chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable consumer (patient). A 05-decade-old male patient (late 40s/early 50s) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot number: Not reported), via an unspecified route of administration on an unspecified date as 1st dose single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, after first dose of COVID-19 vaccine (BNT162b2), the patient experienced a sore arm for 24 hours afterwards on an unspecified date. After second COVID-19 vaccine (BNT162b2), he experienced fatigue for 24 hours afterwards. The outcome of the event was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This is a spontaneous report from a contactable consumer (patient). A 5-decade-old (late 40s/early 50s) male patient received BNT162B2 (Pfizer covid-19 vaccine, solution for injection, Lot number: unknown, Expiration date: Unknown), via an unspecified route on an unknown date at 2nd dose, single dose for covid-19 immunization. The medical history and concomitant medications were unknown. Historical vaccine included first dose of BNT162B2 for covid-19 immunization and experienced a sore arm for 24 hours afterwards. On an unknown date, patient experienced fatigue for 24 hours afterwards. It is unknown if patient received any treatment for the event. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Eye pruritus
Clinical narrative: eye itching; This is a spontaneous report from a contactable consumer(patient) received from Pfizer Sponsored Program. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 02Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced intense eye itching. Patient stated he would normally think it was allergies but with him taking medication he usually does not get itchy eyes. He wants to know if it could be a side effect of vaccine. The outcome of event was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever of 101.5 degrees fahrenheit; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number was not reported) via an unspecified route of administration on an unspecified date as a 2nd dose, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fever of 101.5 degrees Fahrenheit. The patient underwent lab tests and procedures which included body temperature as 101.5 Fahrenheit on an unknown date. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Rash, Swelling face
Clinical narrative: rashes; facial swelling; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for a male patient (Father) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 03Mar2021 as 1st dose, single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. On an unknown date the patient experienced rashes and facial swelling. The outcome of both the events was unknown.  No follow-up attempts were possible; information about lot/batch number could not be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling well; This is a spontaneous report from a Pfizer Sponsored Program COVAX US Support via contactable consumer. A male patient of an unspecified age received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. The patient had missed his 2nd dose because he was not feeling well on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose BNT162B2 (COVID-19 VACCINE), via an unspecified route of administration on 23Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient was experiencing back pain after the 1st dose of Covid-19 vaccine given last 23Feb2021. The patient took Tylenol for pain. She would be given 2nd dose on 16Mar2021. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain
Clinical narrative: dizziness; body aches; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported),via an unspecified route of administration on 27Feb2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced dizziness, body aches on an unspecified date. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19; Loss of taste; Loss of smell; This is a spontaneous report from a contactable consumer (patient). A 25-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6208), via an unspecified route of administration in right arm on 11Mar2021(at the age of 25 years old) as 1st dose, single dose for covid-19 immunization. Medical history and concomitant medications were none. It was stated that they have not had any other recent vaccinations or started any new medications. On 12Mar2021 the patient had tested positive for covid-19 and experienced loss of taste, and loss of smell. Reporter stated as he got the COVID-19 vaccine, his first shot a day before he tested positive for Covid, he would like to know if there is any possibility that it could have triggered a false positive for a COVID test. He said he just tested positive, and he had lost taste and smell. It was reported that the COVID test that was positive was a rapid test that (name) is doing, specific test name unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 12Mar2021. Outcome of the events were unknown.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This is a spontaneous report received from a non-contactable Other Health Care Professional. A 40-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot no: EN6206) via an unspecified route of administration on 15Mar2021 as 2nd dose, single dose for COVID-19 immunization. Patient was 40-years-old at the time of vaccination. Patient medical history included morbidly obese and concurrent conditions and social and family history were not reported. The concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot no- UNKNOWN) via an unspecified route of administration as 1st dose, single dose for COVID-19 immunization. During her 30 minutes waiting period after the injection, the patient began to experience chills. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness. She is morbidly obese and diaphoretic. Treatment included: water, snacks and laying down and covered with blanket. Follow up response to treatment was good. Patient was discharged was stable to go home and follow up with PCP. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient's age/units captured, historical vaccine dosage updated, medical history was added and stop date was added for the suspect drug.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: General malaise; Arm soreness; This is a spontaneous report received from a non-contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH) via an unspecified route of administration on 15Mar2021 (lot number: unknown), at the age of 61-years-old, as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021, the patient experienced general malaise and arm soreness. No therapeutic measures were taken as a result of events. At the time of this report in Mar2021, the events general malaise and arm soreness were recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: patient name and age were added. Indication (COVID-19 immunization) was deleted, previously coded twice. Vaccination Facility Country was updated. In corresponding data fields, treatment received field was reflected as No; and concomitant therapy field was none. Narrative was updated to reflect that reporter was the patient.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Swelling face
Clinical narrative: headache; lightheadedness; facial swelling; This is a spontaneous report received from a non-contactable healthcare professional. A 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration and unspecified anatomical site on 16Mar2021 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 16Mar2021, during 15-minute waiting period after the vaccination, the patient experienced headache, lightheadedness, dizziness and facial swelling. The patient was treated with water, snacks and TYLENOL. The response to treatment was excellent. The patient was discharged on 16Mar2021 as she was stable to go home and was advised to follow up with the primary care physician. The clinical outcome of the events headache, lightheadedness and facial swelling were unknown.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Flushing, Hyperhidrosis, Malaise
Clinical narrative: Flushed; Malaise; Fatigue; She is diaphoretic; feel short of breath; Nausea; This is a spontaneous report from a non-contactable other health care professional. A 49-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number:EN6205) via unspecified route of administration on16Mar2021(at the age 49-year-old) and the patient had previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown)on an unspecified date via an unspecified route of administration as a single dose for COVID 19 immunisation .The medical history included patient was morbidly obese. On 16Mar2021 the patient had stayed for 15 minute waiting period after the injection and asked to stay another 5 minutes. The patient felt fine until she reached the front doors, then she had experienced flush, nausea, malaise/fatigue shortness of breath and diaphoretic. Therapeutic measures were taken as the result of the events included treatment with water and snacks. The patient responded to the treatment excellently. The patient was stable to go home and was discharged and advised to follow up with Primary care physician. The clinical outcome of flush, nausea, malaise/fatigue shortness of breath and diaphoretic were unknown. No follow-up attempts are needed. No further information is expected
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Flushed; Malaise; Fatigue; She is diaphoretic; feel short of breath; Nausea; This is a spontaneous report from a non-contactable other health care professional. A 49-year-old female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number:EN6205) via unspecified route of administration on16Mar2021(at the age 49-year-old) and the patient had previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown)on an unspecified date via an unspecified route of administration as a single dose for COVID 19 immunisation .The medical history included patient was morbidly obese. On 16Mar2021 the patient had stayed for 15 minute waiting period after the injection and asked to stay another 5 minutes. The patient felt fine until she reached the front doors, then she had experienced flush, nausea, malaise/fatigue shortness of breath and diaphoretic. Therapeutic measures were taken as the result of the events included treatment with water and snacks. The patient responded to the treatment excellently. The patient was stable to go home and was discharged and advised to follow up with Primary care physician. The clinical outcome of flush, nausea, malaise/fatigue shortness of breath and diaphoretic were unknown. No follow-up attempts are needed. No further information is expected
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Dizziness/ Lightheadedness; Nausea; Vomiting; This is a spontaneous report received from a non-contactable healthcare professional. A 23-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration on 17Mar2021 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 17Mar2021, after 15 minutes of vaccination, the patient experienced light-headedness, dizziness, nausea and vomiting. The patient received water and was treated with ZOFRAN, PEPCID and ZYRTEC and also applied ice pack. The response to treatment was good and the patient was discharged in a stable condition and was advised to follow up with primary care physician. The clinical outcome of the events light-headedness, nausea and vomiting were recovering.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Pins and needles feeling in left hand; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the left arm on 17Mar2021 at 08:45 hours (at the age of 35-year-old) as a single dose for COVID-19 immunisation. On 17Mar2021, the patient received Sars-cov-2 vaccine via an unknown route of administration for an unknown indication. The patient's medical history and concomitant medications were not reported. The patient had allergy to sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021 at 09:00 hours the patient experienced pins and needles feeling in left hand. The patient did not receive any treatment for the reported event. The clinical outcome for the pins and needles was not resolved.   No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Flushing, Headache, Neck pain, Pain in extremity
Clinical narrative: Pain at injection site; Pain in side of neck; severe headache; feeling flushed; aching in back; aching in legs; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old adult male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration in the left arm on 16Mar2021 at 11:45 AM, as a single dose for COVID-19 immunisation. Medical history was not reported. The patient reported that he did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications reported as none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: El3247), via an unspecified route of administration in the left arm on 23Feb2021 at 13:30 PM, as a single dose for COVID-19 immunisation. On 17Mar2021 at 02:00 AM, the patient experienced significant pain at injection site spreading up the side of his neck, severe headache, feeling flushed, aching in back and legs. No therapeutic measures were taken for the adverse events. The clinical outcome of pain at injection site, pain inside of neck, severe headache, feeling flushed, aching in back and legs were recovering at the time of this report.   No follow up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: patient's first name added in patient tab, patient's Country added and phone/email added in patient tab, Patient's age/unit added in patient tab, Patient's Race information and Ethnic group added in patient tab, duplicate Reported Indication of BNT162B2 removed, For Past Drug Event with BNT162B2 1st dose: Condition Type updated from Past Drug Event to Historical Vaccine; Age/Units captured as 57 years per vaccination date was 23FEB2021, duplicate Reported Indication of BNT162B2 removed, treatment received ticked as No.  Follow-up (02Jun2021) Amendment: This follow-up report is being submitted to amend previously reported information patient information and treatment information added.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injection site; Pain in side of neck; severe headache; feeling flushed; aching in back; aching in legs; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old adult male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247), via an unspecified route of administration in the left arm on 16Mar2021 at 11:45 AM, as a single dose for COVID-19 immunisation. Medical history was not reported. The patient reported that he did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications reported as none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: El3247), via an unspecified route of administration in the left arm on 23Feb2021 at 13:30 PM, as a single dose for COVID-19 immunisation. On 17Mar2021 at 02:00 AM, the patient experienced significant pain at injection site spreading up the side of his neck, severe headache, feeling flushed, aching in back and legs. No therapeutic measures were taken for the adverse events. The clinical outcome of pain at injection site, pain inside of neck, severe headache, feeling flushed, aching in back and legs were recovering at the time of this report.   No follow up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: patient's first name added in patient tab, patient's Country added and phone/email added in patient tab, Patient's age/unit added in patient tab, Patient's Race information and Ethnic group added in patient tab, duplicate Reported Indication of BNT162B2 removed, For Past Drug Event with BNT162B2 1st dose: Condition Type updated from Past Drug Event to Historical Vaccine; Age/Units captured as 57 years per vaccination date was 23FEB2021, duplicate Reported Indication of BNT162B2 removed, treatment received ticked as No.  Follow-up (02Jun2021) Amendment: This follow-up report is being submitted to amend previously reported information patient information and treatment information added.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Left arm hurt for two days; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old non-pregnant female patient received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6206) via an unspecified route of administration on the left arm on 12Mar2021 at 09:00 (age at vaccination was 35-year-old) for COVID-19 immunisation. She has no medical history and has no known allergies. She did not receive any other vaccines within 4 weeks prior to the vaccination. Prior and post the vaccination she was not diagnosed with COVID-19. Concomitant medications (given within 2 weeks of vaccination) reported included melatonin, ibuprofen (ADVIL), collagen supplement, magnesium. On 12Mar2021 at 10:00, she experienced left arm hurt for two days. No therapeutic measures were taken for this event. The clinical outcome of the event left arm hurt was resolved after two days (on an unknown date in Mar2021).  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Somnolence
Clinical narrative: Stomach cramping; Grogginess; Headache; This is a spontaneous report received from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution.     A 53-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ep6955), an unspecified route of administration, administered in right arm on 16Mar2021, at 14:45 as single dose for covid-19 immunization at the age of 53 years old.  Medical history included sulfa allergy. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19.  The patient experienced stomach cramping, grogginess and headache on 17Mar2021, at 08:00.  The events were reported as severe stomach cramping started the next morning, followed by a headache and grogginess. No treatments were given for the events. The clinical outcome of stomach cramping, grogginess and headache was recovering.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchial hyperreactivity, Hypersensitivity, SARS-CoV-2 test, Viral test
Clinical narrative: allergy symptoms; reactive airway; This is a spontaneous report received from a contactable physician (patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES).   A 49-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, administered in left arm on 21Jan2021, at 13:15 as single dose  for covid-19 immunization at the age of 49-years.  The patients medical history was not reported.  There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  No allergies to medications, food, or other products were noted.  The patient previously took BNT162B2 for covid-19 immunization on 04Jan2021 as the first dose in the left arm.  The patient experienced allergy symptoms and reactive airway on 25Jan2021 with outcome of recovering. The events were described as significantly increased allergy symptoms, never previously experienced, unrelenting for last six weeks with reactive airway, now present, and significantly improved with prednisone and inhalers.   The patient underwent lab tests and procedures which included nasal swab that was negative  on 27Jan2021; COVID-19 virus test had  unknown results on an unspecified date.  Therapeutic measures were taken as a result of reactive airway as aforementioned. The outcome of events, allergy symptoms and reactive airway was recovering.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Hypoaesthesia, Lethargy, Paraesthesia
Clinical narrative: Numbness in face/ Numbness in feet; Light headed/ Dizzy; Severe lethargy; GI distress; Low grade fever; very minor almost non existent tenderness atinjection site; Face and feet are tingly; This is a spontaneous report from non-contactable consumer, the patient. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6199), via an unspecified route of administration in the right arm on 16Mar2021 at 10:00 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was allergic to Senna, reaction to latex (but not an allergy) and seasonal allergies. It was reported as unknown, whether the patient was diagnosed with COVID-19, prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Mar2021 at 09:00, the patient's face and feet were tingly a tiny bit numb, felt light headed and dizzy, sudden onset of moderate to severe lethargy, upset stomach, mild to moderate gastrointestinal distress, very minor, almost non-existent tenderness at injection site, a tiny bit warm at site and low-grade fever. On an unspecified date, the patient received treatment with TYLENOL and then ibuprofen (MANUFACTURER UNKNOWN). The clinical outcomes of the events numbness, tingling, light headed, lethargy, distress gastrointestinal, vaccination site tenderness and low-grade fever were recovering.   No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Numbness in face/ Numbness in feet; Light headed/ Dizzy; Severe lethargy; GI distress; Low grade fever; very minor almost non existent tenderness atinjection site; Face and feet are tingly; This is a spontaneous report from non-contactable consumer, the patient. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6199), via an unspecified route of administration in the right arm on 16Mar2021 at 10:00 (at the age of 44-years-old), as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was allergic to Senna, reaction to latex (but not an allergy) and seasonal allergies. It was reported as unknown, whether the patient was diagnosed with COVID-19, prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Mar2021 at 09:00, the patient's face and feet were tingly a tiny bit numb, felt light headed and dizzy, sudden onset of moderate to severe lethargy, upset stomach, mild to moderate gastrointestinal distress, very minor, almost non-existent tenderness at injection site, a tiny bit warm at site and low-grade fever. On an unspecified date, the patient received treatment with TYLENOL and then ibuprofen (MANUFACTURER UNKNOWN). The clinical outcomes of the events numbness, tingling, light headed, lethargy, distress gastrointestinal, vaccination site tenderness and low-grade fever were recovering.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Lymph nodes right arm pit swollen and painful.; Lymph nodes right arm pit swollen and painful.; This is a spontaneous report from a non contactable consumer, the patient. A 63-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6201) via an unspecified route of administration in the right arm on 16Mar2021 (at the age of 63 years old) as a single dose for COVID-19 vaccination. Medical history included autoimmune disease. Concomitant medications were not provided. Prior to the vaccination, the patient was diagnosed with COVID-19. On 17Mar2021, the patient experienced swollen and painful lymph nodes in right arm pit. The clinical outcome of lymph nodes in right arm pit swollen and painful was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: Sore arm; Extreme fatigue; Headache; chills; fever; bodyaches; This is a spontaneous report from a non-contactable consumer (patient). This case is for first dose. A 55-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot Number: EM9810) via an unspecified route of administration in the left arm on 08Feb2021 at 10:15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Since the vaccination, the patient had been tested for COVID-19. The patient also received second dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot Number: EN6205) via an unspecified route on 01Mar2021 at 10:15 in left arm for COVID-19 immunisation. In addition to sore arm lasting weeks, patient experienced extreme fatigue, headache, chills, fever, and body aches, all on an unspecified date in 2021. Sixteen hours after second dose, woke up to heart stuck in overdrive. Heart condition repeated an hour later while still awake. No treatment was received for the adverse events. The outcome of all the events were resolved at the time of report in 2021.  No follow up attempts are needed and no further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Sore arm; Extreme fatigue; Headache; chills; fever; bodyaches; This is a spontaneous report from a non-contactable consumer (patient). This case is for first dose. A 55-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot Number: EM9810) via an unspecified route of administration in the left arm on 08Feb2021 at 10:15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Since the vaccination, the patient had been tested for COVID-19. The patient also received second dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot Number: EN6205) via an unspecified route on 01Mar2021 at 10:15 in left arm for COVID-19 immunisation. In addition to sore arm lasting weeks, patient experienced extreme fatigue, headache, chills, fever, and body aches, all on an unspecified date in 2021. Sixteen hours after second dose, woke up to heart stuck in overdrive. Heart condition repeated an hour later while still awake. No treatment was received for the adverse events. The outcome of all the events were resolved at the time of report in 2021.  No follow up attempts are needed and no further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea following administration of vaccine; This is a spontaneous report received from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES).   A 54-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247), via an unspecified route of administration, administered in right arm on 17Mar2021, at 10:45 as single dose for covid-19 immunization when the patient was 54-yeasr-old.  The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. Concomitant medications  included hydroxychloroquine sulfate (PLAQUENIL) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient previously took BNT162B2 for covid-19 immunization as dose 1 on 23Feb2021. The patient experienced nausea following administration of vaccine on 17Mar2021, at 11:00.  No  treatment was received for the adverse event.The outcome of event was recovering.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Autoscopy, Disease recurrence, Headache, Hypoaesthesia
Clinical narrative: Numbness could not feel my body; Numbness could not feel my body; stomach upset; Mild headache; intense congestion (nasal); Out of body experience; tingling in leg and feet; This is a spontaneous report from a contactable patient. A 63-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: EN6199) via an unspecified route of administration and anatomical site on 06Mar2021 at 08:30 AM (at the age of 63-year-old) as unknown, single dose for COVID-19 immunisation. Medical history included intense numbness started from last 1980s and 1990s with no concrete diagnosis and tested for multiple sclerosis (MS) which got better after a few years. The patient reported allergic to household cleaners, perfumes, sanitizing agents. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The vaccine was administered in a hospital. The patient did not receive any other vaccine within four weeks prior to the vaccination or other concomitant medications in two weeks. On 06Mar2021 at 08:30 AM, patient had numbness and she could not feel her body. When walking, she felt like she was having an out of body experience. She also had mild stomach upset (still after 10 days), mild headache and then intense congestion (nasal) day after. She still had mild numbness and tingling in legs and feet in Mar2021. No therapeutic measures were taken for the reported events. The clinical outcome of the events numbness, headache, nasal congestion and tingling in leg was recovering at the time of this report. The outcome of event stomach upset was not recovered.  No follow-up attempts are needed. No further information is expected
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Paraesthesia
Clinical narrative: Numbness could not feel my body; Numbness could not feel my body; stomach upset; Mild headache; intense congestion (nasal); Out of body experience; tingling in leg and feet; This is a spontaneous report from a contactable patient. A 63-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: EN6199) via an unspecified route of administration and anatomical site on 06Mar2021 at 08:30 AM (at the age of 63-year-old) as unknown, single dose for COVID-19 immunisation. Medical history included intense numbness started from last 1980s and 1990s with no concrete diagnosis and tested for multiple sclerosis (MS) which got better after a few years. The patient reported allergic to household cleaners, perfumes, sanitizing agents. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The vaccine was administered in a hospital. The patient did not receive any other vaccine within four weeks prior to the vaccination or other concomitant medications in two weeks. On 06Mar2021 at 08:30 AM, patient had numbness and she could not feel her body. When walking, she felt like she was having an out of body experience. She also had mild stomach upset (still after 10 days), mild headache and then intense congestion (nasal) day after. She still had mild numbness and tingling in legs and feet in Mar2021. No therapeutic measures were taken for the reported events. The clinical outcome of the events numbness, headache, nasal congestion and tingling in leg was recovering at the time of this report. The outcome of event stomach upset was not recovered.  No follow-up attempts are needed. No further information is expected
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Formication, Pain of skin, Paraesthesia, Pruritus, Rash
Clinical narrative: Rash on right side; Some swelling; Itching right arm, right buttock and right calf; Skin pain right arm, right buttock and right calf; Felt like there were bugs crawling around patient; Tingling all over body with pain around body; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in left arm on 12Mar2021 at 10:30 (at an age of 62-year-old) as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was allergic to bug bites. She had no allergies that she knew of except when she got bitten by a mosquito, she swelled up also bug bites. She had a reaction to them, spiders, fleas ext. There was no other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included Calcium (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN) and vitamin B12 (MANUFACTURER UNKNOWN) for an unknown indication and from an unknown start date and unknown if ongoing. On 12Mar2021 at 18:00, the patient experienced rash on right side, some swelling, itching and skin pain, right arm, right buttock and right calf, she felt like there were bugs crawling around, tingling all over the body with some pain/tingling around her body. The therapeutic measure was taken for event as benadryl. Events lead to doctor or other healthcare professional office/clinic visit. The clinical outcome of all events was resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Rash on right side; Some swelling; Itching right arm, right buttock and right calf; Skin pain right arm, right buttock and right calf; Felt like there were bugs crawling around patient; Tingling all over body with pain around body; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in left arm on 12Mar2021 at 10:30 (at an age of 62-year-old) as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was allergic to bug bites. She had no allergies that she knew of except when she got bitten by a mosquito, she swelled up also bug bites. She had a reaction to them, spiders, fleas ext. There was no other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included Calcium (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN) and vitamin B12 (MANUFACTURER UNKNOWN) for an unknown indication and from an unknown start date and unknown if ongoing. On 12Mar2021 at 18:00, the patient experienced rash on right side, some swelling, itching and skin pain, right arm, right buttock and right calf, she felt like there were bugs crawling around, tingling all over the body with some pain/tingling around her body. The therapeutic measure was taken for event as benadryl. Events lead to doctor or other healthcare professional office/clinic visit. The clinical outcome of all events was resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Chills; High fever; Headache; This is a spontaneous report from a non-contactable consumer, the patient. A 33-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration on an unspecified anatomical site on 16Mar2021 (at the age of 33-years-old) as unknown, single dose for COVID-19 Immunization. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. There was no treatment given for the events. There was no known allergies and no allergies to medications, food, or other products. On 16Mar2021 at 22:00, the patient experienced chills, high fever and headache. No therapeutic measures were taken for the events chills, high fever and headache. The clinical outcome of the events chills, high fever and headache were recovering.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information. Reporter details, patient age, suspect vaccine indication updated, events treatment and other clinical information.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for covid-19; This is a spontaneous report from a Pfizer sponsored Program. A non-contactable male consumer (patient) reported that: An unspecified age male patient received first dose of f BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Expiration date: Unknown; Lot number: Unknown), via unspecified route of administration (Anatomical Location; not reported) on Jan2021 as 1st dose, single for covid-19 immunisation. The medical history and concomitants were not reported. On an unspecified date in 2021, after 10 days the patient tested positive for covid-19. The patient underwent lab tests and procedures which included SARS-CoV-2 test (Covid-19 Positive). The outcome of the event was unknown.   Medical Information: Were any unaddressed medical questions referred or forwarded to Medical Information: No  No follow up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness, SARS-CoV-2 test
Clinical narrative: He was ill; Patient had his first dose; Tested positive for Covid; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A 76-years-old male patient received first 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 06Mar2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient had his first dose on 06Mar2021 and second dose will be 27Mar2021. On 17Mar2021, patient tested positive for Covid. He was ill and received a medication named Bamlanivimab that was used as treatment for Covid and that is for immune system and monoclonal antibodies. So, reporter was asking that the patient had tested positive for Covid, is he still going to receive the second dose? Also, knowing that the patient took that medication (Bamlanivimab), is he still going to receive the second dose? The patient underwent lab test on 17Mar2021 includes Covid Result: Positive. The outcome of events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: SARS-CoV-2 test; This is a spontaneous report from a contactable consumer or other non hcp (patient) via Pfizer spon-sored Program (CEP 159558).  A female patient of an unspecified age received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on 05Mar2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 15Mar2021, the patient had her sars-cov-2 test, and she was positive to it. The patient is concerned about taking 2nd dose of the vaccination. The outcome of the event was reported as unknown at the time of report.  No follow-up attempts are possible. No information about lot/batch number cannot been obtained.