chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm about 75% less sore; Less tired; slight surge energy; This is a spontaneous report from a contactable consumer. A 74-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EK4170; Expiration Date: 20Mar2021) dose 2 via an unspecified route of administration on 08Jan2021 at 17:50 (at the age of 74 years old) as single for COVID-19 immunisation. Medical history include cancer when 27 Years age, blood pressure med, cholesterol med (from an unknown date and unknown if ongoing). Concomitant medication included paracetamol (TYLENOL) taken for an unspecified indication from 21Dec2020 to 23Dec2020. The patient historical vaccine included SHINGRIX on an unspecified date and SHINGRIX second dose 6 months later on an unspecified date. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730, Exp 20Mar2021) on an unspecified date as single for COVID-19 immunisation. Reported as, second shot 08Jan2021 took 4 day early window; arm about 75 percent less sore, less tired felt same slight surge energy right after shot- less tired later next day for four days; time of onset: 09:50. No treatment was received for arm about 75% less sore. Outcome of the event arm about 75% less sore was recovered and unknown for other events.  Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Energy increased, Fatigue, Pain in extremity
Clinical narrative: Arm about 75% less sore; Less tired; slight surge energy; This is a spontaneous report from a contactable consumer. A 74-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EK4170; Expiration Date: 20Mar2021) dose 2 via an unspecified route of administration on 08Jan2021 at 17:50 (at the age of 74 years old) as single for COVID-19 immunisation. Medical history include cancer when 27 Years age, blood pressure med, cholesterol med (from an unknown date and unknown if ongoing). Concomitant medication included paracetamol (TYLENOL) taken for an unspecified indication from 21Dec2020 to 23Dec2020. The patient historical vaccine included SHINGRIX on an unspecified date and SHINGRIX second dose 6 months later on an unspecified date. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730, Exp 20Mar2021) on an unspecified date as single for COVID-19 immunisation. Reported as, second shot 08Jan2021 took 4 day early window; arm about 75 percent less sore, less tired felt same slight surge energy right after shot- less tired later next day for four days; time of onset: 09:50. No treatment was received for arm about 75% less sore. Outcome of the event arm about 75% less sore was recovered and unknown for other events.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Altered visual depth perception, Emotional distress, Feeling abnormal, Headache, Tinnitus
Clinical narrative: My blood pressure is 185/108 and 100 bpm; My blood pressure is 185/108 and 100 bpm; I'm very concerned; A few hours after the injection I woke with severe tinnitus; A slight headache, etc.; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/Batch number: unspecified, Pfizer NTEC), via an unspecified route of administration on 26Jan2021 as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that on 26Jan2021 she received her first Covid-19 Pfizer vaccine. A few hours after the injection she woke with severe tinnitus, a slight headache, etc. she contacted her PCP the next day and have been in contact with several medical personnel. The ringing was intense and has not stopped since the day of the vaccine, morning, noon and night. Her blood pressure was 185/108 and 100 bpm. She was very concerned, next vaccine on Feb 16th. The patient underwent lab tests and procedures which included blood pressure measurement: 185/108, 100 beats per minute on an unspecified date. The clinical outcome for the events was unknown.  Information on lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood pressure abnormal, Blood pressure measurement, Headache, Heart rate abnormal
Clinical narrative: My blood pressure is 185/108 and 100 bpm; My blood pressure is 185/108 and 100 bpm; I'm very concerned; A few hours after the injection I woke with severe tinnitus; A slight headache, etc.; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/Batch number: unspecified, Pfizer NTEC), via an unspecified route of administration on 26Jan2021 as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that on 26Jan2021 she received her first Covid-19 Pfizer vaccine. A few hours after the injection she woke with severe tinnitus, a slight headache, etc. she contacted her PCP the next day and have been in contact with several medical personnel. The ringing was intense and has not stopped since the day of the vaccine, morning, noon and night. Her blood pressure was 185/108 and 100 bpm. She was very concerned, next vaccine on Feb 16th. The patient underwent lab tests and procedures which included blood pressure measurement: 185/108, 100 beats per minute on an unspecified date. The clinical outcome for the events was unknown.  Information on lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Investigation, Tinnitus
Clinical narrative: My blood pressure is 185/108 and 100 bpm; My blood pressure is 185/108 and 100 bpm; I'm very concerned; A few hours after the injection I woke with severe tinnitus; A slight headache, etc.; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot/Batch number: unspecified, Pfizer NTEC), via an unspecified route of administration on 26Jan2021 as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that on 26Jan2021 she received her first Covid-19 Pfizer vaccine. A few hours after the injection she woke with severe tinnitus, a slight headache, etc. she contacted her PCP the next day and have been in contact with several medical personnel. The ringing was intense and has not stopped since the day of the vaccine, morning, noon and night. Her blood pressure was 185/108 and 100 bpm. She was very concerned, next vaccine on Feb 16th. The patient underwent lab tests and procedures which included blood pressure measurement: 185/108, 100 beats per minute on an unspecified date. The clinical outcome for the events was unknown.  Information on lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Chills, Decreased appetite, Dizziness, Dyspnoea
Clinical narrative: I awoke numerous times; chills; experienced difficulty breathing; Nauseated; increased muscle pain; joint pain; dizziness; This is a spontaneous report from a contactable consumer (patient) or other non HCP.  A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration in right arm on 03Feb2021 at 11:30 (age at vaccination 49-year-old) as dose number unknown, single for covid-19 immunization. The patient medical history included multiple sclerosis. Patient was allergic to latex. The patient concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Feb2021 at 08:00, approximately 20 hours after receiving the Pfizer vaccination patient noticed increased muscle and joint pain with an accompanying dizziness. At approximately 30 hours after injection, patient skipped dinner due to sleeping, got up and went back to bed. During the night, patient awoke numerous times with chills but more importantly, experienced difficulty breathing and nauseated. Any treatment received for adverse event was unknown.The outcome of event was recovering.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Injection site pain, Myalgia, Nausea
Clinical narrative: I awoke numerous times; chills; experienced difficulty breathing; Nauseated; increased muscle pain; joint pain; dizziness; This is a spontaneous report from a contactable consumer (patient) or other non HCP.  A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration in right arm on 03Feb2021 at 11:30 (age at vaccination 49-year-old) as dose number unknown, single for covid-19 immunization. The patient medical history included multiple sclerosis. Patient was allergic to latex. The patient concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Feb2021 at 08:00, approximately 20 hours after receiving the Pfizer vaccination patient noticed increased muscle and joint pain with an accompanying dizziness. At approximately 30 hours after injection, patient skipped dinner due to sleeping, got up and went back to bed. During the night, patient awoke numerous times with chills but more importantly, experienced difficulty breathing and nauseated. Any treatment received for adverse event was unknown.The outcome of event was recovering.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Dizziness, Dyspnoea, Insomnia
Clinical narrative: I awoke numerous times; chills; experienced difficulty breathing; Nauseated; increased muscle pain; joint pain; dizziness; This is a spontaneous report from a contactable consumer (patient) or other non HCP.  A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration in right arm on 03Feb2021 at 11:30 (age at vaccination 49-year-old) as dose number unknown, single for covid-19 immunization. The patient medical history included multiple sclerosis. Patient was allergic to latex. The patient concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Feb2021 at 08:00, approximately 20 hours after receiving the Pfizer vaccination patient noticed increased muscle and joint pain with an accompanying dizziness. At approximately 30 hours after injection, patient skipped dinner due to sleeping, got up and went back to bed. During the night, patient awoke numerous times with chills but more importantly, experienced difficulty breathing and nauseated. Any treatment received for adverse event was unknown.The outcome of event was recovering.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: I awoke numerous times; chills; experienced difficulty breathing; Nauseated; increased muscle pain; joint pain; dizziness; This is a spontaneous report from a contactable consumer (patient) or other non HCP.  A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration in right arm on 03Feb2021 at 11:30 (age at vaccination 49-year-old) as dose number unknown, single for covid-19 immunization. The patient medical history included multiple sclerosis. Patient was allergic to latex. The patient concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Feb2021 at 08:00, approximately 20 hours after receiving the Pfizer vaccination patient noticed increased muscle and joint pain with an accompanying dizziness. At approximately 30 hours after injection, patient skipped dinner due to sleeping, got up and went back to bed. During the night, patient awoke numerous times with chills but more importantly, experienced difficulty breathing and nauseated. Any treatment received for adverse event was unknown.The outcome of event was recovering.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Painful itchy circumferential rash on the entire torso; Itchiness in limbs; Painful itchy circumferential rash on the entire torso; This is a spontaneous report from a contactable consumer (patient).   A 53-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EN5318 and Expiration date: unknown), via an unknown route of administration, in left arm on 03Feb2021 at 14:30 (at the age of 53-years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient has allergy to Bactrim and Pneumococcal vaccine. Patient previously took first dose of bnt162b2 on an unknown date for covid-19 immunisation. Patient did not receive any other vaccine within 4 weeks prior to covid vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Also since the vaccination, the patient has not been tested for COVID-19. On 04Feb2021 at 12:00, the patient experienced painful itchy circumferential rash on the entire torso and itchiness in limbs. No treatment was received for the events. At the time of reporting, the outcome of the events were not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Rash pruritic
Clinical narrative: Painful itchy circumferential rash on the entire torso; Itchiness in limbs; Painful itchy circumferential rash on the entire torso; This is a spontaneous report from a contactable consumer (patient).   A 53-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EN5318 and Expiration date: unknown), via an unknown route of administration, in left arm on 03Feb2021 at 14:30 (at the age of 53-years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient has allergy to Bactrim and Pneumococcal vaccine. Patient previously took first dose of bnt162b2 on an unknown date for covid-19 immunisation. Patient did not receive any other vaccine within 4 weeks prior to covid vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Also since the vaccination, the patient has not been tested for COVID-19. On 04Feb2021 at 12:00, the patient experienced painful itchy circumferential rash on the entire torso and itchiness in limbs. No treatment was received for the events. At the time of reporting, the outcome of the events were not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dermatitis contact, Injection site bruising, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: itching; Allergic Contact Dermatitis; rash; welted; red; bruised and sensitive to touch; bruised and sensitive to touch; sore left shoulder at the injection site next day for one day only; This is a spontaneous report from a contactable consumer (patient). A 76-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EL1283) via an unspecified route of administration on 19Jan2021 at 14:30 in left arm (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Not pregnant at the time of vaccination. The patient did not have any allergies to medications, food or other products. Medical history included atrial fibrillation (AFib) and hypothyroidism. Concomitant medication included multaq, bisoprolol and levothyroxine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, Since the vaccination. On 20Jan2021, patient experienced sore left shoulder at the injection site next day for one day only. On 24Jan2021 at 11:00 (5 days after vaccine), patient noticed blood on my shirt where she had been itching, left upper arm between injection site and elbow, appearance of skin was rash, welted, red, bruised and sensitive to touch in an area about 3x3 inches. OTC anti itch cream not effective. Itching became so severe, I went to dermatologist 3 days after itching started. diagnosed as allergic contact dermatitis due to covid 19 vaccine. Treatment received was anti itch cream and told to use cold pack when it was itchy and take OTC antihistamine. Followed doctor's orders and itching finally stopped after 12 days from onset. The adverse event result in visit to doctor or other healthcare professional office/clinic. Seriousness reported as non-serious. The outcome of events was recovered in Feb2021.  Follow-up attempts completed. No further information expected.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site rash, Injection site reaction, Sensitive skin, Urticaria
Clinical narrative: itching; Allergic Contact Dermatitis; rash; welted; red; bruised and sensitive to touch; bruised and sensitive to touch; sore left shoulder at the injection site next day for one day only; This is a spontaneous report from a contactable consumer (patient). A 76-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EL1283) via an unspecified route of administration on 19Jan2021 at 14:30 in left arm (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Not pregnant at the time of vaccination. The patient did not have any allergies to medications, food or other products. Medical history included atrial fibrillation (AFib) and hypothyroidism. Concomitant medication included multaq, bisoprolol and levothyroxine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, Since the vaccination. On 20Jan2021, patient experienced sore left shoulder at the injection site next day for one day only. On 24Jan2021 at 11:00 (5 days after vaccine), patient noticed blood on my shirt where she had been itching, left upper arm between injection site and elbow, appearance of skin was rash, welted, red, bruised and sensitive to touch in an area about 3x3 inches. OTC anti itch cream not effective. Itching became so severe, I went to dermatologist 3 days after itching started. diagnosed as allergic contact dermatitis due to covid 19 vaccine. Treatment received was anti itch cream and told to use cold pack when it was itchy and take OTC antihistamine. Followed doctor's orders and itching finally stopped after 12 days from onset. The adverse event result in visit to doctor or other healthcare professional office/clinic. Seriousness reported as non-serious. The outcome of events was recovered in Feb2021.  Follow-up attempts completed. No further information expected.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Dermatitis contact, Erythema, Pruritus, Rash
Clinical narrative: itching; Allergic Contact Dermatitis; rash; welted; red; bruised and sensitive to touch; bruised and sensitive to touch; sore left shoulder at the injection site next day for one day only; This is a spontaneous report from a contactable consumer (patient). A 76-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EL1283) via an unspecified route of administration on 19Jan2021 at 14:30 in left arm (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Not pregnant at the time of vaccination. The patient did not have any allergies to medications, food or other products. Medical history included atrial fibrillation (AFib) and hypothyroidism. Concomitant medication included multaq, bisoprolol and levothyroxine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, Since the vaccination. On 20Jan2021, patient experienced sore left shoulder at the injection site next day for one day only. On 24Jan2021 at 11:00 (5 days after vaccine), patient noticed blood on my shirt where she had been itching, left upper arm between injection site and elbow, appearance of skin was rash, welted, red, bruised and sensitive to touch in an area about 3x3 inches. OTC anti itch cream not effective. Itching became so severe, I went to dermatologist 3 days after itching started. diagnosed as allergic contact dermatitis due to covid 19 vaccine. Treatment received was anti itch cream and told to use cold pack when it was itchy and take OTC antihistamine. Followed doctor's orders and itching finally stopped after 12 days from onset. The adverse event result in visit to doctor or other healthcare professional office/clinic. Seriousness reported as non-serious. The outcome of events was recovered in Feb2021.  Follow-up attempts completed. No further information expected.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sensitive skin, Urticaria, Vaccination site pain
Clinical narrative: itching; Allergic Contact Dermatitis; rash; welted; red; bruised and sensitive to touch; bruised and sensitive to touch; sore left shoulder at the injection site next day for one day only; This is a spontaneous report from a contactable consumer (patient). A 76-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EL1283) via an unspecified route of administration on 19Jan2021 at 14:30 in left arm (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Not pregnant at the time of vaccination. The patient did not have any allergies to medications, food or other products. Medical history included atrial fibrillation (AFib) and hypothyroidism. Concomitant medication included multaq, bisoprolol and levothyroxine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, Since the vaccination. On 20Jan2021, patient experienced sore left shoulder at the injection site next day for one day only. On 24Jan2021 at 11:00 (5 days after vaccine), patient noticed blood on my shirt where she had been itching, left upper arm between injection site and elbow, appearance of skin was rash, welted, red, bruised and sensitive to touch in an area about 3x3 inches. OTC anti itch cream not effective. Itching became so severe, I went to dermatologist 3 days after itching started. diagnosed as allergic contact dermatitis due to covid 19 vaccine. Treatment received was anti itch cream and told to use cold pack when it was itchy and take OTC antihistamine. Followed doctor's orders and itching finally stopped after 12 days from onset. The adverse event result in visit to doctor or other healthcare professional office/clinic. Seriousness reported as non-serious. The outcome of events was recovered in Feb2021.  Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Myalgia, Night sweats, Pyrexia
Clinical narrative: change shirt 1-2 times at night due to excessive sweating; fatigue; mild head ache; body aches; low grade fever; hot flashes; This is a spontaneous report from a contactable 67-year-old male consumer reported for himself that received Bnt162b2 (BNT162B2; Formulation: Solution for injection, Lot number: GM9810) (Age at vaccination: 67) via unknown route of administration from 03Feb2021 2nd dose (09:15 AM) on left arm for unknown indication, and Bnt162b2 (BNT162B2; Formulation: Solution for injection, Lot number: EL3249) via unknown route of administration from 13Jan2021 1st dose (09:15 AM) on left arm for unknown indication. At Public Health Clinic/Veterans Administration facility was where the most recent COVID-19 vaccine was administered Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Allergies to medications, food, or other products includes Penicillin. Other medical history includes Atrial Fibrillation-under treatment. Other medications the patient received within 2 weeks of vaccination were Lipitor 80mg x1 daily, Lisinopril 20mg x1 daily. It was reported that 2 1/2 weeks after 1st shot, I experienced general fatigue with continued till 2 shot. 3 hours after second shot I continued to experience fatigue, mild headache, body aches and low-grade fever. 1 day after body and headaches disappeared, I've continued to experience fatigue, hot flashes throughout day and low-grade fever at night which result in having to change shirt 1-2 times at night due to excessive sweating. Adverse events start date was 03Feb2021, and adverse event start time was 12:00 PM. No seriousness criteria were reported. No treatment was received for the adverse event. The outcome of the events was Not recovered. Vaccine Facility information available. Ethnicity information is available. Race information is available.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Hot flush, Night sweats, Pain
Clinical narrative: change shirt 1-2 times at night due to excessive sweating; fatigue; mild head ache; body aches; low grade fever; hot flashes; This is a spontaneous report from a contactable 67-year-old male consumer reported for himself that received Bnt162b2 (BNT162B2; Formulation: Solution for injection, Lot number: GM9810) (Age at vaccination: 67) via unknown route of administration from 03Feb2021 2nd dose (09:15 AM) on left arm for unknown indication, and Bnt162b2 (BNT162B2; Formulation: Solution for injection, Lot number: EL3249) via unknown route of administration from 13Jan2021 1st dose (09:15 AM) on left arm for unknown indication. At Public Health Clinic/Veterans Administration facility was where the most recent COVID-19 vaccine was administered Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Allergies to medications, food, or other products includes Penicillin. Other medical history includes Atrial Fibrillation-under treatment. Other medications the patient received within 2 weeks of vaccination were Lipitor 80mg x1 daily, Lisinopril 20mg x1 daily. It was reported that 2 1/2 weeks after 1st shot, I experienced general fatigue with continued till 2 shot. 3 hours after second shot I continued to experience fatigue, mild headache, body aches and low-grade fever. 1 day after body and headaches disappeared, I've continued to experience fatigue, hot flashes throughout day and low-grade fever at night which result in having to change shirt 1-2 times at night due to excessive sweating. Adverse events start date was 03Feb2021, and adverse event start time was 12:00 PM. No seriousness criteria were reported. No treatment was received for the adverse event. The outcome of the events was Not recovered. Vaccine Facility information available. Ethnicity information is available. Race information is available.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: change shirt 1-2 times at night due to excessive sweating; fatigue; mild head ache; body aches; low grade fever; hot flashes; This is a spontaneous report from a contactable 67-year-old male consumer reported for himself that received Bnt162b2 (BNT162B2; Formulation: Solution for injection, Lot number: GM9810) (Age at vaccination: 67) via unknown route of administration from 03Feb2021 2nd dose (09:15 AM) on left arm for unknown indication, and Bnt162b2 (BNT162B2; Formulation: Solution for injection, Lot number: EL3249) via unknown route of administration from 13Jan2021 1st dose (09:15 AM) on left arm for unknown indication. At Public Health Clinic/Veterans Administration facility was where the most recent COVID-19 vaccine was administered Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Allergies to medications, food, or other products includes Penicillin. Other medical history includes Atrial Fibrillation-under treatment. Other medications the patient received within 2 weeks of vaccination were Lipitor 80mg x1 daily, Lisinopril 20mg x1 daily. It was reported that 2 1/2 weeks after 1st shot, I experienced general fatigue with continued till 2 shot. 3 hours after second shot I continued to experience fatigue, mild headache, body aches and low-grade fever. 1 day after body and headaches disappeared, I've continued to experience fatigue, hot flashes throughout day and low-grade fever at night which result in having to change shirt 1-2 times at night due to excessive sweating. Adverse events start date was 03Feb2021, and adverse event start time was 12:00 PM. No seriousness criteria were reported. No treatment was received for the adverse event. The outcome of the events was Not recovered. Vaccine Facility information available. Ethnicity information is available. Race information is available.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Hyperhidrosis, Muscle twitching, Nausea, Peripheral coldness
Clinical narrative: Sweating; muscle twitches; overall shaking; cold hands and feet; nausea; no appetite; This is a spontaneous report from a contactable other health care professional (patient). A 57-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in right arm on 05Feb2021 at 09:30 (at the age of 57-year-old) as a single dose for COVID-19 immunization at doctor's office/urgent care. The patient medical history included high blood pressure and had no known allergies. The patient did not receive any other vaccine within four weeks. Concomitant medications included metoprolol succinate at a dose of 50 mg/day and ascorbic acid (VITAMIN C) at a dose of 1000 mg, for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Feb2021 at 11:30, the patient experienced sweating, muscle twitches and overall shaking, cold hands and feet, nausea and no appetite, which resulted in doctor or other healthcare professional office/clinic visit. Patient did not receive any treatment for the events. The outcome of the events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Sweating; muscle twitches; overall shaking; cold hands and feet; nausea; no appetite; This is a spontaneous report from a contactable other health care professional (patient). A 57-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in right arm on 05Feb2021 at 09:30 (at the age of 57-year-old) as a single dose for COVID-19 immunization at doctor's office/urgent care. The patient medical history included high blood pressure and had no known allergies. The patient did not receive any other vaccine within four weeks. Concomitant medications included metoprolol succinate at a dose of 50 mg/day and ascorbic acid (VITAMIN C) at a dose of 1000 mg, for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Feb2021 at 11:30, the patient experienced sweating, muscle twitches and overall shaking, cold hands and feet, nausea and no appetite, which resulted in doctor or other healthcare professional office/clinic visit. Patient did not receive any treatment for the events. The outcome of the events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Blood cholesterol increased, Breast pain, Lymph node pain, Mammogram
Clinical narrative: Severe to very severe continuous lymph node/breast pain on shot side; Severe to very severe continuous lymph node/breast pain on shot side; Slight reduction breast pain as spread to back pain; shot side arm pit still swollen Pain interferes with sleep; shot side arm pit still swollen Pain interferes with sleep; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 65-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3302), via an unspecified route of administration, administered in Arm Left on 26Jan2021 (at the age of 65-years-old) at 12:45 as DOSE1, SINGLE for covid-19 immunisation. Medical history included sensitive gluten and milk, continuous positive airway pressure (CPAP), sometimes high cholesterol, hay fever, dust allergy, mold allergy, cat and dog allergy and sawdust allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included liothyronine sodium (T3); levothyroxine sodium (T4); colecalciferol (D3); cyanocobalamin, folic acid, pyridoxine hydrochloride (B6 + B12); fish oil and 1/12 allergy shot (unspecified). On 27Jan2021 at 21:00 patient experienced severe to very severe continuous lymph node/breast pain on shot side. On an unknown date in Jan2021 she experienced slight reduction breast pain as spread to back pain and shot side arm pit still swollen pain interferes with sleep. Treatment for the adverse events included heat, pain killer, extra water and tests planned. Reporter stated severe to very severe continuous lymph node/breast pain on shot side through 2/4. Starting 2/4 intensity started to vary i.e., no pain during hot shower but still severe pain majority of time. Slight reduction breast pain as spread to back pain and movement seems to help. On an unspecified date in Jan 2021 on night of 2/3 spread to back-shot sideline of nodes paralleling spine and shoulder/neck area- back pain not as severe as original breast area and heat helps to reduce back pain 2/5 Office Visit 10 days later verified shot side arm pit still swollen Pain interferes with sleep-2/4 finally able to get 4 hours sleep (water, hot shower) (normal is 7 hrs). As of 2/5 still in moderate to severe breast area pain almost continuously on 27Jan2021. She hopes as she was recovering but its 10 days and still mostly constant incapacitating pain. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The seriousness of the events was reported as non-serious. At the time of report events were resolving.  Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder
Clinical narrative: Severe to very severe continuous lymph node/breast pain on shot side; Severe to very severe continuous lymph node/breast pain on shot side; Slight reduction breast pain as spread to back pain; shot side arm pit still swollen Pain interferes with sleep; shot side arm pit still swollen Pain interferes with sleep; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 65-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3302), via an unspecified route of administration, administered in Arm Left on 26Jan2021 (at the age of 65-years-old) at 12:45 as DOSE1, SINGLE for covid-19 immunisation. Medical history included sensitive gluten and milk, continuous positive airway pressure (CPAP), sometimes high cholesterol, hay fever, dust allergy, mold allergy, cat and dog allergy and sawdust allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included liothyronine sodium (T3); levothyroxine sodium (T4); colecalciferol (D3); cyanocobalamin, folic acid, pyridoxine hydrochloride (B6 + B12); fish oil and 1/12 allergy shot (unspecified). On 27Jan2021 at 21:00 patient experienced severe to very severe continuous lymph node/breast pain on shot side. On an unknown date in Jan2021 she experienced slight reduction breast pain as spread to back pain and shot side arm pit still swollen pain interferes with sleep. Treatment for the adverse events included heat, pain killer, extra water and tests planned. Reporter stated severe to very severe continuous lymph node/breast pain on shot side through 2/4. Starting 2/4 intensity started to vary i.e., no pain during hot shower but still severe pain majority of time. Slight reduction breast pain as spread to back pain and movement seems to help. On an unspecified date in Jan 2021 on night of 2/3 spread to back-shot sideline of nodes paralleling spine and shoulder/neck area- back pain not as severe as original breast area and heat helps to reduce back pain 2/5 Office Visit 10 days later verified shot side arm pit still swollen Pain interferes with sleep-2/4 finally able to get 4 hours sleep (water, hot shower) (normal is 7 hrs). As of 2/5 still in moderate to severe breast area pain almost continuously on 27Jan2021. She hopes as she was recovering but its 10 days and still mostly constant incapacitating pain. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The seriousness of the events was reported as non-serious. At the time of report events were resolving.  Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Breast pain, Insomnia, Lymph node pain, Pain assessment
Clinical narrative: Severe to very severe continuous lymph node/breast pain on shot side; Severe to very severe continuous lymph node/breast pain on shot side; Slight reduction breast pain as spread to back pain; shot side arm pit still swollen Pain interferes with sleep; shot side arm pit still swollen Pain interferes with sleep; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 65-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3302), via an unspecified route of administration, administered in Arm Left on 26Jan2021 (at the age of 65-years-old) at 12:45 as DOSE1, SINGLE for covid-19 immunisation. Medical history included sensitive gluten and milk, continuous positive airway pressure (CPAP), sometimes high cholesterol, hay fever, dust allergy, mold allergy, cat and dog allergy and sawdust allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included liothyronine sodium (T3); levothyroxine sodium (T4); colecalciferol (D3); cyanocobalamin, folic acid, pyridoxine hydrochloride (B6 + B12); fish oil and 1/12 allergy shot (unspecified). On 27Jan2021 at 21:00 patient experienced severe to very severe continuous lymph node/breast pain on shot side. On an unknown date in Jan2021 she experienced slight reduction breast pain as spread to back pain and shot side arm pit still swollen pain interferes with sleep. Treatment for the adverse events included heat, pain killer, extra water and tests planned. Reporter stated severe to very severe continuous lymph node/breast pain on shot side through 2/4. Starting 2/4 intensity started to vary i.e., no pain during hot shower but still severe pain majority of time. Slight reduction breast pain as spread to back pain and movement seems to help. On an unspecified date in Jan 2021 on night of 2/3 spread to back-shot sideline of nodes paralleling spine and shoulder/neck area- back pain not as severe as original breast area and heat helps to reduce back pain 2/5 Office Visit 10 days later verified shot side arm pit still swollen Pain interferes with sleep-2/4 finally able to get 4 hours sleep (water, hot shower) (normal is 7 hrs). As of 2/5 still in moderate to severe breast area pain almost continuously on 27Jan2021. She hopes as she was recovering but its 10 days and still mostly constant incapacitating pain. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The seriousness of the events was reported as non-serious. At the time of report events were resolving.  Follow-up attempts completed. No further information expected.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling
Clinical narrative: Severe to very severe continuous lymph node/breast pain on shot side; Severe to very severe continuous lymph node/breast pain on shot side; Slight reduction breast pain as spread to back pain; shot side arm pit still swollen Pain interferes with sleep; shot side arm pit still swollen Pain interferes with sleep; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 65-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3302), via an unspecified route of administration, administered in Arm Left on 26Jan2021 (at the age of 65-years-old) at 12:45 as DOSE1, SINGLE for covid-19 immunisation. Medical history included sensitive gluten and milk, continuous positive airway pressure (CPAP), sometimes high cholesterol, hay fever, dust allergy, mold allergy, cat and dog allergy and sawdust allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included liothyronine sodium (T3); levothyroxine sodium (T4); colecalciferol (D3); cyanocobalamin, folic acid, pyridoxine hydrochloride (B6 + B12); fish oil and 1/12 allergy shot (unspecified). On 27Jan2021 at 21:00 patient experienced severe to very severe continuous lymph node/breast pain on shot side. On an unknown date in Jan2021 she experienced slight reduction breast pain as spread to back pain and shot side arm pit still swollen pain interferes with sleep. Treatment for the adverse events included heat, pain killer, extra water and tests planned. Reporter stated severe to very severe continuous lymph node/breast pain on shot side through 2/4. Starting 2/4 intensity started to vary i.e., no pain during hot shower but still severe pain majority of time. Slight reduction breast pain as spread to back pain and movement seems to help. On an unspecified date in Jan 2021 on night of 2/3 spread to back-shot sideline of nodes paralleling spine and shoulder/neck area- back pain not as severe as original breast area and heat helps to reduce back pain 2/5 Office Visit 10 days later verified shot side arm pit still swollen Pain interferes with sleep-2/4 finally able to get 4 hours sleep (water, hot shower) (normal is 7 hrs). As of 2/5 still in moderate to severe breast area pain almost continuously on 27Jan2021. She hopes as she was recovering but its 10 days and still mostly constant incapacitating pain. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The seriousness of the events was reported as non-serious. At the time of report events were resolving.  Follow-up attempts completed. No further information expected.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disturbance in attention, Dizziness, Dysstasia, Gait disturbance, Respiratory rate decreased
Clinical narrative: intense pain between eyes; difficulty standing and walking due to feeling disoriented; throat felt tight; Seeing trails of moving objects; difficulty transferring thoughts into; This is a spontaneous report from a contactable consumer. A 44-year-old non pregnant female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot No: EN6203), Intramuscularly on 02Mar2021 at 14:00 pm into Left arm as a single dose for COVID-19 immunization. Medical history included heart rate irregular from an unknown date and unknown if ongoing, gastroesophageal reflux disease from an unknown date and unknown if ongoing. Concomitant medication(s) included flecainide taken for an unspecified indication, start and stop date were not reported; pantoprazole taken for an unspecified indication, start and stop date were not reported; spironolactone taken for an unspecified indication, start and stop date were not reported and vitamin. Patient did not receive any other vaccine in four weeks. On 02Mar2021 at 15:00 pm, the patient experienced Seeing trails of moving objects, difficulty transferring thoughts into words, difficulty standing and walking due to feeling disoriented, throat felt tight, intense pain between eyes. Prior the vaccination, patient was not diagnosed with COVID. Post vaccination, Patient was not tested with COVID. Patient had no allergies. No treatment drug was given for the events. The outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.