chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable Other Health Professional (patient). A 38-year-old female patient (no pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) via intramuscular on 22Dec2020 10:00 AM on left arm at single dose for COVID-19 immunization. The patient's medical history included allergy to cefdiner and augmentin and no other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The concomitant drug was not reported. The patient experienced headache on 23Dec2020 05:00 AM. No treatment for adverse event. The outcome of the events was recovered in Dec2020.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain
Clinical narrative: Injection site soreness; This is a spontaneous report from a contactable other healthcare profession (hcp) (patient). A 54-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EJ1685), intramuscularly on 21Dec2020 16:30 at a single dose in left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No known allergies. The patient experienced injection site soreness on 21Dec2020 17:00. No treatment received for this event. The patient underwent lab tests and procedures which included COVID test type post vaccination (Nasal Swab): negative on 14Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. This is a non-serious report. The outcome of event was recovering.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, SARS-CoV-2 test negative
Clinical narrative: Injection site soreness; This is a spontaneous report from a contactable other healthcare profession (hcp) (patient). A 54-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EJ1685), intramuscularly on 21Dec2020 16:30 at a single dose in left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No known allergies. The patient experienced injection site soreness on 21Dec2020 17:00. No treatment received for this event. The patient underwent lab tests and procedures which included COVID test type post vaccination (Nasal Swab): negative on 14Dec2020. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. This is a non-serious report. The outcome of event was recovering.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Hallucination, Headache, Pain in extremity, Pyrexia
Clinical narrative: hallucinations; pain in right arm; headache; fever; chills; This is a spontaneous report from a contactable pharmacist via Regulatory Authority (Regulatory Authority report number not provided). A 35-year-old female received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BionTech), intramuscular, on 18Dec2020 morning, at single dose, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient has never had an adverse event following any previous vaccine. On 18Dec2020  afternoon, 12 hours after receiving vaccine, the patient experienced hallucinations, pain in right arm, headache, fever and chills. The patient underwent lab tests and procedures which included body temperature: fever (18Dec2020). The events recovered in Dec2020, 36 hours after.   The information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Hallucination, Headache, Laboratory test, Pain in extremity
Clinical narrative: hallucinations; pain in right arm; headache; fever; chills; This is a spontaneous report from a contactable pharmacist via Regulatory Authority (Regulatory Authority report number not provided). A 35-year-old female received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BionTech), intramuscular, on 18Dec2020 morning, at single dose, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient has never had an adverse event following any previous vaccine. On 18Dec2020  afternoon, 12 hours after receiving vaccine, the patient experienced hallucinations, pain in right arm, headache, fever and chills. The patient underwent lab tests and procedures which included body temperature: fever (18Dec2020). The events recovered in Dec2020, 36 hours after.   The information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: hallucinations; pain in right arm; headache; fever; chills; This is a spontaneous report from a contactable pharmacist via Regulatory Authority (Regulatory Authority report number not provided). A 35-year-old female received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BionTech), intramuscular, on 18Dec2020 morning, at single dose, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient has never had an adverse event following any previous vaccine. On 18Dec2020  afternoon, 12 hours after receiving vaccine, the patient experienced hallucinations, pain in right arm, headache, fever and chills. The patient underwent lab tests and procedures which included body temperature: fever (18Dec2020). The events recovered in Dec2020, 36 hours after.   The information on the lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Dizziness, Oxygen saturation normal, Respiratory rate increased
Clinical narrative: Anxiety; Anxiety; dizziness; rapid breathing; This is a spontaneous report from a non-contactable other health professional. A 34-year-old female patient received the first of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899) intramuscularly on 22Dec2020 14:00 at left arm, at single dose for covid-19 immunization. Medical history included anxiety and took Hydralazine prn (As needed). The patient's concomitant medications were not reported. The patient denied any history of previous adverse reactions to vaccines. The patient was given the vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience dizziness on 22Dec2020. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. This reporter was notified of patient reaction and she was then assessed in the emergency bay area. The patient presented with rapid breathing and anxiety. Monitored patient for severe reaction symptoms, including respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis. The patient's breathing slowed and felt less anxious by the time she left. The outcome of the events rapid breathing and anxiety was recovering, the outcome of the other event was unknown. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Condition aggravated, Dizziness, Respiratory rate increased
Clinical narrative: Anxiety; Anxiety; dizziness; rapid breathing; This is a spontaneous report from a non-contactable other health professional. A 34-year-old female patient received the first of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899) intramuscularly on 22Dec2020 14:00 at left arm, at single dose for covid-19 immunization. Medical history included anxiety and took Hydralazine prn (As needed). The patient's concomitant medications were not reported. The patient denied any history of previous adverse reactions to vaccines. The patient was given the vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience dizziness on 22Dec2020. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. This reporter was notified of patient reaction and she was then assessed in the emergency bay area. The patient presented with rapid breathing and anxiety. Monitored patient for severe reaction symptoms, including respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis. The patient's breathing slowed and felt less anxious by the time she left. The outcome of the events rapid breathing and anxiety was recovering, the outcome of the other event was unknown. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.  No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This is a spontaneous report from a non-contactable healthcare professional. A 21-year-old male patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EH9899, expiry date not reported), intramuscular on the right arm (right deltoid muscle) on 22Dec2020 18:15 at a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced dizziness on 22Dec2020. He denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, facial swelling, lip swelling and tongue swelling. The provider was notified of patient's reaction and he was then assessed in the emergency bay area. The patient was monitored for severe reaction symptoms, including rapid progression of symptoms, respiratory distress with stridor, wheezing, dyspnea, increased work of breathing, persistent cough and cyanosis, vomiting, abdominal pain, hypotension, dysrhythmia, chest pain and collapse. Therapeutic measures were taken as a result of dizziness that included water and rest. The patient was stable to go home. Clinical outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Pain injection site; numbness in both hands; This is a spontaneous report from a contactable consumer (patient).  A 30-years-old male patient started to receive first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EK5730), via an unspecified route of administration on 22Dec2020 14:00 at single dose (Anatomical Location of Administration: right shoulder) for COVID-19 immunization.  Medical history included ongoing allergy, allergic to Sulfa drugs, Clindamycin, and Vancomycin.  Concomitant medication included ongoing fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) for Allergy and ongoing loratadine for Allergy.  Prior vaccinations within 4 weeks was none. The patient experienced numbness in both hands on 22Dec2020 about ten minutes after the injection, pain injection site on 23Dec2020 09:00. He had an interesting side effect that was not listed on the fact sheet. He mentioned he did not want his information going to any third parties. He clarified the interesting side effect that he did not see listed on the fact sheet as, received the COVID 19 vaccine yesterday (22Dec2020) around 2 pm, after getting the shot he felt fine initially, but then he started to experience both of his hands go numb. He was not sure if had any effect on the nerves, but it effected his hands. Then he noticed today (23Dec2020) he had some pain at injection site. He stated that was normal and saw it listed. It was the numbing of his hands that was weird to him. His left hand felt better, but right hand felt the same. He was calling to see if due to this if he should still take the booster shot or not. He also wanted to see if these details had been reported before. Pain at injection still hurts a good amount and unable to provide outcome. He mentioned the card he received with the lot number the person who wrote on it had terrible hand writing, so he was not sure of the lot number. He stated these reactions are not severe, it is kind of annoying. The action taken in response to the events for bnt162b2 was not applicable. Relevant Test was None. The outcome of the events was not recovered.
Age: 30.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Injection site pain
Clinical narrative: Pain injection site; numbness in both hands; This is a spontaneous report from a contactable consumer (patient).  A 30-years-old male patient started to receive first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EK5730), via an unspecified route of administration on 22Dec2020 14:00 at single dose (Anatomical Location of Administration: right shoulder) for COVID-19 immunization.  Medical history included ongoing allergy, allergic to Sulfa drugs, Clindamycin, and Vancomycin.  Concomitant medication included ongoing fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) for Allergy and ongoing loratadine for Allergy.  Prior vaccinations within 4 weeks was none. The patient experienced numbness in both hands on 22Dec2020 about ten minutes after the injection, pain injection site on 23Dec2020 09:00. He had an interesting side effect that was not listed on the fact sheet. He mentioned he did not want his information going to any third parties. He clarified the interesting side effect that he did not see listed on the fact sheet as, received the COVID 19 vaccine yesterday (22Dec2020) around 2 pm, after getting the shot he felt fine initially, but then he started to experience both of his hands go numb. He was not sure if had any effect on the nerves, but it effected his hands. Then he noticed today (23Dec2020) he had some pain at injection site. He stated that was normal and saw it listed. It was the numbing of his hands that was weird to him. His left hand felt better, but right hand felt the same. He was calling to see if due to this if he should still take the booster shot or not. He also wanted to see if these details had been reported before. Pain at injection still hurts a good amount and unable to provide outcome. He mentioned the card he received with the lot number the person who wrote on it had terrible hand writing, so he was not sure of the lot number. He stated these reactions are not severe, it is kind of annoying. The action taken in response to the events for bnt162b2 was not applicable. Relevant Test was None. The outcome of the events was not recovered.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood glucose increased, Chills, Feeling abnormal, Nausea
Clinical narrative: anxiety; chills; generalized feelings of not feeling quite right; nausea; nervousness; This is a spontaneous report from a non-contactable other hcp.  A 34-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EH9899), intramuscular on 22Dec2020 13:45 (vaccine location: Right arm) at single dose for covid-19 Vaccination. Past medical history includes anxiety for which she took venlafaxine (Effexor) on a daily basis as well as type 2 diabetes, diagnosed approximately seven or 8 years ago during a pregnancy, she was on oral medication during the day and insulin at nighttime. Concomitant medications were not reported. She did take her oral medication today (22Dec2020) and last ate a pasta lunch right before arriving to the vaccine clinic. Last A1c was 6. During her 15-minute waiting period after the injection, the patient began to experience generalized feelings of not feeling quite right as well as anxiety/nervousness, nausea and chills. She denied difficulty breathing, throat tightness, dizziness, chest pain, or other GI complaints.  This provider noticed her raising her hand from across the waiting area and tended to her where she noted the above complaints. she was then assessed in the emergency bay area. She was monitored for severe reaction symptoms, including rapid progression of symptoms, vomiting, hypotension, chest pain, collapse and Respiratory distress. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nervousness, Stress, Tachycardia
Clinical narrative: anxiety; chills; generalized feelings of not feeling quite right; nausea; nervousness; This is a spontaneous report from a non-contactable other hcp.  A 34-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EH9899), intramuscular on 22Dec2020 13:45 (vaccine location: Right arm) at single dose for covid-19 Vaccination. Past medical history includes anxiety for which she took venlafaxine (Effexor) on a daily basis as well as type 2 diabetes, diagnosed approximately seven or 8 years ago during a pregnancy, she was on oral medication during the day and insulin at nighttime. Concomitant medications were not reported. She did take her oral medication today (22Dec2020) and last ate a pasta lunch right before arriving to the vaccine clinic. Last A1c was 6. During her 15-minute waiting period after the injection, the patient began to experience generalized feelings of not feeling quite right as well as anxiety/nervousness, nausea and chills. She denied difficulty breathing, throat tightness, dizziness, chest pain, or other GI complaints.  This provider noticed her raising her hand from across the waiting area and tended to her where she noted the above complaints. she was then assessed in the emergency bay area. She was monitored for severe reaction symptoms, including rapid progression of symptoms, vomiting, hypotension, chest pain, collapse and Respiratory distress. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Chills, Condition aggravated, Feeling abnormal, Nausea
Clinical narrative: anxiety; chills; generalized feelings of not feeling quite right; nausea; nervousness; This is a spontaneous report from a non-contactable other hcp.  A 34-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EH9899), intramuscular on 22Dec2020 13:45 (vaccine location: Right arm) at single dose for covid-19 Vaccination. Past medical history includes anxiety for which she took venlafaxine (Effexor) on a daily basis as well as type 2 diabetes, diagnosed approximately seven or 8 years ago during a pregnancy, she was on oral medication during the day and insulin at nighttime. Concomitant medications were not reported. She did take her oral medication today (22Dec2020) and last ate a pasta lunch right before arriving to the vaccine clinic. Last A1c was 6. During her 15-minute waiting period after the injection, the patient began to experience generalized feelings of not feeling quite right as well as anxiety/nervousness, nausea and chills. She denied difficulty breathing, throat tightness, dizziness, chest pain, or other GI complaints.  This provider noticed her raising her hand from across the waiting area and tended to her where she noted the above complaints. she was then assessed in the emergency bay area. She was monitored for severe reaction symptoms, including rapid progression of symptoms, vomiting, hypotension, chest pain, collapse and Respiratory distress. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nervousness
Clinical narrative: anxiety; chills; generalized feelings of not feeling quite right; nausea; nervousness; This is a spontaneous report from a non-contactable other hcp.  A 34-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EH9899), intramuscular on 22Dec2020 13:45 (vaccine location: Right arm) at single dose for covid-19 Vaccination. Past medical history includes anxiety for which she took venlafaxine (Effexor) on a daily basis as well as type 2 diabetes, diagnosed approximately seven or 8 years ago during a pregnancy, she was on oral medication during the day and insulin at nighttime. Concomitant medications were not reported. She did take her oral medication today (22Dec2020) and last ate a pasta lunch right before arriving to the vaccine clinic. Last A1c was 6. During her 15-minute waiting period after the injection, the patient began to experience generalized feelings of not feeling quite right as well as anxiety/nervousness, nausea and chills. She denied difficulty breathing, throat tightness, dizziness, chest pain, or other GI complaints.  This provider noticed her raising her hand from across the waiting area and tended to her where she noted the above complaints. she was then assessed in the emergency bay area. She was monitored for severe reaction symptoms, including rapid progression of symptoms, vomiting, hypotension, chest pain, collapse and Respiratory distress. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: Runny nose; Congestion; Malaise; Fever; Chills; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). This male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. The patient received the vaccination on Friday, 18Dec2020. The patient was experiencing fever and chills Friday night on 18Dec2020. Then he proceeded to receive a runny nose and congestion still at the time of reporting along with a little bit of malaise. He was wondering if he should get tested for COVID-19 due to the symptom or if the symptoms were due to the vaccination. Outcome of the events runny nose, congestion and malaise was not recovered. Outcome of the events fever and chills was unknown.   Information on the Lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Malaise, Pyrexia, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: Runny nose; Congestion; Malaise; Fever; Chills; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). This male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. The patient received the vaccination on Friday, 18Dec2020. The patient was experiencing fever and chills Friday night on 18Dec2020. Then he proceeded to receive a runny nose and congestion still at the time of reporting along with a little bit of malaise. He was wondering if he should get tested for COVID-19 due to the symptom or if the symptoms were due to the vaccination. Outcome of the events runny nose, congestion and malaise was not recovered. Outcome of the events fever and chills was unknown.   Information on the Lot/batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Dizziness, Dyspnoea, Erythema, Palpitations
Clinical narrative: BP was 176/126; Presyncopal event/tachycardic/slight blurred vision/hr50; Presyncopal event/tachycardic/slight blurred vision/hr50; Presyncopal event/tachycardic/slight blurred vision/hr50; burning/ tingling in my upper face; burning/ tingling in my upper face; slightly short of breath; base of tongue/neck felt tight; base of tongue/neck felt tight; little chest tightness; This is a spontaneous report from a contactable physician.  A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EK5730), via an unspecified route of administration on left arm on 23Dec2020 09:45 at single dose for COVID-19 immunisation. Medical history included Crohn's disease in remission for many years, hypertension, macular degeneration, and allergies: Sulfa.  Concomitant medication included metoprolol, irbesartan, magnesium, ubidecarenone (COQ10 [UBIDECARENONE]) and ergocalciferol (VIT D).  The patient stated, "I received the vaccine today 23Dec2020 at around 9:45 am. I felt fine after 15 minutes and left the hospital. In my car, I noticed burning/ tingling in my upper face and slight blurred vision. Got home and felt slightly short of breath, tachycardic and base of tongue/neck felt tight. Had a presyncopal event and called (emergency number). Took Benadryl 50 mg and prednisone 20 mg. BP was 176/126, O2 sat 99, hr68. Since then, (around 10:15 today 23Dec2020) my face has continued to burn and tingle as well as my arms on and off. At 3:00 I felt a little chest tightness and SOB ago. Took Benadryl 50 mg. Better, but face is still burning. BP now normal 126/60 and hr50". The outcome of BP was 176/126 was recovered on Dec2020, burning/ tingling in my upper face was not recovered and other events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject vaccine, BNT162B2, cannot be excluded for the BP increased and other reported events due to temporal relationship. There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including BP at baseline, EKG, echocardiogram, cardiac enzymes, electrolytes, chemistry panel and serum toxicology screen, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is 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: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Tongue discomfort
Clinical narrative: BP was 176/126; Presyncopal event/tachycardic/slight blurred vision/hr50; Presyncopal event/tachycardic/slight blurred vision/hr50; Presyncopal event/tachycardic/slight blurred vision/hr50; burning/ tingling in my upper face; burning/ tingling in my upper face; slightly short of breath; base of tongue/neck felt tight; base of tongue/neck felt tight; little chest tightness; This is a spontaneous report from a contactable physician.  A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EK5730), via an unspecified route of administration on left arm on 23Dec2020 09:45 at single dose for COVID-19 immunisation. Medical history included Crohn's disease in remission for many years, hypertension, macular degeneration, and allergies: Sulfa.  Concomitant medication included metoprolol, irbesartan, magnesium, ubidecarenone (COQ10 [UBIDECARENONE]) and ergocalciferol (VIT D).  The patient stated, "I received the vaccine today 23Dec2020 at around 9:45 am. I felt fine after 15 minutes and left the hospital. In my car, I noticed burning/ tingling in my upper face and slight blurred vision. Got home and felt slightly short of breath, tachycardic and base of tongue/neck felt tight. Had a presyncopal event and called (emergency number). Took Benadryl 50 mg and prednisone 20 mg. BP was 176/126, O2 sat 99, hr68. Since then, (around 10:15 today 23Dec2020) my face has continued to burn and tingle as well as my arms on and off. At 3:00 I felt a little chest tightness and SOB ago. Took Benadryl 50 mg. Better, but face is still burning. BP now normal 126/60 and hr50". The outcome of BP was 176/126 was recovered on Dec2020, burning/ tingling in my upper face was not recovered and other events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject vaccine, BNT162B2, cannot be excluded for the BP increased and other reported events due to temporal relationship. There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including BP at baseline, EKG, echocardiogram, cardiac enzymes, electrolytes, chemistry panel and serum toxicology screen, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is 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: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Burning sensation, Chest discomfort, Dyspnoea, Muscle tightness
Clinical narrative: BP was 176/126; Presyncopal event/tachycardic/slight blurred vision/hr50; Presyncopal event/tachycardic/slight blurred vision/hr50; Presyncopal event/tachycardic/slight blurred vision/hr50; burning/ tingling in my upper face; burning/ tingling in my upper face; slightly short of breath; base of tongue/neck felt tight; base of tongue/neck felt tight; little chest tightness; This is a spontaneous report from a contactable physician.  A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EK5730), via an unspecified route of administration on left arm on 23Dec2020 09:45 at single dose for COVID-19 immunisation. Medical history included Crohn's disease in remission for many years, hypertension, macular degeneration, and allergies: Sulfa.  Concomitant medication included metoprolol, irbesartan, magnesium, ubidecarenone (COQ10 [UBIDECARENONE]) and ergocalciferol (VIT D).  The patient stated, "I received the vaccine today 23Dec2020 at around 9:45 am. I felt fine after 15 minutes and left the hospital. In my car, I noticed burning/ tingling in my upper face and slight blurred vision. Got home and felt slightly short of breath, tachycardic and base of tongue/neck felt tight. Had a presyncopal event and called (emergency number). Took Benadryl 50 mg and prednisone 20 mg. BP was 176/126, O2 sat 99, hr68. Since then, (around 10:15 today 23Dec2020) my face has continued to burn and tingle as well as my arms on and off. At 3:00 I felt a little chest tightness and SOB ago. Took Benadryl 50 mg. Better, but face is still burning. BP now normal 126/60 and hr50". The outcome of BP was 176/126 was recovered on Dec2020, burning/ tingling in my upper face was not recovered and other events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject vaccine, BNT162B2, cannot be excluded for the BP increased and other reported events due to temporal relationship. There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including BP at baseline, EKG, echocardiogram, cardiac enzymes, electrolytes, chemistry panel and serum toxicology screen, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is 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: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Paraesthesia oral, Presyncope, Tachycardia, Vision blurred
Clinical narrative: BP was 176/126; Presyncopal event/tachycardic/slight blurred vision/hr50; Presyncopal event/tachycardic/slight blurred vision/hr50; Presyncopal event/tachycardic/slight blurred vision/hr50; burning/ tingling in my upper face; burning/ tingling in my upper face; slightly short of breath; base of tongue/neck felt tight; base of tongue/neck felt tight; little chest tightness; This is a spontaneous report from a contactable physician.  A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EK5730), via an unspecified route of administration on left arm on 23Dec2020 09:45 at single dose for COVID-19 immunisation. Medical history included Crohn's disease in remission for many years, hypertension, macular degeneration, and allergies: Sulfa.  Concomitant medication included metoprolol, irbesartan, magnesium, ubidecarenone (COQ10 [UBIDECARENONE]) and ergocalciferol (VIT D).  The patient stated, "I received the vaccine today 23Dec2020 at around 9:45 am. I felt fine after 15 minutes and left the hospital. In my car, I noticed burning/ tingling in my upper face and slight blurred vision. Got home and felt slightly short of breath, tachycardic and base of tongue/neck felt tight. Had a presyncopal event and called (emergency number). Took Benadryl 50 mg and prednisone 20 mg. BP was 176/126, O2 sat 99, hr68. Since then, (around 10:15 today 23Dec2020) my face has continued to burn and tingle as well as my arms on and off. At 3:00 I felt a little chest tightness and SOB ago. Took Benadryl 50 mg. Better, but face is still burning. BP now normal 126/60 and hr50". The outcome of BP was 176/126 was recovered on Dec2020, burning/ tingling in my upper face was not recovered and other events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject vaccine, BNT162B2, cannot be excluded for the BP increased and other reported events due to temporal relationship. There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including BP at baseline, EKG, echocardiogram, cardiac enzymes, electrolytes, chemistry panel and serum toxicology screen, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: fever; Headache; fatigue; This is a spontaneous report from a contactable Other healthcare professional (patient). A 59-year-old male patient received BNT162B2 (lot number: EJ1685) first dose on 22Dec2020 07:30 AM on left arm at single dose for COVID-19 immunization. Medical history included HTN (Hypertension) and Allergies to PCN (Penicillin) and Sensitive to morphine. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), atenolol, ergocalciferol (VIT D) and multivitamin. Facility type vaccine was Hospital. Patient had other vaccine (Trial) in four weeks, patient had it on 02Dec2020 first dose on Left Arm. Patient had other medications in two weeks: Effexor, atenolol, multivitamin, vit D. About 16 hrs (22Dec2020 11:00 PM) after injection patient began fever 100-101. Lasted about 20 hours. Relieved with ibuprofen. Headache and fatigue also. All resolved about 36 hours after injection. Patient did not have covid prior vaccination and no covid tested post vaccination. No treatment received for the adverse event. The outcome of the events was recovered. The seriousness was reported as no.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: fever; Headache; fatigue; This is a spontaneous report from a contactable Other healthcare professional (patient). A 59-year-old male patient received BNT162B2 (lot number: EJ1685) first dose on 22Dec2020 07:30 AM on left arm at single dose for COVID-19 immunization. Medical history included HTN (Hypertension) and Allergies to PCN (Penicillin) and Sensitive to morphine. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), atenolol, ergocalciferol (VIT D) and multivitamin. Facility type vaccine was Hospital. Patient had other vaccine (Trial) in four weeks, patient had it on 02Dec2020 first dose on Left Arm. Patient had other medications in two weeks: Effexor, atenolol, multivitamin, vit D. About 16 hrs (22Dec2020 11:00 PM) after injection patient began fever 100-101. Lasted about 20 hours. Relieved with ibuprofen. Headache and fatigue also. All resolved about 36 hours after injection. Patient did not have covid prior vaccination and no covid tested post vaccination. No treatment received for the adverse event. The outcome of the events was recovered. The seriousness was reported as no.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: she broke out in hives 4 hours after she received the vaccine; This is a spontaneous report from a contactable other-healthcare professional (HCP) (patient). A 34-year-old female patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot #: EL1284) as the first dose via intramuscular on 23Dec2020 13:00 in the right arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine BNT162B2. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient reported that she broke out in hives 4 hours after she received the vaccine on 23Dec2020 (also reported as at 16:00). The event was reported as non-serious. No treatment was received for the event. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: she broke out in hives 4 hours after she received the vaccine; This is a spontaneous report from a contactable other-healthcare professional (HCP) (patient). A 34-year-old female patient received a single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot #: EL1284) as the first dose via intramuscular on 23Dec2020 13:00 in the right arm for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine BNT162B2. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient reported that she broke out in hives 4 hours after she received the vaccine on 23Dec2020 (also reported as at 16:00). The event was reported as non-serious. No treatment was received for the event. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Nausea, Pruritus, Pyrexia
Clinical narrative: Lightheadedness and fatigue. The following afternoon nausea, chills, body aches, severe headache and fever of 101F which lasted till Sunday night 12/20/2020. Monday 12/21/2020 the patient started experiencing hot rash all over the body, and burning Itching two days afterwards and lasted Friday 12/25/2020
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash macular, Rash pruritic, Skin warm
Clinical narrative: Lightheadedness and fatigue. The following afternoon nausea, chills, body aches, severe headache and fever of 101F which lasted till Sunday night 12/20/2020. Monday 12/21/2020 the patient started experiencing hot rash all over the body, and burning Itching two days afterwards and lasted Friday 12/25/2020
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Chills, Dizziness, Fatigue, Feeling hot
Clinical narrative: Lightheadedness and fatigue. The following afternoon nausea, chills, body aches, severe headache and fever of 101F which lasted till Sunday night 12/20/2020. Monday 12/21/2020 the patient started experiencing hot rash all over the body, and burning Itching two days afterwards and lasted Friday 12/25/2020
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Nausea, Pain, Pruritus, Pyrexia
Clinical narrative: Lightheadedness and fatigue. The following afternoon nausea, chills, body aches, severe headache and fever of 101F which lasted till Sunday night 12/20/2020. Monday 12/21/2020 the patient started experiencing hot rash all over the body, and burning Itching two days afterwards and lasted Friday 12/25/2020
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Lightheadedness and fatigue. The following afternoon nausea, chills, body aches, severe headache and fever of 101F which lasted till Sunday night 12/20/2020. Monday 12/21/2020 the patient started experiencing hot rash all over the body, and burning Itching two days afterwards and lasted Friday 12/25/2020
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Erythema, Injection site bruising, Injection site pain, Peripheral swelling
Clinical narrative: My arm is sore; I have really weird red like bump blister that formed on my right hand on my index finger; This is a spontaneous report from a contactable Physician. This Physician(patient) reported that the 48-year-old female patient received bnt162b2 (BNT162B2, Batch/lot number: EJ1685), via unknown route of administration on arm on 19Dec2020 01:30 at single dose for covid-19 immunisation. Medical history was none. Concomitant medications were unknown. Physician stated, "I took the Pfizer Vaccine (COVID Vaccine) yesterday at 1:30 and I am fine. My arm is sore, but I have really weird red like bump blister that formed on my right hand on my finger, on my index finger. I don't have any 'trauma to it'. I don't why it's there? I haven't seen it but its unusual looking." No treatment received. The causality was assessed by Physician stated, "No, I don't know. I have no idea if this it is just a rare coincidence." The outcome of the events was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blister, Erythema, Pain in extremity
Clinical narrative: My arm is sore; I have really weird red like bump blister that formed on my right hand on my index finger; This is a spontaneous report from a contactable Physician. This Physician(patient) reported that the 48-year-old female patient received bnt162b2 (BNT162B2, Batch/lot number: EJ1685), via unknown route of administration on arm on 19Dec2020 01:30 at single dose for covid-19 immunisation. Medical history was none. Concomitant medications were unknown. Physician stated, "I took the Pfizer Vaccine (COVID Vaccine) yesterday at 1:30 and I am fine. My arm is sore, but I have really weird red like bump blister that formed on my right hand on my finger, on my index finger. I don't have any 'trauma to it'. I don't why it's there? I haven't seen it but its unusual looking." No treatment received. The causality was assessed by Physician stated, "No, I don't know. I have no idea if this it is just a rare coincidence." The outcome of the events was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: muscle soreness; fatigue; This is a spontaneous report from a contactable nurse (patient herself). A 42-year-old female patient (non-pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), intramuscular on 22Dec2020 07:30 at single dose at left arm for immunization. Medical history included PCOS, allergy to ragweed, grass. The patient's concomitant medications were not reported. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 22Dec2020 10:00 AM, the patient experienced muscle soreness and fatigue. Patient was unsure if the fatigue was from lack of sleep before working 12 hours and then getting the vaccine, or from the vaccine itself. Patient was recovered from all events in Dec2020, and didn't receive treatment. The report is assessed as non-serious.    Information on the lot/batch number has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nipple pain, Nipple swelling
Clinical narrative: Right nipple soreness and swelling; Right nipple soreness and swelling; This is a spontaneous report from a contactable physician (patient). This 73-year-old male patient reported that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), via intramuscular at arm right on 19Dec2020 03:00 PM at single dose for COVID-19 immunization. Medical history was none. Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food or other products. Concomitant medication was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received no new medications within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. Patient experienced right nipple soreness and swelling on 22Dec2020. No treatment was received for the adverse event. It was reported as non-serious. Outcome of event was not recovered.