chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder, Polymenorrhoea
Clinical narrative: Menstral cycle changes heavier and more frequent.; Menstral cycle changes. heavier, and more frequent.; Menstral cycle changes.; This is a spontaneous report from a contactable nurse, the patient. A 29-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 arm left on 21Dec2020 at 15:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. The medical history included asthma, hypothyroid and allergy to tree nuts. 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 concomitant medications included venlafaxine hydrochloride (EFFEXOR), fexofenadine hydrochloride (ALLEGRA), cetirizine hydrochloride(ZYRTEC) and levothyroxine sodium (SYNTHROID), all from unknown dates for unknown indications and unknown if ongoing. On an unknown date in Feb2021, the patient's menstral cycle changed, became heavier and more frequent. The adverse events did not result in doctor 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event menstral cycle changed, heavier and more frequent were resolved with sequelae on an unknown date in 2021.    No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: Delay in menstrual cycle of 11 days; This is a spontaneous report from a contactable consumer, pfizer employee. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via intramuscular route of administration in the left arm on 22Apr2021 at 15:30 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. The patient's medical history reported was not applicable. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included lamotrigine (LAMICTAL) and lurasidone hydrochloride (LATUDA); both from an unknown date and unknown if ongoing for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via intramuscular route of administration in the left arm on 31Mar2021 at 15:30 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. The patient previously received cefaclor (CECLOR) and experienced drug allergy. On 03May2021 at 00:00, the patient experienced delay in menstrual cycle of 11 days. 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 delay in menstrual cycle of 11 days was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Chills; Headache; Body ache; Sore arm; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 18-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 11May2021 at 11:00 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and alcohol allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included sertraline 100mg (MANUFACTURER UNKNOWN) and ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) 1mg; both for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 20Apr2021 at 11:00 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. On 12May2021 at 00:45 the patient experienced chills, headache, body ache, sore arm and nausea. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event chills, headache, body ache, sore arm and nausea were recovered on 12May2021.   No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Pain, Pain in extremity
Clinical narrative: Shortness of breath; Sore arm; Body aches; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 23-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 11May2021 at 11:00 (at the age of 23-year-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 received HPV vaccine VLP RL1 4V (yeast) (GARDASIL) via an unspecified route of administration in the left arm on an unknown date within four weeks prior to vaccination, for an unknown indication. The patient did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 20Apr2021 (at the age of 23-year-old), as a single dose for COVID-19 immunisation. On 12May2021 at 10:00, the patient experienced shortness of breath, sore arm, body aches and headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shortness of breath, sore arm, body aches and headache was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Emotional disorder, Migraine, Pain in extremity, Peripheral swelling
Clinical narrative: Diarrhea; Emotional; Migraine; Arm swelling; Arm soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 18-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration on 07May2021 (at the age of 18-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was reported as not applicable. 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 COVID-19 vaccine. Concomitant medications were not reported. On 08May2021, the patient experienced diarrhea, migraine, arm swelling and arm soreness and was emotional. 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 diarrhea, emotional, migraine, arm swelling and arm soreness were resolved on an unknown date in May2021.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Tinnitus
Clinical narrative: Moderate high frequency hearing loss diagnosed by audiologist in one ear; Tinnitus in both ears; This is a spontaneous report from a contactable consumer for himself  A 52-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 05Apr2021 21:00 (Batch/Lot Number: EW0153) at the age of 52 years as DOSE 1, SINGLE for covid-19 immunisation.  Facility type vaccine: Pharmacy or Drug Store. Medical history included neuropathy peripheral and drug hypersensitivity to Sulfa. Concomitant medications included gabapentin (GABAPENTIN); vitamin b complex (SUPER B COMPLEX [VITAMIN B COMPLEX]). The patient previously took amoxicillin and experienced drug hypersensitivity. The patient experienced moderate high frequency hearing loss diagnosed by audiologist in one ear on 20Apr2021 with outcome of unknown and tinnitus in both ears on 08Apr2021 06:00 with outcome of recovering. Clinical course: Tinnitus in both ears began 3 days after the injection and continued until being seen by ENT on 10May2021 and prescribed prednisone which is helping reduce the tinnitus symptoms (recovering). Moderate high frequency hearing loss diagnosed by audiologist in one ear on 20Apr2021.  COVID prior vaccination: No, COVID tested post vaccination: No
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling cold, Headache, Heart rate
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 30Apr2021 (at the age of 36-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 COVID-19 vaccine. Concomitant medications included ascorbic acid (VITAMIN C), vitamin d nos (MANUFACTURER UNKNOWN) and fish oil (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received povidone-iodine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 11May2021 at 17:00, in a 24-hour period, the patient went from feeling completely healthy/normal, to extremely ill, then back to healthy to normal. Within an hour of when the patient first started feeling ill, she felt cold and began to experience chills and shaking, then her feet felt numb from feeling so cold. Her body and head felt achy. The patient had a fever of 100 that quickly rose to 104 during this same hour.  The patient heart rate was also much higher than normal. After taking ibuprofen (MOTRIN), drinking water, and resting, the chills stopped and fever dropped to 100. On 12May2021, the next morning, the patient fever had broken (experienced night sweats), body aches were gone, the headache still lingered slightly. From the moment the patient symptoms started, she felt progressively worse, until a few hours later when she started feeling progressively better. The entire process of feeling ill to feeling ok was incredibly fast. The patient had never experienced anything like it before. 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 the reported events except night sweats and included treatment with ibuprofen (MOTRIN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event feeling completely healthy to normal, to extremely ill, then back to healthy to normal was resolved on an unknown date in May2021. The clinical outcome of the event began to experience chills and shaking was resolved on 11May2021. The clinical outcome of the event body felt achy/body aches was resolved on 12May2021, after the duration of one day. The clinical outcome of the events began to experience chills and shaking, feet felt numb from feeling so cold, head felt achy/ headache still lingered slightly, fever of 100 that quickly rose to 104 during this same hour, heart rate was also much higher than normal, night sweats were resolving, at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Hypoaesthesia, Malaise, Night sweats, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 30Apr2021 (at the age of 36-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 COVID-19 vaccine. Concomitant medications included ascorbic acid (VITAMIN C), vitamin d nos (MANUFACTURER UNKNOWN) and fish oil (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received povidone-iodine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 11May2021 at 17:00, in a 24-hour period, the patient went from feeling completely healthy/normal, to extremely ill, then back to healthy to normal. Within an hour of when the patient first started feeling ill, she felt cold and began to experience chills and shaking, then her feet felt numb from feeling so cold. Her body and head felt achy. The patient had a fever of 100 that quickly rose to 104 during this same hour.  The patient heart rate was also much higher than normal. After taking ibuprofen (MOTRIN), drinking water, and resting, the chills stopped and fever dropped to 100. On 12May2021, the next morning, the patient fever had broken (experienced night sweats), body aches were gone, the headache still lingered slightly. From the moment the patient symptoms started, she felt progressively worse, until a few hours later when she started feeling progressively better. The entire process of feeling ill to feeling ok was incredibly fast. The patient had never experienced anything like it before. 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 the reported events except night sweats and included treatment with ibuprofen (MOTRIN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event feeling completely healthy to normal, to extremely ill, then back to healthy to normal was resolved on an unknown date in May2021. The clinical outcome of the event began to experience chills and shaking was resolved on 11May2021. The clinical outcome of the event body felt achy/body aches was resolved on 12May2021, after the duration of one day. The clinical outcome of the events began to experience chills and shaking, feet felt numb from feeling so cold, head felt achy/ headache still lingered slightly, fever of 100 that quickly rose to 104 during this same hour, heart rate was also much higher than normal, night sweats were resolving, at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 30Apr2021 (at the age of 36-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 COVID-19 vaccine. Concomitant medications included ascorbic acid (VITAMIN C), vitamin d nos (MANUFACTURER UNKNOWN) and fish oil (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously received povidone-iodine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 11May2021 at 17:00, in a 24-hour period, the patient went from feeling completely healthy/normal, to extremely ill, then back to healthy to normal. Within an hour of when the patient first started feeling ill, she felt cold and began to experience chills and shaking, then her feet felt numb from feeling so cold. Her body and head felt achy. The patient had a fever of 100 that quickly rose to 104 during this same hour.  The patient heart rate was also much higher than normal. After taking ibuprofen (MOTRIN), drinking water, and resting, the chills stopped and fever dropped to 100. On 12May2021, the next morning, the patient fever had broken (experienced night sweats), body aches were gone, the headache still lingered slightly. From the moment the patient symptoms started, she felt progressively worse, until a few hours later when she started feeling progressively better. The entire process of feeling ill to feeling ok was incredibly fast. The patient had never experienced anything like it before. 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 the reported events except night sweats and included treatment with ibuprofen (MOTRIN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event feeling completely healthy to normal, to extremely ill, then back to healthy to normal was resolved on an unknown date in May2021. The clinical outcome of the event began to experience chills and shaking was resolved on 11May2021. The clinical outcome of the event body felt achy/body aches was resolved on 12May2021, after the duration of one day. The clinical outcome of the events began to experience chills and shaking, feet felt numb from feeling so cold, head felt achy/ headache still lingered slightly, fever of 100 that quickly rose to 104 during this same hour, heart rate was also much higher than normal, night sweats were resolving, at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Joint swelling, Kidney enlargement, Peripheral swelling
Clinical narrative: Swelling of left Knee, left hip, left arm and kidney; Swelling of left Knee, left hip, left arm and kidney; Swelling of left Knee, left hip, left arm and kidney; Swelling of left Knee, left hip, left arm and kidney; Labored breathing; Exhaustion; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 30Apr2021 at 12:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were 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 COVID vaccine. On 30Apr2021 at 15:00, the patient experienced labored breathing and exhaustion and felt that, it was targeting every vulnerable part of her body, swelling of left (L) Knee, left (L) hip, left (L) arm and kidney. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Therapeutic measures were not taken as a result of adverse events labored breathing and exhaustion and felt that, it was targeting every vulnerable part of her body, swelling of left (L) Knee, left (L) hip, left (L) arm and kidney. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events swelling of left Knee, left hip, left arm and kidney, labored breathing and exhaustion were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Headache, Muscle spasms
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 45-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0170), at the age of 45, via an unspecified route of administration, in left arm, on Apr 23, 2021, at 11:15, single dose, for COVID-19 immunisation. Medical history included allergy to shellfish. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. The patient previously took Percocet (paracetamol/oxycodone hydrochloride); and experienced allergy. On Apr 23, 2021, at 12:15, patient experienced severe headache on top of head, muscle cramping in legs, felt like ants crawling through the calves (so much so it was difficult to walk) and unusual exhaustion (for the next 2 weeks). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures taken as a result of events. Since the vaccination, patient has not tested for COVID-19. The outcome of severe headache on top of head, muscle cramping in legs, felt like ants crawling through the calves (so much so it was difficult to walk) resolved on an unknown date in 2021; and unusual exhaustion (for the next 2 weeks) resolved on an unknown date in May 2021. No follow-up attempts needed. No further information expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Body temperature, Cough, Fatigue, Headache
Clinical narrative: Fever chills; Headache; Severe fatigue; Mild fever (100.7),; Asthma also seemed mildly agitated; Cough; Body aches; This is a spontaneous report from a contactable healthcare professional. 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 right arm on 08May2021 at 12:15 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included  COVID-19 on 16Apr2021, asthma, gastrooesophageal reflux disease (GERD) and currently strained psoas muscles since an unspecified date. The patient had unspecified allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included fluticasone furoate/vilanterol trifenatate (BREO ELLIPTA), levocetirizine dihydrochloride (XYZAL), gabapentin (MANUFACTURER UNKNOWN), clonazepam (MANUFACTURER UNKNOWN) and fluvoxamine maleate (LUVOX); all for an unknown indication from an unknown date and unknown if ongoing. On 09May2021 at 04:00, the patient woke up with fever chills and a headache. As that day progressed, the patient developed body aches, severe fatigue, a mild fever (100.7) and cough. The patient's asthma was also mildly agitated. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Therapeutic measures taken included TYLENOL (1000mg) at 6am, 12pm, and 11pm. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever chills, headache, body aches, severe fatigue, fever, cough and asthma also seemed mildly agitated were resolved on 10May2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Fever chills; Headache; Severe fatigue; Mild fever (100.7),; Asthma also seemed mildly agitated; Cough; Body aches; This is a spontaneous report from a contactable healthcare professional. 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 right arm on 08May2021 at 12:15 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included  COVID-19 on 16Apr2021, asthma, gastrooesophageal reflux disease (GERD) and currently strained psoas muscles since an unspecified date. The patient had unspecified allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included fluticasone furoate/vilanterol trifenatate (BREO ELLIPTA), levocetirizine dihydrochloride (XYZAL), gabapentin (MANUFACTURER UNKNOWN), clonazepam (MANUFACTURER UNKNOWN) and fluvoxamine maleate (LUVOX); all for an unknown indication from an unknown date and unknown if ongoing. On 09May2021 at 04:00, the patient woke up with fever chills and a headache. As that day progressed, the patient developed body aches, severe fatigue, a mild fever (100.7) and cough. The patient's asthma was also mildly agitated. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Therapeutic measures taken included TYLENOL (1000mg) at 6am, 12pm, and 11pm. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever chills, headache, body aches, severe fatigue, fever, cough and asthma also seemed mildly agitated were resolved on 10May2021.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia
Clinical narrative: body aches; slight fever (<100 degrees); headache; This is a spontaneous report from a contactable consumer (parent) or other non hcp.   An 18-year-old female (Non pregnant) patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number EP6955) via an unspecified route of administration, administered in left arm, on 12Apr2021 11:15 (age at vaccination 18 year) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number EP6955) via an unspecified route of administration, administered in left arm, on 22Mar2021 12:15 (age at vaccination 18 year) as dose 1, single for covid-19 immunization. The patient was not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On 13Apr2021 at 09:00, the patient experienced slight fever (<100 degrees), body aches, headache. The patient underwent lab tests and procedures which included body temperature: <100 fahrenheit (slight fever (<100 degrees) on 13Apr2021. The patient was not received treatment for the adverse events. The outcome of the slight fever (<100 degrees), body aches, headache was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Feeling abnormal, Nausea, Pain in extremity
Clinical narrative: Sore arm; Fatigue; Nausea; Diarrhea; Brain fog; This is a spontaneous report from a contactable consumer, the patient. A 25-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 12May2021 at 10:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic nerve pain, referred nerve pain migraines, penicillin allergy and known allergies to dawn dish soap (soap allergy). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) from 10May2021 taken for an unknown indication, and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12May2021 at 16:00, the patient experienced sore arm, fatigue, brain fog, nausea and diarrhea. The events did not result in doctor or other healthcare 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 sore arm, fatigue, brain fog, nausea and diarrhea was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Migraine, Myalgia, Nausea
Clinical narrative: Extreme shaking; Chills; Fever; Dizziness; Migraine; Nausea; Vomiting; Body aches; Muscle pain; This is a spontaneous report from a non-contactable consumer, the patient. A 17-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12May2021 at 10:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to mint and latex. 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 unspecified birth control medications for an unknown indication from an unknown date and unknown if ongoing. 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 left arm on 21Apr2021 at 10:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. On 12May2021, the patient experienced extreme shaking, chills, fever, dizziness, migraine, nausea, vomiting, body aches and muscle pain. The events did not result in doctor or other healthcare 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 extreme shaking, chills, fever, dizziness, migraine, nausea, vomiting, body aches and muscle pain were resolving 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: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Tremor, Vomiting
Clinical narrative: Extreme shaking; Chills; Fever; Dizziness; Migraine; Nausea; Vomiting; Body aches; Muscle pain; This is a spontaneous report from a non-contactable consumer, the patient. A 17-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12May2021 at 10:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to mint and latex. 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 unspecified birth control medications for an unknown indication from an unknown date and unknown if ongoing. 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 left arm on 21Apr2021 at 10:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. On 12May2021, the patient experienced extreme shaking, chills, fever, dizziness, migraine, nausea, vomiting, body aches and muscle pain. The events did not result in doctor or other healthcare 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 extreme shaking, chills, fever, dizziness, migraine, nausea, vomiting, body aches and muscle pain were resolving 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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: After receiving second dose started to experience dizziness, been lightheaded and dizzy now for 5 days; This is a spontaneous report from a contactable consumer, the patient. A 38-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 07May2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included trazodone (MANUFACTURER UNKNOWN), ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN), venlafaxine hydrochloride (EFFEXOR), ascorbic acid (VITAMIN C) and vitamin d nos (VIT D); all taken for unknown indications from an unknown date and unknown if ongoing. 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 09Apr2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 09May2021, days after receiving second dose, the patient started to experience dizziness. The vaccine was the only thing different in her system. Been lightheaded and dizzy now (at the time of this report) for 5 days. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were 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 after receiving second dose started to experience dizziness, been lightheaded and dizzy now for 5 days was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Mastication disorder
Clinical narrative: "My" lower jaw was numb, felt "my" teeth are going to fall off, felt "my" teeth are extremely sharp; Couldn't chew a gum and solid food. "I" still have hard time chewing a solid food; This is a spontaneous report from a contactable consumer, the patient. A 34-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 03Apr2021 at 10:00 (at the age of 34-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 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. On 10Apr2021, a week after a first dose, the patient lower jaw was numb, felt his teeth were going to fall off, felt his teeth were extremely sharp, could not chew a gum and solid food. So, the patient switched the diet to liquid or soft food only. (liquid/soft diet from 10Apr2021 to 17Apr2021). As the time progressed the symptoms were improved but the patient still had hard time chewing a solid food. Numbness was gone. The patient had seen two dentist and a primary care since the first dose. His doctors found nothing wrong with his teeth. All teeth were perfect. The patient was fully vaccination at the moment. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the events the patient lower jaw was numb, felt his teeth were going to fall off, felt his teeth were extremely sharp was resolved on an unknown date in 2021, whereas the event could not chew a gum and solid food was not resolved at the time of this report. The patient also 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 (at the age of 34-year-old) as a single dose for COVID-19 immunisation.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: Headaches; Nausea; Diarrhea; Lightheadedness; Fatigue; Muscle aches; This is a spontaneous report from a contactable other healthcare professional, the patient. A 24-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 04May2021 at 16:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS) and hypothyroidism. The patient had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID); taken for unknown indication from an unknown date and unknown if ongoing. 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 08Apr2021 at 15:45 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. On 08May2021 at 08:00, the patient had headaches, nausea, diarrhea, lightheadedness, fatigue and muscle aches for over four days, starting several days after injection of second dose and symptoms ongoing. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headaches, nausea, diarrhea, lightheadedness, fatigue and muscle aches was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Headaches; Nausea; Diarrhea; Lightheadedness; Fatigue; Muscle aches; This is a spontaneous report from a contactable other healthcare professional, the patient. A 24-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 04May2021 at 16:00 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS) and hypothyroidism. The patient had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID); taken for unknown indication from an unknown date and unknown if ongoing. 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 08Apr2021 at 15:45 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. On 08May2021 at 08:00, the patient had headaches, nausea, diarrhea, lightheadedness, fatigue and muscle aches for over four days, starting several days after injection of second dose and symptoms ongoing. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headaches, nausea, diarrhea, lightheadedness, fatigue and muscle aches was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Nausea, Pyrexia
Clinical narrative: Fever 100.9; Diarrhea; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 12May2021 at 08:45 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took morphine (MANUFACTURER UNKNOWN) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 21Apr2021 at 08:45 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. On 13May2021 at 00:30, the patient experienced fever, diarrhea and nausea. On 13May2021, the patient underwent body temperature test and the result was 100.9 with units unspecified. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events fever, diarrhea and nausea. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events fever, diarrhea and nausea were unknown at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joints are very painful; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Concomitant medications included escitalopram oxalate (LEXAPRO) for an unknown indication from an unknown date and unknown if ongoing. 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 previously 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 18Mar2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 02May2021, the patient experienced that his joints were very painful. The event did not result in doctor or other healthcare professional office/clinic visit, and 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 joints were very painful was not resolved at the time of the report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Flatulence, Headache, Malaise
Clinical narrative: Sore arm; Throughout the morning ''I'' developed a fever eventually hitting 102 by late afternoon; Shivering; Body aches; Headache; Generally not feeling well; Extremely gassy; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the right arm on 11May2021 at 17:30 (at the age of 54-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 vaccination, the patient was not diagnosed with COVID -19. Concomitant medications were not reported. 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: EW0164) via an unspecified route of administration in the left arm on 19Apr2021 at 18:15 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. On 12May2021 at 07:00, the morning following the second vaccination shot, the patient started with a sore arm. Throughout the morning the patient developed a fever eventually hitting 102 (unspecified units) by late afternoon. Other symptoms included shivering, body aches, headache and generally not feeling well. The patient eventually became extremely gassy, which lasted through the night. The fever was down to 100 (unspecified units) by morning and after sleeping until nearly 14:00, the fever was gone. Some aching remained in the evening, but the patient was able to function nearly normal at the time of reporting. 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 event fever was recovered on 13May2021 at 14:00. The clinical outcome of the events sore arm, shivering, body aches, headache, generally not feeling well and extremely gassy were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.