chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Chills, Cold sweat, Discomfort, Dizziness
Clinical narrative: 05Apr2021 she started to feel bad again,; I developed a fever of 102 degrees; chills; my whole body ached; I began to feel fatigued; my legs felt tired and heavy; headaches; felt light-headed; This is a spontaneous report from a contactable consumer (Patient). A 54-year-old non-Pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6198, Expiry Date was not provided), via an unspecified route of administration, administered in left arm, on 17Mar2021 at 16:00 (age at vaccination was 54-Years) as DOSE 1, SINGLE for COVID-19 immunization at Workplace clinic. Patient was not pregnant at the time of vaccination. Patient did not have any known allergies and other medical history. The patient did not receive any other vaccines in four weeks and Other medications in two weeks. Patient did not had COVID prior vaccination. Patient has been tested COVID post vaccination. Beginning on 17Mar2021 Patient began to feel fatigued and her legs felt tired and heavy and she had headaches and felt light-headed, then on 25Mar2021 she developed a fever of 102 degrees and had chills and her whole body ached, she contacted her doctor who sent her to the ER for evaluation, the ER tested her for COVID-19, and Influenza type A and B and she was found negative on these tests, they sent her home and instructed her to take Tylenol, drink fluids and relax and follow up with her doctor, she spoke to her doctor the next day and he told her that she was most likely having a long term reaction to the vaccine, she began to feel some better and went back to work but on her first day back 05Apr2021 she started to feel bad again, she went for second dose on 07Apr2021 and was feeling some better so she went back to work on 12Apr2021 however since then she had symptoms such as heaviness in her face and she have occasional chills and light headedness and didn't feel like herself still after 4 1/2 weeks. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab test and procedure included SARS-CoV-2 test (nasal swab) with negative result on 25Mar2021. The outcome of all events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Impaired driving ability, Influenza A virus test negative, Influenza B virus test
Clinical narrative: 05Apr2021 she started to feel bad again,; I developed a fever of 102 degrees; chills; my whole body ached; I began to feel fatigued; my legs felt tired and heavy; headaches; felt light-headed; This is a spontaneous report from a contactable consumer (Patient). A 54-year-old non-Pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6198, Expiry Date was not provided), via an unspecified route of administration, administered in left arm, on 17Mar2021 at 16:00 (age at vaccination was 54-Years) as DOSE 1, SINGLE for COVID-19 immunization at Workplace clinic. Patient was not pregnant at the time of vaccination. Patient did not have any known allergies and other medical history. The patient did not receive any other vaccines in four weeks and Other medications in two weeks. Patient did not had COVID prior vaccination. Patient has been tested COVID post vaccination. Beginning on 17Mar2021 Patient began to feel fatigued and her legs felt tired and heavy and she had headaches and felt light-headed, then on 25Mar2021 she developed a fever of 102 degrees and had chills and her whole body ached, she contacted her doctor who sent her to the ER for evaluation, the ER tested her for COVID-19, and Influenza type A and B and she was found negative on these tests, they sent her home and instructed her to take Tylenol, drink fluids and relax and follow up with her doctor, she spoke to her doctor the next day and he told her that she was most likely having a long term reaction to the vaccine, she began to feel some better and went back to work but on her first day back 05Apr2021 she started to feel bad again, she went for second dose on 07Apr2021 and was feeling some better so she went back to work on 12Apr2021 however since then she had symptoms such as heaviness in her face and she have occasional chills and light headedness and didn't feel like herself still after 4 1/2 weeks. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab test and procedure included SARS-CoV-2 test (nasal swab) with negative result on 25Mar2021. The outcome of all events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Pain, Pyrexia, SARS-CoV-2 test negative, Vaccination complication
Clinical narrative: 05Apr2021 she started to feel bad again,; I developed a fever of 102 degrees; chills; my whole body ached; I began to feel fatigued; my legs felt tired and heavy; headaches; felt light-headed; This is a spontaneous report from a contactable consumer (Patient). A 54-year-old non-Pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6198, Expiry Date was not provided), via an unspecified route of administration, administered in left arm, on 17Mar2021 at 16:00 (age at vaccination was 54-Years) as DOSE 1, SINGLE for COVID-19 immunization at Workplace clinic. Patient was not pregnant at the time of vaccination. Patient did not have any known allergies and other medical history. The patient did not receive any other vaccines in four weeks and Other medications in two weeks. Patient did not had COVID prior vaccination. Patient has been tested COVID post vaccination. Beginning on 17Mar2021 Patient began to feel fatigued and her legs felt tired and heavy and she had headaches and felt light-headed, then on 25Mar2021 she developed a fever of 102 degrees and had chills and her whole body ached, she contacted her doctor who sent her to the ER for evaluation, the ER tested her for COVID-19, and Influenza type A and B and she was found negative on these tests, they sent her home and instructed her to take Tylenol, drink fluids and relax and follow up with her doctor, she spoke to her doctor the next day and he told her that she was most likely having a long term reaction to the vaccine, she began to feel some better and went back to work but on her first day back 05Apr2021 she started to feel bad again, she went for second dose on 07Apr2021 and was feeling some better so she went back to work on 12Apr2021 however since then she had symptoms such as heaviness in her face and she have occasional chills and light headedness and didn't feel like herself still after 4 1/2 weeks. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab test and procedure included SARS-CoV-2 test (nasal swab) with negative result on 25Mar2021. The outcome of all events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Dizziness, Fatigue, Headache
Clinical narrative: 05Apr2021 she started to feel bad again,; I developed a fever of 102 degrees; chills; my whole body ached; I began to feel fatigued; my legs felt tired and heavy; headaches; felt light-headed; This is a spontaneous report from a contactable consumer (Patient). A 54-year-old non-Pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6198, Expiry Date was not provided), via an unspecified route of administration, administered in left arm, on 17Mar2021 at 16:00 (age at vaccination was 54-Years) as DOSE 1, SINGLE for COVID-19 immunization at Workplace clinic. Patient was not pregnant at the time of vaccination. Patient did not have any known allergies and other medical history. The patient did not receive any other vaccines in four weeks and Other medications in two weeks. Patient did not had COVID prior vaccination. Patient has been tested COVID post vaccination. Beginning on 17Mar2021 Patient began to feel fatigued and her legs felt tired and heavy and she had headaches and felt light-headed, then on 25Mar2021 she developed a fever of 102 degrees and had chills and her whole body ached, she contacted her doctor who sent her to the ER for evaluation, the ER tested her for COVID-19, and Influenza type A and B and she was found negative on these tests, they sent her home and instructed her to take Tylenol, drink fluids and relax and follow up with her doctor, she spoke to her doctor the next day and he told her that she was most likely having a long term reaction to the vaccine, she began to feel some better and went back to work but on her first day back 05Apr2021 she started to feel bad again, she went for second dose on 07Apr2021 and was feeling some better so she went back to work on 12Apr2021 however since then she had symptoms such as heaviness in her face and she have occasional chills and light headedness and didn't feel like herself still after 4 1/2 weeks. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab test and procedure included SARS-CoV-2 test (nasal swab) with negative result on 25Mar2021. The outcome of all events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza A virus test, Influenza B virus test, Malaise, Muscular weakness, Pain
Clinical narrative: 05Apr2021 she started to feel bad again,; I developed a fever of 102 degrees; chills; my whole body ached; I began to feel fatigued; my legs felt tired and heavy; headaches; felt light-headed; This is a spontaneous report from a contactable consumer (Patient). A 54-year-old non-Pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6198, Expiry Date was not provided), via an unspecified route of administration, administered in left arm, on 17Mar2021 at 16:00 (age at vaccination was 54-Years) as DOSE 1, SINGLE for COVID-19 immunization at Workplace clinic. Patient was not pregnant at the time of vaccination. Patient did not have any known allergies and other medical history. The patient did not receive any other vaccines in four weeks and Other medications in two weeks. Patient did not had COVID prior vaccination. Patient has been tested COVID post vaccination. Beginning on 17Mar2021 Patient began to feel fatigued and her legs felt tired and heavy and she had headaches and felt light-headed, then on 25Mar2021 she developed a fever of 102 degrees and had chills and her whole body ached, she contacted her doctor who sent her to the ER for evaluation, the ER tested her for COVID-19, and Influenza type A and B and she was found negative on these tests, they sent her home and instructed her to take Tylenol, drink fluids and relax and follow up with her doctor, she spoke to her doctor the next day and he told her that she was most likely having a long term reaction to the vaccine, she began to feel some better and went back to work but on her first day back 05Apr2021 she started to feel bad again, she went for second dose on 07Apr2021 and was feeling some better so she went back to work on 12Apr2021 however since then she had symptoms such as heaviness in her face and she have occasional chills and light headedness and didn't feel like herself still after 4 1/2 weeks. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab test and procedure included SARS-CoV-2 test (nasal swab) with negative result on 25Mar2021. The outcome of all events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: 05Apr2021 she started to feel bad again,; I developed a fever of 102 degrees; chills; my whole body ached; I began to feel fatigued; my legs felt tired and heavy; headaches; felt light-headed; This is a spontaneous report from a contactable consumer (Patient). A 54-year-old non-Pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6198, Expiry Date was not provided), via an unspecified route of administration, administered in left arm, on 17Mar2021 at 16:00 (age at vaccination was 54-Years) as DOSE 1, SINGLE for COVID-19 immunization at Workplace clinic. Patient was not pregnant at the time of vaccination. Patient did not have any known allergies and other medical history. The patient did not receive any other vaccines in four weeks and Other medications in two weeks. Patient did not had COVID prior vaccination. Patient has been tested COVID post vaccination. Beginning on 17Mar2021 Patient began to feel fatigued and her legs felt tired and heavy and she had headaches and felt light-headed, then on 25Mar2021 she developed a fever of 102 degrees and had chills and her whole body ached, she contacted her doctor who sent her to the ER for evaluation, the ER tested her for COVID-19, and Influenza type A and B and she was found negative on these tests, they sent her home and instructed her to take Tylenol, drink fluids and relax and follow up with her doctor, she spoke to her doctor the next day and he told her that she was most likely having a long term reaction to the vaccine, she began to feel some better and went back to work but on her first day back 05Apr2021 she started to feel bad again, she went for second dose on 07Apr2021 and was feeling some better so she went back to work on 12Apr2021 however since then she had symptoms such as heaviness in her face and she have occasional chills and light headedness and didn't feel like herself still after 4 1/2 weeks. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab test and procedure included SARS-CoV-2 test (nasal swab) with negative result on 25Mar2021. The outcome of all events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Constipation, Fatigue, Feeling abnormal, Rash
Clinical narrative: Rash; throwing up; itchiness; difficult to breathe; This is a spontaneous report from a contactable consumer. This 63-year-female consumer (patient) reported. A 63-year-female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown) via unknown route of administration on 13Apr2021, Tuesday (at the age of 63 years old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history included Stevens Johnson syndrome and lung problems. The concomitant medications were not reported. It was reported that, on an unspecified date, Thursday the patient broke out in a rash. On Saturday the patient went to the emergency room because the rash keeps popping up everywhere. The rash was where the caller folds her elbows, the back of her legs and on one arm. This morning the patient woke up throwing up and she got a rash on her other arm and on her boob. The patient had Stevens Johnson syndrome before and her brain was going like that. The patient had itchiness and it scares her, she's itchy everywhere. It was difficult for the caller to breathe sometimes but she had lung problems too so she doesn't know. The patient doesn't know what to do. Everyone the patient calls don't know what to do, her doctors, the agency has never heard of this. The patient was scared. The patient was afraid to get the second shot because she heard you were supposed to get side effects on the second dose, not on the first one like her. The outcome of the events were unknown.  No follow-up attempts were possible, information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Rash; throwing up; itchiness; difficult to breathe; This is a spontaneous report from a contactable consumer. This 63-year-female consumer (patient) reported. A 63-year-female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown) via unknown route of administration on 13Apr2021, Tuesday (at the age of 63 years old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history included Stevens Johnson syndrome and lung problems. The concomitant medications were not reported. It was reported that, on an unspecified date, Thursday the patient broke out in a rash. On Saturday the patient went to the emergency room because the rash keeps popping up everywhere. The rash was where the caller folds her elbows, the back of her legs and on one arm. This morning the patient woke up throwing up and she got a rash on her other arm and on her boob. The patient had Stevens Johnson syndrome before and her brain was going like that. The patient had itchiness and it scares her, she's itchy everywhere. It was difficult for the caller to breathe sometimes but she had lung problems too so she doesn't know. The patient doesn't know what to do. Everyone the patient calls don't know what to do, her doctors, the agency has never heard of this. The patient was scared. The patient was afraid to get the second shot because she heard you were supposed to get side effects on the second dose, not on the first one like her. The outcome of the events were unknown.  No follow-up attempts were possible, information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Pruritus, Rash, Vomiting
Clinical narrative: Rash; throwing up; itchiness; difficult to breathe; This is a spontaneous report from a contactable consumer. This 63-year-female consumer (patient) reported. A 63-year-female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: unknown) via unknown route of administration on 13Apr2021, Tuesday (at the age of 63 years old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history included Stevens Johnson syndrome and lung problems. The concomitant medications were not reported. It was reported that, on an unspecified date, Thursday the patient broke out in a rash. On Saturday the patient went to the emergency room because the rash keeps popping up everywhere. The rash was where the caller folds her elbows, the back of her legs and on one arm. This morning the patient woke up throwing up and she got a rash on her other arm and on her boob. The patient had Stevens Johnson syndrome before and her brain was going like that. The patient had itchiness and it scares her, she's itchy everywhere. It was difficult for the caller to breathe sometimes but she had lung problems too so she doesn't know. The patient doesn't know what to do. Everyone the patient calls don't know what to do, her doctors, the agency has never heard of this. The patient was scared. The patient was afraid to get the second shot because she heard you were supposed to get side effects on the second dose, not on the first one like her. The outcome of the events were unknown.  No follow-up attempts were possible, information about lot/batch number cannot be obtained.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain, Pyrexia, Urticaria
Clinical narrative: body aches; headache; fever of 102.3; 01May2021 Woke up with hives covering 35% of body; This is a spontaneous report from a contactable consumer (patient). A 19-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 27Apr2021 at 18:30 (lot number: EW0151; expiry date: unknown) at the age of 19-years-old, as dose 2, single, for Covid-19 immunisation. Medical history included anxiety and hyperhidrosis. Concomitant medications included sertraline; glycopyrrolate [glycopyrronium bromide]; and melatonin; all taken for unspecified indications, start and stop dates were not reported. The patient previously took amoxicillin and experienced allergies; and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Apr2021 at 14:30, at the age of 19-years-old, in left arm as dose 1, single for Covid-19 immunisation. The patient was diagnosed with Covid prior vaccination and was not tested for Covid-19 post vaccination. The patient did not receive other vaccines in four weeks. 01May2021, at 8:00 AM, patient woke up with hives covering 35% of body. Patient took Benadryl. On 02May2021, patient woke up with hives covering 85% of body. It was cleared up after medications for 4-5 days. Then on 10May2021 and 11May2021, the patient experienced body aches, headache, fever of 102.3. The events resulted in emergency room/department or urgent care. Treatment for the events included steroid injection, steroid dose pack and antihistamine. Outcome of the event hives was recovered on unspecified date in May2021, while for the remaining events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia, Urticaria
Clinical narrative: body aches; headache; fever of 102.3; 01May2021 Woke up with hives covering 35% of body; This is a spontaneous report from a contactable consumer (patient). A 19-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 27Apr2021 at 18:30 (lot number: EW0151; expiry date: unknown) at the age of 19-years-old, as dose 2, single, for Covid-19 immunisation. Medical history included anxiety and hyperhidrosis. Concomitant medications included sertraline; glycopyrrolate [glycopyrronium bromide]; and melatonin; all taken for unspecified indications, start and stop dates were not reported. The patient previously took amoxicillin and experienced allergies; and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Apr2021 at 14:30, at the age of 19-years-old, in left arm as dose 1, single for Covid-19 immunisation. The patient was diagnosed with Covid prior vaccination and was not tested for Covid-19 post vaccination. The patient did not receive other vaccines in four weeks. 01May2021, at 8:00 AM, patient woke up with hives covering 35% of body. Patient took Benadryl. On 02May2021, patient woke up with hives covering 85% of body. It was cleared up after medications for 4-5 days. Then on 10May2021 and 11May2021, the patient experienced body aches, headache, fever of 102.3. The events resulted in emergency room/department or urgent care. Treatment for the events included steroid injection, steroid dose pack and antihistamine. Outcome of the event hives was recovered on unspecified date in May2021, while for the remaining events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Eye pain, Myalgia, Pain in extremity
Clinical narrative: Pain reached "until the fingertips" and caller is still sore; painful eyes; Burning muscles; Pain in both shoulders and arms; Pain in both shoulders and arms; This is a spontaneous report from consumer (patient) via Pfizer sponsored program.   A contactable 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on 05May2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 07May2021 patient experienced side effects such as pain in both shoulders and arms, burning muscles and painful eyes and also reported pain reached until the fingertips and caller is still sore. Patient queried that he had a side effect after the first dose of the vaccine. Should he get the second dose. Patient visited emergency room for the event pain reached until the fingertips and caller is still sore. The outcome of the event pain in extremity with LLT pain in fingers was not recovered and other events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Lip swelling
Clinical narrative: she experienced anaphylactic reaction as her tongue swelled; she experienced anaphylactic reaction as her tongue swelled; This is a spontaneous report from a contactable consumer (patient).  A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 12Apr2021 (9:30 am or 10:00 am ) (Batch/Lot Number: EW0153) age at vaccination of 58-years-old, as single dose, for covid-19 immunisation. Medical history included ongoing asthma, coccidioidomycosis from an unknown date and unknown if ongoing, scar from an unknown date and unknown if ongoing (lungs are scared), tachycardia from an unknown date and unknown if ongoing (Fast resting heartrate). The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 22Mar2021 (Batch/Lot Number: EN6207) age at vaccination of 58-years-old, as single dose, for covid-19 immunisation. Concomitant medication included metoprolol succinate (TOPROL) taken for tachycardia from an unspecified start date and ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated that, on 12Apr2021,15-20 minutes after getting the second dose of the vaccine, she experienced anaphylactic reaction as her tongue swelled. The event did not result in emergency room nor physician Office visit. She had to get a Benadryl shot and they were measuring her heartrate. The patient recovered from anaphylactic reaction on 12Apr2021 while outcome of swollen tongue was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Heart rate, Swollen tongue
Clinical narrative: she experienced anaphylactic reaction as her tongue swelled; she experienced anaphylactic reaction as her tongue swelled; This is a spontaneous report from a contactable consumer (patient).  A 58-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 12Apr2021 (9:30 am or 10:00 am ) (Batch/Lot Number: EW0153) age at vaccination of 58-years-old, as single dose, for covid-19 immunisation. Medical history included ongoing asthma, coccidioidomycosis from an unknown date and unknown if ongoing, scar from an unknown date and unknown if ongoing (lungs are scared), tachycardia from an unknown date and unknown if ongoing (Fast resting heartrate). The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 22Mar2021 (Batch/Lot Number: EN6207) age at vaccination of 58-years-old, as single dose, for covid-19 immunisation. Concomitant medication included metoprolol succinate (TOPROL) taken for tachycardia from an unspecified start date and ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated that, on 12Apr2021,15-20 minutes after getting the second dose of the vaccine, she experienced anaphylactic reaction as her tongue swelled. The event did not result in emergency room nor physician Office visit. She had to get a Benadryl shot and they were measuring her heartrate. The patient recovered from anaphylactic reaction on 12Apr2021 while outcome of swollen tongue was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Confusional state, Dizziness, Herpes zoster, Presyncope
Clinical narrative: Rash on face after first dose still have the rash it comes and goes now; This is a spontaneous report from a contactable consumer (patient) reported that:  A 58-years-old non-pregnant female patient received BNT162B2 (BioNTech/Pfizer vaccine solution for injection), dose 1 via an unspecified route of administration, administered in Leg Left on 12Mar2021 14:15 (Batch/Lot Number: EN6199) as DOSE 1, SINGLE for covid-19 immunization (Age at vaccination 58 years). The patient past medical history included hyperthyroidism from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. The patient allergies to Sulfur, epinephrine and morphine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 13Mar2021 the patient experienced Rash on face after first dose still have the rash it comes and goes now. After the 2nd dose of vaccine, the patient experienced Shingles, Dizziness for 2 weeks, confusion and Near syncope after 24 hours and 4 days later. The patient received a treatment with Antiviral medication and bed rest. The event outcome was Not recovered.  Device Date: 04May2021.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Rash on face after first dose still have the rash it comes and goes now; This is a spontaneous report from a contactable consumer (patient) reported that:  A 58-years-old non-pregnant female patient received BNT162B2 (BioNTech/Pfizer vaccine solution for injection), dose 1 via an unspecified route of administration, administered in Leg Left on 12Mar2021 14:15 (Batch/Lot Number: EN6199) as DOSE 1, SINGLE for covid-19 immunization (Age at vaccination 58 years). The patient past medical history included hyperthyroidism from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported. The patient allergies to Sulfur, epinephrine and morphine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. On 13Mar2021 the patient experienced Rash on face after first dose still have the rash it comes and goes now. After the 2nd dose of vaccine, the patient experienced Shingles, Dizziness for 2 weeks, confusion and Near syncope after 24 hours and 4 days later. The patient received a treatment with Antiviral medication and bed rest. The event outcome was Not recovered.  Device Date: 04May2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy test, Allergy to vaccine, Flushing, Urticaria
Clinical narrative: I am allergic to PEG or polysorbate in the vaccine; had a rash and hives on both arms; red face; had a rash and hives on both arms; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch/lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient reported that I am allergic to PEG or polysorbate in the vaccine, had a rash and hives on both arms (immediately after the vaccination) and red face. Patient wanted to know should she get the second dose and if this was a severe allergic reaction. The outcome of events was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug hypersensitivity, Erythema, Rash, Urticaria
Clinical narrative: I am allergic to PEG or polysorbate in the vaccine; had a rash and hives on both arms; red face; had a rash and hives on both arms; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch/lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient reported that I am allergic to PEG or polysorbate in the vaccine, had a rash and hives on both arms (immediately after the vaccination) and red face. Patient wanted to know should she get the second dose and if this was a severe allergic reaction. The outcome of events was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Chest pain, Dizziness, Dyspnoea, Limb discomfort
Clinical narrative: Chest pain (one day after receiving vaccine); Light-headedness/ dizziness; Shortness of breath; Legs feeling heavy; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Jun2021 at 17:15 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included Known allergies to gluten and dairy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included origanum minutiflorum oil (OREGANO OIL), ascorbic acid (VIT C), probiotics (MANUFACTURER UNKNOWN) and vitamin d NOS (MANUFACTURER UNKNOWN); all from unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jun2021 at 17:15, the patient experienced light-headedness, dizziness, shortness of breath and legs feeling heavy. On 20Jun2021,one day after receiving the vaccine, the patient experienced chest pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event light-headedness/ dizziness, shortness of breath, legs feeling heavy and chest pain  were unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Chest pain (one day after receiving vaccine); Light-headedness/ dizziness; Shortness of breath; Legs feeling heavy; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Jun2021 at 17:15 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included Known allergies to gluten and dairy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included origanum minutiflorum oil (OREGANO OIL), ascorbic acid (VIT C), probiotics (MANUFACTURER UNKNOWN) and vitamin d NOS (MANUFACTURER UNKNOWN); all from unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jun2021 at 17:15, the patient experienced light-headedness, dizziness, shortness of breath and legs feeling heavy. On 20Jun2021,one day after receiving the vaccine, the patient experienced chest pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event light-headedness/ dizziness, shortness of breath, legs feeling heavy and chest pain  were unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Limb discomfort
Clinical narrative: Chest pain (one day after receiving vaccine); Light-headedness/ dizziness; Shortness of breath; Legs feeling heavy; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Jun2021 at 17:15 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included Known allergies to gluten and dairy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included origanum minutiflorum oil (OREGANO OIL), ascorbic acid (VIT C), probiotics (MANUFACTURER UNKNOWN) and vitamin d NOS (MANUFACTURER UNKNOWN); all from unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Jun2021 at 17:15, the patient experienced light-headedness, dizziness, shortness of breath and legs feeling heavy. On 20Jun2021,one day after receiving the vaccine, the patient experienced chest pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event light-headedness/ dizziness, shortness of breath, legs feeling heavy and chest pain  were unknown at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Disturbance in attention, Impaired work ability, Loss of personal independence in daily activities, Sleep disorder, Stress
Clinical narrative: obnoxious ringing in my ears/ head started; hard to fall asleep; lack of sleep; Hard to concentrate; short temper; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) Dose 1 intramuscular, administered in left deltoid on 16Jun2021 at 16:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure abnormal from an unknown date and unknown if ongoing. Concomitant medication included olmesartan medoxomil (BENICAR) for blood pressure abnormal from 16Jun2020 and ongoing.  The patient had not received any other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient experienced obnoxious ringing in my ears/head started on 18Jun2021, considered to be a disability. In 2021, the patient experienced hard to fall asleep, lack of sleep, hard to concentrate, and short temper. The patient reported, "I noticed an obnoxious ringing my ear 2 days after first dose I did not immediately relate this to the vaccine, I had no other side effects. I mentioned it to my doctor during routine physical on 01Jul2021 and she said it might go away after second dose I have found it hard to fall sleep, especially if I get up after a few hours of sleep due to tinnitus. I have tried Tylenol pm and melatonin but only effective for about one night a week. Lack of sleep has caused me to have a short temper and has made it hard to concentrate". The patient had not recovered from the events. The patient received the 2nd dose of BNT162B2 intramuscular, administered in left deltoid on 07Jul2021 at 15:00.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: obnoxious ringing in my ears/ head started; hard to fall asleep; lack of sleep; Hard to concentrate; short temper; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) Dose 1 intramuscular, administered in left deltoid on 16Jun2021 at 16:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure abnormal from an unknown date and unknown if ongoing. Concomitant medication included olmesartan medoxomil (BENICAR) for blood pressure abnormal from 16Jun2020 and ongoing.  The patient had not received any other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient experienced obnoxious ringing in my ears/head started on 18Jun2021, considered to be a disability. In 2021, the patient experienced hard to fall asleep, lack of sleep, hard to concentrate, and short temper. The patient reported, "I noticed an obnoxious ringing my ear 2 days after first dose I did not immediately relate this to the vaccine, I had no other side effects. I mentioned it to my doctor during routine physical on 01Jul2021 and she said it might go away after second dose I have found it hard to fall sleep, especially if I get up after a few hours of sleep due to tinnitus. I have tried Tylenol pm and melatonin but only effective for about one night a week. Lack of sleep has caused me to have a short temper and has made it hard to concentrate". The patient had not recovered from the events. The patient received the 2nd dose of BNT162B2 intramuscular, administered in left deltoid on 07Jul2021 at 15:00.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Affective disorder, Insomnia, Tinnitus
Clinical narrative: obnoxious ringing in my ears/ head started; hard to fall asleep; lack of sleep; Hard to concentrate; short temper; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) Dose 1 intramuscular, administered in left deltoid on 16Jun2021 at 16:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure abnormal from an unknown date and unknown if ongoing. Concomitant medication included olmesartan medoxomil (BENICAR) for blood pressure abnormal from 16Jun2020 and ongoing.  The patient had not received any other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient experienced obnoxious ringing in my ears/head started on 18Jun2021, considered to be a disability. In 2021, the patient experienced hard to fall asleep, lack of sleep, hard to concentrate, and short temper. The patient reported, "I noticed an obnoxious ringing my ear 2 days after first dose I did not immediately relate this to the vaccine, I had no other side effects. I mentioned it to my doctor during routine physical on 01Jul2021 and she said it might go away after second dose I have found it hard to fall sleep, especially if I get up after a few hours of sleep due to tinnitus. I have tried Tylenol pm and melatonin but only effective for about one night a week. Lack of sleep has caused me to have a short temper and has made it hard to concentrate". The patient had not recovered from the events. The patient received the 2nd dose of BNT162B2 intramuscular, administered in left deltoid on 07Jul2021 at 15:00.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anger, Disturbance in attention, Initial insomnia, Insomnia, Tinnitus
Clinical narrative: obnoxious ringing in my ears/ head started; hard to fall asleep; lack of sleep; Hard to concentrate; short temper; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) Dose 1 intramuscular, administered in left deltoid on 16Jun2021 at 16:30 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure abnormal from an unknown date and unknown if ongoing. Concomitant medication included olmesartan medoxomil (BENICAR) for blood pressure abnormal from 16Jun2020 and ongoing.  The patient had not received any other vaccine within 4 weeks prior to the COVID-19 vaccine. The patient experienced obnoxious ringing in my ears/head started on 18Jun2021, considered to be a disability. In 2021, the patient experienced hard to fall asleep, lack of sleep, hard to concentrate, and short temper. The patient reported, "I noticed an obnoxious ringing my ear 2 days after first dose I did not immediately relate this to the vaccine, I had no other side effects. I mentioned it to my doctor during routine physical on 01Jul2021 and she said it might go away after second dose I have found it hard to fall sleep, especially if I get up after a few hours of sleep due to tinnitus. I have tried Tylenol pm and melatonin but only effective for about one night a week. Lack of sleep has caused me to have a short temper and has made it hard to concentrate". The patient had not recovered from the events. The patient received the 2nd dose of BNT162B2 intramuscular, administered in left deltoid on 07Jul2021 at 15:00.