chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness postural, Fatigue, Hypersensitivity, Sinus disorder
Clinical narrative: Allergies; Sinus problems; Dizziness when he is up and moving around; Equilibrium is off; Fatigued; This is a spontaneous report from a contactable consumer (patient who is a transit operator). A 62-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN5318), via an unspecified route of administration in right arm, on 25Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history included ongoing urinary incontinence (use of medication that does not make him run to the bathroom and helps him hold his urine), ongoing acne, drowsy, and ongoing flow of urine or weak bladder. The patient's concomitant medications included fesoterodine fumarate (TOVIAZ; Expiration Date: 04Dec2021) (about 2 weeks prior to getting the COVID-19 vaccine) for urinary incontinence, doxycycline (Expiration Date: 26Nov2021; makes him drowsy) for acne, and tamsulosin (Expiration Date: 12Nov2021) for flow of urine or weak bladder; all from Jan2021 and ongoing. The patient does not take any of these medications while driving. The patient took his first Pfizer COVID-19 shot on 25Jan2021 (Monday). The patient had been experiencing dizziness which started a few days after getting the vaccine (Jan2021). The patient was supposed to work from Tuesday to Friday, but he did not go into work on Wednesday. The patient was unsure of the specific day the dizziness started. The patient did have allergies (unspecified date), but when he called in his doctor, he sent him a medication for allergies, meclizine (Expiration Date: 28Jan2022). Normally, the medication takes a couple days to make him feel better. After he took meclizine for dizziness, he feels better. The patient notices the dizziness when he is up and moving around. The patient can tell something is off, like his equilibrium is off in Jan2021. It may not be due to the shot, but looking at the paper it says tiredness, which he has been feeling fatigued (also started a few days after the vaccine, but he is unsure specifically what day) and dizziness, which he has in Jan2021. The medication he is taking (meclizine), can also do the same thing, but never for this long. When he takes it, it normally makes him feel better after a few days. The patient has sinus problems as well on an unspecified date, but never lasting this long. The patient had not started feeling better since taking the medication, meclizine (as reported). The patient also said that meclizine could be causing the fatigue because it does make his drowsy and he just sleeps when he takes it - he cannot take it when he drives. The patient would go back for the second dose on 15Feb2021. The patient was recovering from "Dizziness when he is up and moving around". The outcome of "Allergies" was unknown. The patient had not recovered from the remaining events.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: headache; mild intermittent fatigue; This is a spontaneous report from a non-contactable consumer (patient himself). A 63-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6201), intramuscularly in left arm on 07Feb2021 11:30 AM at single dose for COVID-19 immunization in facility type other. The patient's medical history included heart disease, type 2 diabetes mellitus, throat cancer. The patient did not have allergies to medications, food, or other products. Concomitant medications included atorvastatin calcium (LIPITOR) at 40 mg daily, clopidogrel bisulfate (PLAVIX) at 75 mg daily, metformin at 500 mg daily, lisinopril at 5 mg daily, ascorbic acid, betacarotene, biotin, calcium carbonate, calcium pantothenate, chromic chloride, colecalciferol, copper sulfate, cyanocobalamin, ferrous fumarate, folic acid, lycopene, magnesium oxide, manganese sulfate, nicotinamide, phytomenadione, potassium chloride, potassium iodide, pyridoxine hydrochloride, retinol acetate, riboflavin, sodium molybdate, sodium selenate, thiamine mononitrate, tocopheryl acetate, xantofyl, zinc oxide (CENTRUM FORTE) at 1 DF (Dosage Form) daily. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. On 07Feb2021 13:00, the patient experienced headache post dose x 1-2 hours (resolved after taking a short nap) and mild intermittent fatigue post dose x 4 days (recovering). The events were considered as non-serious by the consumer. No treatment received for the adverse events. The outcome of the event headache was resolved on 07Feb2021 and recovering for the other event.   No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, SARS-CoV-2 antibody test
Clinical narrative: Blood pressure feels really high; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 16Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history included COVID-19 virus in the past year (2020) from which her husband died last year (2020), receiving occupation therapy (OT) at home, and stroke (in the past). The patient's concomitant medications were not reported. The patient received her first Pfizer COVID-19 vaccine dose on 16Jan2021 and is scheduled to receive her next COVID-19 vaccine booster on 06Feb2021. The last time the patient had her COVID-19 virus antibody blood work was on 11Jan2021, and her COVID-19 virus antibodies were down to 1.9 from 8 (on an unspecified date). The patient's COVID-19 virus antibodies have been progressively going down since she was first being tested for them. The patient received a call today that her occupational therapist tested positive for the COVID-19 virus. Both her occupational therapist and she were wearing masks when working together. The patient received the call today because she was exposed to the occupational therapist. The patient asked if she can still take the COVID-19 vaccine booster that she is scheduled for on Saturday (06Feb2021). The patient really wanted to get the COVID-19 vaccine booster on 06Feb2021. The patient was going to be speaking with a trained healthcare professional when she is transferred to Pfizer medical information. Anyone the patient has spoken to about getting her second COVID-19 vaccine has not been willing to answer her questions. The patient's blood pressure feels really high now (02Feb2021), and she has had a stroke in the past. The outcome of the event was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Pain in extremity
Clinical narrative: Arm is slightly stiff; Muscle is slightly sore; Sore arms; just little tender; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 01Feb2021, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included medroxyprogesterone and estradiol. The patient previously took the first dose of BNT162B2 in Jan2021 for COVID-19 immunization (got the first shot exactly 3 weeks before for which the patient was not sure of the date). On 01Feb2021, just shortly after the patient and his husband both got the shot, the patient had sore arms by the time they drove home yesterday afternoon. The patient's sore arm was much better today but it was still just little tender - that is the only thing she had. Currently (02Feb2021), the patient's arm was slightly stiff still, just the muscle is slightly sore. No treatment was taken for the adverse events. The patient was recovering from "Sore arms; just little tender". The outcome of the other events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm is slightly stiff; Muscle is slightly sore; Sore arms; just little tender; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 01Feb2021, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included medroxyprogesterone and estradiol. The patient previously took the first dose of BNT162B2 in Jan2021 for COVID-19 immunization (got the first shot exactly 3 weeks before for which the patient was not sure of the date). On 01Feb2021, just shortly after the patient and his husband both got the shot, the patient had sore arms by the time they drove home yesterday afternoon. The patient's sore arm was much better today but it was still just little tender - that is the only thing she had. Currently (02Feb2021), the patient's arm was slightly stiff still, just the muscle is slightly sore. No treatment was taken for the adverse events. The patient was recovering from "Sore arms; just little tender". The outcome of the other events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abnormal dreams, Chills, Fatigue, Headache, Peripheral coldness
Clinical narrative: shivering/having in and out chills; slight fever; fever, headache, dry heaves, fatigue, and crazy dreams; Adding strange dreams/crazy dreams/ so vivid and frightening that he was afraid to go to sleep over fear that he would never wake up; hands were cold; headache fades in and out; Dry heaves; This is a spontaneous report from a contactable consumer, the patient. A 78-years-old male patient received the second dose  of  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EM5318,  via an unspecified route of administration in the right arm on  08Feb2021 at 11:45 (at the age of 78-years-old)  as a SINGLE DOSE for Covid-19 Vaccination.  Historical vaccine includes BNT162B2 Dose 1, Lot Number 'He thinks its EL3302'. The patient had no known medical history or allergies.   Concomitant medication included metoprolol tartrate (METOPROLOL TARTRATE), lisinopril (LISINOPRIL), atorvastatin (LIPITOR [ATORVASTATIN]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  Late on Wednesday 10Feb2021 The patient experienced his hands were cold, he went to bed and he was shivering, he had to put on clothes and 3 quilts and in the meantime he was having in and out chills and slight fever, fatigue and crazy dreams/so vivid and frightening that he was afraid to go to sleep over fear that he would never wake up/three types all repeating four or more times and on Feb2021 experienced headache fades in and out and dry heaves. The patient underwent lab tests and procedures which included pyrexia: little high (using the strips on his forehead) on an unspecified date. As a result of the event abnormal dreams patient did visit a professional office/clinic visit.  No treatment was given for the event. The clinical outcome of the event shivering/having in and out chills, slight fever, dry heaves, fatigue, headache and hands were cold were unknown while abnormal dreams was recovered Feb2021.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Retching
Clinical narrative: shivering/having in and out chills; slight fever; fever, headache, dry heaves, fatigue, and crazy dreams; Adding strange dreams/crazy dreams/ so vivid and frightening that he was afraid to go to sleep over fear that he would never wake up; hands were cold; headache fades in and out; Dry heaves; This is a spontaneous report from a contactable consumer, the patient. A 78-years-old male patient received the second dose  of  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EM5318,  via an unspecified route of administration in the right arm on  08Feb2021 at 11:45 (at the age of 78-years-old)  as a SINGLE DOSE for Covid-19 Vaccination.  Historical vaccine includes BNT162B2 Dose 1, Lot Number 'He thinks its EL3302'. The patient had no known medical history or allergies.   Concomitant medication included metoprolol tartrate (METOPROLOL TARTRATE), lisinopril (LISINOPRIL), atorvastatin (LIPITOR [ATORVASTATIN]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  Late on Wednesday 10Feb2021 The patient experienced his hands were cold, he went to bed and he was shivering, he had to put on clothes and 3 quilts and in the meantime he was having in and out chills and slight fever, fatigue and crazy dreams/so vivid and frightening that he was afraid to go to sleep over fear that he would never wake up/three types all repeating four or more times and on Feb2021 experienced headache fades in and out and dry heaves. The patient underwent lab tests and procedures which included pyrexia: little high (using the strips on his forehead) on an unspecified date. As a result of the event abnormal dreams patient did visit a professional office/clinic visit.  No treatment was given for the event. The clinical outcome of the event shivering/having in and out chills, slight fever, dry heaves, fatigue, headache and hands were cold were unknown while abnormal dreams was recovered Feb2021.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abnormal dreams, Atrial fibrillation, Cough, Pneumonia, Retching
Clinical narrative: shivering/having in and out chills; slight fever; fever, headache, dry heaves, fatigue, and crazy dreams; Adding strange dreams/crazy dreams/ so vivid and frightening that he was afraid to go to sleep over fear that he would never wake up; hands were cold; headache fades in and out; Dry heaves; This is a spontaneous report from a contactable consumer, the patient. A 78-years-old male patient received the second dose  of  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EM5318,  via an unspecified route of administration in the right arm on  08Feb2021 at 11:45 (at the age of 78-years-old)  as a SINGLE DOSE for Covid-19 Vaccination.  Historical vaccine includes BNT162B2 Dose 1, Lot Number 'He thinks its EL3302'. The patient had no known medical history or allergies.   Concomitant medication included metoprolol tartrate (METOPROLOL TARTRATE), lisinopril (LISINOPRIL), atorvastatin (LIPITOR [ATORVASTATIN]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  Late on Wednesday 10Feb2021 The patient experienced his hands were cold, he went to bed and he was shivering, he had to put on clothes and 3 quilts and in the meantime he was having in and out chills and slight fever, fatigue and crazy dreams/so vivid and frightening that he was afraid to go to sleep over fear that he would never wake up/three types all repeating four or more times and on Feb2021 experienced headache fades in and out and dry heaves. The patient underwent lab tests and procedures which included pyrexia: little high (using the strips on his forehead) on an unspecified date. As a result of the event abnormal dreams patient did visit a professional office/clinic visit.  No treatment was given for the event. The clinical outcome of the event shivering/having in and out chills, slight fever, dry heaves, fatigue, headache and hands were cold were unknown while abnormal dreams was recovered Feb2021.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: shivering/having in and out chills; slight fever; fever, headache, dry heaves, fatigue, and crazy dreams; Adding strange dreams/crazy dreams/ so vivid and frightening that he was afraid to go to sleep over fear that he would never wake up; hands were cold; headache fades in and out; Dry heaves; This is a spontaneous report from a contactable consumer, the patient. A 78-years-old male patient received the second dose  of  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EM5318,  via an unspecified route of administration in the right arm on  08Feb2021 at 11:45 (at the age of 78-years-old)  as a SINGLE DOSE for Covid-19 Vaccination.  Historical vaccine includes BNT162B2 Dose 1, Lot Number 'He thinks its EL3302'. The patient had no known medical history or allergies.   Concomitant medication included metoprolol tartrate (METOPROLOL TARTRATE), lisinopril (LISINOPRIL), atorvastatin (LIPITOR [ATORVASTATIN]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  Late on Wednesday 10Feb2021 The patient experienced his hands were cold, he went to bed and he was shivering, he had to put on clothes and 3 quilts and in the meantime he was having in and out chills and slight fever, fatigue and crazy dreams/so vivid and frightening that he was afraid to go to sleep over fear that he would never wake up/three types all repeating four or more times and on Feb2021 experienced headache fades in and out and dry heaves. The patient underwent lab tests and procedures which included pyrexia: little high (using the strips on his forehead) on an unspecified date. As a result of the event abnormal dreams patient did visit a professional office/clinic visit.  No treatment was given for the event. The clinical outcome of the event shivering/having in and out chills, slight fever, dry heaves, fatigue, headache and hands were cold were unknown while abnormal dreams was recovered Feb2021.
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Illness
Clinical narrative: Very sick, then hospitalized Died; This is a spontaneous report from a contactable Other Health Professional (patient). A 71-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 28Jan2021 06:00 at single dose for COVID-19 immunization. Medical history included Esrd controlled a-fib.  Concomitant medication in two weeks included diphenhydramine hydrochloride (BENADRYL) before vaccine and some dialysis Ned maybe. Facility type vaccine: Other. If other vaccine in four weeks: No. If covid prior vaccination: No. The patient previously received first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient experienced very sick on 29Jan2021.  The patient was not recovered from the event very sick. Event reported as Very sick and my father died. AE resulted in: Emergency room/department or urgent care, Hospitalization. AE treatment: Famotidine and nausea meds then hospitalized Died. It was unknown if an autopsy was done.  Information on batch/lot number has been requested.; Sender's Comments: The limited information provided precludes a full clinical assessment of the case. Significant in the assessment would be the date when the first dose of the vaccine was given, the patient's complete medical history, and the full clinical course of the event (including specific symptoms/events associated with reported 'very sick'), which were unknown at the time of this report. This case will be reassessed once with additional information. 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.; Reported Cause(s) of Death: Very sick, then hospitalized Died
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Back pain, Blood test, Computerised tomogram abdomen, Death
Clinical narrative: Very sick, then hospitalized Died; This is a spontaneous report from a contactable Other Health Professional (patient). A 71-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 28Jan2021 06:00 at single dose for COVID-19 immunization. Medical history included Esrd controlled a-fib.  Concomitant medication in two weeks included diphenhydramine hydrochloride (BENADRYL) before vaccine and some dialysis Ned maybe. Facility type vaccine: Other. If other vaccine in four weeks: No. If covid prior vaccination: No. The patient previously received first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient experienced very sick on 29Jan2021.  The patient was not recovered from the event very sick. Event reported as Very sick and my father died. AE resulted in: Emergency room/department or urgent care, Hospitalization. AE treatment: Famotidine and nausea meds then hospitalized Died. It was unknown if an autopsy was done.  Information on batch/lot number has been requested.; Sender's Comments: The limited information provided precludes a full clinical assessment of the case. Significant in the assessment would be the date when the first dose of the vaccine was given, the patient's complete medical history, and the full clinical course of the event (including specific symptoms/events associated with reported 'very sick'), which were unknown at the time of this report. This case will be reassessed once with additional information. 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.; Reported Cause(s) of Death: Very sick, then hospitalized Died
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Electrocardiogram, Embolic stroke, Endocarditis, Gastritis
Clinical narrative: Very sick, then hospitalized Died; This is a spontaneous report from a contactable Other Health Professional (patient). A 71-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 28Jan2021 06:00 at single dose for COVID-19 immunization. Medical history included Esrd controlled a-fib.  Concomitant medication in two weeks included diphenhydramine hydrochloride (BENADRYL) before vaccine and some dialysis Ned maybe. Facility type vaccine: Other. If other vaccine in four weeks: No. If covid prior vaccination: No. The patient previously received first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient experienced very sick on 29Jan2021.  The patient was not recovered from the event very sick. Event reported as Very sick and my father died. AE resulted in: Emergency room/department or urgent care, Hospitalization. AE treatment: Famotidine and nausea meds then hospitalized Died. It was unknown if an autopsy was done.  Information on batch/lot number has been requested.; Sender's Comments: The limited information provided precludes a full clinical assessment of the case. Significant in the assessment would be the date when the first dose of the vaccine was given, the patient's complete medical history, and the full clinical course of the event (including specific symptoms/events associated with reported 'very sick'), which were unknown at the time of this report. This case will be reassessed once with additional information. 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.; Reported Cause(s) of Death: Very sick, then hospitalized Died
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Multiple organ dysfunction syndrome, Nausea, Renal failure, Sepsis
Clinical narrative: Very sick, then hospitalized Died; This is a spontaneous report from a contactable Other Health Professional (patient). A 71-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 28Jan2021 06:00 at single dose for COVID-19 immunization. Medical history included Esrd controlled a-fib.  Concomitant medication in two weeks included diphenhydramine hydrochloride (BENADRYL) before vaccine and some dialysis Ned maybe. Facility type vaccine: Other. If other vaccine in four weeks: No. If covid prior vaccination: No. The patient previously received first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The patient experienced very sick on 29Jan2021.  The patient was not recovered from the event very sick. Event reported as Very sick and my father died. AE resulted in: Emergency room/department or urgent care, Hospitalization. AE treatment: Famotidine and nausea meds then hospitalized Died. It was unknown if an autopsy was done.  Information on batch/lot number has been requested.; Sender's Comments: The limited information provided precludes a full clinical assessment of the case. Significant in the assessment would be the date when the first dose of the vaccine was given, the patient's complete medical history, and the full clinical course of the event (including specific symptoms/events associated with reported 'very sick'), which were unknown at the time of this report. This case will be reassessed once with additional information. 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.; Reported Cause(s) of Death: Very sick, then hospitalized Died
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood test, Dizziness, Dysstasia, Headache
Clinical narrative: barely able to stand; swollen lymph nodes; irregular heartbeat; severe upper back and neck pain; severe upper back and neck pain; She has barely been able to move for several weeks; dizzy; vertigo; headache; This is a spontaneous report from a contactable consumer, the patient's parent.  A 20-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ), via an unspecified route of administration on 25Jan2021 at 10:30 AM (at the age of 20-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included allergy to eggs. Historical vaccination included the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ), via an unspecified route of administration on 04Jan2021 at 10:30 AM (at the age of 20-years-old) in the left arm for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The vaccine was administered in a hospital. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The reporter explained that the patient's adverse events "started as expected" with a  headache side effect (date not specified), however two days after the vaccine, while working as an EMT the patient became very dizzy and had to stop work. She remained dizzy, like vertigo, the next day but attempted to go to work. Her co-worker could see she wasn't right and took her to the hospital. The patient spent two days in the hospital, barely able to stand, getting a head MRI with contrast, evaluated for vertigo, blood tests, and they did not find anything and gave her vertigo medicine and sent her home. She has since had shifting symptoms, swollen lymph nodes, irregular heartbeat, severe upper back and neck pain. She has barely been able to move for several weeks and has seen an ENT doctor, another emergency doctor, and her regular doctor. None have found any other cause and have tried treating her with steroids. The events were treated with Meklazine and unspecified steroids. Lab data included SARS-CoV-2 test COVID 19 testing on 28Jan2021 which was negative. The clinical outcomes of headache, dizziness, vertigo, difficulty standing, swollen glands, irregular heart rate, back pain, neck pain and unable to more for several weeks were reported as not recovered.  The patient was tested for COIVD-19 after the vaccination, on 28Jan2021, and was found to be negative.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular, Lymphadenopathy, Magnetic resonance imaging, Mobility decreased, Neck pain
Clinical narrative: barely able to stand; swollen lymph nodes; irregular heartbeat; severe upper back and neck pain; severe upper back and neck pain; She has barely been able to move for several weeks; dizzy; vertigo; headache; This is a spontaneous report from a contactable consumer, the patient's parent.  A 20-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ), via an unspecified route of administration on 25Jan2021 at 10:30 AM (at the age of 20-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included allergy to eggs. Historical vaccination included the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ), via an unspecified route of administration on 04Jan2021 at 10:30 AM (at the age of 20-years-old) in the left arm for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The vaccine was administered in a hospital. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The reporter explained that the patient's adverse events "started as expected" with a  headache side effect (date not specified), however two days after the vaccine, while working as an EMT the patient became very dizzy and had to stop work. She remained dizzy, like vertigo, the next day but attempted to go to work. Her co-worker could see she wasn't right and took her to the hospital. The patient spent two days in the hospital, barely able to stand, getting a head MRI with contrast, evaluated for vertigo, blood tests, and they did not find anything and gave her vertigo medicine and sent her home. She has since had shifting symptoms, swollen lymph nodes, irregular heartbeat, severe upper back and neck pain. She has barely been able to move for several weeks and has seen an ENT doctor, another emergency doctor, and her regular doctor. None have found any other cause and have tried treating her with steroids. The events were treated with Meklazine and unspecified steroids. Lab data included SARS-CoV-2 test COVID 19 testing on 28Jan2021 which was negative. The clinical outcomes of headache, dizziness, vertigo, difficulty standing, swollen glands, irregular heart rate, back pain, neck pain and unable to more for several weeks were reported as not recovered.  The patient was tested for COIVD-19 after the vaccination, on 28Jan2021, and was found to be negative.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vertigo
Clinical narrative: barely able to stand; swollen lymph nodes; irregular heartbeat; severe upper back and neck pain; severe upper back and neck pain; She has barely been able to move for several weeks; dizzy; vertigo; headache; This is a spontaneous report from a contactable consumer, the patient's parent.  A 20-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ), via an unspecified route of administration on 25Jan2021 at 10:30 AM (at the age of 20-years-old) as a single dose in the left arm for COVID-19 vaccination. Medical history included allergy to eggs. Historical vaccination included the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number unknown ), via an unspecified route of administration on 04Jan2021 at 10:30 AM (at the age of 20-years-old) in the left arm for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The vaccine was administered in a hospital. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The reporter explained that the patient's adverse events "started as expected" with a  headache side effect (date not specified), however two days after the vaccine, while working as an EMT the patient became very dizzy and had to stop work. She remained dizzy, like vertigo, the next day but attempted to go to work. Her co-worker could see she wasn't right and took her to the hospital. The patient spent two days in the hospital, barely able to stand, getting a head MRI with contrast, evaluated for vertigo, blood tests, and they did not find anything and gave her vertigo medicine and sent her home. She has since had shifting symptoms, swollen lymph nodes, irregular heartbeat, severe upper back and neck pain. She has barely been able to move for several weeks and has seen an ENT doctor, another emergency doctor, and her regular doctor. None have found any other cause and have tried treating her with steroids. The events were treated with Meklazine and unspecified steroids. Lab data included SARS-CoV-2 test COVID 19 testing on 28Jan2021 which was negative. The clinical outcomes of headache, dizziness, vertigo, difficulty standing, swollen glands, irregular heart rate, back pain, neck pain and unable to more for several weeks were reported as not recovered.  The patient was tested for COIVD-19 after the vaccination, on 28Jan2021, and was found to be negative.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hand fracture, Loss of consciousness, Malaise, Skin laceration
Clinical narrative: Lost consciousness for brief period; bleeding from small gash in head; broke my finger; feeling out of sorts; feeling light headed; This is a spontaneous report from a contactable consumer (patient) who reported that a 70-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number:EL3246), via an unspecified route of administration into the right arm on 10Feb2021 07:45 at a single dose for COVID-19 immunisation. Medical history included known allergies to CT dye, COVID-19 from an unknown date prior to vaccination and known allergies to sulfa drugs. Patient was not pregnant. Patient had unspecified concomitant medications. On 11Feb2021 08:00, patient woke up feeling out of sorts and feeling light headed, patient sat down and the next thing she knew she was on the floor bleeding from a small gash in her head, she lost consciousness for a brief period and also broke her finger. The events required emergency room and physician office visit. The patient had 3 staples in her head and a finger splint for the events "bleeding from a small gash in her head" and "broke her finger". Outcome of events was recovering.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Bone pain, Chills
Clinical narrative: racing heart; fever 103; hard chills; headache; joints and bones felt like they were going to break; joints and bones felt like they were going to break; no appetite; weakness, unable to get up out of bed; unable to get up out of bed; patient received second dose of BNT162B2; sjogrens disease/syndrome (immune disease); patient received second dose of BNT162B2; sjogrens disease/syndrome (immune disease); tired; This is a spontaneous report from a contactable other healthcare professional (patient). A 59-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL3302 and expiry date unknown, via unspecified route of administration on 09Feb2021 at single dose for Covid-19 immunization in a workplace clinic. Medical history included sjogrens disease/syndrome (immune disease), sulfa allergies.  The patient's concomitant medications included several medications daily. The patient previously took morphine and experienced allergies and made her sick. Historical vaccine included first dose of BNT162B2, lot number EJ 1686 on 15Jan2021 for Covid-19 immunization. The patient has no Covid prior vaccination. On 09Feb2021 11:00 am (also reported as started 12 hours after 2nd shot), she experienced fever 103, hard chills, racing heart, headache, joints and bones felt like they were going to break, no appetite, weakness, unable to get up out of bed. The patient informed that the hardest time and highest fever was 11 PM to 6 AM Tue/Wed. The chills were severe, felt like her spine would snap into. The patient was still sick Wed (10Feb2021), the fever was not as high 101 to 102. The patient informed that what was scary was heart racing for hours that first night. The patient thought she was going to die. The patient informed that she didn't have heart problems, but she has Sjogrens, an immune disease. The patient informed that the fever was finally back to normal on Thursday (11Feb2021) afternoon after getting shot Tuesday noon. The patient informed that it's Sunday (14Feb2021) and she was still tired and has headache. The patient informed that it has to be something to do with Sjogrens. The patient informed that her rheumatologist said nobody so far had the kind of fever/reactions she had. The patient has not Covid tested post vaccination. The patient has explicit consent. The patient did not received treatment due to the events. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the event "racing heart" with BNT162b2 can not be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Movement disorder, Off label use
Clinical narrative: racing heart; fever 103; hard chills; headache; joints and bones felt like they were going to break; joints and bones felt like they were going to break; no appetite; weakness, unable to get up out of bed; unable to get up out of bed; patient received second dose of BNT162B2; sjogrens disease/syndrome (immune disease); patient received second dose of BNT162B2; sjogrens disease/syndrome (immune disease); tired; This is a spontaneous report from a contactable other healthcare professional (patient). A 59-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL3302 and expiry date unknown, via unspecified route of administration on 09Feb2021 at single dose for Covid-19 immunization in a workplace clinic. Medical history included sjogrens disease/syndrome (immune disease), sulfa allergies.  The patient's concomitant medications included several medications daily. The patient previously took morphine and experienced allergies and made her sick. Historical vaccine included first dose of BNT162B2, lot number EJ 1686 on 15Jan2021 for Covid-19 immunization. The patient has no Covid prior vaccination. On 09Feb2021 11:00 am (also reported as started 12 hours after 2nd shot), she experienced fever 103, hard chills, racing heart, headache, joints and bones felt like they were going to break, no appetite, weakness, unable to get up out of bed. The patient informed that the hardest time and highest fever was 11 PM to 6 AM Tue/Wed. The chills were severe, felt like her spine would snap into. The patient was still sick Wed (10Feb2021), the fever was not as high 101 to 102. The patient informed that what was scary was heart racing for hours that first night. The patient thought she was going to die. The patient informed that she didn't have heart problems, but she has Sjogrens, an immune disease. The patient informed that the fever was finally back to normal on Thursday (11Feb2021) afternoon after getting shot Tuesday noon. The patient informed that it's Sunday (14Feb2021) and she was still tired and has headache. The patient informed that it has to be something to do with Sjogrens. The patient informed that her rheumatologist said nobody so far had the kind of fever/reactions she had. The patient has not Covid tested post vaccination. The patient has explicit consent. The patient did not received treatment due to the events. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the event "racing heart" with BNT162b2 can not be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Product use issue, Pyrexia
Clinical narrative: racing heart; fever 103; hard chills; headache; joints and bones felt like they were going to break; joints and bones felt like they were going to break; no appetite; weakness, unable to get up out of bed; unable to get up out of bed; patient received second dose of BNT162B2; sjogrens disease/syndrome (immune disease); patient received second dose of BNT162B2; sjogrens disease/syndrome (immune disease); tired; This is a spontaneous report from a contactable other healthcare professional (patient). A 59-year-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL3302 and expiry date unknown, via unspecified route of administration on 09Feb2021 at single dose for Covid-19 immunization in a workplace clinic. Medical history included sjogrens disease/syndrome (immune disease), sulfa allergies.  The patient's concomitant medications included several medications daily. The patient previously took morphine and experienced allergies and made her sick. Historical vaccine included first dose of BNT162B2, lot number EJ 1686 on 15Jan2021 for Covid-19 immunization. The patient has no Covid prior vaccination. On 09Feb2021 11:00 am (also reported as started 12 hours after 2nd shot), she experienced fever 103, hard chills, racing heart, headache, joints and bones felt like they were going to break, no appetite, weakness, unable to get up out of bed. The patient informed that the hardest time and highest fever was 11 PM to 6 AM Tue/Wed. The chills were severe, felt like her spine would snap into. The patient was still sick Wed (10Feb2021), the fever was not as high 101 to 102. The patient informed that what was scary was heart racing for hours that first night. The patient thought she was going to die. The patient informed that she didn't have heart problems, but she has Sjogrens, an immune disease. The patient informed that the fever was finally back to normal on Thursday (11Feb2021) afternoon after getting shot Tuesday noon. The patient informed that it's Sunday (14Feb2021) and she was still tired and has headache. The patient informed that it has to be something to do with Sjogrens. The patient informed that her rheumatologist said nobody so far had the kind of fever/reactions she had. The patient has not Covid tested post vaccination. The patient has explicit consent. The patient did not received treatment due to the events. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relationship, the association between the event "racing heart" with BNT162b2 can not be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Nausea, Pneumonia, Pyrexia
Clinical narrative: pneumonia; Fever; chills; nausea; difficulty breathing; This is a spontaneous report from a contactable other HCP (patient). A 33-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247), via an unspecified route of administration in the left arm on 21Jan2021 11:00 at a single dose for COVID-19 immunisation. There were no medical history and concomitant medications. The patient experienced fever, chills, nausea, pneumonia, and difficulty breathing on 11Feb2021 23:00 with outcome of recovering. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was not diagnosed of covid prior vaccination. The patient underwent lab tests and procedures which included Nasal Swab test post vaccination: negative on 13Feb2021. Therapeutic measures were taken as a result of events (antibiotics, IV fluids, Tylenol). The patient received second dose (Lot Number: EN6201) on 12Feb2021 12:00 PM in the left arm.; Sender's Comments: There is a reasonable possibility that the events fever, chills, and nausea were related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the events pneumonia and difficulty breathing with Bnt162b2 can not be fully 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.