chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Injections triggered mild pain crisis; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Jun2021 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history included sickle cell trait. The patient had no known allergies.  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 over the counter (OTC) and severe flu medicine. On an unknown date in 2021, the patient had sickle trait (SC) and injections triggered mild pain crisis. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of event and included hydration with pedialyte after the first one and it went away. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event injections triggered mild pain crisis was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Mass, Pain, Pain in extremity
Clinical narrative: fatigue; sore arm; Flu like symptoms; developed a lump on the left side of her clavicle; painful to touch; This is a spontaneous report from a Contactable consumer (parent). A 15-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0178), via an unspecified route on 19Jul2021 at 11:00 (at the age of 15-years) as dose 2, single in the left arm for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0172), via an unspecified route on 28Jun2021 at 14:30 (at the age of 15-years) as dose 1, single in the left arm for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced and developed a lump on the left side of her clavicle. She said the lump was squishy, and painful to touch and had fatigue, flu like symptoms, sore arm on 20Jul2021. It was explained that with the first dose her daughter was fine, she didn't hurt or anything. Yesterday her daughter felt fatigue and all that, which is normal but then reported the lump on her clavicle. It is on the left side, the same side of the shot on the clavicle. Reporter says her daughter was not quite as tired today. Yesterday she felt like she had a mild flu which they told her would be normal. She also had the sore arm and are using ice packs to treat that. The lump on the clavicle is a bit bigger than quarter and if they push on it, it hurts. She read on the internet that this might be normal and put a heat pack on it but she wanted to call us first and was then going to call the doctor. Patient did not visit to Emergency Room or Physician Office. The outcome of the events developed a lump on the left side of her clavicle was not recovered, painful to touch, sore arm, flu like symptoms was unknown, fatigue was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Starting on Saturday the patient has been having diarrhea; This is a spontaneous report from a contactable consumer. A 12-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the left arm on 23Jul2021 at 10:15 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not reported. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 24Jul2021, starting on Saturday, the patient had been having diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the event diarrhea was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cognitive disorder, Fatigue
Clinical narrative: extreme mental fog/ could hardly hold a conversation... could not put together words for a sentence; extreme fatigue; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2, via an unspecified route of administration, administered in arm left on 09Apr2021 11:00 (Batch/Lot Number: ER8729) at the age of 60 years old, as dose 2, single for COVID-19 immunisation. Medical history included Chronic kidney disease, gastroparesis, arthritis, known allergies: penicillin, sulfa and bactrum. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. The patient previously took first dose of BNT162B2 (Batch/Lot Number: EN6199) administered in arm left on 12Mar2021 09:00 for COVID-19 immunisation and experienced no problems. No COVID prior vaccination. Not COVID tested post vaccination. On 10Apr2021 17:00 (on the 2nd day of second dose), the patient had extreme fatigue for 4 days with continued fatigue, now almost 4 months later. Also had extreme mental fog for 4 days in which he could hardly hold a conversation as he could not put together words for a sentence. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient recovered with lasting effects. No treatment for adverse events. Outcome of events was recovered with sequelae.  Follow-up attempts are completed. No further information is expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Could not get second dose because he was sick; This is a spontaneous report from a contactable consumer (patient's mother) via a Pfizer sponsored program. A 17-years-old male patient (son) received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot number was not reported) via an unspecified route of administration on 27Apr2021 (at the age of 17 years) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced could not get second dose because he was sick on 2021. Reporter, (name) wants to know if the Pfizer Covid-19 the vaccine would work if her son will just receive his 2nd dose today and his 1st dose was given on 27Apr2021. Her son is 17 years old. He is unable to receive his 2nd dose because he is sick. The outcome of event was unknown.  Follow-up attempts are completed; No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Pyrexia, Rhinorrhoea, Tremor
Clinical narrative: Breathing difficulty; Coughing; Runny nose; Fever; Shaking; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Jul2021 at 15:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The medical history was not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. On 29Jul2021 at 09:00, the patient experienced breathing difficulty, coughing, runny nose, fever and shaking. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events breathing difficulty, coughing, runny nose, fever and shaking were not resolved at the time of this report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Extreme swelling in "my" arm all the way up into "my" neck.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the right arm on 02Aug2021 at 13:45(at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. 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 were not reported. On 02Aug2021 at 14:30, the patient experienced extreme swelling in arm all the way into her neck and went urgent and was prescribed 3 antibiotics. That was something had to pay for due to the reaction. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the event and included treatment with antibiotics(unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extreme swelling in arm all the way into her neck and went urgent and was prescribed 3 antibiotics. That was something had to pay for due to the reaction was not recovered at the time of this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Dental discomfort, Head discomfort, Ocular discomfort
Clinical narrative: Woke up next morning with a nasty cough -- made chest sore.; Woke up next morning with a nasty cough -- made chest sore; Major sinus pain and pressure / Felt like I had a major sinus infection -- pain was that bad; Major sinus pain and pressure -head, eyes, sinuses, teeth - lasted 5-6 days.; Major sinus pain and pressure -head, eyes, sinuses, teeth - lasted 5-6 days.; Major sinus pain and pressure -head, eyes, sinuses, teeth - lasted 5-6 days.; Major sinus pain and pressure -head, eyes, sinuses, teeth - lasted 5-6 days.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the right arm on 19Jul2021 at 12:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to cat dander and allergy to msg.  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. The patient did not receive any medication within two weeks of vaccination. The patient previously took iron (MANUFACTURER UNKNOWN) for 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: EW0181) via an unspecified route of administration in the right arm on 28Jun2021 at 13:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. On 20Jul2021 at 05:30, the patient woke up next morning with a nasty cough that made chest sore. Cough lasted for 5-6 days. On 20Jul2021 at 05:30, the patient had major sinus pain and pressure- head, eyes, sinuses, teeth- that lasted 5-6 days. The patient took homeopathic meds to relieve pressure. The patient felt like she had major sinus infection as the pain was that bad. 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 pressure head, eyes, sinuses, teeth, sinus infection which included homeopathic medicines (unspecified). Since the vaccination, the patient had been tested for COVID-19. On 02Aug2021, the patient underwent antigen COVID test via nasal swab and the result was negative. The clinical outcome of the events nasty cough, chest sore, major sinus pain and pressure - head, eyes, sinuses, teeth were resolved on an unknown date in Jul2021.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Paranasal sinus discomfort, SARS-CoV-2 test, Sinus pain
Clinical narrative: Woke up next morning with a nasty cough -- made chest sore.; Woke up next morning with a nasty cough -- made chest sore; Major sinus pain and pressure / Felt like I had a major sinus infection -- pain was that bad; Major sinus pain and pressure -head, eyes, sinuses, teeth - lasted 5-6 days.; Major sinus pain and pressure -head, eyes, sinuses, teeth - lasted 5-6 days.; Major sinus pain and pressure -head, eyes, sinuses, teeth - lasted 5-6 days.; Major sinus pain and pressure -head, eyes, sinuses, teeth - lasted 5-6 days.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181) via an unspecified route of administration in the right arm on 19Jul2021 at 12:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to cat dander and allergy to msg.  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. The patient did not receive any medication within two weeks of vaccination. The patient previously took iron (MANUFACTURER UNKNOWN) for 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: EW0181) via an unspecified route of administration in the right arm on 28Jun2021 at 13:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. On 20Jul2021 at 05:30, the patient woke up next morning with a nasty cough that made chest sore. Cough lasted for 5-6 days. On 20Jul2021 at 05:30, the patient had major sinus pain and pressure- head, eyes, sinuses, teeth- that lasted 5-6 days. The patient took homeopathic meds to relieve pressure. The patient felt like she had major sinus infection as the pain was that bad. 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 pressure head, eyes, sinuses, teeth, sinus infection which included homeopathic medicines (unspecified). Since the vaccination, the patient had been tested for COVID-19. On 02Aug2021, the patient underwent antigen COVID test via nasal swab and the result was negative. The clinical outcome of the events nasty cough, chest sore, major sinus pain and pressure - head, eyes, sinuses, teeth were resolved on an unknown date in Jul2021.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstruation delayed
Clinical narrative: Delayed menstrual cycle (7) days total; Severe cramping -more than usual; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7488) via an unspecified route of administration in the left arm on 28Jul2021 at 13:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the left arm on 07Jul2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On an unknown date in 2021, the patient experienced delayed menstrual cycle (7) days total and severe cramping - more than usual when it started. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of reported events. The clinical outcome of the events delayed menstrual cycle (7) days total and severe cramping - more than usual was unknown at the time of this report.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Fatigue, Headache, Pain
Clinical narrative: Severe headache; Loss of appetite; High fever (102.5); Body aches; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 21Apr2021 at 11:00, (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Patient had no known allergies. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19.The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021 at 18:00, the patient experienced severe headache, loss of appetite, high fever (102.5), body aches and fatigue. On 21Apr2021, the patient underwent body temperature test and the result was 102.5 (unspecified units). 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 had not been tested for COVID-19. The clinical outcome of the events severe headache, loss of appetite, high fever (102.5), body aches and fatigue were resolved on an unknown date in 2021, which lasted for 9-10days.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Severe headache; Loss of appetite; High fever (102.5); Body aches; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 21Apr2021 at 11:00, (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. Patient had no known allergies. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19.The patient did not take any concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021 at 18:00, the patient experienced severe headache, loss of appetite, high fever (102.5), body aches and fatigue. On 21Apr2021, the patient underwent body temperature test and the result was 102.5 (unspecified units). 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 had not been tested for COVID-19. The clinical outcome of the events severe headache, loss of appetite, high fever (102.5), body aches and fatigue were resolved on an unknown date in 2021, which lasted for 9-10days.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menstruation delayed
Clinical narrative: Period delayed by 4-5 days every cycle since second and last covid vaccine shot; Also began spotting mid-cycle, which is abnormal and a new development since vaccine shot; This is a spontaneous report from a non-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 22Apr2021 at 10:00 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included multivitamin, on an unknown date, for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Apr2021, the patient's period delayed by 4-5 days every cycle since second and last covid vaccine shot. Also began spotting mid-cycle, which was abnormal and a new development since vaccine shot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event period delayed by 4-5 days every cycle since second and last covid vaccine shot and also began spotting mid-cycle, which was abnormal and a new development since vaccine shot was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Less than 24 hours after the vaccine, "I" got "my" period early. "I" am very regular, and this is not normal for "me".; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Aug2021 at 17:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The medical history included COVID-19 and allergic to neoprene.  Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the COVID-19 vaccine. The concomitant medications included lisdexamfetamine mesilate (VYVANSE) for an unknown indication from an unknown date and unknown if ongoing. On 12Aug2021 at 15:45, less than 24 hours after the vaccine, the patient got her period early. The patient reported that she was very regular and this was not normal for her. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event got period early was resolved on an unspecified date in Aug2021.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Heart rate, Heart rate increased
Clinical narrative: Rapid heart rate for 24 hours (125-130); Fever; Dizziness; Weakness; Tired; This is a spontaneous report from a non-contactable consumer, the patient. An 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Aug2021 at 15:00 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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 sertraline hydrochloride (ZOLOFT) and levocabastine hydrochloride (ZYRTEC) both started from an unknown date for an unknown indication and unknown if ongoing. On 10Aug2021 at 19:00, the patient experienced rapid heart rate for 24 hours (125-130), fever, dizziness, tired and weakness. The events resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. On 10aug2021 at 19:00, the patient underwent heart rate test and the result was 125-130. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rapid heart rate for 24 hours (125-130), fever, weakness, dizziness, tired were not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Rapid heart rate for 24 hours (125-130); Fever; Dizziness; Weakness; Tired; This is a spontaneous report from a non-contactable consumer, the patient. An 18-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Aug2021 at 15:00 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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 sertraline hydrochloride (ZOLOFT) and levocabastine hydrochloride (ZYRTEC) both started from an unknown date for an unknown indication and unknown if ongoing. On 10Aug2021 at 19:00, the patient experienced rapid heart rate for 24 hours (125-130), fever, dizziness, tired and weakness. The events resulted in emergency room/department or urgent care. Therapeutic measures were not taken as a result of events. On 10aug2021 at 19:00, the patient underwent heart rate test and the result was 125-130. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rapid heart rate for 24 hours (125-130), fever, weakness, dizziness, tired were not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: My latest menstrual cycle lasted about three weeks, typically, my period is predicable, once a month more or less, and last about 7 days; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 12May2021 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Jul2021, the patient experienced her latest menstrual cycle that lasted for about three weeks. Typically, her period was predictable, once a month more or less, and lasted for about 7 days. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event latest menstrual cycle that lasted for about three weeks was recovered on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Constant tingling in Left arm; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the arm left on 24Jul2021 at 14:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. 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 were not reported. On 27Jul2021, the patient experienced constant tingling in Left arm. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event constant tingling in Left arm was not recovered at the time of this report.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea
Clinical narrative: Migraine: headache to the right side of the head, temple, behind the right eye.; Nausea: more severe at night; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3181) via an unspecified route of administration on 13Aug2021 at 12:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Aug2021 at 22:00, the patient experienced migraine, headache to the right side of the head, temple, behind the right eye and nausea, more severe at night. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events migraine, headache to the right side of the head, temple, behind the right eye and nausea more severe at night were not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Broke out in hives two days after second shot.; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on 14Aug2021 at 14:15 (at the age of 49-years-old)  as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications within 2 weeks of vaccination. 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: GWO198) via an unspecified route of administration in the left arm on 24Jul2021 at 15:30 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. On 17Aug2021, two days after the second shot, the patient broke out in hives. The event 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 event and included treatment with diphenhydramine hydrochloride (BENADRYL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event broke out in hives two days after second shot was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Lethargy, Pyrexia, Swelling face
Clinical narrative: Abdominal pain; Diarrhea; Swollen face; Lethargic; Fever; This is a spontaneous report from a non-contactable consumer, the patient. A 47-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 19Aug2021 at 16:45(at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had known allergy to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. 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 29Jul2021 at 12:00(at the age of 47-years-old) as a single dose for COVID-19 immunisation. On 20Aug2021 at 07:00, the patient experienced abdominal pain, diarrhea, swollen face, lethargic and fever. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events abdominal pain, diarrhea, swollen face, lethargic and fever was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Depressed mood, Headache
Clinical narrative: All day had a hard time keeping it from going low or even crashing; All day had a hard time keeping it from going low or even crashing; Chills; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 16-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the right arm on 19Aug2021 at 14:45 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history included type I diabetes. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included esomeprazole magnesium (MANUFACTURER UNKNOWN) and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL XR); both for an unknown indication, from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Aug2021, the day after receiving the vaccine, all day the patient had a hard time keeping it from going low or even crashing along with the chills and headaches. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events all day had a hard time keeping it from going low or even, chills and headache was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Hypoaesthesia, Myalgia, Vomiting
Clinical narrative: Complete numbness of vaccinated arm; Coughing; Vomiting; Headache; Muscle pain/Muscle soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the right arm on 20Aug2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient previously received halperidol (MANUFACTURER UNKNOW) on an unknown date for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. 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: FA7485) via an unspecified route of administration in the right arm on 27Jul2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. On 20Aug2021, the patient experienced complete numbness of vaccinated arm, coughing, vomiting, headache, muscle soreness and muscle pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events complete numbness of vaccinated arm, coughing, vomiting, headache, muscle soreness and muscle pain were resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Headache, Pain
Clinical narrative: Severe headache; Extreme body aches; Joint pain.; Difficulty breathing; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Feb2021  at 12:00(at the age of 71-years-old)  and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on unknown in 2021 at 18:00(at the age of 71-years-old); as a single dose for COVID-19 immunisation. The patient also received booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Aug2021 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), high blood pressure and chronic back pain. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Concomitant medications included valsartan (MANUFACTURER UNKNOWN), amitriptyline (MANUFACTURER UNKNOWN) and fentanyl citrate (NARCO) for unknown indication from unknown date and unknown if ongoing. The patient previously took levaquin (MANUFACTURER UNKNOWN) and oxycodone (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. On an unknown date in 2021, the patient experienced severe headache, extreme body aches, joint pain and difficulty breathing. It was reported that this was patient's 3rd dose, and each time the side effects got worse. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe headache, extreme body aches, joint pain and difficulty breathing were not recovered at the time of this report.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: Chest pressure/pain; Chest pressure/pain; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the right arm on 11Aug2021 at 10:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the right arm on 21Jul2021 at 10:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 13Aug2021 at 19:00, the patient experienced chest pressure/pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events chest pressure/pain was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Pain in extremity, Vaccination site mass, Vaccination site rash
Clinical narrative: burning sensation in my armpit; small rash around injection site; Hard lump under injection site; other pains in my arm; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/ lot number was not reported), via an unspecified route of administration on 23Aug2021 as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Aug2021 the patient experienced a severe burning sensation in his armpit on the same arm he got the shot. He also had a small rash around injection site and had a hard lump under injection site. The patient also mentioned It was also causing him other pains in his arm not near the injection site. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Chest pain, Chills, Decreased appetite
Clinical narrative: Persistent fever of 101 F and above despite fever reducing medications; Chest pain; Palpitations; Muscle pain; Bone pains; Headache; Nausea; Lack of appetite; Dizziness and feeling faint; Chills; Malaise; This is a spontaneous report from a non-contactable nurse, the patient. A 30-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26Aug2021(at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, diagnosed prior to the vaccination. The patient had no known allergies. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. On 27Aug2021 at 00:00, the patient experienced persistent fever with a body temperature of 101 F and above despite fever reducing medications. On 27Aug2021 at 00:00, the patient experienced chest pain, palpitations, muscle and bone pains, headache, nausea, lack of appetite, dizziness, feeling faint, chills and malaise. 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 event fever which included treatment with unspecified medications. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events persistent fever, chest pain, palpitations, muscle and bone pains, headache, nausea, lack of appetite, dizziness, feeling faint, chills and malaise were recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Malaise, Myalgia, Nausea
Clinical narrative: Persistent fever of 101 F and above despite fever reducing medications; Chest pain; Palpitations; Muscle pain; Bone pains; Headache; Nausea; Lack of appetite; Dizziness and feeling faint; Chills; Malaise; This is a spontaneous report from a non-contactable nurse, the patient. A 30-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 26Aug2021(at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, diagnosed prior to the vaccination. The patient had no known allergies. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. On 27Aug2021 at 00:00, the patient experienced persistent fever with a body temperature of 101 F and above despite fever reducing medications. On 27Aug2021 at 00:00, the patient experienced chest pain, palpitations, muscle and bone pains, headache, nausea, lack of appetite, dizziness, feeling faint, chills and malaise. 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 event fever which included treatment with unspecified medications. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events persistent fever, chest pain, palpitations, muscle and bone pains, headache, nausea, lack of appetite, dizziness, feeling faint, chills and malaise were recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.