chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Fatigue, Headache, Heart rate increased, Hypertension
Clinical narrative: chest pressure; tightness /pressure in throat; Face red; BP 186/90; within 2 min. of injection had near syncope that would come in waves every 2-3 minutes; Headache; rapid HR; Chills; mild cough; Dizziness; fatigue; This is a spontaneous report from a non-contactable health care professional nurse, the patient. A 53-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1685), in the right arm on 28DEC2020 08:15 as a single dose, for COVID-19 vaccination. Facility where the most recent COVID-19 vaccine was administered was a Hospital.  Medical history included asthma and  gastroesophageal reflux disease from an unknown date and unknown if ongoing. Known allergies include Tape, Walnuts, and Cat hair. Concomitant medication received within 2 weeks of vaccination included acyclovir [aciclovir] (ACYCLOVIR [ACICLOVIR]), ferrous gluconate, herbal nos, vitamins nos (FLORADIX), lansoprazole (PREVACID), cholecalciferol (VITAMIN D [COLECALCIFEROL]).  No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19.  On 28DEC2020 08:15 within 2 min. of injection had near syncope that would come in waves every 2-3 minutes, face red, chest pressure, tightness /pressure in throat, headache, BP 186/90, rapid HR. The patient Spent 1 hour in ER. Later in day 28Dec2020, continued to have dizziness, chest pressure, chills, headache, fatigue. This continued for 4 days and had mild cough.  The adverse events resulted in an emergency room (ER) visit. and Physician Office Visit. Treatment included Xyzal which relieved majority of symptoms. Laboratory test and procedures on 28Dec2020 include Electrocardiogram (EKG) with normal results, Blood Pressure Measurement 186/90 and Heart Rate Rapid. Treatment was given for chest tightness, throat tightness and red face and No treatment was given for chills, cough, dizziness, fatigue, headache, heart rate increase, blood pressure high and near syncope. The clinical outcome of near syncope that would come in waves every 2-3 minutes, face red, chest pressure, tightness /pressure in throat, headache, BP 186/90, rapid HR, dizziness, chest pressure, chills, headache, fatigue, mild cough was recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported face red, chest pressure, tightness /pressure in throat, blood pressure increased (BP 186/90), near syncope and the administration of BNT162B2, based on the reasonable temporal association.   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 RA, IEC, as appropriate.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Presyncope, Throat tightness
Clinical narrative: chest pressure; tightness /pressure in throat; Face red; BP 186/90; within 2 min. of injection had near syncope that would come in waves every 2-3 minutes; Headache; rapid HR; Chills; mild cough; Dizziness; fatigue; This is a spontaneous report from a non-contactable health care professional nurse, the patient. A 53-years-old non-pregnant female patient (nurse) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1685), in the right arm on 28DEC2020 08:15 as a single dose, for COVID-19 vaccination. Facility where the most recent COVID-19 vaccine was administered was a Hospital.  Medical history included asthma and  gastroesophageal reflux disease from an unknown date and unknown if ongoing. Known allergies include Tape, Walnuts, and Cat hair. Concomitant medication received within 2 weeks of vaccination included acyclovir [aciclovir] (ACYCLOVIR [ACICLOVIR]), ferrous gluconate, herbal nos, vitamins nos (FLORADIX), lansoprazole (PREVACID), cholecalciferol (VITAMIN D [COLECALCIFEROL]).  No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19.  On 28DEC2020 08:15 within 2 min. of injection had near syncope that would come in waves every 2-3 minutes, face red, chest pressure, tightness /pressure in throat, headache, BP 186/90, rapid HR. The patient Spent 1 hour in ER. Later in day 28Dec2020, continued to have dizziness, chest pressure, chills, headache, fatigue. This continued for 4 days and had mild cough.  The adverse events resulted in an emergency room (ER) visit. and Physician Office Visit. Treatment included Xyzal which relieved majority of symptoms. Laboratory test and procedures on 28Dec2020 include Electrocardiogram (EKG) with normal results, Blood Pressure Measurement 186/90 and Heart Rate Rapid. Treatment was given for chest tightness, throat tightness and red face and No treatment was given for chills, cough, dizziness, fatigue, headache, heart rate increase, blood pressure high and near syncope. The clinical outcome of near syncope that would come in waves every 2-3 minutes, face red, chest pressure, tightness /pressure in throat, headache, BP 186/90, rapid HR, dizziness, chest pressure, chills, headache, fatigue, mild cough was recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported face red, chest pressure, tightness /pressure in throat, blood pressure increased (BP 186/90), near syncope and the administration of BNT162B2, based on the reasonable temporal association.   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 RA, IEC, as appropriate.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Antinuclear antibody negative, C-reactive protein increased, Fibrin D dimer increased, Hepatitis C antibody negative, Pericarditis
Clinical narrative: Adverse event: Pericarditis Treatment: ER visit x 2, Hospitalization for 1 day. Medications (Ibuprofen 600mg, 3 times per day for 14 days), (Colchicine 0.6 mg, 2 times per day for 3 months), (Omeprazole 20mg, 1 per day for 14 days).
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Red blood cell sedimentation rate normal, Troponin T increased
Clinical narrative: Adverse event: Pericarditis Treatment: ER visit x 2, Hospitalization for 1 day. Medications (Ibuprofen 600mg, 3 times per day for 14 days), (Colchicine 0.6 mg, 2 times per day for 3 months), (Omeprazole 20mg, 1 per day for 14 days).
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: C-reactive protein increased, Chest X-ray, Computerised tomogram, Echocardiogram, Electrocardiogram
Clinical narrative: Adverse event: Pericarditis Treatment: ER visit x 2, Hospitalization for 1 day. Medications (Ibuprofen 600mg, 3 times per day for 14 days), (Colchicine 0.6 mg, 2 times per day for 3 months), (Omeprazole 20mg, 1 per day for 14 days).
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fibrin D dimer increased, Pericarditis, Scan with contrast, Troponin increased
Clinical narrative: Adverse event: Pericarditis Treatment: ER visit x 2, Hospitalization for 1 day. Medications (Ibuprofen 600mg, 3 times per day for 14 days), (Colchicine 0.6 mg, 2 times per day for 3 months), (Omeprazole 20mg, 1 per day for 14 days).
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pericarditis
Clinical narrative: Adverse event: Pericarditis Treatment: ER visit x 2, Hospitalization for 1 day. Medications (Ibuprofen 600mg, 3 times per day for 14 days), (Colchicine 0.6 mg, 2 times per day for 3 months), (Omeprazole 20mg, 1 per day for 14 days).
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Clumsiness, Computerised tomogram spine, Grip strength decreased, Hypoaesthesia, Impaired work ability
Clinical narrative: Left idiopathic brachial Neuritis with progressive numbness and associated weakness. Distribution in multiple upper extremity peripheral nerves. Pt was started on High dose steroids with partial and ongoing improvement.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscular weakness, Neck pain, Neuralgic amyotrophy, Radiculitis brachial, Sensory loss
Clinical narrative: Left idiopathic brachial Neuritis with progressive numbness and associated weakness. Distribution in multiple upper extremity peripheral nerves. Pt was started on High dose steroids with partial and ongoing improvement.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anti-RNA polymerase III antibody negative, Asthenia, C-reactive protein normal, Hypoaesthesia, Radiculitis brachial
Clinical narrative: Left idiopathic brachial Neuritis with progressive numbness and associated weakness. Distribution in multiple upper extremity peripheral nerves. Pt was started on High dose steroids with partial and ongoing improvement.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Red blood cell sedimentation rate normal
Clinical narrative: Left idiopathic brachial Neuritis with progressive numbness and associated weakness. Distribution in multiple upper extremity peripheral nerves. Pt was started on High dose steroids with partial and ongoing improvement.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Brachial plexus injury, Computerised tomogram neck, Fine motor skill dysfunction, Grip strength decreased, Hypoaesthesia
Clinical narrative: Left idiopathic brachial Neuritis with progressive numbness and associated weakness. Distribution in multiple upper extremity peripheral nerves. Pt was started on High dose steroids with partial and ongoing improvement.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Impaired work ability, Muscular weakness
Clinical narrative: Left idiopathic brachial Neuritis with progressive numbness and associated weakness. Distribution in multiple upper extremity peripheral nerves. Pt was started on High dose steroids with partial and ongoing improvement.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Lymphadenopathy, Odynophagia
Clinical narrative: swollen lymph node, right side of neck; caused pain when swallowing; This is a spontaneous report from a contactable other healthcare professoonal (patient). A 35-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0140), via an unspecified route of administration in the right arm on 29Dec2020 11:30 at a single dose for COVID-19 immunization. The patient's medical history included chronic asthma and allergy to animal dander, mold, pollen. The patient was not pregnant. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), bupropion hydrochloride (WELLBUTRIN), ethinylestradiol, etonogestrel (NUVARING), salbutamol sulfate (PROAIR), and OTC vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took erythromycin and experienced drug allergy to erythromycin. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. 1 day after vaccination, on 30Dec2020 08:00, the patient woke up with swollen lymph node, right side of neck. Between 30Dec2020 and 04Jan2021, it increased in size and caused pain when swallowing. On 04Jan2021, the patient sought care at local emergency room (ER) due to concerns that it may be blocking esophagus. The patient underwent lab tests and procedures which included computerised tomogram (CT scan) with unknown results on 04Jan2021. Therapeutic measures were taken as a result of the events and included treatment with intravenous antibiotic. Outcome of the events was not recovered. The events were considered non-serious by the reporter.  Information about lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Lymphadenopathy, Odynophagia
Clinical narrative: swollen lymph node, right side of neck; caused pain when swallowing; This is a spontaneous report from a contactable other healthcare professoonal (patient). A 35-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL0140), via an unspecified route of administration in the right arm on 29Dec2020 11:30 at a single dose for COVID-19 immunization. The patient's medical history included chronic asthma and allergy to animal dander, mold, pollen. The patient was not pregnant. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), bupropion hydrochloride (WELLBUTRIN), ethinylestradiol, etonogestrel (NUVARING), salbutamol sulfate (PROAIR), and OTC vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took erythromycin and experienced drug allergy to erythromycin. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. 1 day after vaccination, on 30Dec2020 08:00, the patient woke up with swollen lymph node, right side of neck. Between 30Dec2020 and 04Jan2021, it increased in size and caused pain when swallowing. On 04Jan2021, the patient sought care at local emergency room (ER) due to concerns that it may be blocking esophagus. The patient underwent lab tests and procedures which included computerised tomogram (CT scan) with unknown results on 04Jan2021. Therapeutic measures were taken as a result of the events and included treatment with intravenous antibiotic. Outcome of the events was not recovered. The events were considered non-serious by the reporter.  Information about lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash pruritic, Swelling
Clinical narrative: RASH DEVELOPED AT INJECTION SITE 12/23/2020 AND SPREAD TO REST OF BODY. RASE DESCRIBED AS SMELL RAISSE BUMPS  EMPLOYEE USE BENADRLY AND HYDROCORTISONE CREAM TO TREAT.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site rash, Rash
Clinical narrative: RASH DEVELOPED AT INJECTION SITE 12/23/2020 AND SPREAD TO REST OF BODY. RASE DESCRIBED AS SMELL RAISSE BUMPS  EMPLOYEE USE BENADRLY AND HYDROCORTISONE CREAM TO TREAT.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Appendicectomy
Clinical narrative: Acute appendicitis; Severe acute abdominal pain; Chills; Fever; This is a spontaneous report from a contactable Nurse (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (expiration date Mar2021, incomplete lot number L0140, not sure the first letter it is C or E), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. None medical history. Concomitant medication included escitalopram oxalate (LEXAPRO). The patient experienced a little bit chills and fever she felt coming exactly on the 26th but she expected that and that was all fine but patient ended up in (Incomplete sentence). She went to work on 30th December and had some onset of severe acute abdominal pain and she ended up in an emergency appendectomy by 6 O'clock that evening. So she had an acute appendicitis and she did some research and it says that she can be listed in to the severe complications that the number in the vaccinated group was double back to the procedural group. The 26th it resided and patient felt better until the 30th when she have acute severe abdominal pain onset. She left work went for emergency room and she was in surgery within four hours. The outcome of events chills and fever was recovering, the other events was unknown. Because of the research that is on the website patient cannot help and think that it is related. Patient believed the relatedness of drug to events was related.  Information about lot/batch number has been requested.; 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: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Appendicectomy, Appendicitis, Chills, Pyrexia
Clinical narrative: Acute appendicitis; Severe acute abdominal pain; Chills; Fever; This is a spontaneous report from a contactable Nurse (patient). A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (expiration date Mar2021, incomplete lot number L0140, not sure the first letter it is C or E), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. None medical history. Concomitant medication included escitalopram oxalate (LEXAPRO). The patient experienced a little bit chills and fever she felt coming exactly on the 26th but she expected that and that was all fine but patient ended up in (Incomplete sentence). She went to work on 30th December and had some onset of severe acute abdominal pain and she ended up in an emergency appendectomy by 6 O'clock that evening. So she had an acute appendicitis and she did some research and it says that she can be listed in to the severe complications that the number in the vaccinated group was double back to the procedural group. The 26th it resided and patient felt better until the 30th when she have acute severe abdominal pain onset. She left work went for emergency room and she was in surgery within four hours. The outcome of events chills and fever was recovering, the other events was unknown. Because of the research that is on the website patient cannot help and think that it is related. Patient believed the relatedness of drug to events was related.  Information about lot/batch number has been requested.; 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: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Chest discomfort, Dry throat, Dyspnoea, Feeling hot
Clinical narrative: I had my first COVID 19 Moderna vaccine Lot: 025J20-2A at hospital. Within about 60 seconds of receiving it, my heart started pounding hard and rapidly and I let a nurse know. She took my vitals and my heart rate was very high, as was my blood pressure. My O2 was fine. I had some tightness and heaviness I my chest. I felt flush in my cheeks, but did not have hives. The nurse said my color was very pale. I was warm, given an ice pack, and then a bit later cold. At one point they wanted me to go to the Emergency Department, which I refused (perhaps stupidly). I'm not sure I was thinking clearly. I was trying very hard to stay calm and relaxed. My blood pressure was very elevated for about an hour and a half. They finally let me go home when I was 140/95 (my usual is 110 over 70 ish). I had some tongue tingling at home, very briefly.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Nausea, Palpitations, Throat irritation
Clinical narrative: I had my first COVID 19 Moderna vaccine Lot: 025J20-2A at hospital. Within about 60 seconds of receiving it, my heart started pounding hard and rapidly and I let a nurse know. She took my vitals and my heart rate was very high, as was my blood pressure. My O2 was fine. I had some tightness and heaviness I my chest. I felt flush in my cheeks, but did not have hives. The nurse said my color was very pale. I was warm, given an ice pack, and then a bit later cold. At one point they wanted me to go to the Emergency Department, which I refused (perhaps stupidly). I'm not sure I was thinking clearly. I was trying very hard to stay calm and relaxed. My blood pressure was very elevated for about an hour and a half. They finally let me go home when I was 140/95 (my usual is 110 over 70 ish). I had some tongue tingling at home, very briefly.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Confusional state, Feeling cold, Flushing, Heart rate increased
Clinical narrative: I had my first COVID 19 Moderna vaccine Lot: 025J20-2A at hospital. Within about 60 seconds of receiving it, my heart started pounding hard and rapidly and I let a nurse know. She took my vitals and my heart rate was very high, as was my blood pressure. My O2 was fine. I had some tightness and heaviness I my chest. I felt flush in my cheeks, but did not have hives. The nurse said my color was very pale. I was warm, given an ice pack, and then a bit later cold. At one point they wanted me to go to the Emergency Department, which I refused (perhaps stupidly). I'm not sure I was thinking clearly. I was trying very hard to stay calm and relaxed. My blood pressure was very elevated for about an hour and a half. They finally let me go home when I was 140/95 (my usual is 110 over 70 ish). I had some tongue tingling at home, very briefly.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Pallor, Palpitations, Paraesthesia oral, Skin warm
Clinical narrative: I had my first COVID 19 Moderna vaccine Lot: 025J20-2A at hospital. Within about 60 seconds of receiving it, my heart started pounding hard and rapidly and I let a nurse know. She took my vitals and my heart rate was very high, as was my blood pressure. My O2 was fine. I had some tightness and heaviness I my chest. I felt flush in my cheeks, but did not have hives. The nurse said my color was very pale. I was warm, given an ice pack, and then a bit later cold. At one point they wanted me to go to the Emergency Department, which I refused (perhaps stupidly). I'm not sure I was thinking clearly. I was trying very hard to stay calm and relaxed. My blood pressure was very elevated for about an hour and a half. They finally let me go home when I was 140/95 (my usual is 110 over 70 ish). I had some tongue tingling at home, very briefly.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Abortion spontaneous, Human chorionic gonadotropin decreased, Ultrasound antenatal screen abnormal, Uterine haemorrhage
Clinical narrative: miscarriage at 5 weeks of gestation; pregnant patient received the vaccine; pregnant patient received the vaccine; This is a spontaneous report from a contactable physician (patient herself) from a Pfizer Sponsored program. This physician only reported information for the mother (herself). This is the maternal case. A pregnant female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK5730), via an unspecified route of administration, on 17Dec2020 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The pregnant patient received the vaccine on 17Dec2020 and experienced miscarriage at 5 weeks of gestation on 31Dec2020. The clinical outcome of pregnant patient received the vaccine and miscarriage at 5 weeks of gestation was unknown.; Sender's Comments: The association between the event "miscarriage" with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: miscarriage at 5 weeks of gestation; pregnant patient received the vaccine; pregnant patient received the vaccine; This is a spontaneous report from a contactable physician (patient herself) from a Pfizer Sponsored program. This physician only reported information for the mother (herself). This is the maternal case. A pregnant female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK5730), via an unspecified route of administration, on 17Dec2020 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The pregnant patient received the vaccine on 17Dec2020 and experienced miscarriage at 5 weeks of gestation on 31Dec2020. The clinical outcome of pregnant patient received the vaccine and miscarriage at 5 weeks of gestation was unknown.; Sender's Comments: The association between the event "miscarriage" with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, SARS-CoV-2 test
Clinical narrative: nasal swab test positive; This is a spontaneous report from a contactable physician (the patient). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date unknown ) via an unspecified route of administration on 22Dec2020 (at the age of 35-years-old) at an unspecified dose  for COVID-19 vaccination. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient had a nasal swab test the day before her vaccine and did not receive the results prior to getting her injection. The results came back positive. The patient underwent lab tests and procedures which included sars-cov-2 test on 21Dec2020 which was positive. The clinical outcome of COVID-19 test positive was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: nasal swab test positive; This is a spontaneous report from a contactable physician (the patient). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number and expiration date unknown ) via an unspecified route of administration on 22Dec2020 (at the age of 35-years-old) at an unspecified dose  for COVID-19 vaccination. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient had a nasal swab test the day before her vaccine and did not receive the results prior to getting her injection. The results came back positive. The patient underwent lab tests and procedures which included sars-cov-2 test on 21Dec2020 which was positive. The clinical outcome of COVID-19 test positive was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, C-reactive protein increased, Headache, Pain in extremity, Red blood cell sedimentation rate increased
Clinical narrative: severe muscle pain, diagnosis of polymyalgia rheumatica; This is a spontaneous report from a contactable other HCP (patient). A 53-year-old female patient received the first dose of BNT162b2 (Lot/batch number and Expiration date were not provided), at the age of 53-year-old, via an unspecified route of administration at right arm on 18Dec2020 08:30 at single dose for covid-19 immunization. Medical history included hypertension (htn), allergies: penicillin. Concomitant medication included cefatrizine propyleneglycolate (CEFTIN), lisinopril, levothyroxine sodium (SYNTHROID). The patient experienced severe muscle pain, diagnosis of polymyalgia rheumatica on an unspecified date. The patient was not pregnant at the time of vaccination. The patient underwent lab tests and procedures which included COVID test rapid (Nasal Swab): negative on 06Jan2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect drug BNT162B2 on reported event 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: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Polymyalgia rheumatica, SARS-CoV-2 test negative
Clinical narrative: severe muscle pain, diagnosis of polymyalgia rheumatica; This is a spontaneous report from a contactable other HCP (patient). A 53-year-old female patient received the first dose of BNT162b2 (Lot/batch number and Expiration date were not provided), at the age of 53-year-old, via an unspecified route of administration at right arm on 18Dec2020 08:30 at single dose for covid-19 immunization. Medical history included hypertension (htn), allergies: penicillin. Concomitant medication included cefatrizine propyleneglycolate (CEFTIN), lisinopril, levothyroxine sodium (SYNTHROID). The patient experienced severe muscle pain, diagnosis of polymyalgia rheumatica on an unspecified date. The patient was not pregnant at the time of vaccination. The patient underwent lab tests and procedures which included COVID test rapid (Nasal Swab): negative on 06Jan2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect drug BNT162B2 on reported event 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: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face, Swollen tongue
Clinical narrative: 30 mins after receiving the vaccine, I started feeling my tongue more in my mouth. I also experienced difficulty breathing. I was told that my lips and cheeks were swollen and that my eyes were red. I was first given benadryl (25 mg) and prednisone (20 mg). I was later given epinephrine ( 0.3 mg/0.3mL injection). I was then taken to the emergency room where they prescribed the above medications to be taken for 3 days (minus the epinephrine).
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Lip swelling, Ocular hyperaemia, Swelling face, Swollen tongue
Clinical narrative: 30 mins after receiving the vaccine, I started feeling my tongue more in my mouth. I also experienced difficulty breathing. I was told that my lips and cheeks were swollen and that my eyes were red. I was first given benadryl (25 mg) and prednisone (20 mg). I was later given epinephrine ( 0.3 mg/0.3mL injection). I was then taken to the emergency room where they prescribed the above medications to be taken for 3 days (minus the epinephrine).
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Had vaccine on 12/28, then on 1/5 in the evening noticed a rash from top of left shoulder halfway down arm. Had not noticed rash immediately after injection and did not notice until 1/5. Mild itching around sight, not raised or warm to the touch. Does not appear as cellulitis, not tender to touch, otherwise asymptomatic currently.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: Had vaccine on 12/28, then on 1/5 in the evening noticed a rash from top of left shoulder halfway down arm. Had not noticed rash immediately after injection and did not notice until 1/5. Mild itching around sight, not raised or warm to the touch. Does not appear as cellulitis, not tender to touch, otherwise asymptomatic currently.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Nausea, Pain, Pyrexia, Sleep disorder
Clinical narrative: Fever, chills and body aches
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever, chills and body aches
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Peripheral swelling, Rash macular
Clinical narrative: 12/29/20 Dose #1 COVID (Moderna) administered at approximately 1:00pm.  At approximately 8:00pm, patient experienced red blotches an swollen feet which resolved on 12/30/20.  On 01/06/21, patient experienced swelling, redness and itching at injection site.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Peripheral swelling, Rash macular
Clinical narrative: 12/29/20 Dose #1 COVID (Moderna) administered at approximately 1:00pm.  At approximately 8:00pm, patient experienced red blotches an swollen feet which resolved on 12/30/20.  On 01/06/21, patient experienced swelling, redness and itching at injection site.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: broke out on face, neck and chest area
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: broke out on face, neck and chest area
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Oedema peripheral, Paraesthesia
Clinical narrative: Developed a tingling sensation on the left side of her body and face after getting the first vaccine. She had no weakness and was able to go about her normal day to day activities. The sensation went away with Tylenol and resolved the following day.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Developed a tingling sensation on the left side of her body and face after getting the first vaccine. She had no weakness and was able to go about her normal day to day activities. The sensation went away with Tylenol and resolved the following day.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antibiotic therapy, Injection site erythema
Clinical narrative: After shot on December 30, injection site became red and swollen. After two or three days soreness and redness went away. On the evening of January 6 noticed that the injection site area was becoming red and swollen again. On January 7 was seen at the urgent care as the area was becoming more sore, warm to the  touch, red, itchy. Medical provider assessed and was provided with  antibiotics in case it is cellulitis. Next day swelling seemed to have gone down but also was taking Aleve for a headache. The next few days site area was just itchy and continued to take antibiotics. Currently still on antibiotics and the injection site seems to be better.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: After shot on December 30, injection site became red and swollen. After two or three days soreness and redness went away. On the evening of January 6 noticed that the injection site area was becoming red and swollen again. On January 7 was seen at the urgent care as the area was becoming more sore, warm to the  touch, red, itchy. Medical provider assessed and was provided with  antibiotics in case it is cellulitis. Next day swelling seemed to have gone down but also was taking Aleve for a headache. The next few days site area was just itchy and continued to take antibiotics. Currently still on antibiotics and the injection site seems to be better.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site warmth
Clinical narrative: After shot on December 30, injection site became red and swollen. After two or three days soreness and redness went away. On the evening of January 6 noticed that the injection site area was becoming red and swollen again. On January 7 was seen at the urgent care as the area was becoming more sore, warm to the  touch, red, itchy. Medical provider assessed and was provided with  antibiotics in case it is cellulitis. Next day swelling seemed to have gone down but also was taking Aleve for a headache. The next few days site area was just itchy and continued to take antibiotics. Currently still on antibiotics and the injection site seems to be better.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis
Clinical narrative: Patient expressed: Pain in the left side of the face and migraine on 25Dec2020, and came to emergency room where apparently they diagnosed facial paralysis; Patient expressed: Pain in the left side of the face and migraine on 25Dec2020, and came to emergency room where apparently they diagnosed facial paralysis; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK5730) intramuscular, on 17Dec2020 04:15, single dose arm left  for COVID-19 immunization. Relevant medical history included hypothyroidism, hypertension, hyperlipidemia, obesity, and penicillin allergy. Concomitant medications included levothyroxine sodium (SYNTHROID), butalbital, caffeine, paracetamol (FIORICET 50-40- 325mg), dexamethasone 4mg Inj., diclofenac (VOLTAREN 1% Gel), Magnesium, valsartan (VASOFLEX) (pending confirmation), cyanocobalamin (VITAMIN B12), losartan potassium. The patient was not pregnant and did not received any vaccine in four weeks. The patient previously took cephalosporin and experienced allergy. On 24Dec2020, the patient experienced pain left side of the face and migraine, and came to emergency room where apparently they diagnosed facial paralysis. The events resulted in emergency room visit/ urgent care where the patient was administered dexamethasone 4mg Inj, Medrol dose pack, Vit B12 500mcg, and Fioricet 50-325-40. Facility where the most recent COVID-19 vaccine was administered was in the doctor's office/urgent care. It was unknown if the patient was diagnosed with COVID-19 prior or since the vaccination. The events were assessed by the nurse as non-serious. Outcome of the events was recovering at the time of the report.; 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: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial pain, Facial paralysis, Migraine
Clinical narrative: Patient expressed: Pain in the left side of the face and migraine on 25Dec2020, and came to emergency room where apparently they diagnosed facial paralysis; Patient expressed: Pain in the left side of the face and migraine on 25Dec2020, and came to emergency room where apparently they diagnosed facial paralysis; This is a spontaneous report from a contactable nurse. A 42-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EK5730) intramuscular, on 17Dec2020 04:15, single dose arm left  for COVID-19 immunization. Relevant medical history included hypothyroidism, hypertension, hyperlipidemia, obesity, and penicillin allergy. Concomitant medications included levothyroxine sodium (SYNTHROID), butalbital, caffeine, paracetamol (FIORICET 50-40- 325mg), dexamethasone 4mg Inj., diclofenac (VOLTAREN 1% Gel), Magnesium, valsartan (VASOFLEX) (pending confirmation), cyanocobalamin (VITAMIN B12), losartan potassium. The patient was not pregnant and did not received any vaccine in four weeks. The patient previously took cephalosporin and experienced allergy. On 24Dec2020, the patient experienced pain left side of the face and migraine, and came to emergency room where apparently they diagnosed facial paralysis. The events resulted in emergency room visit/ urgent care where the patient was administered dexamethasone 4mg Inj, Medrol dose pack, Vit B12 500mcg, and Fioricet 50-325-40. Facility where the most recent COVID-19 vaccine was administered was in the doctor's office/urgent care. It was unknown if the patient was diagnosed with COVID-19 prior or since the vaccination. The events were assessed by the nurse as non-serious. Outcome of the events was recovering at the time of the report.; 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: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Nausea, Pain
Clinical narrative: Body aches, chills, nausea lasting through January 5th and 6th.  Missed work both of these days.  Previously had Covid-19 in July 2020.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Impaired work ability, Nausea, Pain
Clinical narrative: Body aches, chills, nausea lasting through January 5th and 6th.  Missed work both of these days.  Previously had Covid-19 in July 2020.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mouth swelling, Pharyngeal swelling
Clinical narrative: Ten minutes after receiving injection patient started to feel like her throat was swelling, 20  minutes after started to turn red and having rash to neck
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pharyngeal swelling, Rash
Clinical narrative: Ten minutes after receiving injection patient started to feel like her throat was swelling, 20  minutes after started to turn red and having rash to neck
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Hypoaesthesia oral, Taste disorder, Throat tightness
Clinical narrative: Felt and appeared flushed, as well as feeling her throat closing up and being "unable to breathe" within 6 hours of receiving the immunization
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Flushing, Pharyngeal swelling
Clinical narrative: Felt and appeared flushed, as well as feeling her throat closing up and being "unable to breathe" within 6 hours of receiving the immunization
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Confusional state, Dizziness, Heart rate increased, Throat irritation, Throat tightness
Clinical narrative: Approx. 12-15 min after injection patient reported feeling itching in throat and was immediately taken to ER per wheelchair. Patient reported feet feeling like they were not there when she stood. Patient then reported dizziness and reported feeling "weird." patient noted to have elevated heart rate of 104 and reported confusion and feeling tired.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Confusional state, Dizziness, Fatigue, Feeling abnormal, Heart rate increased
Clinical narrative: Approx. 12-15 min after injection patient reported feeling itching in throat and was immediately taken to ER per wheelchair. Patient reported feet feeling like they were not there when she stood. Patient then reported dizziness and reported feeling "weird." patient noted to have elevated heart rate of 104 and reported confusion and feeling tired.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat irritation
Clinical narrative: Approx. 12-15 min after injection patient reported feeling itching in throat and was immediately taken to ER per wheelchair. Patient reported feet feeling like they were not there when she stood. Patient then reported dizziness and reported feeling "weird." patient noted to have elevated heart rate of 104 and reported confusion and feeling tired.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Dizziness, Dysgeusia, Fatigue, Flushing
Clinical narrative: feeling flushed  elevated HR dizzy nausea evaluated by EMS, VSS and wnl except HR 100 bpm lungs cta  at 5:36 patient reported to be feeling better - drank water - declined transport to ER - felt able/safe to drive home
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Nausea, Pain, Palpitations
Clinical narrative: feeling flushed  elevated HR dizzy nausea evaluated by EMS, VSS and wnl except HR 100 bpm lungs cta  at 5:36 patient reported to be feeling better - drank water - declined transport to ER - felt able/safe to drive home
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose normal, Dizziness, Electrocardiogram normal, Flushing, Heart rate increased
Clinical narrative: feeling flushed  elevated HR dizzy nausea evaluated by EMS, VSS and wnl except HR 100 bpm lungs cta  at 5:36 patient reported to be feeling better - drank water - declined transport to ER - felt able/safe to drive home
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: feeling flushed  elevated HR dizzy nausea evaluated by EMS, VSS and wnl except HR 100 bpm lungs cta  at 5:36 patient reported to be feeling better - drank water - declined transport to ER - felt able/safe to drive home
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site reaction, Skin reaction
Clinical narrative: about a week later 1/7/2021 I woke up to about 10 large hives that looked like burn blisters and sore, swollen lymph node under right arm.  I had been treating the hives with alcohol and anti-itch cream along with Ice packs. As of today 1/11/2021 the hives and swollen lymph node are gone and I feel much better. I reached out to the CDC and they could not explain what the reaction was about nor have they heard of the symptoms. I called my PCP and I'm waiting on him to call me back. I am not sure about getting the second dose due on 1/28/2021.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Urticaria
Clinical narrative: about a week later 1/7/2021 I woke up to about 10 large hives that looked like burn blisters and sore, swollen lymph node under right arm.  I had been treating the hives with alcohol and anti-itch cream along with Ice packs. As of today 1/11/2021 the hives and swollen lymph node are gone and I feel much better. I reached out to the CDC and they could not explain what the reaction was about nor have they heard of the symptoms. I called my PCP and I'm waiting on him to call me back. I am not sure about getting the second dose due on 1/28/2021.