chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Palpitations
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This is the second report for 1st dose of BNT162B2. A 61 years-old female patient received 1st dose of BNT162B2 (Covid vaccine, Expiry Date: 31May2021, lot#EN9581) on 17Feb2021 at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. Consumer stated, "I had severe reaction to COVID vaccine and I want to report that (Refer to AER#2021439636 for 2nd dose). Consumer stated, "I had reaction after the first one but I want to say 13 days later I started feeling sick and I wholly got sick. Outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021439636 same patient/reporter/drug in separate time.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This is the second report for 1st dose of BNT162B2. A 61 years-old female patient received 1st dose of BNT162B2 (Covid vaccine, Expiry Date: 31May2021, lot#EN9581) on 17Feb2021 at single dose for covid-19 immunization. Medical history and concomitant drug were not reported. Consumer stated, "I had severe reaction to COVID vaccine and I want to report that (Refer to AER#2021439636 for 2nd dose). Consumer stated, "I had reaction after the first one but I want to say 13 days later I started feeling sick and I wholly got sick. Outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021439636 same patient/reporter/drug in separate time.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: rash, itching, facial swelling lasting 3 weeks after vaccine
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pruritus, Injection site rash, Swelling face
Clinical narrative: rash, itching, facial swelling lasting 3 weeks after vaccine
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Death, Fatigue, Malaise
Clinical narrative: Patient passed away one week after receiving the vaccine.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient passed away one week after receiving the vaccine.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris, Blood pressure measurement, Hypertension
Clinical narrative: heart attack; blood pressure irregular and high; blood pressure irregular and high; may have increased my cholesterol; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and patient's concomitant medications were not reported. Patient believed that vaccine had made his blood pressure irregular and high, may had increased his cholesterol and led to a heart attack 10 days after the second dose. The event outcome for events was unknown.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood cholesterol increased, Blood pressure abnormal, Hypertension, Myocardial infarction
Clinical narrative: heart attack; blood pressure irregular and high; blood pressure irregular and high; may have increased my cholesterol; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and patient's concomitant medications were not reported. Patient believed that vaccine had made his blood pressure irregular and high, may had increased his cholesterol and led to a heart attack 10 days after the second dose. The event outcome for events was unknown.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: approx: 3 hours after vaccine I developed an terrible headache. I went to bed and slept the rest of the night. I woke up feeling a little better. After being up for 2 or so hours I developed a sharp pain in the back of my head along with nausea, dizziness, extreme headache and vomiting. The dizziness was so bad that I couldn't even keep my eyes open. I went to the ER where they did a CT Scan with and without contrast which showed a Cerebral Stroke. I was admitted on 3/28/2021 and was released on 3/31/2021. I was readmitted with dizziness and confusion on  4/7/2021 and released on 4/10/2021. I seen a Hematologist which done lab work to rule out  any pre existing conditions that would bring on blood clots and stroke. The tests came back normal and it has been determined there were no pre existing condition. I am currently on disability thru work and am under the care of my primary care physician, Neurologist, Cardiologist , Physical and Occupational Therapist.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram head abnormal, Confusional state, Dizziness, Headache
Clinical narrative: approx: 3 hours after vaccine I developed an terrible headache. I went to bed and slept the rest of the night. I woke up feeling a little better. After being up for 2 or so hours I developed a sharp pain in the back of my head along with nausea, dizziness, extreme headache and vomiting. The dizziness was so bad that I couldn't even keep my eyes open. I went to the ER where they did a CT Scan with and without contrast which showed a Cerebral Stroke. I was admitted on 3/28/2021 and was released on 3/31/2021. I was readmitted with dizziness and confusion on  4/7/2021 and released on 4/10/2021. I seen a Hematologist which done lab work to rule out  any pre existing conditions that would bring on blood clots and stroke. The tests came back normal and it has been determined there were no pre existing condition. I am currently on disability thru work and am under the care of my primary care physician, Neurologist, Cardiologist , Physical and Occupational Therapist.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Impaired work ability, Laboratory test normal, Magnetic resonance imaging head abnormal, Nausea, Scan with contrast abnormal
Clinical narrative: approx: 3 hours after vaccine I developed an terrible headache. I went to bed and slept the rest of the night. I woke up feeling a little better. After being up for 2 or so hours I developed a sharp pain in the back of my head along with nausea, dizziness, extreme headache and vomiting. The dizziness was so bad that I couldn't even keep my eyes open. I went to the ER where they did a CT Scan with and without contrast which showed a Cerebral Stroke. I was admitted on 3/28/2021 and was released on 3/31/2021. I was readmitted with dizziness and confusion on  4/7/2021 and released on 4/10/2021. I seen a Hematologist which done lab work to rule out  any pre existing conditions that would bring on blood clots and stroke. The tests came back normal and it has been determined there were no pre existing condition. I am currently on disability thru work and am under the care of my primary care physician, Neurologist, Cardiologist , Physical and Occupational Therapist.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: approx: 3 hours after vaccine I developed an terrible headache. I went to bed and slept the rest of the night. I woke up feeling a little better. After being up for 2 or so hours I developed a sharp pain in the back of my head along with nausea, dizziness, extreme headache and vomiting. The dizziness was so bad that I couldn't even keep my eyes open. I went to the ER where they did a CT Scan with and without contrast which showed a Cerebral Stroke. I was admitted on 3/28/2021 and was released on 3/31/2021. I was readmitted with dizziness and confusion on  4/7/2021 and released on 4/10/2021. I seen a Hematologist which done lab work to rule out  any pre existing conditions that would bring on blood clots and stroke. The tests came back normal and it has been determined there were no pre existing condition. I am currently on disability thru work and am under the care of my primary care physician, Neurologist, Cardiologist , Physical and Occupational Therapist.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Hot flush, Lip swelling
Clinical narrative: had an allergy induced asthma attack; had an allergy induced asthma attack; low grade fever; chills; fatigue/ extreme fatigue; severe hot flashes; light headed; lips began to swell; heart rate and blood pressure were up; heart rate and blood pressure were up; did not feel that she was back to her "normal" as it were before receiving the vaccine; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 14Apr2021 07:15 (lot number: EW0151) at age of 46 years as single dose for covid-19 immunisation. The patient medical history included known allergies: Sulfa drugs and penicillin. Concomitant medications included ascorbic acid, biotin, boron citrate, calcium pantothenate, calcium phosphate, choline bitartrate, chromium picolinate, colecalciferol, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, inositol nicotinate, potassium iodide, pyridoxine hydrochloride, retinol palmitate (VITAFUSION WOMEN'S) daily received within 2 weeks of vaccination. Patient had historical vaccine included the first dose of BNT162B2 (lot number: ER8733) via an unspecified route of administration, administered in right arm on 24Mar2021 07:15 at age of 46 years as single dose for covid-19 immunisation. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was not pregnant. It started with low grade fever, chills, fatigue and severe hot flashes, within 12 hours of the shot. Then the next day, extreme fatigue and light headed. Four days later the fatigue was still coming and going and then her lips began to swell, her heart rate and blood pressure were up and she had an allergy induced asthma attack. That was when she went to the hospital. They gave her a liquid shot Pepcid and prednisone with a bag of iv fluids. And sent in prescriptions for Benadryl, prednisone and Pepcid. Patient had taken them for a week. Patient was still suffering from some fatigue that came and went with her heart rate that appeared to be elevated. Patient did not feel that she was back to her "normal" as it were before receiving the vaccine. Adverse event start date was on 18Apr2021 10:30 AM. Adverse events resulted in emergency room/department or urgent care, hospitalization. Treatment was received. Since the vaccination, patient had not been tested for COVID-19. Outcome of events was recovered/resolved with sequel.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pyrexia, Skin reaction, Wheezing
Clinical narrative: had an allergy induced asthma attack; had an allergy induced asthma attack; low grade fever; chills; fatigue/ extreme fatigue; severe hot flashes; light headed; lips began to swell; heart rate and blood pressure were up; heart rate and blood pressure were up; did not feel that she was back to her "normal" as it were before receiving the vaccine; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 14Apr2021 07:15 (lot number: EW0151) at age of 46 years as single dose for covid-19 immunisation. The patient medical history included known allergies: Sulfa drugs and penicillin. Concomitant medications included ascorbic acid, biotin, boron citrate, calcium pantothenate, calcium phosphate, choline bitartrate, chromium picolinate, colecalciferol, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, inositol nicotinate, potassium iodide, pyridoxine hydrochloride, retinol palmitate (VITAFUSION WOMEN'S) daily received within 2 weeks of vaccination. Patient had historical vaccine included the first dose of BNT162B2 (lot number: ER8733) via an unspecified route of administration, administered in right arm on 24Mar2021 07:15 at age of 46 years as single dose for covid-19 immunisation. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was not pregnant. It started with low grade fever, chills, fatigue and severe hot flashes, within 12 hours of the shot. Then the next day, extreme fatigue and light headed. Four days later the fatigue was still coming and going and then her lips began to swell, her heart rate and blood pressure were up and she had an allergy induced asthma attack. That was when she went to the hospital. They gave her a liquid shot Pepcid and prednisone with a bag of iv fluids. And sent in prescriptions for Benadryl, prednisone and Pepcid. Patient had taken them for a week. Patient was still suffering from some fatigue that came and went with her heart rate that appeared to be elevated. Patient did not feel that she was back to her "normal" as it were before receiving the vaccine. Adverse event start date was on 18Apr2021 10:30 AM. Adverse events resulted in emergency room/department or urgent care, hospitalization. Treatment was received. Since the vaccination, patient had not been tested for COVID-19. Outcome of events was recovered/resolved with sequel.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy to vaccine, Asthma, Blood pressure increased, Chills, Dizziness
Clinical narrative: had an allergy induced asthma attack; had an allergy induced asthma attack; low grade fever; chills; fatigue/ extreme fatigue; severe hot flashes; light headed; lips began to swell; heart rate and blood pressure were up; heart rate and blood pressure were up; did not feel that she was back to her "normal" as it were before receiving the vaccine; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 14Apr2021 07:15 (lot number: EW0151) at age of 46 years as single dose for covid-19 immunisation. The patient medical history included known allergies: Sulfa drugs and penicillin. Concomitant medications included ascorbic acid, biotin, boron citrate, calcium pantothenate, calcium phosphate, choline bitartrate, chromium picolinate, colecalciferol, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, inositol nicotinate, potassium iodide, pyridoxine hydrochloride, retinol palmitate (VITAFUSION WOMEN'S) daily received within 2 weeks of vaccination. Patient had historical vaccine included the first dose of BNT162B2 (lot number: ER8733) via an unspecified route of administration, administered in right arm on 24Mar2021 07:15 at age of 46 years as single dose for covid-19 immunisation. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was not pregnant. It started with low grade fever, chills, fatigue and severe hot flashes, within 12 hours of the shot. Then the next day, extreme fatigue and light headed. Four days later the fatigue was still coming and going and then her lips began to swell, her heart rate and blood pressure were up and she had an allergy induced asthma attack. That was when she went to the hospital. They gave her a liquid shot Pepcid and prednisone with a bag of iv fluids. And sent in prescriptions for Benadryl, prednisone and Pepcid. Patient had taken them for a week. Patient was still suffering from some fatigue that came and went with her heart rate that appeared to be elevated. Patient did not feel that she was back to her "normal" as it were before receiving the vaccine. Adverse event start date was on 18Apr2021 10:30 AM. Adverse events resulted in emergency room/department or urgent care, hospitalization. Treatment was received. Since the vaccination, patient had not been tested for COVID-19. Outcome of events was recovered/resolved with sequel.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Heart rate increased, Hot flush, Lip swelling
Clinical narrative: had an allergy induced asthma attack; had an allergy induced asthma attack; low grade fever; chills; fatigue/ extreme fatigue; severe hot flashes; light headed; lips began to swell; heart rate and blood pressure were up; heart rate and blood pressure were up; did not feel that she was back to her "normal" as it were before receiving the vaccine; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 14Apr2021 07:15 (lot number: EW0151) at age of 46 years as single dose for covid-19 immunisation. The patient medical history included known allergies: Sulfa drugs and penicillin. Concomitant medications included ascorbic acid, biotin, boron citrate, calcium pantothenate, calcium phosphate, choline bitartrate, chromium picolinate, colecalciferol, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, inositol nicotinate, potassium iodide, pyridoxine hydrochloride, retinol palmitate (VITAFUSION WOMEN'S) daily received within 2 weeks of vaccination. Patient had historical vaccine included the first dose of BNT162B2 (lot number: ER8733) via an unspecified route of administration, administered in right arm on 24Mar2021 07:15 at age of 46 years as single dose for covid-19 immunisation. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was not pregnant. It started with low grade fever, chills, fatigue and severe hot flashes, within 12 hours of the shot. Then the next day, extreme fatigue and light headed. Four days later the fatigue was still coming and going and then her lips began to swell, her heart rate and blood pressure were up and she had an allergy induced asthma attack. That was when she went to the hospital. They gave her a liquid shot Pepcid and prednisone with a bag of iv fluids. And sent in prescriptions for Benadryl, prednisone and Pepcid. Patient had taken them for a week. Patient was still suffering from some fatigue that came and went with her heart rate that appeared to be elevated. Patient did not feel that she was back to her "normal" as it were before receiving the vaccine. Adverse event start date was on 18Apr2021 10:30 AM. Adverse events resulted in emergency room/department or urgent care, hospitalization. Treatment was received. Since the vaccination, patient had not been tested for COVID-19. Outcome of events was recovered/resolved with sequel.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: had an allergy induced asthma attack; had an allergy induced asthma attack; low grade fever; chills; fatigue/ extreme fatigue; severe hot flashes; light headed; lips began to swell; heart rate and blood pressure were up; heart rate and blood pressure were up; did not feel that she was back to her "normal" as it were before receiving the vaccine; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 14Apr2021 07:15 (lot number: EW0151) at age of 46 years as single dose for covid-19 immunisation. The patient medical history included known allergies: Sulfa drugs and penicillin. Concomitant medications included ascorbic acid, biotin, boron citrate, calcium pantothenate, calcium phosphate, choline bitartrate, chromium picolinate, colecalciferol, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, inositol nicotinate, potassium iodide, pyridoxine hydrochloride, retinol palmitate (VITAFUSION WOMEN'S) daily received within 2 weeks of vaccination. Patient had historical vaccine included the first dose of BNT162B2 (lot number: ER8733) via an unspecified route of administration, administered in right arm on 24Mar2021 07:15 at age of 46 years as single dose for covid-19 immunisation. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was not pregnant. It started with low grade fever, chills, fatigue and severe hot flashes, within 12 hours of the shot. Then the next day, extreme fatigue and light headed. Four days later the fatigue was still coming and going and then her lips began to swell, her heart rate and blood pressure were up and she had an allergy induced asthma attack. That was when she went to the hospital. They gave her a liquid shot Pepcid and prednisone with a bag of iv fluids. And sent in prescriptions for Benadryl, prednisone and Pepcid. Patient had taken them for a week. Patient was still suffering from some fatigue that came and went with her heart rate that appeared to be elevated. Patient did not feel that she was back to her "normal" as it were before receiving the vaccine. Adverse event start date was on 18Apr2021 10:30 AM. Adverse events resulted in emergency room/department or urgent care, hospitalization. Treatment was received. Since the vaccination, patient had not been tested for COVID-19. Outcome of events was recovered/resolved with sequel.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Body temperature increased, Pruritus, Swelling, Urticaria
Clinical narrative: Caller experienced scattered hives & swelling; Caller experienced scattered hives & swelling; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A male patient of an unspecified age (Age: 57 unit not provided) received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: unknown) via an unspecified route of administration on 14Apr2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 16Apr2021 the patient experienced scattered hives and swelling. He was seen in the ER and received Epi-injection and Benadryl. On Sunday 18Apr2021 he was seen for the second time in the ER for the same symptoms. Patient asked how long the symptoms may last. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Swelling, Urticaria
Clinical narrative: Caller experienced scattered hives & swelling; Caller experienced scattered hives & swelling; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A male patient of an unspecified age (Age: 57 unit not provided) received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: unknown) via an unspecified route of administration on 14Apr2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 16Apr2021 the patient experienced scattered hives and swelling. He was seen in the ER and received Epi-injection and Benadryl. On Sunday 18Apr2021 he was seen for the second time in the ER for the same symptoms. Patient asked how long the symptoms may last. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral
Clinical narrative: sore arm which dissipated over time. But then had severe nerve pain in her legs,; had severe nerve pain in her legs; having "fire and burning in the legs and feet"; inflammation to her eyes; the nerve pain is now pins and needles; numbness and tingling started happening in my face; lips with tingling and numbness, along with the left side of my tongue; lips with tingling and numbness, along with the left side of my tongue; I am also having trouble with vision; This is a spontaneous report from a contactable consumer. This 43-year-old (non-pregnant) female consumer (patient) reported that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER8729, Expiry date: Jul2021) via an unspecified route of administration into the left arm on 03Apr2021 14:30 (at the age of 43-year-old) as single dose for COVID-19 immunisation. The patient medical history included endometriosis, allergy to medications like augmentin, Bactrim and flagyl. Concomitant medication included phentermine (37.5 mg, tablet). On an unspecified date, the patient reported that she experienced a sore arm (left side arm pain) which dissipated over time. But then had severe nerve pain in her legs. Her symptoms seemed more pronounced on her left side, had fire and burning in the legs and feet. She experienced inflammation in her eyes (had trouble with vision) stating she was not sure if this was really a bad case of allergies. Now her nerve pain was pins and needles but then numbness and tingling started happening in her face but that got better, lips with tingling and numbness, along with the left side of her tongue. She reported her second dose is due in a week and that she was unique and her symptoms were not listed as common but did not know if it was something that would prevent her from getting the second shot as she had side effect after the first dose of the vaccine. She asked if the symptoms she was having are being reported and if there would be a contraindication to getting the second shot and was referred to healthcare professional for guidance. The patient did not receive any other vaccines within four weeks prior to the Covid vaccine. No treatment was received for the adverse events. It was unknown if the patient was diagnosed with Covid-19 prior to vaccination. The patient had not been tested for Covid-19 since the vaccination. Outcome was unknown for all the events.  Follow up #01(18Apr2021): This is a follow-up spontaneous report from a contactable consumer. This 43-year-old female consumer (patient) reported for herself which included event details, lot number and expiry date.  Follow up#02 (18Apr2021): This is a follow-up spontaneous report from a contactable consumer. This 43-year-old female consumer (patient) reported for herself which included event seriousness, vaccine details, medical history and concomitant medication details.  No Follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Eye inflammation, Hypoaesthesia, Hypoaesthesia oral, Neuralgia
Clinical narrative: sore arm which dissipated over time. But then had severe nerve pain in her legs,; had severe nerve pain in her legs; having "fire and burning in the legs and feet"; inflammation to her eyes; the nerve pain is now pins and needles; numbness and tingling started happening in my face; lips with tingling and numbness, along with the left side of my tongue; lips with tingling and numbness, along with the left side of my tongue; I am also having trouble with vision; This is a spontaneous report from a contactable consumer. This 43-year-old (non-pregnant) female consumer (patient) reported that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER8729, Expiry date: Jul2021) via an unspecified route of administration into the left arm on 03Apr2021 14:30 (at the age of 43-year-old) as single dose for COVID-19 immunisation. The patient medical history included endometriosis, allergy to medications like augmentin, Bactrim and flagyl. Concomitant medication included phentermine (37.5 mg, tablet). On an unspecified date, the patient reported that she experienced a sore arm (left side arm pain) which dissipated over time. But then had severe nerve pain in her legs. Her symptoms seemed more pronounced on her left side, had fire and burning in the legs and feet. She experienced inflammation in her eyes (had trouble with vision) stating she was not sure if this was really a bad case of allergies. Now her nerve pain was pins and needles but then numbness and tingling started happening in her face but that got better, lips with tingling and numbness, along with the left side of her tongue. She reported her second dose is due in a week and that she was unique and her symptoms were not listed as common but did not know if it was something that would prevent her from getting the second shot as she had side effect after the first dose of the vaccine. She asked if the symptoms she was having are being reported and if there would be a contraindication to getting the second shot and was referred to healthcare professional for guidance. The patient did not receive any other vaccines within four weeks prior to the Covid vaccine. No treatment was received for the adverse events. It was unknown if the patient was diagnosed with Covid-19 prior to vaccination. The patient had not been tested for Covid-19 since the vaccination. Outcome was unknown for all the events.  Follow up #01(18Apr2021): This is a follow-up spontaneous report from a contactable consumer. This 43-year-old female consumer (patient) reported for herself which included event details, lot number and expiry date.  Follow up#02 (18Apr2021): This is a follow-up spontaneous report from a contactable consumer. This 43-year-old female consumer (patient) reported for herself which included event seriousness, vaccine details, medical history and concomitant medication details.  No Follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia, Paraesthesia oral, Visual impairment
Clinical narrative: sore arm which dissipated over time. But then had severe nerve pain in her legs,; had severe nerve pain in her legs; having "fire and burning in the legs and feet"; inflammation to her eyes; the nerve pain is now pins and needles; numbness and tingling started happening in my face; lips with tingling and numbness, along with the left side of my tongue; lips with tingling and numbness, along with the left side of my tongue; I am also having trouble with vision; This is a spontaneous report from a contactable consumer. This 43-year-old (non-pregnant) female consumer (patient) reported that she received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER8729, Expiry date: Jul2021) via an unspecified route of administration into the left arm on 03Apr2021 14:30 (at the age of 43-year-old) as single dose for COVID-19 immunisation. The patient medical history included endometriosis, allergy to medications like augmentin, Bactrim and flagyl. Concomitant medication included phentermine (37.5 mg, tablet). On an unspecified date, the patient reported that she experienced a sore arm (left side arm pain) which dissipated over time. But then had severe nerve pain in her legs. Her symptoms seemed more pronounced on her left side, had fire and burning in the legs and feet. She experienced inflammation in her eyes (had trouble with vision) stating she was not sure if this was really a bad case of allergies. Now her nerve pain was pins and needles but then numbness and tingling started happening in her face but that got better, lips with tingling and numbness, along with the left side of her tongue. She reported her second dose is due in a week and that she was unique and her symptoms were not listed as common but did not know if it was something that would prevent her from getting the second shot as she had side effect after the first dose of the vaccine. She asked if the symptoms she was having are being reported and if there would be a contraindication to getting the second shot and was referred to healthcare professional for guidance. The patient did not receive any other vaccines within four weeks prior to the Covid vaccine. No treatment was received for the adverse events. It was unknown if the patient was diagnosed with Covid-19 prior to vaccination. The patient had not been tested for Covid-19 since the vaccination. Outcome was unknown for all the events.  Follow up #01(18Apr2021): This is a follow-up spontaneous report from a contactable consumer. This 43-year-old female consumer (patient) reported for herself which included event details, lot number and expiry date.  Follow up#02 (18Apr2021): This is a follow-up spontaneous report from a contactable consumer. This 43-year-old female consumer (patient) reported for herself which included event seriousness, vaccine details, medical history and concomitant medication details.  No Follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: I developed tinnitus in both ears this morning, the day after my shot. It's very unnerving and I am worried about it not going away, because of reports I have read about others with the same issue for; This is a spontaneous report from a contactable consumer (the patient). A 56 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via an unspecified route of administration on 20Apr2021 13:00 at age of 56 years old at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took naproxen and experienced "allergy: Naproxen". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient developed tinnitus in both ears this morning (21Apr2021-the day after her shot). It's very unnerving and she was worried about it not going away, because of reports she had read about others with the same issue for weeks and weeks! No treatment received for the event. The outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time prolonged, Acute myocardial infarction, Arteriogram coronary normal, Blood test, Chest pain
Clinical narrative: chest pains; short of breath; troponin at 4.6/Went up to 5.0/troponin peaked at 9.9; Echo shows decreased blood flow (50%); This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in arm left on 15Apr2021 12:45 (Batch/Lot Number: EW0162) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included loratadine/ pseudoephedrine (CLARIDIN-D). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, administered in arm left on 25Mar2021 04:30 PM (Batch/Lot Number: ER8730) for covid-19 immunisation. The patient experienced chest pains, and short of breath both on 17Apr2021 22:00. Tried to sleep it off. 24 hours, didn't get better. On 17Apr2021, went to local ER, troponin at 4.6 ng/L. Doctors didn't believe it, did another blood draw. Went up to 5.0 ng/L. Ambulance to nearby hospital, troponin peaked at 9.9 ng/L. Echo showed decreased blood flow (50%) and EKG was irregular. Angiogram and CT scan show no blood clots or blockages. Patient was a healthy 38 male who was a distance runner. No history of chest pain or heart issues. Doctors determined incident almost certainly related to vaccine. The serious criteria for all events were hospitalization and duration were 2 days. The adverse events result in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Colchicine received as treatment for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient has been tested for COVID 19. The patient underwent lab tests and procedures which included COVID test (COVID antibody blood test): negative on 20Apr2021, Covid test (Nasal Swab): negative on 18Apr2021. The outcomes of events were recovering.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram coronary artery normal, Echocardiogram abnormal, Electrocardiogram normal, Myocarditis, Troponin increased
Clinical narrative: chest pains; short of breath; troponin at 4.6/Went up to 5.0/troponin peaked at 9.9; Echo shows decreased blood flow (50%); This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in arm left on 15Apr2021 12:45 (Batch/Lot Number: EW0162) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included loratadine/ pseudoephedrine (CLARIDIN-D). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, administered in arm left on 25Mar2021 04:30 PM (Batch/Lot Number: ER8730) for covid-19 immunisation. The patient experienced chest pains, and short of breath both on 17Apr2021 22:00. Tried to sleep it off. 24 hours, didn't get better. On 17Apr2021, went to local ER, troponin at 4.6 ng/L. Doctors didn't believe it, did another blood draw. Went up to 5.0 ng/L. Ambulance to nearby hospital, troponin peaked at 9.9 ng/L. Echo showed decreased blood flow (50%) and EKG was irregular. Angiogram and CT scan show no blood clots or blockages. Patient was a healthy 38 male who was a distance runner. No history of chest pain or heart issues. Doctors determined incident almost certainly related to vaccine. The serious criteria for all events were hospitalization and duration were 2 days. The adverse events result in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Colchicine received as treatment for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient has been tested for COVID 19. The patient underwent lab tests and procedures which included COVID test (COVID antibody blood test): negative on 20Apr2021, Covid test (Nasal Swab): negative on 18Apr2021. The outcomes of events were recovering.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Cardiovascular disorder, Chest pain, Computerised tomogram, Dyspnoea
Clinical narrative: chest pains; short of breath; troponin at 4.6/Went up to 5.0/troponin peaked at 9.9; Echo shows decreased blood flow (50%); This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in arm left on 15Apr2021 12:45 (Batch/Lot Number: EW0162) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included loratadine/ pseudoephedrine (CLARIDIN-D). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, administered in arm left on 25Mar2021 04:30 PM (Batch/Lot Number: ER8730) for covid-19 immunisation. The patient experienced chest pains, and short of breath both on 17Apr2021 22:00. Tried to sleep it off. 24 hours, didn't get better. On 17Apr2021, went to local ER, troponin at 4.6 ng/L. Doctors didn't believe it, did another blood draw. Went up to 5.0 ng/L. Ambulance to nearby hospital, troponin peaked at 9.9 ng/L. Echo showed decreased blood flow (50%) and EKG was irregular. Angiogram and CT scan show no blood clots or blockages. Patient was a healthy 38 male who was a distance runner. No history of chest pain or heart issues. Doctors determined incident almost certainly related to vaccine. The serious criteria for all events were hospitalization and duration were 2 days. The adverse events result in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Colchicine received as treatment for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient has been tested for COVID 19. The patient underwent lab tests and procedures which included COVID test (COVID antibody blood test): negative on 20Apr2021, Covid test (Nasal Swab): negative on 18Apr2021. The outcomes of events were recovering.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, SARS-CoV-2 antibody test, SARS-CoV-2 test, Troponin
Clinical narrative: chest pains; short of breath; troponin at 4.6/Went up to 5.0/troponin peaked at 9.9; Echo shows decreased blood flow (50%); This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in arm left on 15Apr2021 12:45 (Batch/Lot Number: EW0162) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included loratadine/ pseudoephedrine (CLARIDIN-D). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, administered in arm left on 25Mar2021 04:30 PM (Batch/Lot Number: ER8730) for covid-19 immunisation. The patient experienced chest pains, and short of breath both on 17Apr2021 22:00. Tried to sleep it off. 24 hours, didn't get better. On 17Apr2021, went to local ER, troponin at 4.6 ng/L. Doctors didn't believe it, did another blood draw. Went up to 5.0 ng/L. Ambulance to nearby hospital, troponin peaked at 9.9 ng/L. Echo showed decreased blood flow (50%) and EKG was irregular. Angiogram and CT scan show no blood clots or blockages. Patient was a healthy 38 male who was a distance runner. No history of chest pain or heart issues. Doctors determined incident almost certainly related to vaccine. The serious criteria for all events were hospitalization and duration were 2 days. The adverse events result in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Colchicine received as treatment for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient has been tested for COVID 19. The patient underwent lab tests and procedures which included COVID test (COVID antibody blood test): negative on 20Apr2021, Covid test (Nasal Swab): negative on 18Apr2021. The outcomes of events were recovering.
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin increased
Clinical narrative: chest pains; short of breath; troponin at 4.6/Went up to 5.0/troponin peaked at 9.9; Echo shows decreased blood flow (50%); This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in arm left on 15Apr2021 12:45 (Batch/Lot Number: EW0162) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included loratadine/ pseudoephedrine (CLARIDIN-D). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, administered in arm left on 25Mar2021 04:30 PM (Batch/Lot Number: ER8730) for covid-19 immunisation. The patient experienced chest pains, and short of breath both on 17Apr2021 22:00. Tried to sleep it off. 24 hours, didn't get better. On 17Apr2021, went to local ER, troponin at 4.6 ng/L. Doctors didn't believe it, did another blood draw. Went up to 5.0 ng/L. Ambulance to nearby hospital, troponin peaked at 9.9 ng/L. Echo showed decreased blood flow (50%) and EKG was irregular. Angiogram and CT scan show no blood clots or blockages. Patient was a healthy 38 male who was a distance runner. No history of chest pain or heart issues. Doctors determined incident almost certainly related to vaccine. The serious criteria for all events were hospitalization and duration were 2 days. The adverse events result in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Colchicine received as treatment for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient has been tested for COVID 19. The patient underwent lab tests and procedures which included COVID test (COVID antibody blood test): negative on 20Apr2021, Covid test (Nasal Swab): negative on 18Apr2021. The outcomes of events were recovering.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Blood test, Eye pain, Feeling hot, Neck pain
Clinical narrative: Had tingling all over her body, especially in her legs, hands, arms, and feet; Tired; Achy neck and shoulders; Achy neck and shoulders; Sharp pain in her right eye and right foot; Sharp pain in her right eye and right foot; Her eyes felt very hot; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown), via an unspecified route of administration on 12Mar2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated that she received her first Pfizer Covid vaccine dose on 12Mar2021, 5 minutes after the dose of the vaccine her eyes felt very hot and it lasted for 30 seconds or so. On 13Mar2021, she developed tired and achy neck and shoulders and sharp pain in her right eye and right foot. On 14Mar2021 she woke up and her neck and shoulders felt better but she had tingling all over her body, especially in her legs, hands, arms, and feet. She says it has improved but still continuing. Outcome of the events tired, sharp pain in her right eye and right foot was unknown, had tingling all over her body, especially in her legs, hands, arms, and feet was not recovered, while events achy neck and shoulders was recovering, and her eyes felt very hot was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia, SARS-CoV-2 antibody test
Clinical narrative: Had tingling all over her body, especially in her legs, hands, arms, and feet; Tired; Achy neck and shoulders; Achy neck and shoulders; Sharp pain in her right eye and right foot; Sharp pain in her right eye and right foot; Her eyes felt very hot; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: unknown), via an unspecified route of administration on 12Mar2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated that she received her first Pfizer Covid vaccine dose on 12Mar2021, 5 minutes after the dose of the vaccine her eyes felt very hot and it lasted for 30 seconds or so. On 13Mar2021, she developed tired and achy neck and shoulders and sharp pain in her right eye and right foot. On 14Mar2021 she woke up and her neck and shoulders felt better but she had tingling all over her body, especially in her legs, hands, arms, and feet. She says it has improved but still continuing. Outcome of the events tired, sharp pain in her right eye and right foot was unknown, had tingling all over her body, especially in her legs, hands, arms, and feet was not recovered, while events achy neck and shoulders was recovering, and her eyes felt very hot was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.