chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate abnormal, Presyncope, Thyroid function test, Troponin
Clinical narrative: Episode of atrial fibrillation; This is a spontaneous report from a contactable physician (patient).  A 60-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK4176), via an unspecified route of administration at Left arm on 13Jan2021 09:15 at SINGLE DOSE for COVID-19 immunization. The patient was not pregnant. Medical history included scoliosis and depression. Concomitant medications in two weeks included duloxetine hydrochloride (CYMBALTA), estradiol/norethisterone acetate (COMBIPATCH). Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number, EH9899) received on 20Dec2020 05:00 PM at left arm for COVID-19 immunization. The patient previously took codeine and experienced drug allergies. The patient experienced episode of atrial fibrillation on 17Jan2021 at 05:45 AM. No treatment received, no COVID prior vaccination. The outcome of the event was unknown.; Sender's Comments: Based on a compatible temporal relationship, causality between event episode of atrial fibrillation and BNT162B2 vaccine 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: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Episode of atrial fibrillation; This is a spontaneous report from a contactable physician (patient).  A 60-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK4176), via an unspecified route of administration at Left arm on 13Jan2021 09:15 at SINGLE DOSE for COVID-19 immunization. The patient was not pregnant. Medical history included scoliosis and depression. Concomitant medications in two weeks included duloxetine hydrochloride (CYMBALTA), estradiol/norethisterone acetate (COMBIPATCH). Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number, EH9899) received on 20Dec2020 05:00 PM at left arm for COVID-19 immunization. The patient previously took codeine and experienced drug allergies. The patient experienced episode of atrial fibrillation on 17Jan2021 at 05:45 AM. No treatment received, no COVID prior vaccination. The outcome of the event was unknown.; Sender's Comments: Based on a compatible temporal relationship, causality between event episode of atrial fibrillation and BNT162B2 vaccine 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: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram cerebral, Balance disorder, Computerised tomogram head, Laboratory test, Magnetic resonance imaging brain
Clinical narrative: lost all sense of balance; developed very severe migraines; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EJ1685, on 21Dec2020 13:00 at single dose in right arm for COVID-19 immunization. Medical history included Hypertension, Depression, PCN allergy, Topical Iodine allergy. The patient was not Pregnant at the time of vaccination. Concomitant medications included metoprolol, HCTZ, bupropion hydrochloride (WELLBUTRIN), methylphenidate hydrochloride (CONCERTA), omeprazole (PRILOSEC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Approximately eight days after receiving the Pfizer Covid vaccine, the patient lost all sense of balance on 30Dec2020. She developed very severe migraines. She was hospitalized for four days. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. She was on multiple doses of steroids. She was now starting IV I G infusions. Treatment received for the events included Relpax, steroids, IV Infusions. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had been tested for COVID-19 since the vaccination. Lab data included Nasal Swab: negative on 30Dec2020.  The outcome of both events was not resolved.; Sender's Comments: Based on the available information causality between events lost all sense of balance and very severe migraines and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine
Clinical narrative: lost all sense of balance; developed very severe migraines; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EJ1685, on 21Dec2020 13:00 at single dose in right arm for COVID-19 immunization. Medical history included Hypertension, Depression, PCN allergy, Topical Iodine allergy. The patient was not Pregnant at the time of vaccination. Concomitant medications included metoprolol, HCTZ, bupropion hydrochloride (WELLBUTRIN), methylphenidate hydrochloride (CONCERTA), omeprazole (PRILOSEC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Approximately eight days after receiving the Pfizer Covid vaccine, the patient lost all sense of balance on 30Dec2020. She developed very severe migraines. She was hospitalized for four days. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. She was on multiple doses of steroids. She was now starting IV I G infusions. Treatment received for the events included Relpax, steroids, IV Infusions. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had been tested for COVID-19 since the vaccination. Lab data included Nasal Swab: negative on 30Dec2020.  The outcome of both events was not resolved.; Sender's Comments: Based on the available information causality between events lost all sense of balance and very severe migraines and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Immunoglobulin therapy, Migraine, SARS-CoV-2 test negative
Clinical narrative: lost all sense of balance; developed very severe migraines; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EJ1685, on 21Dec2020 13:00 at single dose in right arm for COVID-19 immunization. Medical history included Hypertension, Depression, PCN allergy, Topical Iodine allergy. The patient was not Pregnant at the time of vaccination. Concomitant medications included metoprolol, HCTZ, bupropion hydrochloride (WELLBUTRIN), methylphenidate hydrochloride (CONCERTA), omeprazole (PRILOSEC). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Approximately eight days after receiving the Pfizer Covid vaccine, the patient lost all sense of balance on 30Dec2020. She developed very severe migraines. She was hospitalized for four days. The events resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. She was on multiple doses of steroids. She was now starting IV I G infusions. Treatment received for the events included Relpax, steroids, IV Infusions. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had been tested for COVID-19 since the vaccination. Lab data included Nasal Swab: negative on 30Dec2020.  The outcome of both events was not resolved.; Sender's Comments: Based on the available information causality between events lost all sense of balance and very severe migraines and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Wheezing
Clinical narrative: The patient stated that she received the vaccine and return to her area of work. Within 40 min she began to experience wheezing and shortness of breath. She then proceeded to our ER and was evaluated. She was given steroids and a breathing treatment as well as was discharge with a 7 day prednisone taper.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Feeling abnormal, Musculoskeletal stiffness
Clinical narrative: mental fogginess; fatigue; muscle tightness/aches; muscle tightness/aches; This is a spontaneous report from a contactable pharmacist (patient). A 31-year-old female patient (not pregnant at the time of vaccination) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on 20Jan2021 01:30 PM (vaccine location: Left arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on 30Dec2020 04:00 PM (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's medical history included controlled asthma and obesity. The concomitant medications were reported as fluticasone nasal, prenatal, colecalciferol (Vit D3) 5000 IU. There was no other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced fatigue, mental fogginess, muscle tightness/aches on 21Jan2021 11:00 AM. The outcome of events was recovering after self-administered ibuprofen 800 mg x1.  Information on the batch/Lot number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Muscle tightness, Myalgia
Clinical narrative: mental fogginess; fatigue; muscle tightness/aches; muscle tightness/aches; This is a spontaneous report from a contactable pharmacist (patient). A 31-year-old female patient (not pregnant at the time of vaccination) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on 20Jan2021 01:30 PM (vaccine location: Left arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on 30Dec2020 04:00 PM (vaccine location: Left arm) at single dose for COVID-19 immunisation. The patient's medical history included controlled asthma and obesity. The concomitant medications were reported as fluticasone nasal, prenatal, colecalciferol (Vit D3) 5000 IU. There was no other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced fatigue, mental fogginess, muscle tightness/aches on 21Jan2021 11:00 AM. The outcome of events was recovering after self-administered ibuprofen 800 mg x1.  Information on the batch/Lot number has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Injection Site Pain/Muscle Pain- ongoing soreness; Injection Site Pain/Muscle Pain- ongoing soreness; General Fatigue; Headache; Chills; Chest Pain; Fever; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A 23-year-old female patient received second dose of bnt162b2 (manufacturer: Pfizer, lot number and expiration date: unknown), via an unspecified route of administration on her left arm on 21Jan2021 09:45 at single dose for covid-19 immunization. The patient's medical history included anaemia from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took the first dose of bnt162b2 on 02Jan2021 for covid-19 immunization. On 22Jan2021 at 00:30, the patient experienced injection site pain/muscle pain-ongoing soreness, general fatigue, headache, chills, chest pain, and fever. 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 events was recovering.  Information on the lot/batch number has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia
Clinical narrative: Injection Site Pain/Muscle Pain- ongoing soreness; Injection Site Pain/Muscle Pain- ongoing soreness; General Fatigue; Headache; Chills; Chest Pain; Fever; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A 23-year-old female patient received second dose of bnt162b2 (manufacturer: Pfizer, lot number and expiration date: unknown), via an unspecified route of administration on her left arm on 21Jan2021 09:45 at single dose for covid-19 immunization. The patient's medical history included anaemia from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took the first dose of bnt162b2 on 02Jan2021 for covid-19 immunization. On 22Jan2021 at 00:30, the patient experienced injection site pain/muscle pain-ongoing soreness, general fatigue, headache, chills, chest pain, and fever. 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 events was recovering.  Information on the lot/batch number has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Injection Site Pain/Muscle Pain- ongoing soreness; Injection Site Pain/Muscle Pain- ongoing soreness; General Fatigue; Headache; Chills; Chest Pain; Fever; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A 23-year-old female patient received second dose of bnt162b2 (manufacturer: Pfizer, lot number and expiration date: unknown), via an unspecified route of administration on her left arm on 21Jan2021 09:45 at single dose for covid-19 immunization. The patient's medical history included anaemia from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took the first dose of bnt162b2 on 02Jan2021 for covid-19 immunization. On 22Jan2021 at 00:30, the patient experienced injection site pain/muscle pain-ongoing soreness, general fatigue, headache, chills, chest pain, and fever. 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 events was recovering.  Information on the lot/batch number has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Injection Site Pain/Muscle Pain- ongoing soreness; Injection Site Pain/Muscle Pain- ongoing soreness; General Fatigue; Headache; Chills; Chest Pain; Fever; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A 23-year-old female patient received second dose of bnt162b2 (manufacturer: Pfizer, lot number and expiration date: unknown), via an unspecified route of administration on her left arm on 21Jan2021 09:45 at single dose for covid-19 immunization. The patient's medical history included anaemia from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took the first dose of bnt162b2 on 02Jan2021 for covid-19 immunization. On 22Jan2021 at 00:30, the patient experienced injection site pain/muscle pain-ongoing soreness, general fatigue, headache, chills, chest pain, and fever. 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 events was recovering.  Information on the lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Hyperhidrosis, Migraine, Pain, Photophobia
Clinical narrative: body aches; chills; sweats; migraine; light sensitivity; This is a spontaneous report from a contactable healthcare professional (patient). A 28-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), intramuscular on left arm on 20Jan2021 at 13:00 at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not allergic to medications, foods, or other products. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and multivitamin. The patient was not pregnant at the time of vaccination. The vaccine was administered at the patient's workplace clinic. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced body aches, chills, sweats, migraine, and light sensitivity, all on 21Jan2021 at 09:00. She did not receive any treatment for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination. The outcome of the events was recovered on Jan2021.   No follow-up attempts are possible. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Hyperhidrosis, Migraine, Pain, Photosensitivity reaction
Clinical narrative: body aches; chills; sweats; migraine; light sensitivity; This is a spontaneous report from a contactable healthcare professional (patient). A 28-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), intramuscular on left arm on 20Jan2021 at 13:00 at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not allergic to medications, foods, or other products. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) and multivitamin. The patient was not pregnant at the time of vaccination. The vaccine was administered at the patient's workplace clinic. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced body aches, chills, sweats, migraine, and light sensitivity, all on 21Jan2021 at 09:00. She did not receive any treatment for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19 and has not been tested for COVID-19 since the vaccination. The outcome of the events was recovered on Jan2021.   No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Headache, Myalgia & Fever Narrative:
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: Headache, Myalgia & Fever Narrative:
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: severe itchiness from waist up - behind ears, head, back, neck, shoulders; This is a spontaneous report from a contactable consumer (patient) reported for herself.  A 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL9261) on 21Jan2021 at 12:45 at single dose in Left arm for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), asthma, osteopenia/porosus and sulfa allergy.  Patient was not pregnant. Concomitant medication included fluticasone propionate (FLONASE); nitrofurantoin (MACRODANTIN); alendronate sodium; budesonide/ formoterol fumarate (SYMBICORT); dupilumab (DUPIXENT) from12Jan2021. On 22Jan2021 the patient experienced severe itchiness from waist up - behind ears, head, back, neck, shoulders.  Case is reported as non serious. No treatment administered for the adverse event. Outcome of the event was not recovered.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Balance disorder, Chest discomfort, Chills, Dizziness
Clinical narrative: Fuzzy; Unsteady; Weak/Not very energic/Fatigued; Lightheaded/Dizzy; Chest tight; My eyed began swimming with a sensatoin of shutters being opened and closed in front of me/could not see very well; Eyes very photosensitive; Chills; Headache; This is a spontaneous report from a contactable consumer (patient).  This 68-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unknown route, on 14Jan2021 (at 08:30) at single dose on the left arm for COVID-19 immunization. Relevant medical history included orthostatic intolerance, myalgic encephalomyelitis and chronic fatigue syndrome (ME/CFS). Relevant concomitant medications included hydrocortisone (CORTEF), levothyroxine sodium (SYNTHROID), fludrocortisone acetate (FLUDROCORTISON) and pyridostigmine. No other vaccine was received in four weeks. On 14Jan2021, after vaccination, she began to feel unsteady, weak, lightheaded, chest tight, and dizzy. Her eyed began swimming with a sensation of shutters being opened and closed in front of her. She could not see very well, eyes were very photosensitive. Layed down and slept, rested in a dark room most of the day. She had also chills and headache. But nightfall she felt mostly recovered, although not very energetic. About one week later, on 20Jan2021, it all happened again, all at once. She also rested for the day and slowly recovered. But this time it hasn't all gone away. She is still weak, fuzzy, unsteady, fatigued, she had headache, and 'my eyes are not right' (as reported). Pre-vaccination and post-vaccination COVID tests were not performed. No treatments were given for the events. The outcome of the events 'unsteady', 'weak/not very energic/fatigued', 'Lightheaded/Dizzy', and 'chest tight' was not recovered while the outcome of the remaining events was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye disorder, Eye pain, Feeling abnormal, Impaired driving ability, Malaise
Clinical narrative: Fuzzy; Unsteady; Weak/Not very energic/Fatigued; Lightheaded/Dizzy; Chest tight; My eyed began swimming with a sensatoin of shutters being opened and closed in front of me/could not see very well; Eyes very photosensitive; Chills; Headache; This is a spontaneous report from a contactable consumer (patient).  This 68-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unknown route, on 14Jan2021 (at 08:30) at single dose on the left arm for COVID-19 immunization. Relevant medical history included orthostatic intolerance, myalgic encephalomyelitis and chronic fatigue syndrome (ME/CFS). Relevant concomitant medications included hydrocortisone (CORTEF), levothyroxine sodium (SYNTHROID), fludrocortisone acetate (FLUDROCORTISON) and pyridostigmine. No other vaccine was received in four weeks. On 14Jan2021, after vaccination, she began to feel unsteady, weak, lightheaded, chest tight, and dizzy. Her eyed began swimming with a sensation of shutters being opened and closed in front of her. She could not see very well, eyes were very photosensitive. Layed down and slept, rested in a dark room most of the day. She had also chills and headache. But nightfall she felt mostly recovered, although not very energetic. About one week later, on 20Jan2021, it all happened again, all at once. She also rested for the day and slowly recovered. But this time it hasn't all gone away. She is still weak, fuzzy, unsteady, fatigued, she had headache, and 'my eyes are not right' (as reported). Pre-vaccination and post-vaccination COVID tests were not performed. No treatments were given for the events. The outcome of the events 'unsteady', 'weak/not very energic/fatigued', 'Lightheaded/Dizzy', and 'chest tight' was not recovered while the outcome of the remaining events was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ophthalmological examination normal, Photopsia, Photosensitivity reaction, Tremor, Vision blurred
Clinical narrative: Fuzzy; Unsteady; Weak/Not very energic/Fatigued; Lightheaded/Dizzy; Chest tight; My eyed began swimming with a sensatoin of shutters being opened and closed in front of me/could not see very well; Eyes very photosensitive; Chills; Headache; This is a spontaneous report from a contactable consumer (patient).  This 68-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unknown route, on 14Jan2021 (at 08:30) at single dose on the left arm for COVID-19 immunization. Relevant medical history included orthostatic intolerance, myalgic encephalomyelitis and chronic fatigue syndrome (ME/CFS). Relevant concomitant medications included hydrocortisone (CORTEF), levothyroxine sodium (SYNTHROID), fludrocortisone acetate (FLUDROCORTISON) and pyridostigmine. No other vaccine was received in four weeks. On 14Jan2021, after vaccination, she began to feel unsteady, weak, lightheaded, chest tight, and dizzy. Her eyed began swimming with a sensation of shutters being opened and closed in front of her. She could not see very well, eyes were very photosensitive. Layed down and slept, rested in a dark room most of the day. She had also chills and headache. But nightfall she felt mostly recovered, although not very energetic. About one week later, on 20Jan2021, it all happened again, all at once. She also rested for the day and slowly recovered. But this time it hasn't all gone away. She is still weak, fuzzy, unsteady, fatigued, she had headache, and 'my eyes are not right' (as reported). Pre-vaccination and post-vaccination COVID tests were not performed. No treatments were given for the events. The outcome of the events 'unsteady', 'weak/not very energic/fatigued', 'Lightheaded/Dizzy', and 'chest tight' was not recovered while the outcome of the remaining events was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chest discomfort, Chills, Dizziness, Eye disorder
Clinical narrative: Fuzzy; Unsteady; Weak/Not very energic/Fatigued; Lightheaded/Dizzy; Chest tight; My eyed began swimming with a sensatoin of shutters being opened and closed in front of me/could not see very well; Eyes very photosensitive; Chills; Headache; This is a spontaneous report from a contactable consumer (patient).  This 68-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unknown route, on 14Jan2021 (at 08:30) at single dose on the left arm for COVID-19 immunization. Relevant medical history included orthostatic intolerance, myalgic encephalomyelitis and chronic fatigue syndrome (ME/CFS). Relevant concomitant medications included hydrocortisone (CORTEF), levothyroxine sodium (SYNTHROID), fludrocortisone acetate (FLUDROCORTISON) and pyridostigmine. No other vaccine was received in four weeks. On 14Jan2021, after vaccination, she began to feel unsteady, weak, lightheaded, chest tight, and dizzy. Her eyed began swimming with a sensation of shutters being opened and closed in front of her. She could not see very well, eyes were very photosensitive. Layed down and slept, rested in a dark room most of the day. She had also chills and headache. But nightfall she felt mostly recovered, although not very energetic. About one week later, on 20Jan2021, it all happened again, all at once. She also rested for the day and slowly recovered. But this time it hasn't all gone away. She is still weak, fuzzy, unsteady, fatigued, she had headache, and 'my eyes are not right' (as reported). Pre-vaccination and post-vaccination COVID tests were not performed. No treatments were given for the events. The outcome of the events 'unsteady', 'weak/not very energic/fatigued', 'Lightheaded/Dizzy', and 'chest tight' was not recovered while the outcome of the remaining events was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Headache, Malaise, Photophobia
Clinical narrative: Fuzzy; Unsteady; Weak/Not very energic/Fatigued; Lightheaded/Dizzy; Chest tight; My eyed began swimming with a sensatoin of shutters being opened and closed in front of me/could not see very well; Eyes very photosensitive; Chills; Headache; This is a spontaneous report from a contactable consumer (patient).  This 68-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unknown route, on 14Jan2021 (at 08:30) at single dose on the left arm for COVID-19 immunization. Relevant medical history included orthostatic intolerance, myalgic encephalomyelitis and chronic fatigue syndrome (ME/CFS). Relevant concomitant medications included hydrocortisone (CORTEF), levothyroxine sodium (SYNTHROID), fludrocortisone acetate (FLUDROCORTISON) and pyridostigmine. No other vaccine was received in four weeks. On 14Jan2021, after vaccination, she began to feel unsteady, weak, lightheaded, chest tight, and dizzy. Her eyed began swimming with a sensation of shutters being opened and closed in front of her. She could not see very well, eyes were very photosensitive. Layed down and slept, rested in a dark room most of the day. She had also chills and headache. But nightfall she felt mostly recovered, although not very energetic. About one week later, on 20Jan2021, it all happened again, all at once. She also rested for the day and slowly recovered. But this time it hasn't all gone away. She is still weak, fuzzy, unsteady, fatigued, she had headache, and 'my eyes are not right' (as reported). Pre-vaccination and post-vaccination COVID tests were not performed. No treatments were given for the events. The outcome of the events 'unsteady', 'weak/not very energic/fatigued', 'Lightheaded/Dizzy', and 'chest tight' was not recovered while the outcome of the remaining events was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Headache, Injection site pain, Pain
Clinical narrative: fever 102F; headache; chills; body aches, joint pain, injections site pain; joint pain; injections site pain; patient received the second dose of BNT162B2, which was 23 days after the first dose; This is a spontaneous report from a contactable pharmacist, the patient.  A 52-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247), via an unspecified route of administration in the left arm on 22Jan2021 at 07:45 (at the age of 52-years-old) as a single dose for COVID-19 immunization.   The patient's medical history and concomitant medications were not reported.  The patient did not have any allergies to medications, food, or other products. 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 previously received the first dose of BNT162B2 (Lot Number: EL1284) on 30Dec2020 at 16:00 (at the age of 52-years-old) in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination (except the first dose). On 22Jan2021 at 07:45, the patient received the second dose of BNT162B2, which was 23 days after the first dose. On 22Jan2021 at 18:00, the patient experienced fever of 102 degrees Fahrenheit, headache, chills, body aches, joint pain, and injections site pain. Therapeutic measures were taken for the fever, headache, chills, body aches, joint pain, and injections site pain and included treatment with acetaminophen (TYLENOL) orally at 650 mg. The clinical outcomes of the fever, headache, chills, body aches, joint pain, and injections site pain were recovered in Jan2021.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: fever 102F; headache; chills; body aches, joint pain, injections site pain; joint pain; injections site pain; patient received the second dose of BNT162B2, which was 23 days after the first dose; This is a spontaneous report from a contactable pharmacist, the patient.  A 52-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247), via an unspecified route of administration in the left arm on 22Jan2021 at 07:45 (at the age of 52-years-old) as a single dose for COVID-19 immunization.   The patient's medical history and concomitant medications were not reported.  The patient did not have any allergies to medications, food, or other products. 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 previously received the first dose of BNT162B2 (Lot Number: EL1284) on 30Dec2020 at 16:00 (at the age of 52-years-old) in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination (except the first dose). On 22Jan2021 at 07:45, the patient received the second dose of BNT162B2, which was 23 days after the first dose. On 22Jan2021 at 18:00, the patient experienced fever of 102 degrees Fahrenheit, headache, chills, body aches, joint pain, and injections site pain. Therapeutic measures were taken for the fever, headache, chills, body aches, joint pain, and injections site pain and included treatment with acetaminophen (TYLENOL) orally at 650 mg. The clinical outcomes of the fever, headache, chills, body aches, joint pain, and injections site pain were recovered in Jan2021.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Inappropriate schedule of product administration
Clinical narrative: fever 102F; headache; chills; body aches, joint pain, injections site pain; joint pain; injections site pain; patient received the second dose of BNT162B2, which was 23 days after the first dose; This is a spontaneous report from a contactable pharmacist, the patient.  A 52-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247), via an unspecified route of administration in the left arm on 22Jan2021 at 07:45 (at the age of 52-years-old) as a single dose for COVID-19 immunization.   The patient's medical history and concomitant medications were not reported.  The patient did not have any allergies to medications, food, or other products. 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 previously received the first dose of BNT162B2 (Lot Number: EL1284) on 30Dec2020 at 16:00 (at the age of 52-years-old) in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination (except the first dose). On 22Jan2021 at 07:45, the patient received the second dose of BNT162B2, which was 23 days after the first dose. On 22Jan2021 at 18:00, the patient experienced fever of 102 degrees Fahrenheit, headache, chills, body aches, joint pain, and injections site pain. Therapeutic measures were taken for the fever, headache, chills, body aches, joint pain, and injections site pain and included treatment with acetaminophen (TYLENOL) orally at 650 mg. The clinical outcomes of the fever, headache, chills, body aches, joint pain, and injections site pain were recovered in Jan2021.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: fever 102F; headache; chills; body aches, joint pain, injections site pain; joint pain; injections site pain; patient received the second dose of BNT162B2, which was 23 days after the first dose; This is a spontaneous report from a contactable pharmacist, the patient.  A 52-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247), via an unspecified route of administration in the left arm on 22Jan2021 at 07:45 (at the age of 52-years-old) as a single dose for COVID-19 immunization.   The patient's medical history and concomitant medications were not reported.  The patient did not have any allergies to medications, food, or other products. 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 previously received the first dose of BNT162B2 (Lot Number: EL1284) on 30Dec2020 at 16:00 (at the age of 52-years-old) in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination (except the first dose). On 22Jan2021 at 07:45, the patient received the second dose of BNT162B2, which was 23 days after the first dose. On 22Jan2021 at 18:00, the patient experienced fever of 102 degrees Fahrenheit, headache, chills, body aches, joint pain, and injections site pain. Therapeutic measures were taken for the fever, headache, chills, body aches, joint pain, and injections site pain and included treatment with acetaminophen (TYLENOL) orally at 650 mg. The clinical outcomes of the fever, headache, chills, body aches, joint pain, and injections site pain were recovered in Jan2021.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Pericarditis, Pyrexia
Clinical narrative: pericarditis; This is a spontaneous from a contactable physician reporting for himself. A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231, expiry date unknown) via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 19Jan2021, the patient developed pericarditis. The physician considered it was possible complication from his first dose of the COVID-19 vaccine. The outcome of the event was not reported. His second dose was scheduled for 27Jan2021.; Sender's Comments: Based on the limited information available, causality between event pericarditis and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pericarditis
Clinical narrative: pericarditis; This is a spontaneous from a contactable physician reporting for himself. A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231, expiry date unknown) via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 19Jan2021, the patient developed pericarditis. The physician considered it was possible complication from his first dose of the COVID-19 vaccine. The outcome of the event was not reported. His second dose was scheduled for 27Jan2021.; Sender's Comments: Based on the limited information available, causality between event pericarditis and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Muscle atrophy, Neuralgic amyotrophy, Pain in extremity, Radiculitis brachial
Clinical narrative: Employee experienced soreness post vaccination on 1/5/21 with fatigue, myalgia, chills that resolved after 24 hours.  However, developed increase of pain in Left Shoulder on 1/9/21. Pain is intermittent but progressive with a peak of excruciating pain on 1/16/21.  Now pain is persistent.  Developed weakness in Lt arm as well.  Employee completed a self-exam, noticing muscle atrophy in deltoid/bicep, along with other symptoms that fits Parsonage Turner Syndrome.  Employee made arrangements to see PCP prior to calling Call Center for treatment.  However, Employee wanted to call the Call Center to report the specifics of side effects post Vaccination (very isolated/specific to Vaccination Site/Arm).
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Employee experienced soreness post vaccination on 1/5/21 with fatigue, myalgia, chills that resolved after 24 hours.  However, developed increase of pain in Left Shoulder on 1/9/21. Pain is intermittent but progressive with a peak of excruciating pain on 1/16/21.  Now pain is persistent.  Developed weakness in Lt arm as well.  Employee completed a self-exam, noticing muscle atrophy in deltoid/bicep, along with other symptoms that fits Parsonage Turner Syndrome.  Employee made arrangements to see PCP prior to calling Call Center for treatment.  However, Employee wanted to call the Call Center to report the specifics of side effects post Vaccination (very isolated/specific to Vaccination Site/Arm).
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Muscle atrophy, Neuralgic amyotrophy, Pain, Radiculitis brachial
Clinical narrative: Employee experienced soreness post vaccination on 1/5/21 with fatigue, myalgia, chills that resolved after 24 hours.  However, developed increase of pain in Left Shoulder on 1/9/21. Pain is intermittent but progressive with a peak of excruciating pain on 1/16/21.  Now pain is persistent.  Developed weakness in Lt arm as well.  Employee completed a self-exam, noticing muscle atrophy in deltoid/bicep, along with other symptoms that fits Parsonage Turner Syndrome.  Employee made arrangements to see PCP prior to calling Call Center for treatment.  However, Employee wanted to call the Call Center to report the specifics of side effects post Vaccination (very isolated/specific to Vaccination Site/Arm).
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chills, Fatigue, Injection site pain, Muscle atrophy, Muscular weakness
Clinical narrative: Employee experienced soreness post vaccination on 1/5/21 with fatigue, myalgia, chills that resolved after 24 hours.  However, developed increase of pain in Left Shoulder on 1/9/21. Pain is intermittent but progressive with a peak of excruciating pain on 1/16/21.  Now pain is persistent.  Developed weakness in Lt arm as well.  Employee completed a self-exam, noticing muscle atrophy in deltoid/bicep, along with other symptoms that fits Parsonage Turner Syndrome.  Employee made arrangements to see PCP prior to calling Call Center for treatment.  However, Employee wanted to call the Call Center to report the specifics of side effects post Vaccination (very isolated/specific to Vaccination Site/Arm).
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Myalgia, Neuralgic amyotrophy, Pain, Pain in extremity
Clinical narrative: Employee experienced soreness post vaccination on 1/5/21 with fatigue, myalgia, chills that resolved after 24 hours.  However, developed increase of pain in Left Shoulder on 1/9/21. Pain is intermittent but progressive with a peak of excruciating pain on 1/16/21.  Now pain is persistent.  Developed weakness in Lt arm as well.  Employee completed a self-exam, noticing muscle atrophy in deltoid/bicep, along with other symptoms that fits Parsonage Turner Syndrome.  Employee made arrangements to see PCP prior to calling Call Center for treatment.  However, Employee wanted to call the Call Center to report the specifics of side effects post Vaccination (very isolated/specific to Vaccination Site/Arm).
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: small bump at site with redness and mild itchiness; small bump at site with redness and mild itchiness; small bump at site with redness and mild itchiness; This is a spontaneous report from a contactable other health professional (patient). A 26-year-old female patient was administered the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), intramuscular (left arm) on 17Jan2021 16:30 at single dose for Covid-19 immunization. The patient was administered the first dose of BNT162B2 (lot number: EL0140) on 29Dec2020 at left arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE). The patient previously took Amoxicillin and experienced allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Jan2021 (also reported as "day 6 post vaccine"), the patient experienced small bump at site with redness and mild itchiness. There was no treatment received for the adverse event. The outcome of events was unknown. The outcome of events was unknown. The patient has not been tested for COVID-19 since the vaccination.