chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative, Tinnitus
Clinical narrative: feeling of fullness in her ear; it felt like fluid in her right ear; Hearing loss in right ear; Soreness in the left arm; This is a spontaneous report from a contactable Other-HCP.   A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number # EH9899) 16Dec2020 at 07:40AM in the left arm at single dose via intramuscular for COVID-19 immunization. Medical history included seasonal allergy.  Concomitant medications included fluticasone propionate  for seasonal allergy. The day after vaccination she noticed soreness of the left arm. Then two days later she noticed hearing loss secondary to a feeling of fullness in her ear; it felt like fluid in her right ear which has improved and she states it was not serious after the first dose. Patient received the second dose of vaccine on 04Jan2021 at 08:00AM in the left arm. That night she experienced myalgia, fever, chills, back pain, and started with a constant ringing in her right ear and the hearing loss that worsened from before (reported under AER 2021012152. All of these effects have resolved except the hearing loss and ringing in her ear. Additionally she went to see an ENT doctor and get a hearing test. The Hearing test showed moderate hearing loss and speech clarity of 96% in her left ear compared to 52% in the right ear. They don't know if it is permanent. She was currently being treated with 80mg of Prednisone daily by mouth and getting Dexamethasone injections to her middle eardrum. Patient informed that on 17Dec2020 she was tested for COVID 19 with the PCR test due to an exposure at work. The result was negative. The patient recovered from soreness in the left arm on 19Dec2020. The patient had not yet recovered from deafness.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events ear congestion and hearing loss unilateral cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Audiogram abnormal, Back pain, Chills, Deafness
Clinical narrative: feeling of fullness in her ear; it felt like fluid in her right ear; Hearing loss in right ear; Soreness in the left arm; This is a spontaneous report from a contactable Other-HCP.   A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number # EH9899) 16Dec2020 at 07:40AM in the left arm at single dose via intramuscular for COVID-19 immunization. Medical history included seasonal allergy.  Concomitant medications included fluticasone propionate  for seasonal allergy. The day after vaccination she noticed soreness of the left arm. Then two days later she noticed hearing loss secondary to a feeling of fullness in her ear; it felt like fluid in her right ear which has improved and she states it was not serious after the first dose. Patient received the second dose of vaccine on 04Jan2021 at 08:00AM in the left arm. That night she experienced myalgia, fever, chills, back pain, and started with a constant ringing in her right ear and the hearing loss that worsened from before (reported under AER 2021012152. All of these effects have resolved except the hearing loss and ringing in her ear. Additionally she went to see an ENT doctor and get a hearing test. The Hearing test showed moderate hearing loss and speech clarity of 96% in her left ear compared to 52% in the right ear. They don't know if it is permanent. She was currently being treated with 80mg of Prednisone daily by mouth and getting Dexamethasone injections to her middle eardrum. Patient informed that on 17Dec2020 she was tested for COVID 19 with the PCR test due to an exposure at work. The result was negative. The patient recovered from soreness in the left arm on 19Dec2020. The patient had not yet recovered from deafness.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events ear congestion and hearing loss unilateral cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Myalgia, Pyrexia, SARS-CoV-2 test negative, Tinnitus
Clinical narrative: feeling of fullness in her ear; it felt like fluid in her right ear; Hearing loss in right ear; Soreness in the left arm; This is a spontaneous report from a contactable Other-HCP.   A 34-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number # EH9899) 16Dec2020 at 07:40AM in the left arm at single dose via intramuscular for COVID-19 immunization. Medical history included seasonal allergy.  Concomitant medications included fluticasone propionate  for seasonal allergy. The day after vaccination she noticed soreness of the left arm. Then two days later she noticed hearing loss secondary to a feeling of fullness in her ear; it felt like fluid in her right ear which has improved and she states it was not serious after the first dose. Patient received the second dose of vaccine on 04Jan2021 at 08:00AM in the left arm. That night she experienced myalgia, fever, chills, back pain, and started with a constant ringing in her right ear and the hearing loss that worsened from before (reported under AER 2021012152. All of these effects have resolved except the hearing loss and ringing in her ear. Additionally she went to see an ENT doctor and get a hearing test. The Hearing test showed moderate hearing loss and speech clarity of 96% in her left ear compared to 52% in the right ear. They don't know if it is permanent. She was currently being treated with 80mg of Prednisone daily by mouth and getting Dexamethasone injections to her middle eardrum. Patient informed that on 17Dec2020 she was tested for COVID 19 with the PCR test due to an exposure at work. The result was negative. The patient recovered from soreness in the left arm on 19Dec2020. The patient had not yet recovered from deafness.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events ear congestion and hearing loss unilateral cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Back pain, Chills, Headache, Myalgia
Clinical narrative: constant ringing in right ear; Myalgia; Fever; Chills; back pain; Inappropriate schedule of vaccine administered; hearing loss that worsened from before; hearing loss that worsened from before; This is a spontaneous report from a contactable physician (patient).  This 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EH9899), via an unspecified route of administration, on 04Jan2021 at 08:00AM at single dose for COVID-19 immunisation. The first dose was received on 16Dec2020 at 7:40 AM at single dose. Vaccine location was in the left arm. The patient was vaccinated at hospital, age at vaccination was 34-years-old. No other vaccine was received in four weeks. Medical history was none. Concomitant medications included ongoing fluticasone proprionate (FLONASE) for seasonal allergy taking for two years. On 17Dec2020, COVID-19 PCR test was negative.  On 04Jan2021 at night, she experienced myalgia, fever, chills, back pain and started with a constant ringing in her right ear and the hearing loss that worsened from before (started on 18Dec2020 after first dose, see AER # 2021012126). Start date of constant ringing in right ear was 05Jan2021. The events resulted in Physician Office visit. Hearing loss in right ear worsened and constant ringing in right ear were reported serious as medically significant while the other events were reported as non-serious. She went to see an ENT doctor and get a hearing test. The hearing test showed moderate hearing loss and speech clarity of 96% in her left ear compared to 52% in the right ear. They don't know if it is permanent. She is currently being treated with 80mg of Prednisone daily by mouth and getting dexamethasone injections to her middle eardrum. All of these effects have resolved except the hearing loss and ringing in her ear.   All the events were considered related to the vaccine per reporter.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pyrexia, Tinnitus
Clinical narrative: constant ringing in right ear; Myalgia; Fever; Chills; back pain; Inappropriate schedule of vaccine administered; hearing loss that worsened from before; hearing loss that worsened from before; This is a spontaneous report from a contactable physician (patient).  This 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EH9899), via an unspecified route of administration, on 04Jan2021 at 08:00AM at single dose for COVID-19 immunisation. The first dose was received on 16Dec2020 at 7:40 AM at single dose. Vaccine location was in the left arm. The patient was vaccinated at hospital, age at vaccination was 34-years-old. No other vaccine was received in four weeks. Medical history was none. Concomitant medications included ongoing fluticasone proprionate (FLONASE) for seasonal allergy taking for two years. On 17Dec2020, COVID-19 PCR test was negative.  On 04Jan2021 at night, she experienced myalgia, fever, chills, back pain and started with a constant ringing in her right ear and the hearing loss that worsened from before (started on 18Dec2020 after first dose, see AER # 2021012126). Start date of constant ringing in right ear was 05Jan2021. The events resulted in Physician Office visit. Hearing loss in right ear worsened and constant ringing in right ear were reported serious as medically significant while the other events were reported as non-serious. She went to see an ENT doctor and get a hearing test. The hearing test showed moderate hearing loss and speech clarity of 96% in her left ear compared to 52% in the right ear. They don't know if it is permanent. She is currently being treated with 80mg of Prednisone daily by mouth and getting dexamethasone injections to her middle eardrum. All of these effects have resolved except the hearing loss and ringing in her ear.   All the events were considered related to the vaccine per reporter.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Audiogram, Deafness, Hypoacusis
Clinical narrative: constant ringing in right ear; Myalgia; Fever; Chills; back pain; Inappropriate schedule of vaccine administered; hearing loss that worsened from before; hearing loss that worsened from before; This is a spontaneous report from a contactable physician (patient).  This 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EH9899), via an unspecified route of administration, on 04Jan2021 at 08:00AM at single dose for COVID-19 immunisation. The first dose was received on 16Dec2020 at 7:40 AM at single dose. Vaccine location was in the left arm. The patient was vaccinated at hospital, age at vaccination was 34-years-old. No other vaccine was received in four weeks. Medical history was none. Concomitant medications included ongoing fluticasone proprionate (FLONASE) for seasonal allergy taking for two years. On 17Dec2020, COVID-19 PCR test was negative.  On 04Jan2021 at night, she experienced myalgia, fever, chills, back pain and started with a constant ringing in her right ear and the hearing loss that worsened from before (started on 18Dec2020 after first dose, see AER # 2021012126). Start date of constant ringing in right ear was 05Jan2021. The events resulted in Physician Office visit. Hearing loss in right ear worsened and constant ringing in right ear were reported serious as medically significant while the other events were reported as non-serious. She went to see an ENT doctor and get a hearing test. The hearing test showed moderate hearing loss and speech clarity of 96% in her left ear compared to 52% in the right ear. They don't know if it is permanent. She is currently being treated with 80mg of Prednisone daily by mouth and getting dexamethasone injections to her middle eardrum. All of these effects have resolved except the hearing loss and ringing in her ear.   All the events were considered related to the vaccine per reporter.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Audiogram abnormal, Back pain, Chills, Deafness unilateral
Clinical narrative: constant ringing in right ear; Myalgia; Fever; Chills; back pain; Inappropriate schedule of vaccine administered; hearing loss that worsened from before; hearing loss that worsened from before; This is a spontaneous report from a contactable physician (patient).  This 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EH9899), via an unspecified route of administration, on 04Jan2021 at 08:00AM at single dose for COVID-19 immunisation. The first dose was received on 16Dec2020 at 7:40 AM at single dose. Vaccine location was in the left arm. The patient was vaccinated at hospital, age at vaccination was 34-years-old. No other vaccine was received in four weeks. Medical history was none. Concomitant medications included ongoing fluticasone proprionate (FLONASE) for seasonal allergy taking for two years. On 17Dec2020, COVID-19 PCR test was negative.  On 04Jan2021 at night, she experienced myalgia, fever, chills, back pain and started with a constant ringing in her right ear and the hearing loss that worsened from before (started on 18Dec2020 after first dose, see AER # 2021012126). Start date of constant ringing in right ear was 05Jan2021. The events resulted in Physician Office visit. Hearing loss in right ear worsened and constant ringing in right ear were reported serious as medically significant while the other events were reported as non-serious. She went to see an ENT doctor and get a hearing test. The hearing test showed moderate hearing loss and speech clarity of 96% in her left ear compared to 52% in the right ear. They don't know if it is permanent. She is currently being treated with 80mg of Prednisone daily by mouth and getting dexamethasone injections to her middle eardrum. All of these effects have resolved except the hearing loss and ringing in her ear.   All the events were considered related to the vaccine per reporter.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Ear discomfort, Exposure to SARS-CoV-2, Middle ear effusion, Myalgia, Pain in extremity
Clinical narrative: constant ringing in right ear; Myalgia; Fever; Chills; back pain; Inappropriate schedule of vaccine administered; hearing loss that worsened from before; hearing loss that worsened from before; This is a spontaneous report from a contactable physician (patient).  This 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EH9899), via an unspecified route of administration, on 04Jan2021 at 08:00AM at single dose for COVID-19 immunisation. The first dose was received on 16Dec2020 at 7:40 AM at single dose. Vaccine location was in the left arm. The patient was vaccinated at hospital, age at vaccination was 34-years-old. No other vaccine was received in four weeks. Medical history was none. Concomitant medications included ongoing fluticasone proprionate (FLONASE) for seasonal allergy taking for two years. On 17Dec2020, COVID-19 PCR test was negative.  On 04Jan2021 at night, she experienced myalgia, fever, chills, back pain and started with a constant ringing in her right ear and the hearing loss that worsened from before (started on 18Dec2020 after first dose, see AER # 2021012126). Start date of constant ringing in right ear was 05Jan2021. The events resulted in Physician Office visit. Hearing loss in right ear worsened and constant ringing in right ear were reported serious as medically significant while the other events were reported as non-serious. She went to see an ENT doctor and get a hearing test. The hearing test showed moderate hearing loss and speech clarity of 96% in her left ear compared to 52% in the right ear. They don't know if it is permanent. She is currently being treated with 80mg of Prednisone daily by mouth and getting dexamethasone injections to her middle eardrum. All of these effects have resolved except the hearing loss and ringing in her ear.   All the events were considered related to the vaccine per reporter.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative, Tinnitus
Clinical narrative: constant ringing in right ear; Myalgia; Fever; Chills; back pain; Inappropriate schedule of vaccine administered; hearing loss that worsened from before; hearing loss that worsened from before; This is a spontaneous report from a contactable physician (patient).  This 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EH9899), via an unspecified route of administration, on 04Jan2021 at 08:00AM at single dose for COVID-19 immunisation. The first dose was received on 16Dec2020 at 7:40 AM at single dose. Vaccine location was in the left arm. The patient was vaccinated at hospital, age at vaccination was 34-years-old. No other vaccine was received in four weeks. Medical history was none. Concomitant medications included ongoing fluticasone proprionate (FLONASE) for seasonal allergy taking for two years. On 17Dec2020, COVID-19 PCR test was negative.  On 04Jan2021 at night, she experienced myalgia, fever, chills, back pain and started with a constant ringing in her right ear and the hearing loss that worsened from before (started on 18Dec2020 after first dose, see AER # 2021012126). Start date of constant ringing in right ear was 05Jan2021. The events resulted in Physician Office visit. Hearing loss in right ear worsened and constant ringing in right ear were reported serious as medically significant while the other events were reported as non-serious. She went to see an ENT doctor and get a hearing test. The hearing test showed moderate hearing loss and speech clarity of 96% in her left ear compared to 52% in the right ear. They don't know if it is permanent. She is currently being treated with 80mg of Prednisone daily by mouth and getting dexamethasone injections to her middle eardrum. All of these effects have resolved except the hearing loss and ringing in her ear.   All the events were considered related to the vaccine per reporter.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests abnormal, Audiogram abnormal, Back pain, Chills, Deafness
Clinical narrative: constant ringing in right ear; Myalgia; Fever; Chills; back pain; Inappropriate schedule of vaccine administered; hearing loss that worsened from before; hearing loss that worsened from before; This is a spontaneous report from a contactable physician (patient).  This 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EH9899), via an unspecified route of administration, on 04Jan2021 at 08:00AM at single dose for COVID-19 immunisation. The first dose was received on 16Dec2020 at 7:40 AM at single dose. Vaccine location was in the left arm. The patient was vaccinated at hospital, age at vaccination was 34-years-old. No other vaccine was received in four weeks. Medical history was none. Concomitant medications included ongoing fluticasone proprionate (FLONASE) for seasonal allergy taking for two years. On 17Dec2020, COVID-19 PCR test was negative.  On 04Jan2021 at night, she experienced myalgia, fever, chills, back pain and started with a constant ringing in her right ear and the hearing loss that worsened from before (started on 18Dec2020 after first dose, see AER # 2021012126). Start date of constant ringing in right ear was 05Jan2021. The events resulted in Physician Office visit. Hearing loss in right ear worsened and constant ringing in right ear were reported serious as medically significant while the other events were reported as non-serious. She went to see an ENT doctor and get a hearing test. The hearing test showed moderate hearing loss and speech clarity of 96% in her left ear compared to 52% in the right ear. They don't know if it is permanent. She is currently being treated with 80mg of Prednisone daily by mouth and getting dexamethasone injections to her middle eardrum. All of these effects have resolved except the hearing loss and ringing in her ear.   All the events were considered related to the vaccine per reporter.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Myalgia, Pyrexia, SARS-CoV-2 test negative, Tinnitus
Clinical narrative: constant ringing in right ear; Myalgia; Fever; Chills; back pain; Inappropriate schedule of vaccine administered; hearing loss that worsened from before; hearing loss that worsened from before; This is a spontaneous report from a contactable physician (patient).  This 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EH9899), via an unspecified route of administration, on 04Jan2021 at 08:00AM at single dose for COVID-19 immunisation. The first dose was received on 16Dec2020 at 7:40 AM at single dose. Vaccine location was in the left arm. The patient was vaccinated at hospital, age at vaccination was 34-years-old. No other vaccine was received in four weeks. Medical history was none. Concomitant medications included ongoing fluticasone proprionate (FLONASE) for seasonal allergy taking for two years. On 17Dec2020, COVID-19 PCR test was negative.  On 04Jan2021 at night, she experienced myalgia, fever, chills, back pain and started with a constant ringing in her right ear and the hearing loss that worsened from before (started on 18Dec2020 after first dose, see AER # 2021012126). Start date of constant ringing in right ear was 05Jan2021. The events resulted in Physician Office visit. Hearing loss in right ear worsened and constant ringing in right ear were reported serious as medically significant while the other events were reported as non-serious. She went to see an ENT doctor and get a hearing test. The hearing test showed moderate hearing loss and speech clarity of 96% in her left ear compared to 52% in the right ear. They don't know if it is permanent. She is currently being treated with 80mg of Prednisone daily by mouth and getting dexamethasone injections to her middle eardrum. All of these effects have resolved except the hearing loss and ringing in her ear.   All the events were considered related to the vaccine per reporter.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation between vaccination and onset of events. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram abnormal, Dyspnoea, Pulmonary embolism
Clinical narrative: Saturday January 2nd I was working a 12 hour night shift as a nurse and about 8:00 am i noticed i was getting short of breath. I continued working my weekend shift, January 3rd another 12 hour night shift. Monday morning when i woke up i was still short of breath and not feeling good, i had chest pains/ pressure and couldn't  catch my breath. I went to the doctors January 5th had positive Dimer, had a CT of the chest which showed bilateral extensive pulmonary embolism.  So now I am on Lovenox shots 2 times a day, Coumadian  daily until therapeutic.I have been to the doctor every other day now for INR to regulate my Coumadian. I feel like this is not coincidence that 3 days after getting my vaccine immunization  I suddenly have blood clots in my lungs!
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Computerised tomogram thorax abnormal, Dyspnoea, Feeling abnormal
Clinical narrative: Saturday January 2nd I was working a 12 hour night shift as a nurse and about 8:00 am i noticed i was getting short of breath. I continued working my weekend shift, January 3rd another 12 hour night shift. Monday morning when i woke up i was still short of breath and not feeling good, i had chest pains/ pressure and couldn't  catch my breath. I went to the doctors January 5th had positive Dimer, had a CT of the chest which showed bilateral extensive pulmonary embolism.  So now I am on Lovenox shots 2 times a day, Coumadian  daily until therapeutic.I have been to the doctor every other day now for INR to regulate my Coumadian. I feel like this is not coincidence that 3 days after getting my vaccine immunization  I suddenly have blood clots in my lungs!
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer increased, International normalised ratio, Pulmonary embolism
Clinical narrative: Saturday January 2nd I was working a 12 hour night shift as a nurse and about 8:00 am i noticed i was getting short of breath. I continued working my weekend shift, January 3rd another 12 hour night shift. Monday morning when i woke up i was still short of breath and not feeling good, i had chest pains/ pressure and couldn't  catch my breath. I went to the doctors January 5th had positive Dimer, had a CT of the chest which showed bilateral extensive pulmonary embolism.  So now I am on Lovenox shots 2 times a day, Coumadian  daily until therapeutic.I have been to the doctor every other day now for INR to regulate my Coumadian. I feel like this is not coincidence that 3 days after getting my vaccine immunization  I suddenly have blood clots in my lungs!
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache
Clinical narrative: Off-label use; Severe headache; Chills; This is a spontaneous report from a contactable consumer (patient himself).  This 39-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL1284 with Expiration Date Mar2021), via an unknown route, on 19Dec2020 at single dose; and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL1284 with Expiration date Apr2021), via an unknown route, on 05Jan2021 at 18:30; both doses for COVID-19 immunisation. Vaccine location was right arm. The patient did not have a relevant medical history. No additional drugs were reported. The patient was vaccinated at hospital, age at vaccination was 39-year-old. Then last night, on 06Jan2021 around 23:00PM-23:30 she started to have chills that lasted throughout the night. He stated he felt 95% better. Just minor lingering effects there with the chills, nothing too bad. On 07Jan2021, he woke up with a severe headache. It took a fewhours to subside.  Therapeutic measures taken as result of the events included ibuprofen (strength: 200 mg) which pretty much resolved. It had resolved 95%, ibuprofen helped. It took several hours for it to subside. The patient took 4 tablets of ibuprofen. The patient was recovering from the events headache and chills.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cellulitis, Fatigue, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: The patient was seen on 1/5 for swelling and soreness at injection site with blotchy red raised patches. The patient was advised to apply ice to the area and use topical Benadryl for itching. The patient was then seen on 1/6 and reported pain, burning, swelling and itching to the injection site as well as numbness and tingling that extended up to her neck. The patient was advised to continue with applying ice and an OTC topical steroid to the area. The patient was also given an Rx for an antibiotic for cellulitis of the left upper extremity. Patient was advised to follow-up in 2 days. The patient was seen on 1/7, at this time the patient reported improvement of redness, itching, burning and swelling to the area. The patient continued to report soreness to the area that extended up to her neck. The patient was advised to continue current medications and follow-up as needed.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Injection site pruritus, Limb discomfort, Paraesthesia
Clinical narrative: The patient was seen on 1/5 for swelling and soreness at injection site with blotchy red raised patches. The patient was advised to apply ice to the area and use topical Benadryl for itching. The patient was then seen on 1/6 and reported pain, burning, swelling and itching to the injection site as well as numbness and tingling that extended up to her neck. The patient was advised to continue with applying ice and an OTC topical steroid to the area. The patient was also given an Rx for an antibiotic for cellulitis of the left upper extremity. Patient was advised to follow-up in 2 days. The patient was seen on 1/7, at this time the patient reported improvement of redness, itching, burning and swelling to the area. The patient continued to report soreness to the area that extended up to her neck. The patient was advised to continue current medications and follow-up as needed.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Injection site cellulitis, Injection site hypoaesthesia, Injection site pain, Injection site paraesthesia
Clinical narrative: The patient was seen on 1/5 for swelling and soreness at injection site with blotchy red raised patches. The patient was advised to apply ice to the area and use topical Benadryl for itching. The patient was then seen on 1/6 and reported pain, burning, swelling and itching to the injection site as well as numbness and tingling that extended up to her neck. The patient was advised to continue with applying ice and an OTC topical steroid to the area. The patient was also given an Rx for an antibiotic for cellulitis of the left upper extremity. Patient was advised to follow-up in 2 days. The patient was seen on 1/7, at this time the patient reported improvement of redness, itching, burning and swelling to the area. The patient continued to report soreness to the area that extended up to her neck. The patient was advised to continue current medications and follow-up as needed.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Injection site pruritus, Injection site reaction, Injection site swelling, Paraesthesia, Rash macular
Clinical narrative: The patient was seen on 1/5 for swelling and soreness at injection site with blotchy red raised patches. The patient was advised to apply ice to the area and use topical Benadryl for itching. The patient was then seen on 1/6 and reported pain, burning, swelling and itching to the injection site as well as numbness and tingling that extended up to her neck. The patient was advised to continue with applying ice and an OTC topical steroid to the area. The patient was also given an Rx for an antibiotic for cellulitis of the left upper extremity. Patient was advised to follow-up in 2 days. The patient was seen on 1/7, at this time the patient reported improvement of redness, itching, burning and swelling to the area. The patient continued to report soreness to the area that extended up to her neck. The patient was advised to continue current medications and follow-up as needed.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Injection site swelling, Injection site urticaria
Clinical narrative: The patient was seen on 1/5 for swelling and soreness at injection site with blotchy red raised patches. The patient was advised to apply ice to the area and use topical Benadryl for itching. The patient was then seen on 1/6 and reported pain, burning, swelling and itching to the injection site as well as numbness and tingling that extended up to her neck. The patient was advised to continue with applying ice and an OTC topical steroid to the area. The patient was also given an Rx for an antibiotic for cellulitis of the left upper extremity. Patient was advised to follow-up in 2 days. The patient was seen on 1/7, at this time the patient reported improvement of redness, itching, burning and swelling to the area. The patient continued to report soreness to the area that extended up to her neck. The patient was advised to continue current medications and follow-up as needed.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cellulitis, Fatigue, Hypersensitivity, Injection site erythema, Injection site mass
Clinical narrative: The patient was seen on 1/5 for swelling and soreness at injection site with blotchy red raised patches. The patient was advised to apply ice to the area and use topical Benadryl for itching. The patient was then seen on 1/6 and reported pain, burning, swelling and itching to the injection site as well as numbness and tingling that extended up to her neck. The patient was advised to continue with applying ice and an OTC topical steroid to the area. The patient was also given an Rx for an antibiotic for cellulitis of the left upper extremity. Patient was advised to follow-up in 2 days. The patient was seen on 1/7, at this time the patient reported improvement of redness, itching, burning and swelling to the area. The patient continued to report soreness to the area that extended up to her neck. The patient was advised to continue current medications and follow-up as needed.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Injection site swelling, Injection site warmth, Limb discomfort, Paraesthesia
Clinical narrative: The patient was seen on 1/5 for swelling and soreness at injection site with blotchy red raised patches. The patient was advised to apply ice to the area and use topical Benadryl for itching. The patient was then seen on 1/6 and reported pain, burning, swelling and itching to the injection site as well as numbness and tingling that extended up to her neck. The patient was advised to continue with applying ice and an OTC topical steroid to the area. The patient was also given an Rx for an antibiotic for cellulitis of the left upper extremity. Patient was advised to follow-up in 2 days. The patient was seen on 1/7, at this time the patient reported improvement of redness, itching, burning and swelling to the area. The patient continued to report soreness to the area that extended up to her neck. The patient was advised to continue current medications and follow-up as needed.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Fatigue, Hypoaesthesia, Injection site mass, Injection site pain
Clinical narrative: The patient was seen on 1/5 for swelling and soreness at injection site with blotchy red raised patches. The patient was advised to apply ice to the area and use topical Benadryl for itching. The patient was then seen on 1/6 and reported pain, burning, swelling and itching to the injection site as well as numbness and tingling that extended up to her neck. The patient was advised to continue with applying ice and an OTC topical steroid to the area. The patient was also given an Rx for an antibiotic for cellulitis of the left upper extremity. Patient was advised to follow-up in 2 days. The patient was seen on 1/7, at this time the patient reported improvement of redness, itching, burning and swelling to the area. The patient continued to report soreness to the area that extended up to her neck. The patient was advised to continue current medications and follow-up as needed.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Injection site pruritus, Injection site warmth, Pain in extremity, Paraesthesia
Clinical narrative: The patient was seen on 1/5 for swelling and soreness at injection site with blotchy red raised patches. The patient was advised to apply ice to the area and use topical Benadryl for itching. The patient was then seen on 1/6 and reported pain, burning, swelling and itching to the injection site as well as numbness and tingling that extended up to her neck. The patient was advised to continue with applying ice and an OTC topical steroid to the area. The patient was also given an Rx for an antibiotic for cellulitis of the left upper extremity. Patient was advised to follow-up in 2 days. The patient was seen on 1/7, at this time the patient reported improvement of redness, itching, burning and swelling to the area. The patient continued to report soreness to the area that extended up to her neck. The patient was advised to continue current medications and follow-up as needed.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Immediate post-injection reaction, Inflammation, Joint range of motion decreased, Magnetic resonance imaging joint
Clinical narrative: the vaccine may have been administered into sub-acromial space; the vaccine may have been administered into sub-acromial space; Seemed to be higher on arm; soreness; Continued having progressed symptoms of decreased ROM; n/t (numbness and tingling); n/t (numbness and tingling); weakness; frozen shoulder; This is a spontaneous report from a contactable Nurse reporting for herself. A 30-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK9231), on 22Dec2020 at 15:30 at single dose in left arm, for COVID-19 immunisation. Age at vaccination was 30-year-old. No other vaccine was given within 4 weeks prior to the COVID vaccine. COVID was not tested prior or post vaccination. Medical history included type 1 diabetes mellitus, migraines, postural orthostatic tachycardia syndrome. The patient had known allergies to morphine and tomatoes. Concomitant medications included insulin aspart (NOVOLOG), topiramate (TROKENDI), metoprolol (METOPROLOL). The patient reported seemed to be higher on arm; immediately had soreness informed this was normal. Continued having progressed symptoms of decreased range of motion (ROM), n/t (numbness and tingling), weakness. Was evaluated on 31Dec2020 for this by an Orthopedic provider at employment. X-rays obtained at that time. Based off exam, he (orthopedic) reported other patient's having similar issues with this after being administered a vaccine and reporting frozen shoulder. Informed the patient the vaccine may have been administered into sub-acromial space. Strongly recommended magnetic resonance imaging (MRI); obtained the same day on 31Dec2020. Informed the patient this was the case and recommended a follow-up visit to discuss surgery. He was not able to provide injection to help with relief due to 2nd vaccine on 12Jan2021. He strongly recommended a different administration site on 12Jan2021. The events started on 22Dec2020 at 15:30, resulted in doctor or other healthcare professional office/clinic visit, and were considered serious for disability or permanent damage. The events had not resolved.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events 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: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Musculoskeletal discomfort, Pain, X-ray limb
Clinical narrative: the vaccine may have been administered into sub-acromial space; the vaccine may have been administered into sub-acromial space; Seemed to be higher on arm; soreness; Continued having progressed symptoms of decreased ROM; n/t (numbness and tingling); n/t (numbness and tingling); weakness; frozen shoulder; This is a spontaneous report from a contactable Nurse reporting for herself. A 30-year-old female patient (non-pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK9231), on 22Dec2020 at 15:30 at single dose in left arm, for COVID-19 immunisation. Age at vaccination was 30-year-old. No other vaccine was given within 4 weeks prior to the COVID vaccine. COVID was not tested prior or post vaccination. Medical history included type 1 diabetes mellitus, migraines, postural orthostatic tachycardia syndrome. The patient had known allergies to morphine and tomatoes. Concomitant medications included insulin aspart (NOVOLOG), topiramate (TROKENDI), metoprolol (METOPROLOL). The patient reported seemed to be higher on arm; immediately had soreness informed this was normal. Continued having progressed symptoms of decreased range of motion (ROM), n/t (numbness and tingling), weakness. Was evaluated on 31Dec2020 for this by an Orthopedic provider at employment. X-rays obtained at that time. Based off exam, he (orthopedic) reported other patient's having similar issues with this after being administered a vaccine and reporting frozen shoulder. Informed the patient the vaccine may have been administered into sub-acromial space. Strongly recommended magnetic resonance imaging (MRI); obtained the same day on 31Dec2020. Informed the patient this was the case and recommended a follow-up visit to discuss surgery. He was not able to provide injection to help with relief due to 2nd vaccine on 12Jan2021. He strongly recommended a different administration site on 12Jan2021. The events started on 22Dec2020 at 15:30, resulted in doctor or other healthcare professional office/clinic visit, and were considered serious for disability or permanent damage. The events had not resolved.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events 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.