chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysmenorrhoea, Gynaecological examination, Heavy menstrual bleeding, Physical examination
Clinical narrative: Severe menstrual bleeding and cramping, now lasting 10 days and ongoing.; Severe menstrual bleeding and cramping, now lasting 10 days and ongoing.; This is a spontaneous report from a contactable Physician (patient, reported for self). A 26-years-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Lot Number: EW0175), via intramuscular route, administered in left arm on 27Apr2021 (at the age of 26-years-old) as dose 1, single for COVID-19 immunisation. Medical history included s/p covid 19; attention deficit hyperactivity disorder (ADHD), HX of TBI (Traumatic brain injury) and exercise induced asthma all from an unspecified date and unknown if ongoing. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI 24 FE) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05May2021, the patient experienced severe menstrual bleeding and cramping, now lasting 10 days and ongoing. The adverse events result in doctor or other healthcare professional office/clinic visit. Since the vaccination, patient has not been tested for COVID-19. Therapeutic measure was taken as a result of the events. Treatment received for the adverse event was reported as, Gynecologic examination. The outcome of the events was not recovered. Device Date : 18May2021.  Follow-up attempts completed. No further information expected.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding
Clinical narrative: Severe menstrual bleeding and cramping, now lasting 10 days and ongoing.; Severe menstrual bleeding and cramping, now lasting 10 days and ongoing.; This is a spontaneous report from a contactable Physician (patient, reported for self). A 26-years-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Lot Number: EW0175), via intramuscular route, administered in left arm on 27Apr2021 (at the age of 26-years-old) as dose 1, single for COVID-19 immunisation. Medical history included s/p covid 19; attention deficit hyperactivity disorder (ADHD), HX of TBI (Traumatic brain injury) and exercise induced asthma all from an unspecified date and unknown if ongoing. Concomitant medication included ethinylestradiol, ferrous fumarate, norethisterone acetate (BLISOVI 24 FE) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 05May2021, the patient experienced severe menstrual bleeding and cramping, now lasting 10 days and ongoing. The adverse events result in doctor or other healthcare professional office/clinic visit. Since the vaccination, patient has not been tested for COVID-19. Therapeutic measure was taken as a result of the events. Treatment received for the adverse event was reported as, Gynecologic examination. The outcome of the events was not recovered. Device Date : 18May2021.  Follow-up attempts completed. No further information expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: When trying to sleep O experienced what I now know to be low tone pulsative tinnitus/ experiencing high pitched ringing in my left ear (seeming to originate from my left rear side of my head); Affected my concentration; Affected ability to sleep; This is a spontaneous report from a contactable consumer. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 41-years-old, via an unspecified route of administration, administered in Arm Left on 03May2021 12:00 (Batch/Lot Number: EW0172) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included angioedema (seen her immunologist, who didn't have concerns about the vaccine). Concomitant medications included levocetirizine dihydrochloride (XYZAL) and cetirizine hydrochloride (ZYRTEC) both taken for an unspecified indication, start and stop date were not reported. The patient previously took doxycycline and experienced drug allergies. COVID-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The evening of her shot when trying to sleep she experienced what she now knows to be low tone pulsative tinnitus. When she awoke the following day, she began experiencing high pitched ringing in my left ear (seeming to originate from my left rear side of my head). It has not stopped since then. It varies in frequency from mild to screaming loud. It has affected her concentration and ability to sleep. Her immunologist directed her to the GP who directed her to an ENT and she have been unable to get an appointment but after researching it doesn't seem there's much of a treatment. This could be a lifelong illness. The events occurred on 03May2021 21:00 which resulted to disability/ permanent damage. No treatments received. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disturbance in attention, Insomnia, Tinnitus
Clinical narrative: When trying to sleep O experienced what I now know to be low tone pulsative tinnitus/ experiencing high pitched ringing in my left ear (seeming to originate from my left rear side of my head); Affected my concentration; Affected ability to sleep; This is a spontaneous report from a contactable consumer. A 41-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 41-years-old, via an unspecified route of administration, administered in Arm Left on 03May2021 12:00 (Batch/Lot Number: EW0172) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included angioedema (seen her immunologist, who didn't have concerns about the vaccine). Concomitant medications included levocetirizine dihydrochloride (XYZAL) and cetirizine hydrochloride (ZYRTEC) both taken for an unspecified indication, start and stop date were not reported. The patient previously took doxycycline and experienced drug allergies. COVID-19 vaccine was administered in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The evening of her shot when trying to sleep she experienced what she now knows to be low tone pulsative tinnitus. When she awoke the following day, she began experiencing high pitched ringing in my left ear (seeming to originate from my left rear side of my head). It has not stopped since then. It varies in frequency from mild to screaming loud. It has affected her concentration and ability to sleep. Her immunologist directed her to the GP who directed her to an ENT and she have been unable to get an appointment but after researching it doesn't seem there's much of a treatment. This could be a lifelong illness. The events occurred on 03May2021 21:00 which resulted to disability/ permanent damage. No treatments received. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: very tired; Slept a lot; have a sound in my head, not ears, like an outside sound and it continues; This is a spontaneous report from a contactable consumer (patient). A 73-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 vaccine, Solution for injection Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 23Apr2021 10:45 (age at the vaccination 73-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Patient was not pregnant at time of vaccination. The patient medical history included Bulbar Polio at age of 5. No known allergies reported. The patient's concomitant medication(s) included losartan, metoprolol venlafaxine, biotin, and ascorbic acid (VIT C). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Apr2021, the patient noticed days later to be very tired, slept a lot and had sound in head, not ears, like an outside sound and it continued. Patient did not receive any treatment for an events. Prior to vaccination the patient was not diagnosed with Covid-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Hypersomnia, Tinnitus
Clinical narrative: very tired; Slept a lot; have a sound in my head, not ears, like an outside sound and it continues; This is a spontaneous report from a contactable consumer (patient). A 73-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 vaccine, Solution for injection Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 23Apr2021 10:45 (age at the vaccination 73-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Patient was not pregnant at time of vaccination. The patient medical history included Bulbar Polio at age of 5. No known allergies reported. The patient's concomitant medication(s) included losartan, metoprolol venlafaxine, biotin, and ascorbic acid (VIT C). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Apr2021, the patient noticed days later to be very tired, slept a lot and had sound in head, not ears, like an outside sound and it continued. Patient did not receive any treatment for an events. Prior to vaccination the patient was not diagnosed with Covid-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Paraesthesia oral, Swollen tongue, Tongue pruritus
Clinical narrative: Swelling of tongue; Some loss of taste; Tingling in tongue and numbness; Tingling in tongue and numbness; This is a spontaneous report from a contactable consumer (patient). A 20-years-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0167 SHC-VC and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 13May2021 at 13:00 hours as dose 2, single (at the age of 20-years-old) for covid-19 immunisation. Patient had no medical history. Patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0161 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 17Apr2021 at 14:00 hours as dose 1, single (at the age of 20-years-old) for covid-19 immunisation. Concomitant medication(s) in two weeks included escitalopram and duloxetine hydrochloride (Cymbalta) (both taken for an unspecified indication, start and stop date were not reported). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. On 14May2021, patient had swelling of tongue, some loss of taste, tingling in tongue and numbness. On 17May2021, patient had been tested for COVID-19 by nasal swab and result was negative. Patient received no treatment for all the events. All events were assessed as non-serious by the reporter. The outcome of all the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ageusia, Hypoaesthesia, Paraesthesia oral, SARS-CoV-2 test, Swollen tongue
Clinical narrative: Swelling of tongue; Some loss of taste; Tingling in tongue and numbness; Tingling in tongue and numbness; This is a spontaneous report from a contactable consumer (patient). A 20-years-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0167 SHC-VC and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 13May2021 at 13:00 hours as dose 2, single (at the age of 20-years-old) for covid-19 immunisation. Patient had no medical history. Patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0161 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 17Apr2021 at 14:00 hours as dose 1, single (at the age of 20-years-old) for covid-19 immunisation. Concomitant medication(s) in two weeks included escitalopram and duloxetine hydrochloride (Cymbalta) (both taken for an unspecified indication, start and stop date were not reported). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. On 14May2021, patient had swelling of tongue, some loss of taste, tingling in tongue and numbness. On 17May2021, patient had been tested for COVID-19 by nasal swab and result was negative. Patient received no treatment for all the events. All events were assessed as non-serious by the reporter. The outcome of all the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Dialysis, Dyspnoea, Myocardial infarction, Oropharyngeal pain
Clinical narrative: He couldn't breathe/ husband passed away after receiving the 2nd dose; This is a spontaneous report from a contactable consumer (wife). A 73-year-old patient (husband) received BNT162B2 (COMIRANTY; Formulation: Solution for injection; Batch/Lot number: was not reported, Expiration date: was not reported, Age at vaccination: 73-year-old) via an unspecified route of administration on 19Apr2021 11:00 AM as dose 2, single for COVID-19 immunization. Medical history included kidney failure. Concomitant medications were not reported. Historical vaccine included BNT162B2 on an unspecified date for covid-19 immunization. It was reported that her husband had passed away, 21Apr2021 around 8:00AM, because he couldn't breathe even with the ventilator. She stated they both received the 2nd dose of the covid vaccine on 19Apr2021 around 11:00 am. On tuesday, the following day, around 1:00 pm, he couldn't breathe, so he went to the hospital at about 1:30 pm. They said he had to go to the big hospital downtown as they did not have dialysis and her husband had had kidney failure.  In the morning, she was told that her husband had passed away, 21Apr2021 around 8:00AM, because he couldn't breathe even with the ventilator.; Reported Cause(s) of Death: He couldn't breathe/ husband passed away after receiving the 2nd dose
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pallor
Clinical narrative: He couldn't breathe/ husband passed away after receiving the 2nd dose; This is a spontaneous report from a contactable consumer (wife). A 73-year-old patient (husband) received BNT162B2 (COMIRANTY; Formulation: Solution for injection; Batch/Lot number: was not reported, Expiration date: was not reported, Age at vaccination: 73-year-old) via an unspecified route of administration on 19Apr2021 11:00 AM as dose 2, single for COVID-19 immunization. Medical history included kidney failure. Concomitant medications were not reported. Historical vaccine included BNT162B2 on an unspecified date for covid-19 immunization. It was reported that her husband had passed away, 21Apr2021 around 8:00AM, because he couldn't breathe even with the ventilator. She stated they both received the 2nd dose of the covid vaccine on 19Apr2021 around 11:00 am. On tuesday, the following day, around 1:00 pm, he couldn't breathe, so he went to the hospital at about 1:30 pm. They said he had to go to the big hospital downtown as they did not have dialysis and her husband had had kidney failure.  In the morning, she was told that her husband had passed away, 21Apr2021 around 8:00AM, because he couldn't breathe even with the ventilator.; Reported Cause(s) of Death: He couldn't breathe/ husband passed away after receiving the 2nd dose
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea
Clinical narrative: He couldn't breathe/ husband passed away after receiving the 2nd dose; This is a spontaneous report from a contactable consumer (wife). A 73-year-old patient (husband) received BNT162B2 (COMIRANTY; Formulation: Solution for injection; Batch/Lot number: was not reported, Expiration date: was not reported, Age at vaccination: 73-year-old) via an unspecified route of administration on 19Apr2021 11:00 AM as dose 2, single for COVID-19 immunization. Medical history included kidney failure. Concomitant medications were not reported. Historical vaccine included BNT162B2 on an unspecified date for covid-19 immunization. It was reported that her husband had passed away, 21Apr2021 around 8:00AM, because he couldn't breathe even with the ventilator. She stated they both received the 2nd dose of the covid vaccine on 19Apr2021 around 11:00 am. On tuesday, the following day, around 1:00 pm, he couldn't breathe, so he went to the hospital at about 1:30 pm. They said he had to go to the big hospital downtown as they did not have dialysis and her husband had had kidney failure.  In the morning, she was told that her husband had passed away, 21Apr2021 around 8:00AM, because he couldn't breathe even with the ventilator.; Reported Cause(s) of Death: He couldn't breathe/ husband passed away after receiving the 2nd dose
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Lymphadenopathy, Nausea, Pyrexia, Swelling face
Clinical narrative: The lymph nodes on throat and armpit on the left side (side of injection) started swelling rapidly; High fever; Nausea; Feeling very sick; Bad diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11May2021 at 13:30 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included lithium (MANUFACTURER UNKNOWN) on unknown date for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11May2021 at 11:30 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. On 14May2021 at 23:00, the patient experienced  the lymph nodes on his throat and armpit on the left side (side of injection) started swelling rapidly. The patient had high fever and nausea. The onset felt very sudden and within one hour the patient  was feeling very sick. She took 500mg acetaminophen and also had bad diarrhea Thursday and Friday without any changes in her diet. She was not sure if that was a side effect too. The next day she felt better, and took acetaminophen again. The swelling in her lymph nodes did not fully go away for 3 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with (500mg) acetaminophen. The clinical outcome of the event bad diarrhoea was recovered on 15May2021 after the duration of 2 days. The clinical outcome of the event the lymph nodes on throat and armpit on the left side (side of injection) started swelling rapidly was recovered on 17May2021 after the duration of 3 days. The clinical outcome of the events high fever, nausea and feeling very sick was recovered on unspecified date May2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Lymphadenopathy, Malaise, Nausea, Pyrexia
Clinical narrative: The lymph nodes on throat and armpit on the left side (side of injection) started swelling rapidly; High fever; Nausea; Feeling very sick; Bad diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11May2021 at 13:30 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included lithium (MANUFACTURER UNKNOWN) on unknown date for unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11May2021 at 11:30 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. On 14May2021 at 23:00, the patient experienced  the lymph nodes on his throat and armpit on the left side (side of injection) started swelling rapidly. The patient had high fever and nausea. The onset felt very sudden and within one hour the patient  was feeling very sick. She took 500mg acetaminophen and also had bad diarrhea Thursday and Friday without any changes in her diet. She was not sure if that was a side effect too. The next day she felt better, and took acetaminophen again. The swelling in her lymph nodes did not fully go away for 3 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with (500mg) acetaminophen. The clinical outcome of the event bad diarrhoea was recovered on 15May2021 after the duration of 2 days. The clinical outcome of the event the lymph nodes on throat and armpit on the left side (side of injection) started swelling rapidly was recovered on 17May2021 after the duration of 3 days. The clinical outcome of the events high fever, nausea and feeling very sick was recovered on unspecified date May2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Within 2 hours of the vaccine my arm began to hurt at 7/10.Roughly 8 hours later then pain was about the same. The following day the pain was 9/10for the majority of the day. Today the pain is much better at 2/10.No other symptoms; This is a spontaneous report from a contactable nurse, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the left arm on 18May2021 at 11:15 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient previously took Gentamycin eye/ear drops and experienced drug allergy. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18May2021 at 14:00, within 2 hours of the vaccine the patients arm began to hurt at 7/10. Roughly 8 hours later then pain was about the same. The following day the pain was 9/10 for the majority of the day. On the day of report, the pain was much better at 2/10. No other symptoms. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event within 2 hours of the vaccine arm began to hurt at 7/10, roughly 8 hours later then pain was about the same, the following day the pain was 9/10 for the majority of the day, on the day of report the pain was much better at 2/10 was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Dyspepsia, Inflammation
Clinical narrative: Within 2 hours of receiving the 2nd dose of the covid vaccine I began to have intense stomach pain in my intestines / At times it feels like needles inside my intestines stabbing me internally.; I have had indigestion and pain in my abdomen and stomach for 1 month straight.; I have had indigestion and pain in my abdomen and stomach for 1 month straight.; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 15May2021 at 12:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications included buprenorphine hydrochloride 8.6mg, naloxone hydrochloride 2.1mg (ZUBSOLV) and ibuprofen 400mg (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 17Apr2021 at 12:00 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15May2021 at 14:00, Within 2 hours of receiving the 2nd dose of the COVID vaccine the patient began to have intense stomach pain in the intestines. The patient had indigestion and pain in abdomen and stomach for 1 month straight. "The pain comes and goes. At times it feels like needles inside my intestines stabbing me internally. I am in horrible pain every day". The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events intense stomach pain in the intestines, indigestion and pain in abdomen and stomach for 1 month straight was not recovered at the time of this report.   The lot number for BNT162b2, were not provided and will be requested during follow up.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Dyspepsia, Gastrointestinal pain
Clinical narrative: Within 2 hours of receiving the 2nd dose of the covid vaccine I began to have intense stomach pain in my intestines / At times it feels like needles inside my intestines stabbing me internally.; I have had indigestion and pain in my abdomen and stomach for 1 month straight.; I have had indigestion and pain in my abdomen and stomach for 1 month straight.; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 15May2021 at 12:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Concomitant medications included buprenorphine hydrochloride 8.6mg, naloxone hydrochloride 2.1mg (ZUBSOLV) and ibuprofen 400mg (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient previously received amoxicillin (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 17Apr2021 at 12:00 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15May2021 at 14:00, Within 2 hours of receiving the 2nd dose of the COVID vaccine the patient began to have intense stomach pain in the intestines. The patient had indigestion and pain in abdomen and stomach for 1 month straight. "The pain comes and goes. At times it feels like needles inside my intestines stabbing me internally. I am in horrible pain every day". The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events intense stomach pain in the intestines, indigestion and pain in abdomen and stomach for 1 month straight was not recovered at the time of this report.   The lot number for BNT162b2, were not provided and will be requested during follow up.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood creatine, Blood potassium, Blood sodium, Blood test normal, Chest X-ray
Clinical narrative: Extreme rapid heartbeats from one week later for till now almost a month; have constant breathing difficulties; chest pressure; dizziness; Ears pain sometimes and sometimes feel like blocked or congested; Fluttering/racing heartbeats; ears clogged for three days; This is a spontaneous report from contactable Consumer (patient)  A  50-Year-Old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0151) on 29Apr2021 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history was not reported. On 08Apr2021 the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8734) at 14:15 on left arm and experienced 1 week later breathlessness and legs numb and went to ER. On 30Apr2021, next day after second dose, ears clogged for three days and on and off still. One week later on 08May2021 extreme rapid heartbeats from for till now almost a month. Patient went to Dr. 4 times and all reports and tests were normal and no preexisting conditions. But heartbeat increases even for very short activity and have constant breathing difficulties, chest pressure and dizziness. Heart beat erratic if I get up, walk or even do a small activity. Ears pain sometimes and sometimes feel like blocked or congested. Fluttering/ racing heartbeats almost since 08May2021 occurred throughout the day and sometimes even during sleep. Reported events resulted in healthcare professional office/clinic visit, emergency room/department or urgent care. At the time of the reporting patient had not yet recovered from events.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Electrocardiogram, Electrocardiogram ambulatory, Electrocardiogram normal, Electrophoresis protein
Clinical narrative: Extreme rapid heartbeats from one week later for till now almost a month; have constant breathing difficulties; chest pressure; dizziness; Ears pain sometimes and sometimes feel like blocked or congested; Fluttering/racing heartbeats; ears clogged for three days; This is a spontaneous report from contactable Consumer (patient)  A  50-Year-Old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0151) on 29Apr2021 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history was not reported. On 08Apr2021 the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8734) at 14:15 on left arm and experienced 1 week later breathlessness and legs numb and went to ER. On 30Apr2021, next day after second dose, ears clogged for three days and on and off still. One week later on 08May2021 extreme rapid heartbeats from for till now almost a month. Patient went to Dr. 4 times and all reports and tests were normal and no preexisting conditions. But heartbeat increases even for very short activity and have constant breathing difficulties, chest pressure and dizziness. Heart beat erratic if I get up, walk or even do a small activity. Ears pain sometimes and sometimes feel like blocked or congested. Fluttering/ racing heartbeats almost since 08May2021 occurred throughout the day and sometimes even during sleep. Reported events resulted in healthcare professional office/clinic visit, emergency room/department or urgent care. At the time of the reporting patient had not yet recovered from events.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer, Full blood count, Haemoglobin, Heart rate increased, Hypoaesthesia
Clinical narrative: Extreme rapid heartbeats from one week later for till now almost a month; have constant breathing difficulties; chest pressure; dizziness; Ears pain sometimes and sometimes feel like blocked or congested; Fluttering/racing heartbeats; ears clogged for three days; This is a spontaneous report from contactable Consumer (patient)  A  50-Year-Old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0151) on 29Apr2021 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history was not reported. On 08Apr2021 the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8734) at 14:15 on left arm and experienced 1 week later breathlessness and legs numb and went to ER. On 30Apr2021, next day after second dose, ears clogged for three days and on and off still. One week later on 08May2021 extreme rapid heartbeats from for till now almost a month. Patient went to Dr. 4 times and all reports and tests were normal and no preexisting conditions. But heartbeat increases even for very short activity and have constant breathing difficulties, chest pressure and dizziness. Heart beat erratic if I get up, walk or even do a small activity. Ears pain sometimes and sometimes feel like blocked or congested. Fluttering/ racing heartbeats almost since 08May2021 occurred throughout the day and sometimes even during sleep. Reported events resulted in healthcare professional office/clinic visit, emergency room/department or urgent care. At the time of the reporting patient had not yet recovered from events.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lipids, Thyroid function test, Troponin I, Vitamin B12, Vitamin D
Clinical narrative: Extreme rapid heartbeats from one week later for till now almost a month; have constant breathing difficulties; chest pressure; dizziness; Ears pain sometimes and sometimes feel like blocked or congested; Fluttering/racing heartbeats; ears clogged for three days; This is a spontaneous report from contactable Consumer (patient)  A  50-Year-Old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0151) on 29Apr2021 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history was not reported. On 08Apr2021 the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8734) at 14:15 on left arm and experienced 1 week later breathlessness and legs numb and went to ER. On 30Apr2021, next day after second dose, ears clogged for three days and on and off still. One week later on 08May2021 extreme rapid heartbeats from for till now almost a month. Patient went to Dr. 4 times and all reports and tests were normal and no preexisting conditions. But heartbeat increases even for very short activity and have constant breathing difficulties, chest pressure and dizziness. Heart beat erratic if I get up, walk or even do a small activity. Ears pain sometimes and sometimes feel like blocked or congested. Fluttering/ racing heartbeats almost since 08May2021 occurred throughout the day and sometimes even during sleep. Reported events resulted in healthcare professional office/clinic visit, emergency room/department or urgent care. At the time of the reporting patient had not yet recovered from events.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: White blood cell count
Clinical narrative: Extreme rapid heartbeats from one week later for till now almost a month; have constant breathing difficulties; chest pressure; dizziness; Ears pain sometimes and sometimes feel like blocked or congested; Fluttering/racing heartbeats; ears clogged for three days; This is a spontaneous report from contactable Consumer (patient)  A  50-Year-Old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0151) on 29Apr2021 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history was not reported. On 08Apr2021 the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8734) at 14:15 on left arm and experienced 1 week later breathlessness and legs numb and went to ER. On 30Apr2021, next day after second dose, ears clogged for three days and on and off still. One week later on 08May2021 extreme rapid heartbeats from for till now almost a month. Patient went to Dr. 4 times and all reports and tests were normal and no preexisting conditions. But heartbeat increases even for very short activity and have constant breathing difficulties, chest pressure and dizziness. Heart beat erratic if I get up, walk or even do a small activity. Ears pain sometimes and sometimes feel like blocked or congested. Fluttering/ racing heartbeats almost since 08May2021 occurred throughout the day and sometimes even during sleep. Reported events resulted in healthcare professional office/clinic visit, emergency room/department or urgent care. At the time of the reporting patient had not yet recovered from events.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac flutter, Chest discomfort, Dizziness, Dyspnoea, Ear discomfort
Clinical narrative: Extreme rapid heartbeats from one week later for till now almost a month; have constant breathing difficulties; chest pressure; dizziness; Ears pain sometimes and sometimes feel like blocked or congested; Fluttering/racing heartbeats; ears clogged for three days; This is a spontaneous report from contactable Consumer (patient)  A  50-Year-Old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0151) on 29Apr2021 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history was not reported. On 08Apr2021 the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8734) at 14:15 on left arm and experienced 1 week later breathlessness and legs numb and went to ER. On 30Apr2021, next day after second dose, ears clogged for three days and on and off still. One week later on 08May2021 extreme rapid heartbeats from for till now almost a month. Patient went to Dr. 4 times and all reports and tests were normal and no preexisting conditions. But heartbeat increases even for very short activity and have constant breathing difficulties, chest pressure and dizziness. Heart beat erratic if I get up, walk or even do a small activity. Ears pain sometimes and sometimes feel like blocked or congested. Fluttering/ racing heartbeats almost since 08May2021 occurred throughout the day and sometimes even during sleep. Reported events resulted in healthcare professional office/clinic visit, emergency room/department or urgent care. At the time of the reporting patient had not yet recovered from events.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Heart rate, Heart rate increased
Clinical narrative: Extreme rapid heartbeats from one week later for till now almost a month; have constant breathing difficulties; chest pressure; dizziness; Ears pain sometimes and sometimes feel like blocked or congested; Fluttering/racing heartbeats; ears clogged for three days; This is a spontaneous report from contactable Consumer (patient)  A  50-Year-Old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0151) on 29Apr2021 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history was not reported. On 08Apr2021 the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8734) at 14:15 on left arm and experienced 1 week later breathlessness and legs numb and went to ER. On 30Apr2021, next day after second dose, ears clogged for three days and on and off still. One week later on 08May2021 extreme rapid heartbeats from for till now almost a month. Patient went to Dr. 4 times and all reports and tests were normal and no preexisting conditions. But heartbeat increases even for very short activity and have constant breathing difficulties, chest pressure and dizziness. Heart beat erratic if I get up, walk or even do a small activity. Ears pain sometimes and sometimes feel like blocked or congested. Fluttering/ racing heartbeats almost since 08May2021 occurred throughout the day and sometimes even during sleep. Reported events resulted in healthcare professional office/clinic visit, emergency room/department or urgent care. At the time of the reporting patient had not yet recovered from events.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Flushing, Rash
Clinical narrative: upper body measles-type rash (stomach, chest, back); facial flush; This is a spontaneous report from a contactable other healthcare professional (patient) reported for herself.  A 66-year-old (non-pregnant) female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9267), via intramuscular route of administration, administered in the Left arm on 23Feb2021 at 14.00 as dose 1, single for COVID-19 immunisation. The patient's medical history includes known allergies to Benadryl, codeine, gadolinium contrast medium, PCN, Tramadol, Zyrtec, mushrooms. Other medical History includes, esophageal spasms, inverse psoriasis, tachycardia, IBS, Vitamin B & D deficiency. The patient's concomitant medications/List of other medications the patient received within 2 weeks of vaccination includes: Famotidine; Metoprolol; Trazodone; fexofenadine hydrochloride (ALLEGRA); colecalciferol (D3); cyanocobalamin (B12) all taken for unspecified indication and unknown if ongoing. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The adverse events (AE) start time was reported as 14:15, on 23Feb2021 the patient experienced upper body measles-type rash (stomach, chest, back); facial flush Symptoms began 12 minutes after medication dispensed IM Symptoms began dissipating 90 minutes after onset, completely cleared at 3 hours post injection. Seen at site by paramedics, suggested Benadryl, refused due to allergy; remained at site for 90 minutes, then sent home. Reaction reported to primary care physician 24Feb2021. No treatment received for the adverse events. Since the vaccination, patient has not been tested for COVID-19. The adverse events were reported as non-serious. The outcome of the adverse events was reported as recovered on 23Feb2021.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Flushing, Pruritus, Rash
Clinical narrative: upper body measles-type rash (stomach, chest, back); facial flush; This is a spontaneous report from a contactable other healthcare professional (patient) reported for herself.  A 66-year-old (non-pregnant) female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9267), via intramuscular route of administration, administered in the Left arm on 23Feb2021 at 14.00 as dose 1, single for COVID-19 immunisation. The patient's medical history includes known allergies to Benadryl, codeine, gadolinium contrast medium, PCN, Tramadol, Zyrtec, mushrooms. Other medical History includes, esophageal spasms, inverse psoriasis, tachycardia, IBS, Vitamin B & D deficiency. The patient's concomitant medications/List of other medications the patient received within 2 weeks of vaccination includes: Famotidine; Metoprolol; Trazodone; fexofenadine hydrochloride (ALLEGRA); colecalciferol (D3); cyanocobalamin (B12) all taken for unspecified indication and unknown if ongoing. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The adverse events (AE) start time was reported as 14:15, on 23Feb2021 the patient experienced upper body measles-type rash (stomach, chest, back); facial flush Symptoms began 12 minutes after medication dispensed IM Symptoms began dissipating 90 minutes after onset, completely cleared at 3 hours post injection. Seen at site by paramedics, suggested Benadryl, refused due to allergy; remained at site for 90 minutes, then sent home. Reaction reported to primary care physician 24Feb2021. No treatment received for the adverse events. Since the vaccination, patient has not been tested for COVID-19. The adverse events were reported as non-serious. The outcome of the adverse events was reported as recovered on 23Feb2021.  Follow-up attempts are completed. No further information is expected.