?: Yes: Advil; Started to feel fatigue; fatigue/fatigue intense that prevent me to do habitual physical activity; This is a spontaneous report from a contactable consumer or other non hcp (patient).     A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: Unknown), via an unspecified route of administration, administered in left arm on 09Mar2021 at 09:30 (age at the time of vaccination: 46-year-old) as unknown, single dose for covid-19 immunization. The patient also received ibuprofen (ADVIL [IBUPROFEN]), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication.    Medical history included hypertension and allergy with shellfish. Patient not administered other vaccine in four weeks. Patient not had Covid prior vaccination; Patient was tested Covid post vaccination. Concomitant medications included losartan potassium (COZAAR), cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), vitamin d (VITAMIN D [VITAMIN D NOS]). On 14Mar2021 at 13:00 after vaccination, the patient experienced fatigue and received Advil for the treatment of adverse event. It was reported that the patient started to feel fatigue on 14Mar2021 (D5) but on Mar162021 (D7) fatigue intense that prevent him to do habitual physical activity. (Patient was an athlete preparing for a triathlon but 16Mar2021 and he was not able to finish a 4mile run, which was very simple to his fitness level. The outcome of the events was resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Insomnia, Tinnitus
Clinical narrative: JOINT PAIN; RINGING IN EARS; DIZZINESS; PAIN IN ARM; INABILITY TO SLEEP; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight was 132 pounds, and height was 66 inches. The patient's past medical history included car accident, and bad knee trauma, and concurrent conditions included dyslexia, alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: 25-MAY-2021) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced inability to sleep. On 18-MAR-2021, the subject experienced dizziness. On 18-MAR-2021, the subject experienced pain in arm. On APR-2021, the subject experienced ringing in ears. On JUN-2021, the subject experienced joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ringing in ears, and dizziness, and the outcome of pain in arm, joint pain and inability to sleep was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Dizziness, Insomnia, Pain in extremity, Tinnitus
Clinical narrative: JOINT PAIN; RINGING IN EARS; DIZZINESS; PAIN IN ARM; INABILITY TO SLEEP; This spontaneous report received from a patient concerned a 52 year old female. The patient's weight was 132 pounds, and height was 66 inches. The patient's past medical history included car accident, and bad knee trauma, and concurrent conditions included dyslexia, alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: 25-MAY-2021) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced inability to sleep. On 18-MAR-2021, the subject experienced dizziness. On 18-MAR-2021, the subject experienced pain in arm. On APR-2021, the subject experienced ringing in ears. On JUN-2021, the subject experienced joint pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ringing in ears, and dizziness, and the outcome of pain in arm, joint pain and inability to sleep was not reported. This report was non-serious.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac failure, Catheterisation cardiac abnormal, Chest discomfort, Coronary artery occlusion, Electrocardiogram abnormal
Clinical narrative: About 2 weeks after second dose, experienced heart attack with complete blockage of LAD artery, requiring cardiac catheterization with two stents.; This is a spontaneous report from a contactable consumer (patient).   A 35-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 29Apr2021 12:45 (Batch/Lot Number: EW0179) as single dose at the age of 35-year-old for COVID-19 immunisation, administered at School. Medical history included pre-diabetic. Patient had not COVID prior vaccination. Concomitant medication(s) included budesonide, formoterol fumarate (SYMBICORT, Inhaler) taken for an unspecified indication, start and stop date were not reported.  The patient previously took garlic [allium sativum] and experienced drug hypersensitivity. Vaccine history included bnt162b2 (BNT162B2), dose 1 in right arm on 08Apr2021 02:30 PM (Batch/Lot Number EW0158) for COVID-19 immunisation. No other vaccine in four weeks. About 2 weeks after second dose, on 12May2021 the patient experienced heart attack with complete blockage of LAD artery, requiring cardiac catheterization with two stents. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness. The event outcome was recovered with sequelae. The patient was hospitalized for the events for 4 days.  The patient underwent lab tests and procedures which included: Sars-cov-2 test (nasal swab): negative on 14May2021. Therapeutic measures were taken as a result of the event, which required cardiac catheterization with two stents.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Myocardial infarction, Stent placement
Clinical narrative: About 2 weeks after second dose, experienced heart attack with complete blockage of LAD artery, requiring cardiac catheterization with two stents.; This is a spontaneous report from a contactable consumer (patient).   A 35-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 29Apr2021 12:45 (Batch/Lot Number: EW0179) as single dose at the age of 35-year-old for COVID-19 immunisation, administered at School. Medical history included pre-diabetic. Patient had not COVID prior vaccination. Concomitant medication(s) included budesonide, formoterol fumarate (SYMBICORT, Inhaler) taken for an unspecified indication, start and stop date were not reported.  The patient previously took garlic [allium sativum] and experienced drug hypersensitivity. Vaccine history included bnt162b2 (BNT162B2), dose 1 in right arm on 08Apr2021 02:30 PM (Batch/Lot Number EW0158) for COVID-19 immunisation. No other vaccine in four weeks. About 2 weeks after second dose, on 12May2021 the patient experienced heart attack with complete blockage of LAD artery, requiring cardiac catheterization with two stents. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness. The event outcome was recovered with sequelae. The patient was hospitalized for the events for 4 days.  The patient underwent lab tests and procedures which included: Sars-cov-2 test (nasal swab): negative on 14May2021. Therapeutic measures were taken as a result of the event, which required cardiac catheterization with two stents.
Age: 35.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction, SARS-CoV-2 test negative
Clinical narrative: About 2 weeks after second dose, experienced heart attack with complete blockage of LAD artery, requiring cardiac catheterization with two stents.; This is a spontaneous report from a contactable consumer (patient).   A 35-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in arm left on 29Apr2021 12:45 (Batch/Lot Number: EW0179) as single dose at the age of 35-year-old for COVID-19 immunisation, administered at School. Medical history included pre-diabetic. Patient had not COVID prior vaccination. Concomitant medication(s) included budesonide, formoterol fumarate (SYMBICORT, Inhaler) taken for an unspecified indication, start and stop date were not reported.  The patient previously took garlic [allium sativum] and experienced drug hypersensitivity. Vaccine history included bnt162b2 (BNT162B2), dose 1 in right arm on 08Apr2021 02:30 PM (Batch/Lot Number EW0158) for COVID-19 immunisation. No other vaccine in four weeks. About 2 weeks after second dose, on 12May2021 the patient experienced heart attack with complete blockage of LAD artery, requiring cardiac catheterization with two stents. The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness. The event outcome was recovered with sequelae. The patient was hospitalized for the events for 4 days.  The patient underwent lab tests and procedures which included: Sars-cov-2 test (nasal swab): negative on 14May2021. Therapeutic measures were taken as a result of the event, which required cardiac catheterization with two stents.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody increased, Laboratory test, Ocular hyperaemia, White blood cell count increased
Clinical narrative: BILATERAL KNEE PAIN; MILD HEADACHE; SCLERITIS; This spontaneous report received from a consumer concerned a 37 year old Asian Not Hispanic or Latino female. The patient's weight was 124 pounds, and height was 160 centimeters. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included no known allergies drug, abuse or illicit drug usage and no pertinent medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A expiry: UNKNOWN) frequency 1 total dose was not reported, administered on left arm deltoid 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-May-2021, reporter explained that the patient developed mild headache and redness on the left corner of the left eye that looked like a clothing on the eye, it had mild pain, uncomfortable, no secretion and did not affect patient's vision. On 07-May-2021 patient went to eye doctor for a check up. Patient was prescribed prednisone eye drop but it did not work therefore was given prednisone tablet. Patient was also diagnosed with scleritis. Patient had blood work done and test results showed that WBC count was up and ANA was 1.8. On 10th-May-2021, patient also started feel pain on knees bilaterally when bending, the pain usually last 2-3 minutes. Patient was referred to a rheumatologist however the rheumatologist would not like to start any medication unless it is rule out that the side effect is due to the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from scleritis, bilateral knee pain, and mild headache. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210605970-COVID-19 VACCINE AD26.COV2.S-Scleritis. 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: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody, Arthralgia, Headache, Scleritis, White blood cell count
Clinical narrative: BILATERAL KNEE PAIN; MILD HEADACHE; SCLERITIS; This spontaneous report received from a consumer concerned a 37 year old Asian Not Hispanic or Latino female. The patient's weight was 124 pounds, and height was 160 centimeters. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included no known allergies drug, abuse or illicit drug usage and no pertinent medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 041A21A expiry: UNKNOWN) frequency 1 total dose was not reported, administered on left arm deltoid 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-May-2021, reporter explained that the patient developed mild headache and redness on the left corner of the left eye that looked like a clothing on the eye, it had mild pain, uncomfortable, no secretion and did not affect patient's vision. On 07-May-2021 patient went to eye doctor for a check up. Patient was prescribed prednisone eye drop but it did not work therefore was given prednisone tablet. Patient was also diagnosed with scleritis. Patient had blood work done and test results showed that WBC count was up and ANA was 1.8. On 10th-May-2021, patient also started feel pain on knees bilaterally when bending, the pain usually last 2-3 minutes. Patient was referred to a rheumatologist however the rheumatologist would not like to start any medication unless it is rule out that the side effect is due to the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from scleritis, bilateral knee pain, and mild headache. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210605970-COVID-19 VACCINE AD26.COV2.S-Scleritis. 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).