chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: four weeks after "my" first dose "I" have have loosestool every two to three days.; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on an unknown date in Mar2021 (at the age of 70-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 08Apr2021 at 18:15 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. The medical history included hypertension, type 2 diabetes and hypothyroidism. 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 levothyroxine (MANUFACTURER UNKNOWN), allopurinol (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and metformin (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications and unknown if ongoing. The patient previously took morphine (MANUFACTURER UNKNOWN) and glyceryl trinitrate (NITROGLYCERIN) on unknown dates and experienced allergy. On 12Apr2021, four weeks after the first dose, the patient experienced loose stools every two to three days. The patient reported that it was not an adverse event and he just wanted to mention that he was experiencing loose stool every two to three days after the four weeks of his first dose. He further stated that it was not an adverse event, but at his age was a concern for him. The adverse 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 reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event loose stools every two to three days was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, SARS-CoV-2 test, Vertigo
Clinical narrative: Dizziness that has increased to vertigo.; Dizziness that has increased to vertigo; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the arm left on 19Apr2021 at 09:15(at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. 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 amlodipine (MANUFACTURER UNKNOWN), colchicine (COLCRYS), silodosin (MANUFACTURER UNKNOWN), loratidine (CLARITIN), vitamin d nos (MANUFACTURER UNKNOWN), and ascorbic acid (VITAMIN C) all from unknown date for unspecified indication and unknown if ongoing. The patient previously received metoclopromide (REGLAN) and codeine(MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 29Mar2021 at 09:00(at the age of 65-year-old) as a single dose for COVID-19 immunisation. On 21Apr2021 at 08:00, the patient experienced dizziness that had increased to vertigo. 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. On 24Apr2021, the patient underwent SARS CoV-2 test (PCR COVID test and rapid COVID test) and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the events, dizziness that has increased to vertigo was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Lymphadenopathy, Myalgia
Clinical narrative: Fever; Joint pain; Nausea; Severe headache; Swollen lymph nodes under left arm; Injection site pain; Muscle pain; Chills; 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 29Apr2021 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from 28Jan2021 to 14Feb2021 with the same symptoms as the events experienced after the vaccination, high blood pressure and mild pollen 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 bupropion (MANUFACTURER UNKNOWN), losartan potassium (LOSARTIN) and hydrochlorothiazide (MANUFACTURER UNKNOWN), all taken for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received morphine (MANUFACTURER UNKNOWN) and codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 30Apr2021 at 15:30, the patient experienced fever, joint pain, nausea, severe headache, swollen lymph nodes under left arm, injection site pain, muscle pain and chills. 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 fever, joint pain, nausea, severe headache, swollen lymph nodes under left arm, injection site pain, muscle pain and chills was resolved 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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Fever; Joint pain; Nausea; Severe headache; Swollen lymph nodes under left arm; Injection site pain; Muscle pain; Chills; 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 29Apr2021 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 from 28Jan2021 to 14Feb2021 with the same symptoms as the events experienced after the vaccination, high blood pressure and mild pollen 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 bupropion (MANUFACTURER UNKNOWN), losartan potassium (LOSARTIN) and hydrochlorothiazide (MANUFACTURER UNKNOWN), all taken for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received morphine (MANUFACTURER UNKNOWN) and codeine (MANUFACTURER UNKNOWN) and experienced drug allergy. On 30Apr2021 at 15:30, the patient experienced fever, joint pain, nausea, severe headache, swollen lymph nodes under left arm, injection site pain, muscle pain and chills. 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 fever, joint pain, nausea, severe headache, swollen lymph nodes under left arm, injection site pain, muscle pain and chills was resolved 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Fatigue; Fever; Arm pain; Nausea; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 29Apr2021 at 16:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines and prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included magnesium glycinate (MANUFACTURER UNKNOWN), acetylsalicylic acid (BABY ASPIRIN) and colecalciferol (VITAMIN D3); all for unknown indications from unknown dates and unknown if ongoing. On 29Apr2021 at 20:30, the patient experienced fatigue, fever, arm pain, 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 fatigue, fever, arm pain, nausea and diarrhea were unknown 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: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Malaise, Pyrexia
Clinical narrative: Pyrexia 37.2 degrees C; Arthralgia; Malaise; This is a spontaneous report from a contactable consumer (patient). A 40-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, administrated in left arm on 30Apr2021 09:30 (age at the time of vaccination 40-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had no known allergies. Patient previously received first dose of BNT162B2 vaccine, on an unspecified date for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 01May2021 12:00, the patient experienced Pyrexia 37.2 degrees C, Arthralgia, and Malaise. On an unspecified date, the patient underwent lab tests and procedures which included Pyrexia, Body temperature: 37.2 degrees Centigrade. Patient did not received treatment for adverse events. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Lymph node pain, Lymphadenopathy, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Pain on the Right Axilar linfatic node; It is swollen too; Fever (103 F); This is a spontaneous report from a contactable Nurse. This Nurse reported for a 41-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via intramuscular route of administration, administrated on left arm on 17Apr2021 11:00 (age at the time of vaccination 41-year-old), as a single dose for COVID-19 immunization. The patient's medical history included COVID-19, Prior to vaccination, the patient was diagnosed with COVID-19. The patient concomitant medications were not reported. Patient previously received first dose of BNT162B2 (COMIRNATY COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via intramuscular route of administration, administrated on Left arm on an unspecified date Mar2021 11:00 (age at the time of vaccination 41-year-old), as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has been tested for COVID-19. On 30Apr2021 22:00, the patient experienced Pain on the Right Axilar linfatic node, it is swollen too, and fever (103 F). On 30Apr2021 the patient underwent lab tests and procedures which included Body temperature: 103; and on 01May2021 Nasal Swab, SARS-CoV-2 test: Negative. The adverse event result in Emergency room/department or urgent care visit. Patient received treatment for adverse events was unknown. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Joint pain; Low grade fever; Chills; Headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the right arm on 30Apr2021 at 03:15 (at the age of 46-yeasr-old) as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT) and lisdexamfetamine mesilate (VYVANSE); 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 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 09Apr2021 at 09:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. On 30Apr2021 at 21:15, 18 hours after injection, the patient experienced joint pain, low grade fever, chills, headache and fatigue which were severe for the first 4 hours and had been moderate since then. 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 joint pain, low grade fever, chills, headache and fatigue was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Fatigue, Oropharyngeal pain, Pharyngeal swelling
Clinical narrative: Swollen face; Swollen throat; Severe throat pain; Fatigue; Weakness/ no strengths to get up; No appetite; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the right arm on 29Apr2021 at 16:45 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, thyroid disorder, high blood pressure and penicillin 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 loratadine (MANUFACTURER UNKNOWN), fluticasone (MANUFACTURER UNKNOWN) and unspecified high blood pressure drug, all for an unknown indication from an unknown date and unknown if ongoing. The patient previously took ascorbic acid (vitamin C) (MANUFACTURER UNKNOWN) and prednisolone (MANUFACTURER UNKNOWN) and experienced drug allergy for both. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the right arm on 08Apr2021 at 16:45 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. On 01May2021 at 10:00, the patient experienced swollen face, swollen throat, severe throat pain, fatigue, no appetite, weakness/no strength to get up. 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 swollen face, swollen throat, severe throat pain, fatigue, no appetite, weakness/no strength to get up was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Swollen face; Swollen throat; Severe throat pain; Fatigue; Weakness/ no strengths to get up; No appetite; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the right arm on 29Apr2021 at 16:45 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, thyroid disorder, high blood pressure and penicillin 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 loratadine (MANUFACTURER UNKNOWN), fluticasone (MANUFACTURER UNKNOWN) and unspecified high blood pressure drug, all for an unknown indication from an unknown date and unknown if ongoing. The patient previously took ascorbic acid (vitamin C) (MANUFACTURER UNKNOWN) and prednisolone (MANUFACTURER UNKNOWN) and experienced drug allergy for both. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the right arm on 08Apr2021 at 16:45 (at the age of 58-year-old) as a single dose for COVID-19 immunisation. On 01May2021 at 10:00, the patient experienced swollen face, swollen throat, severe throat pain, fatigue, no appetite, weakness/no strength to get up. 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 swollen face, swollen throat, severe throat pain, fatigue, no appetite, weakness/no strength to get up was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Fever; intense headache; pain and swelling in arm; pain and swelling in arm; dizziness; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0171), via an unspecified route of administration, administrated in right arm on 29Apr2021 18:45 (age at the time of vaccination 27-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had known allergies to Sulfas. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. On 30Apr2021 04:15, the patient experienced Fever, intense headache, pain and swelling in arm, and dizziness. Patient did not received treatment for adverse events. The outcome of the events was not recovered.  Follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Gait inability, Headache, Pyrexia
Clinical narrative: severe headache, fever, could hardly walk, chills, severe stomachache; severe headache, fever, could hardly walk, chills, severe stomachache; severe headache, fever, could hardly walk, chills, severe stomachache; severe headache, fever, could hardly walk, chills, severe stomachache; severe headache, fever, could hardly walk, chills, severe stomachache; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the arm left on 09Apr2021 at 10:30 (at the age of 52-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 receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included venlafaxine (MANUFACTURER UNKNOWN), multi vitamin CBD (MANUFACTURER UNKNOWN) and melatonin (MANUFACTURER UNKNOWN) all for an unknown indication from an unknown date and unknown if ongoing. The patient previously took loratadine (LORATAB) and experienced drug allergy. On 09Apr2021 at 14:00 the patient experienced severe headache, fever, could hardly walk, chills, severe stomach ache. 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe headache, fever, could hardly walk, chills, severe stomach ache was recovered on an unknown date in 2021. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) in the arm left on 30Apr2021 at 10:30 (at the age of 52-years-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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Gait disturbance, Headache, Pyrexia
Clinical narrative: Severe headache; Could barely walk; Fever; Chills; Severe stomach ache; This is a spontaneous report from a contactable consumer, the patient. A 52-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 30Apr2021 at 10:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included depression and COVID-19. 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 venlafaxine (MANUFACTURER UNKNOWN), multivitamin (MANUFACTURER UNKNOWN), cannabidiol (CBD) (MANUFACTURER UNKNOWN) and melatonin (MANUFACTURER UNKNOWN), all taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received loratadine (LORATAB) and experienced drug allergy. 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 10:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. On 30Apr2021 at 14:00, the patient experienced severe headache, could barely walk, fever, chills and severe stomach ache. 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, could barely walk, fever, chills and severe stomach ache was not resolving 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Vertigo
Clinical narrative: Cervical and facial lymph nodes swelling and pain; Cervical and facial lymph nodes swelling and pain; Cervical and facial lymph nodes swelling and pain; Vertigo; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 12Apr2021 at 12:30 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included previous mononucleosis infection (mononucleosis infectious) from 2003, chronic shoulder pain, anxiety, irritable bowel syndrome (IBS) and gluten allergy (gluten intolerance). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included gabapentin (MANUFACTURER UNKNOWN), sertraline (MANUFACTURER UNKNOWN), cabergoline (MANUFACTURER UNKNOWN) and zolpidem tartrate (AMBIEN) all were taken 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. The patient previously received diphenhydramine hydrochloride (BENADRYL) and oxycodone hydrochloride (OXYCONTIN) and experienced drug allergy. On 16Apr2021, the patient experienced cervical and facial lymph nodes swelling and pain for 3 weeks after first shot and vertigo intermittent over 2 weeks. 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 cervical and facial lymph nodes swelling and pain and vertigo were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: I woke up with a headache; fever; muscle pain; chills; My arm is really hurting and sore; fatigue and tiredness; This is a spontaneous report from a contactable consumer (patient). A 24-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 01May2021 (age at the time of vaccination 24-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 vaccine, on an unspecified date, for COVID-19 immunization. On an unspecified date May2021, the patient experienced I woke up with a headache, fever, muscle pain, chills, My arm is really hurting and sore, fatigue and tiredness. Patient was asking Can I take Tylenol or ibuprofen'. The outcome of the events was unknown.  Further probing was not done as Consumer hung up the call abruptly. Hence, Limited information was available over the call.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I woke up with a headache; fever; muscle pain; chills; My arm is really hurting and sore; fatigue and tiredness; This is a spontaneous report from a contactable consumer (patient). A 24-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 01May2021 (age at the time of vaccination 24-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 vaccine, on an unspecified date, for COVID-19 immunization. On an unspecified date May2021, the patient experienced I woke up with a headache, fever, muscle pain, chills, My arm is really hurting and sore, fatigue and tiredness. Patient was asking Can I take Tylenol or ibuprofen'. The outcome of the events was unknown.  Further probing was not done as Consumer hung up the call abruptly. Hence, Limited information was available over the call.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness, still currently feeling; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Apr2021 at 17:15 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, hypertension, depression and known allergies to strawberries and apples. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), sertraline hydrochloride (ZOLOFT), montelukast sodium (SINGULAIR), fluticasone (MANUFACTURER UNKNOWN) and diltiazem hydrochloride (DILTIA); all for 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 24Apr2021 at 14:00, the patient experienced dizziness and was still currently feeling. 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 event dizziness, still currently feeling was not recovered 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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Uterine spasm
Clinical narrative: Severe uterine cramps; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 09Apr2021 at 13:15 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to sulfa. The patient previously received loperamide hydrochloride (IMODIUM AD) 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-19 vaccine. Concomitant medications included ethinylestradiol;norgestimate (SPRINTEC 28 DAY) and omeprazole (MANUFACTURER UNKNOWN); both for unspecified indication from unknown date and unknown if ongoing. On 13Apr2021 at 19:00, 4 days after vaccination, the patient experienced severe uterine cramps, the patient wasn't due for period until two weeks after 23Apr2021. 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 severe uterine cramps was resolved on an unknown date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Eye contusion
Clinical narrative: I woke up this morning with partial black eye near my nose/a partial black eye under area of my eye close to my nose, on my lid; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 24Apr2021 as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. The patient previously received first dose of bnt162b2 via an unspecified route of administration on 02Apr2021 Good Friday, (Batch/Lot Number, Expiry Date were Unknown) as dose 1, single for COVID-19 immunisation. The patient's concomitant medications were not reported. On 25Apr2021, the patient experienced I woke up this morning with partial black eye near my nose/a partial black eye under area of my eye close to my nose, on my lid. The patient reported, got second Pfizer vaccine (Pfizer COVID Vaccine) yesterday (24April2021). The patient was woke up this morning (25April2021) with partial black eye near the nose. So, was just wondered if there has been a reported side effect or should go to the doctor or what. The outcome of the event was unknown.  No follow-up attempts are needed; Information related to batch/Lot number could not be requested.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes simplex
Clinical narrative: HSV2 outbreak; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 14Apr2021 at 15:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. Medical history included herpes simplex (HSV2) and was ongoing at the time of this report. The patient had no known allergies to medications, food or other products. 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. Concomitant medications were not reported. On 15Apr2021, a day after receiving the vaccine, the patient experienced HSV2 (Herpes simplex virus-2) outbreak. The patient had gone almost a year without an outbreak. 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 HSV2 outbreak was unknown 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: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the right arm on 21Apr2021 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included celiac and had known allergies to computed tomography scan dye. 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 acetylsalicylic acid (ASPIRIN), multivitamin (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (reported as Generic ZYRTEC); all medications from an unknown date and unknown if ongoing for unknown indications. The patient previously took acetylsalicylic acid (ASPIRIN) and experienced drug allergy (Known allergies: Aspirin). On 22Apr2021 the patient experienced diarrhea. The patient reported that she never had diarrhea before but it became a daily occurrence since she had the vaccine. Therapeutic measures were not taken as a result of the event. 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.  The clinical outcome of the event diarrhea was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal pain, Pain, Skin disorder, Tenderness
Clinical narrative: Shoulder blade hurts; Upper arm now has shooting/stabbing pain that comes and goes all day long; I started to get bumps on my left shoulder blade that are deep under the skin; Left arm to be tender to the touch; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 19Apr2021 at 12:30 (at the age of 31-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 to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 at 08:00, patient started to get bumps on my left shoulder blade that were deep under the skin which appeared within 24 hours of the vaccine. There was probably 5 of them in a cluster. They seemed to be pressing down on a nerve that caused the whole bottom of the patient's left arm to be tender to the touch, all the way down the side of the thumb. On 25Apr2021, that pain just ended, but now more bumps appeared above the injection site (three of them in a line). On 26Apr2021, the patient experienced shoulder blade hurts if someone were to touch it and when the patient would move her arm. The patient's upper arm had shooting/stabbing pain that would comes and go all day long. 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event left arm to be tender to the touch was recovered on 25Apr2021. The clinical outcome of the events I started to get bumps on my left shoulder blade that are deep under the skin, shoulder blade hurts, upper arm now has shooting/stabbing pain that comes and goes all day long was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain, Pyrexia
Clinical narrative: Fever; Body aches; Mild to moderate and increasing dizziness; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 42321) via an unspecified route of administration in the left arm on 24Apr2021 at 11:15 as a single dose for COVID-19 immunisation. Medical history included obesity. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two 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: ER8737) via an unspecified route of administration in the left arm on 02Apr2021 at 11:30 as a single dose for COVID-19 immunisation. On 25Apr2021 at 21:00, the patient experienced mild to moderate and increasing dizziness, fever, body aches. 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 mild to moderate and increasing dizziness, fever, body aches was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hyperhidrosis, Hypersomnia, Motion sickness
Clinical narrative: Woke up with extreme vertigo and sweating; Woke up with extreme vertigo and sweating; Could not lift head off of pillow due to dizziness; Fell back asleep/ Spent most of next four days in bed; Felt motion sick and tired; Felt motion sick and tired; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0150) via an unspecified route of administration in the left arm on 14Apr2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies to medications, food or other products. 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 concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er2613) via an unspecified route of administration in the left arm on 24Mar2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 03:00, approximately 40 hours post second dose, the patient woke up with extreme vertigo and sweating and could not lift head off of pillow due to dizziness. The patient felled back asleep. Approximately 2 hours later, woke up with same symptoms. It was reported that the patient spent most of next four days in bed. The patient felt motion sick and tired. The patient went to the doctor and the doctor stated that patient had vertigo and told it would go away with time. Nine days later the patient finally felt about 80 percent better. Occasionally, the patient still had times of motion sickness. 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 woke up with extreme vertigo and sweating, could not lift head off of pillow due to dizziness, fell back asleep/ spent most of next four days in bed and felt motion sick and tired was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Woke up with extreme vertigo and sweating; Woke up with extreme vertigo and sweating; Could not lift head off of pillow due to dizziness; Fell back asleep/ Spent most of next four days in bed; Felt motion sick and tired; Felt motion sick and tired; This is a spontaneous report from a non-contactable consumer, the patient. A 49-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0150) via an unspecified route of administration in the left arm on 14Apr2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and known allergies to medications, food or other products. 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 concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er2613) via an unspecified route of administration in the left arm on 24Mar2021 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 03:00, approximately 40 hours post second dose, the patient woke up with extreme vertigo and sweating and could not lift head off of pillow due to dizziness. The patient felled back asleep. Approximately 2 hours later, woke up with same symptoms. It was reported that the patient spent most of next four days in bed. The patient felt motion sick and tired. The patient went to the doctor and the doctor stated that patient had vertigo and told it would go away with time. Nine days later the patient finally felt about 80 percent better. Occasionally, the patient still had times of motion sickness. 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 woke up with extreme vertigo and sweating, could not lift head off of pillow due to dizziness, fell back asleep/ spent most of next four days in bed and felt motion sick and tired 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: Pain, Pyrexia, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Fever; body pain; under the left arm at injection site it got red and warm; under the left arm at injection site it got red and warm; This is a spontaneous report from a contactable consumer (patient). A 33-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: Ew0170) via an unspecified route of administration, administered in arm left on 28Apr2021 (age at vaccination was 33-year-old) as a dose number unknown, single for covid-19 immunisation. The patient's medical history included known allergies: lactose. The patient's concomitant medications were not reported. No other vaccine in four weeks. No covid prior vaccination. The patient experienced fever and body pain, on second day under the left arm at injection site it got red and warm on 30Apr2021. She did not receive treatments for adverse events. No covid tested post vaccination. The outcome of events was recovering.   Follow up activities were closed. No follow up attempt was made.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Decreased appetite, Headache, Pyrexia
Clinical narrative: 100 deg F fever; Joints aching severely; Headache; Slight loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 25-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 25Apr2021 at 14:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and acid reflux. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN), omeprazole (PRILOSEC) and ethinylestradio/norgestimate (TRI-CYCLEN LO) and bupropion hydrochloride(WELLBUTRIN); all taken 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. 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 04Apr2021 at 14:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. On 26Apr2021 at 03:00, the patient experienced 100 degrees Fahrenheit fever, joints aching severely, headache and slight loss of appetite. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. On 26Apr2021, the patient underwent body temperature and the result was 100 degrees Fahrenheit. The clinical outcome of the events 100 degrees Fahrenheit fever, joints aching severely, headache and slight loss of appetite 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.