chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Cough, Dizziness, Fatigue, Headache
Clinical narrative: blood blisters all over my body on day 3; 101 fever; chills; headache; cough; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A female non-pregnant patient of an age 58 (units: unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 25Mar2021 as a dose 1, single for COVID-19 immunization. The patient's medical history included immune system disorder. The patient's concomitant medications were not reported. The patient was not pregnant at time of vaccination. Enquired that, forwarded as an Adverse Event and Medical Inquiry by the team on 12Apr2021, the reporter provided verification of contact address on 12Apr2021. CEP ID #5570. It was reported that, on 25Mar2021, the patient had Pfizer Covid vaccine 1st dose. Stated that, she broke out with blood blisters all over her body on day 3, 28Mar2021, after getting shot. Stated that, on Day 2 and 3, 27Mar2021, the patient had 101 fever, cough, chills and headache. Stated that, the reporter called Pfizer, VAERS, , hospital and her doctor but no one answered and no one called back. Stated that, she did not know where to turn. The second dose was coming up. Stated that, the reporter asked her doctor whether she should get the 2nd one. Stated that, he said to call the clinic where she got the first shot. The patient enquired that, who should she call if she had these reactions. The blood blisters are a rare blood disorder. Stated that, she needed a plan in place, if she had it worse. Stated that, she had recovered from those adverse effects. Stated that, the reporter don't know what to expect after the 2nd dose. Stated that, you are the first person who called me. Stated that, she can't afford to wait 2 and 1/2 weeks if it's any worse. Enquried, what does a person do if the event of having adverse event after the 2nd dose. Stated that, can she had a list of hospitals that have been working on the research in the (place) area who did research or was part of the clinical trials that would know more about this. Stated that, the patient had an immune disease and she didn't believe they were in the study. Enquired, the patient had a side effect after the first dose of the vaccine. Should she get the second dose. The patient underwent lab tests and procedures which included pyrexia, resulted as 101 on 27Mar2021 and on 28Mar2021. The outcome for the events for blood blisters all over my body on day 3 was recovered on an unspecified date in 2021 while for the other events was recovered on 28Mar2021.  No follow-up attempts are possible. Information on Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Oropharyngeal pain, Pain in jaw, Palpitations, Pyrexia
Clinical narrative: blood blisters all over my body on day 3; 101 fever; chills; headache; cough; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A female non-pregnant patient of an age 58 (units: unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 25Mar2021 as a dose 1, single for COVID-19 immunization. The patient's medical history included immune system disorder. The patient's concomitant medications were not reported. The patient was not pregnant at time of vaccination. Enquired that, forwarded as an Adverse Event and Medical Inquiry by the team on 12Apr2021, the reporter provided verification of contact address on 12Apr2021. CEP ID #5570. It was reported that, on 25Mar2021, the patient had Pfizer Covid vaccine 1st dose. Stated that, she broke out with blood blisters all over her body on day 3, 28Mar2021, after getting shot. Stated that, on Day 2 and 3, 27Mar2021, the patient had 101 fever, cough, chills and headache. Stated that, the reporter called Pfizer, VAERS, , hospital and her doctor but no one answered and no one called back. Stated that, she did not know where to turn. The second dose was coming up. Stated that, the reporter asked her doctor whether she should get the 2nd one. Stated that, he said to call the clinic where she got the first shot. The patient enquired that, who should she call if she had these reactions. The blood blisters are a rare blood disorder. Stated that, she needed a plan in place, if she had it worse. Stated that, she had recovered from those adverse effects. Stated that, the reporter don't know what to expect after the 2nd dose. Stated that, you are the first person who called me. Stated that, she can't afford to wait 2 and 1/2 weeks if it's any worse. Enquried, what does a person do if the event of having adverse event after the 2nd dose. Stated that, can she had a list of hospitals that have been working on the research in the (place) area who did research or was part of the clinical trials that would know more about this. Stated that, the patient had an immune disease and she didn't believe they were in the study. Enquired, the patient had a side effect after the first dose of the vaccine. Should she get the second dose. The patient underwent lab tests and procedures which included pyrexia, resulted as 101 on 27Mar2021 and on 28Mar2021. The outcome for the events for blood blisters all over my body on day 3 was recovered on an unspecified date in 2021 while for the other events was recovered on 28Mar2021.  No follow-up attempts are possible. Information on Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood blister, Chills, Headache, Oropharyngeal discomfort, Pyrexia
Clinical narrative: blood blisters all over my body on day 3; 101 fever; chills; headache; cough; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A female non-pregnant patient of an age 58 (units: unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 25Mar2021 as a dose 1, single for COVID-19 immunization. The patient's medical history included immune system disorder. The patient's concomitant medications were not reported. The patient was not pregnant at time of vaccination. Enquired that, forwarded as an Adverse Event and Medical Inquiry by the team on 12Apr2021, the reporter provided verification of contact address on 12Apr2021. CEP ID #5570. It was reported that, on 25Mar2021, the patient had Pfizer Covid vaccine 1st dose. Stated that, she broke out with blood blisters all over her body on day 3, 28Mar2021, after getting shot. Stated that, on Day 2 and 3, 27Mar2021, the patient had 101 fever, cough, chills and headache. Stated that, the reporter called Pfizer, VAERS, , hospital and her doctor but no one answered and no one called back. Stated that, she did not know where to turn. The second dose was coming up. Stated that, the reporter asked her doctor whether she should get the 2nd one. Stated that, he said to call the clinic where she got the first shot. The patient enquired that, who should she call if she had these reactions. The blood blisters are a rare blood disorder. Stated that, she needed a plan in place, if she had it worse. Stated that, she had recovered from those adverse effects. Stated that, the reporter don't know what to expect after the 2nd dose. Stated that, you are the first person who called me. Stated that, she can't afford to wait 2 and 1/2 weeks if it's any worse. Enquried, what does a person do if the event of having adverse event after the 2nd dose. Stated that, can she had a list of hospitals that have been working on the research in the (place) area who did research or was part of the clinical trials that would know more about this. Stated that, the patient had an immune disease and she didn't believe they were in the study. Enquired, the patient had a side effect after the first dose of the vaccine. Should she get the second dose. The patient underwent lab tests and procedures which included pyrexia, resulted as 101 on 27Mar2021 and on 28Mar2021. The outcome for the events for blood blisters all over my body on day 3 was recovered on an unspecified date in 2021 while for the other events was recovered on 28Mar2021.  No follow-up attempts are possible. Information on Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood blister, Chills, Cough, Headache, Pyrexia
Clinical narrative: blood blisters all over my body on day 3; 101 fever; chills; headache; cough; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A female non-pregnant patient of an age 58 (units: unspecified) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 25Mar2021 as a dose 1, single for COVID-19 immunization. The patient's medical history included immune system disorder. The patient's concomitant medications were not reported. The patient was not pregnant at time of vaccination. Enquired that, forwarded as an Adverse Event and Medical Inquiry by the team on 12Apr2021, the reporter provided verification of contact address on 12Apr2021. CEP ID #5570. It was reported that, on 25Mar2021, the patient had Pfizer Covid vaccine 1st dose. Stated that, she broke out with blood blisters all over her body on day 3, 28Mar2021, after getting shot. Stated that, on Day 2 and 3, 27Mar2021, the patient had 101 fever, cough, chills and headache. Stated that, the reporter called Pfizer, VAERS, , hospital and her doctor but no one answered and no one called back. Stated that, she did not know where to turn. The second dose was coming up. Stated that, the reporter asked her doctor whether she should get the 2nd one. Stated that, he said to call the clinic where she got the first shot. The patient enquired that, who should she call if she had these reactions. The blood blisters are a rare blood disorder. Stated that, she needed a plan in place, if she had it worse. Stated that, she had recovered from those adverse effects. Stated that, the reporter don't know what to expect after the 2nd dose. Stated that, you are the first person who called me. Stated that, she can't afford to wait 2 and 1/2 weeks if it's any worse. Enquried, what does a person do if the event of having adverse event after the 2nd dose. Stated that, can she had a list of hospitals that have been working on the research in the (place) area who did research or was part of the clinical trials that would know more about this. Stated that, the patient had an immune disease and she didn't believe they were in the study. Enquired, the patient had a side effect after the first dose of the vaccine. Should she get the second dose. The patient underwent lab tests and procedures which included pyrexia, resulted as 101 on 27Mar2021 and on 28Mar2021. The outcome for the events for blood blisters all over my body on day 3 was recovered on an unspecified date in 2021 while for the other events was recovered on 28Mar2021.  No follow-up attempts are possible. Information on Lot/batch number cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; dizziness/ lightheaded; diarrhea; insomnia; anxiety; headaches; loss of taste and smell for 2 days; loss of smell; Loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734) via an unspecified route of administration in the right arm on 27Mar2021 at 13:15 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included melatonin (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6205) via an unspecified route of administration in the left arm on 03Mar2021 at 00:00 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. On 27Mar2021 at 14:45, the patient experienced tinnitus, dizziness, diarrhea, insomnia, anxiety, lightheaded, headaches, loss of taste and smell for 2 days and loss of appetite. Most symptoms lasted for about two weeks and have resolved but the tinnitus remained very loud. On 23Apr2021, the patient underwent lab tests and procedures which included COVID-19 PCR test and the result was found to be negative. The events resulted in doctor or other healthcare professional office or clinic visit. Therapeutic measures taken as a result of the reported events and included sleep medications. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events loss of taste and smell were recovered on 29Mar2021, while the events tinnitus, dizziness, diarrhea, insomnia, anxiety, lightheaded, headaches were recovering and the event loss of appetite was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Anosmia, Anxiety, Decreased appetite, Diarrhoea
Clinical narrative: Tinnitus; dizziness/ lightheaded; diarrhea; insomnia; anxiety; headaches; loss of taste and smell for 2 days; loss of smell; Loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734) via an unspecified route of administration in the right arm on 27Mar2021 at 13:15 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included melatonin (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6205) via an unspecified route of administration in the left arm on 03Mar2021 at 00:00 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. On 27Mar2021 at 14:45, the patient experienced tinnitus, dizziness, diarrhea, insomnia, anxiety, lightheaded, headaches, loss of taste and smell for 2 days and loss of appetite. Most symptoms lasted for about two weeks and have resolved but the tinnitus remained very loud. On 23Apr2021, the patient underwent lab tests and procedures which included COVID-19 PCR test and the result was found to be negative. The events resulted in doctor or other healthcare professional office or clinic visit. Therapeutic measures taken as a result of the reported events and included sleep medications. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events loss of taste and smell were recovered on 29Mar2021, while the events tinnitus, dizziness, diarrhea, insomnia, anxiety, lightheaded, headaches were recovering and the event loss of appetite was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache, Insomnia, SARS-CoV-2 test, Tinnitus
Clinical narrative: Tinnitus; dizziness/ lightheaded; diarrhea; insomnia; anxiety; headaches; loss of taste and smell for 2 days; loss of smell; Loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8734) via an unspecified route of administration in the right arm on 27Mar2021 at 13:15 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included melatonin (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6205) via an unspecified route of administration in the left arm on 03Mar2021 at 00:00 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. On 27Mar2021 at 14:45, the patient experienced tinnitus, dizziness, diarrhea, insomnia, anxiety, lightheaded, headaches, loss of taste and smell for 2 days and loss of appetite. Most symptoms lasted for about two weeks and have resolved but the tinnitus remained very loud. On 23Apr2021, the patient underwent lab tests and procedures which included COVID-19 PCR test and the result was found to be negative. The events resulted in doctor or other healthcare professional office or clinic visit. Therapeutic measures taken as a result of the reported events and included sleep medications. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events loss of taste and smell were recovered on 29Mar2021, while the events tinnitus, dizziness, diarrhea, insomnia, anxiety, lightheaded, headaches were recovering and the event loss of appetite was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Body temperature, COVID-19, Pain, SARS-CoV-2 test
Clinical narrative: got COVID after the 1st shot; got COVID after the 1st shot; This is a spontaneous report from two contactable consumers, one of them was the patient. These consumers reported similar events for three patients. This is the first of three reports.  A patient of unspecified age and gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient got COVID after the 1st dose. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unspecified date. The outcome of the events was unknown.  Follow-up (13May2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made.   Follow-up attempts have been completed and no further information is expected.  Follow-up (07Oct2021): New information from a contactable consumer included: reporter information updated and E2B link numbers updated.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-up (19Oct2021): This is a follow-up report to notify that the case 2021503608 and case 202101400234  are duplicates.  All subsequent follow-up information will be reported under Manufacturer report number 202101400234.    ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021503620 same reporter/vaccine, similar events, different patient;US-PFIZER INC-2021618698 same reporter/vaccine, similar events, different patient
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Secretion discharge, Tremor
Clinical narrative: got COVID after the 1st shot; got COVID after the 1st shot; This is a spontaneous report from two contactable consumers, one of them was the patient. These consumers reported similar events for three patients. This is the first of three reports.  A patient of unspecified age and gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient got COVID after the 1st dose. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unspecified date. The outcome of the events was unknown.  Follow-up (13May2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made.   Follow-up attempts have been completed and no further information is expected.  Follow-up (07Oct2021): New information from a contactable consumer included: reporter information updated and E2B link numbers updated.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-up (19Oct2021): This is a follow-up report to notify that the case 2021503608 and case 202101400234  are duplicates.  All subsequent follow-up information will be reported under Manufacturer report number 202101400234.    ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021503620 same reporter/vaccine, similar events, different patient;US-PFIZER INC-2021618698 same reporter/vaccine, similar events, different patient
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got COVID after the 1st shot; got COVID after the 1st shot; This is a spontaneous report from two contactable consumers, one of them was the patient. These consumers reported similar events for three patients. This is the first of three reports.  A patient of unspecified age and gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient got COVID after the 1st dose. The patient underwent lab tests and procedures which included COVID-19 test: positive on an unspecified date. The outcome of the events was unknown.  Follow-up (13May2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made.   Follow-up attempts have been completed and no further information is expected.  Follow-up (07Oct2021): New information from a contactable consumer included: reporter information updated and E2B link numbers updated.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-up (19Oct2021): This is a follow-up report to notify that the case 2021503608 and case 202101400234  are duplicates.  All subsequent follow-up information will be reported under Manufacturer report number 202101400234.    ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021503620 same reporter/vaccine, similar events, different patient;US-PFIZER INC-2021618698 same reporter/vaccine, similar events, different patient
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood folate, Blood magnesium, Blood test, Burning sensation, Chills
Clinical narrative: Burning feeling on top of tongue; Tingling in feet up to ankles/ hands up to elbows; Burning in feet up to ankles,/burning in hands up to elbows; Significantly increased tinnitus; Nausea; Lack of appetite; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 03Apr2021 at 09:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included shellfish allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included estrogens conjugated / medroxyprogesterone acetate (PREMPRO) for an unknown indication from an unknown date and unknown if ongoing. The patient previously took acetylsalicylic acid (ASPIRIN) for an unknown indication on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on 13Mar2021 at 11:15 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. On 03Apr2021 at 05:00, the patient experienced burning/tingling in feet up to ankles, tingling/burning in hands up to elbows, burning feeling on top of tongue, significantly increased tinnitus, nausea and lack of appetite. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of the events burning/tingling in feet up to ankles, tingling/burning in hands up to elbows, burning feeling on top of tongue, significantly increased tinnitus, nausea, lack of appetite was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Decreased appetite, Diarrhoea, Fatigue, Full blood count, Lyme disease
Clinical narrative: Burning feeling on top of tongue; Tingling in feet up to ankles/ hands up to elbows; Burning in feet up to ankles,/burning in hands up to elbows; Significantly increased tinnitus; Nausea; Lack of appetite; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 03Apr2021 at 09:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included shellfish allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included estrogens conjugated / medroxyprogesterone acetate (PREMPRO) for an unknown indication from an unknown date and unknown if ongoing. The patient previously took acetylsalicylic acid (ASPIRIN) for an unknown indication on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on 13Mar2021 at 11:15 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. On 03Apr2021 at 05:00, the patient experienced burning/tingling in feet up to ankles, tingling/burning in hands up to elbows, burning feeling on top of tongue, significantly increased tinnitus, nausea and lack of appetite. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of the events burning/tingling in feet up to ankles, tingling/burning in hands up to elbows, burning feeling on top of tongue, significantly increased tinnitus, nausea, lack of appetite was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, Nausea, Paraesthesia, Pyrexia, Tinnitus
Clinical narrative: Burning feeling on top of tongue; Tingling in feet up to ankles/ hands up to elbows; Burning in feet up to ankles,/burning in hands up to elbows; Significantly increased tinnitus; Nausea; Lack of appetite; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 03Apr2021 at 09:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included shellfish allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included estrogens conjugated / medroxyprogesterone acetate (PREMPRO) for an unknown indication from an unknown date and unknown if ongoing. The patient previously took acetylsalicylic acid (ASPIRIN) for an unknown indication on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on 13Mar2021 at 11:15 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. On 03Apr2021 at 05:00, the patient experienced burning/tingling in feet up to ankles, tingling/burning in hands up to elbows, burning feeling on top of tongue, significantly increased tinnitus, nausea and lack of appetite. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of the events burning/tingling in feet up to ankles, tingling/burning in hands up to elbows, burning feeling on top of tongue, significantly increased tinnitus, nausea, lack of appetite was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tongue discomfort, Vitamin B12
Clinical narrative: Burning feeling on top of tongue; Tingling in feet up to ankles/ hands up to elbows; Burning in feet up to ankles,/burning in hands up to elbows; Significantly increased tinnitus; Nausea; Lack of appetite; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 03Apr2021 at 09:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included shellfish allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included estrogens conjugated / medroxyprogesterone acetate (PREMPRO) for an unknown indication from an unknown date and unknown if ongoing. The patient previously took acetylsalicylic acid (ASPIRIN) for an unknown indication on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on 13Mar2021 at 11:15 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. On 03Apr2021 at 05:00, the patient experienced burning/tingling in feet up to ankles, tingling/burning in hands up to elbows, burning feeling on top of tongue, significantly increased tinnitus, nausea and lack of appetite. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of the events burning/tingling in feet up to ankles, tingling/burning in hands up to elbows, burning feeling on top of tongue, significantly increased tinnitus, nausea, lack of appetite was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Decreased appetite, Nausea, Paraesthesia, Tinnitus
Clinical narrative: Burning feeling on top of tongue; Tingling in feet up to ankles/ hands up to elbows; Burning in feet up to ankles,/burning in hands up to elbows; Significantly increased tinnitus; Nausea; Lack of appetite; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 03Apr2021 at 09:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included shellfish allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included estrogens conjugated / medroxyprogesterone acetate (PREMPRO) for an unknown indication from an unknown date and unknown if ongoing. The patient previously took acetylsalicylic acid (ASPIRIN) for an unknown indication on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on 13Mar2021 at 11:15 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. On 03Apr2021 at 05:00, the patient experienced burning/tingling in feet up to ankles, tingling/burning in hands up to elbows, burning feeling on top of tongue, significantly increased tinnitus, nausea and lack of appetite. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of the events burning/tingling in feet up to ankles, tingling/burning in hands up to elbows, burning feeling on top of tongue, significantly increased tinnitus, nausea, lack of appetite was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tongue discomfort
Clinical narrative: Burning feeling on top of tongue; Tingling in feet up to ankles/ hands up to elbows; Burning in feet up to ankles,/burning in hands up to elbows; Significantly increased tinnitus; Nausea; Lack of appetite; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the right arm on 03Apr2021 at 09:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included shellfish allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included estrogens conjugated / medroxyprogesterone acetate (PREMPRO) for an unknown indication from an unknown date and unknown if ongoing. The patient previously took acetylsalicylic acid (ASPIRIN) for an unknown indication on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the right arm on 13Mar2021 at 11:15 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. On 03Apr2021 at 05:00, the patient experienced burning/tingling in feet up to ankles, tingling/burning in hands up to elbows, burning feeling on top of tongue, significantly increased tinnitus, nausea and lack of appetite. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of the events burning/tingling in feet up to ankles, tingling/burning in hands up to elbows, burning feeling on top of tongue, significantly increased tinnitus, nausea, lack of appetite was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test negative, Vaccine positive rechallenge
Clinical narrative: extreme fatigue; intense headaches that would not go away with medication; chest pain; body aches severe to the point every part of my body was in pain; shoulder and neck pain; shoulder and neck pain; chills; sweats; fever; nausea; stomach pain; low back pain; non stop diarrhea after anything I ate or drank; very dizzy almost like motion sickness and higher blood pressure; motion sickness; higher blood pressure; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the right arm on 31Mar2021 (at the age of 48 years old) (Lot Number: EP6955) as dose 2, single for COVID-19 immunisation. Medical history included hypothyroidism and hormone replacement therapy. The patient was not pregnant at the time of the events. Concomitant medications included thyroid taken for an unspecified indication, start and stop date were not reported and vitamins nos (DAILY VITAMINS) taken for an unspecified indication, start and stop date were not reported.  The patient previously took Compazine and experienced drug allergy. The patient also previously took Crestor (low dose crestor 2.5 mg). The patient previously took the first dose of BNT162B2 on 10Mar2021 (Lot Number: EN 6199) for COVID-19 immunisation and experienced extreme fatigue, headaches, chest pain, dizziness, chills, sweats, fever, body aches, and nausea. The patient did not have COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Daily vitamins, BHR hormone replacement, and thyroid were received within 2 weeks of vaccination. The patient had been tested for COVID-19 post-vaccination. On 31Mar2021 at 19:00, the patient experienced extreme fatigue, intense headaches that would not go away with medication, chest pain, body aches severe to the point every part of my body was in pain, shoulder and neck pain, chills, sweats, fever, nausea, stomach pain, low back pain, non stop diarrhea after anything I ate or drank, very dizzy almost like motion sickness and higher blood pressure. Treatment was received for the events. Events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood pressure measurement: higher blood pressure on 31Mar2021, SARS-CoV-2 test: negative on 19Mar2021 and SARS-CoV-2 test: negative on 09Apr2021. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Blood pressure measurement, Chest pain
Clinical narrative: extreme fatigue; intense headaches that would not go away with medication; chest pain; body aches severe to the point every part of my body was in pain; shoulder and neck pain; shoulder and neck pain; chills; sweats; fever; nausea; stomach pain; low back pain; non stop diarrhea after anything I ate or drank; very dizzy almost like motion sickness and higher blood pressure; motion sickness; higher blood pressure; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the right arm on 31Mar2021 (at the age of 48 years old) (Lot Number: EP6955) as dose 2, single for COVID-19 immunisation. Medical history included hypothyroidism and hormone replacement therapy. The patient was not pregnant at the time of the events. Concomitant medications included thyroid taken for an unspecified indication, start and stop date were not reported and vitamins nos (DAILY VITAMINS) taken for an unspecified indication, start and stop date were not reported.  The patient previously took Compazine and experienced drug allergy. The patient also previously took Crestor (low dose crestor 2.5 mg). The patient previously took the first dose of BNT162B2 on 10Mar2021 (Lot Number: EN 6199) for COVID-19 immunisation and experienced extreme fatigue, headaches, chest pain, dizziness, chills, sweats, fever, body aches, and nausea. The patient did not have COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Daily vitamins, BHR hormone replacement, and thyroid were received within 2 weeks of vaccination. The patient had been tested for COVID-19 post-vaccination. On 31Mar2021 at 19:00, the patient experienced extreme fatigue, intense headaches that would not go away with medication, chest pain, body aches severe to the point every part of my body was in pain, shoulder and neck pain, chills, sweats, fever, nausea, stomach pain, low back pain, non stop diarrhea after anything I ate or drank, very dizzy almost like motion sickness and higher blood pressure. Treatment was received for the events. Events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood pressure measurement: higher blood pressure on 31Mar2021, SARS-CoV-2 test: negative on 19Mar2021 and SARS-CoV-2 test: negative on 09Apr2021. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: extreme fatigue; intense headaches that would not go away with medication; chest pain; body aches severe to the point every part of my body was in pain; shoulder and neck pain; shoulder and neck pain; chills; sweats; fever; nausea; stomach pain; low back pain; non stop diarrhea after anything I ate or drank; very dizzy almost like motion sickness and higher blood pressure; motion sickness; higher blood pressure; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the right arm on 31Mar2021 (at the age of 48 years old) (Lot Number: EP6955) as dose 2, single for COVID-19 immunisation. Medical history included hypothyroidism and hormone replacement therapy. The patient was not pregnant at the time of the events. Concomitant medications included thyroid taken for an unspecified indication, start and stop date were not reported and vitamins nos (DAILY VITAMINS) taken for an unspecified indication, start and stop date were not reported.  The patient previously took Compazine and experienced drug allergy. The patient also previously took Crestor (low dose crestor 2.5 mg). The patient previously took the first dose of BNT162B2 on 10Mar2021 (Lot Number: EN 6199) for COVID-19 immunisation and experienced extreme fatigue, headaches, chest pain, dizziness, chills, sweats, fever, body aches, and nausea. The patient did not have COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Daily vitamins, BHR hormone replacement, and thyroid were received within 2 weeks of vaccination. The patient had been tested for COVID-19 post-vaccination. On 31Mar2021 at 19:00, the patient experienced extreme fatigue, intense headaches that would not go away with medication, chest pain, body aches severe to the point every part of my body was in pain, shoulder and neck pain, chills, sweats, fever, nausea, stomach pain, low back pain, non stop diarrhea after anything I ate or drank, very dizzy almost like motion sickness and higher blood pressure. Treatment was received for the events. Events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood pressure measurement: higher blood pressure on 31Mar2021, SARS-CoV-2 test: negative on 19Mar2021 and SARS-CoV-2 test: negative on 09Apr2021. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hyperhidrosis, Hypertension, Motion sickness, Nausea, Neck pain
Clinical narrative: extreme fatigue; intense headaches that would not go away with medication; chest pain; body aches severe to the point every part of my body was in pain; shoulder and neck pain; shoulder and neck pain; chills; sweats; fever; nausea; stomach pain; low back pain; non stop diarrhea after anything I ate or drank; very dizzy almost like motion sickness and higher blood pressure; motion sickness; higher blood pressure; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the right arm on 31Mar2021 (at the age of 48 years old) (Lot Number: EP6955) as dose 2, single for COVID-19 immunisation. Medical history included hypothyroidism and hormone replacement therapy. The patient was not pregnant at the time of the events. Concomitant medications included thyroid taken for an unspecified indication, start and stop date were not reported and vitamins nos (DAILY VITAMINS) taken for an unspecified indication, start and stop date were not reported.  The patient previously took Compazine and experienced drug allergy. The patient also previously took Crestor (low dose crestor 2.5 mg). The patient previously took the first dose of BNT162B2 on 10Mar2021 (Lot Number: EN 6199) for COVID-19 immunisation and experienced extreme fatigue, headaches, chest pain, dizziness, chills, sweats, fever, body aches, and nausea. The patient did not have COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Daily vitamins, BHR hormone replacement, and thyroid were received within 2 weeks of vaccination. The patient had been tested for COVID-19 post-vaccination. On 31Mar2021 at 19:00, the patient experienced extreme fatigue, intense headaches that would not go away with medication, chest pain, body aches severe to the point every part of my body was in pain, shoulder and neck pain, chills, sweats, fever, nausea, stomach pain, low back pain, non stop diarrhea after anything I ate or drank, very dizzy almost like motion sickness and higher blood pressure. Treatment was received for the events. Events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included blood pressure measurement: higher blood pressure on 31Mar2021, SARS-CoV-2 test: negative on 19Mar2021 and SARS-CoV-2 test: negative on 09Apr2021. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.