chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Nausea
Clinical narrative: Chills; Headache; Joint aches; Tired; Nausea; This is a spontaneous report from a contactable non healthcare professional, the patient. A 52-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via an unspecified route of administration in the left arm on 26Apr2021 at 11:30 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included barrett's esophagus. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), multivitamin (MANUFACTURER UNKNOWN) and calcium (MANUFACTURER UNKNOWN); all from unknown date for unknown indications and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 27Apr2021 at 09:00,  the patient experienced chills, headache, joint aches, tired, nausea. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events chills, headache, joint aches, tired, nausea. was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cheilitis, Cough, Depressed mood, Headache, Nasal congestion
Clinical narrative: developed 3 blister-like sores on lips (one center lower lip, one near peak of each side of upper lip); cold-like symptoms (congestion); cough; persistent headache; overall feeling run-down; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0151) via an unspecified route of administration in the left arm on 14Apr2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medications included birth control (MANUFACTURER UNKNOWN) and multivitamin (MANUFACTURER UNKNOWN), both taken for unspecified indications from unknown dates. The patient previously took cefaclor (CECLOR) and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, approximately 1.5 weeks after the first dose, the patient developed 3 blister-like sores on lips (one center lower lip, one near peak of each side of upper lip) and cold-like symptoms (congestion, cough, persistent headache) and in addition to overall, the patient felt run-down. The clinical outcome of the events blister-like sores on lips, cold-like symptoms (congestion, cough, persistent headache) and felt run-down were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Lymphadenopathy, Nasal congestion
Clinical narrative: cough; congestion; runny nose; sore throat; swollen lymph nodes; chills; fatigue; fever; This is a spontaneous report from a non-contactable consumer, the patient. A 54-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 19Apr2021 at 15:15 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. 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 bupropion hydrochloride (WELLBUTRIN), fluoxetine hydrochloride (PROZAC) and multivitamin (MANUFACTURER UNKNOWN) all for unknown indications on unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left  arm on 29Mar2021 at 15:15 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. On 19Apr2021, on day 1, the patient experienced chills, fatigue and fever. On day 2, the patient still had fatigue. On 21Apr2021, on day 3, the patient experienced cough, congestion, runny nose, sore throat, swollen lymph nodes, fatigue. Days 5-7, the patient continued to have congestion and runny nose. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures for the reported events included treatment with albuterol and TESSALON PERLES. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, fatigue, fever, cough, congestion, runny nose, sore throat and swollen lymph nodes were resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: cough; congestion; runny nose; sore throat; swollen lymph nodes; chills; fatigue; fever; This is a spontaneous report from a non-contactable consumer, the patient. A 54-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 19Apr2021 at 15:15 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. 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 bupropion hydrochloride (WELLBUTRIN), fluoxetine hydrochloride (PROZAC) and multivitamin (MANUFACTURER UNKNOWN) all for unknown indications on unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left  arm on 29Mar2021 at 15:15 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. On 19Apr2021, on day 1, the patient experienced chills, fatigue and fever. On day 2, the patient still had fatigue. On 21Apr2021, on day 3, the patient experienced cough, congestion, runny nose, sore throat, swollen lymph nodes, fatigue. Days 5-7, the patient continued to have congestion and runny nose. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures for the reported events included treatment with albuterol and TESSALON PERLES. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, fatigue, fever, cough, congestion, runny nose, sore throat and swollen lymph nodes were resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Retching
Clinical narrative: Nausea; Dry heaving; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 27Apr2021 (at the age of 28-year-old) as a single dose for COVID-19 immunisation. Medical history included fruit allergy (avocado). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 28Apr2021, the patient experienced nausea and dry heaving. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea and dry heaving was not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 18Apr2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021, about a week after the first dose, the patient developed shingles. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles and included treatment with Valtrex. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event shingles was not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 26Apr2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 27Apr2021, the patient experienced tinnitus. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported event. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient gave nasal swab for SARS-CoV-2 test and the result was unknown. The clinical outcome of the event tinnitus was not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Therapeutic response unexpected
Clinical narrative: My wife has had a lifelong struggle with seasonal After the second does her allergy completely went away for the first time in her life; At the time of second vaccination, the patient was at gestation period of 32 weeks; This is a spontaneous report from a contactable consumer. This is the second of two reports. A 34-year-old pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 31Mar2021 at 14:00 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergy (reported as "lifelong struggle with seasonal allergy"), COVID-19 and pregnancy (Gestation period: 32 weeks). The patient's Last menstrual period (LMP) was 16Sep2019. The patient had earlier received first dose of (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 34-year-old) as a single dose for COVID-19 immunisation (maternal drug exposure). Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 31Mar2021 At the time of second vaccination, the patient was at gestation period of 32 weeks. On 30Apr2021 at 15:00 after having second dose of vaccination, the patient's lifelong struggle with seasonal allergy completely went away for the first time in her life she started doing gardening with in April that was a miracle. Patient struggled with severe allergies. It was reported that would be where she would have a call in sick because her eyes would be happy and asthmatic since the second COVID-19 shot no allergies pollen allergies are no more. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The events were non-serious. The clinical outcome of the allergy completely went away for the first time in her life was recovered with sequelae and Maternal Exposure During Pregnancy, third trimester was unknown.  Follow-up (05Aug2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Vaccination site pain
Clinical narrative: Received vaccine while pregnant; Mild soreness at injection site; This is a spontaneous report from a contactable nurse (patient, self-reporting). A 31-year-old pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration in the left arm on 04May2021 at 16:45 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Patient has no medical and past drug history. Concomitant medications included pre-natal and acetylsalicylic acid (BABY ASPIRIN) from unknown dates for unknown indication. The patient was in her eighteen weeks of gestation period at the time of vaccination. Delivery date was provided as 28Sep2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 the patient experienced mild soreness at injection site. No treatment was received. The clinical outcome of the event mild soreness at injection site was not recovered and the event Received vaccine while pregnant was unknown at the time of this report.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Communication disorder, Fatigue, Myalgia
Clinical narrative: Fever; chills; muscle ache; Fatigue; Difficulty communicating; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 03May2021 at 16:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any concomitant medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER9729) via an unspecified route of administration in the left arm on 05Apr2021 at 09:30 (at the age of 47-years-old) as single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 04May2021 at 10:00, the patient experienced fever (101.3 from 10 am to 4 pm, 101.0 from 4 pm to 8 pm), chills, muscle ache, fatigue and difficulty communicating. Therapeutic measures were taken as a result of the events and included treatment with ibuprofen, 500mg, oral, two doses. The adverse events didn't result in doctor or other healthcare professional office/clinic visit, or emergency room/department or urgent care. The clinical outcome of the events fever (101.3 from 10 am to 4 pm, 101.0 from 4 pm to 8 pm), chills, muscle ache, fatigue and difficulty communicating were recovered on an unknown date in May2021.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: added medical history as none, event difficulty communicating updated as communication disorder.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; chills; muscle ache; Fatigue; Difficulty communicating; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 03May2021 at 16:30 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any concomitant medications within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER9729) via an unspecified route of administration in the left arm on 05Apr2021 at 09:30 (at the age of 47-years-old) as single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 04May2021 at 10:00, the patient experienced fever (101.3 from 10 am to 4 pm, 101.0 from 4 pm to 8 pm), chills, muscle ache, fatigue and difficulty communicating. Therapeutic measures were taken as a result of the events and included treatment with ibuprofen, 500mg, oral, two doses. The adverse events didn't result in doctor or other healthcare professional office/clinic visit, or emergency room/department or urgent care. The clinical outcome of the events fever (101.3 from 10 am to 4 pm, 101.0 from 4 pm to 8 pm), chills, muscle ache, fatigue and difficulty communicating were recovered on an unknown date in May2021.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: added medical history as none, event difficulty communicating updated as communication disorder.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: a delay in my period; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ep1533) via an unspecified route of administration in the arm right on 11Apr2021 at 11:00 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. The patient previously took BONADOXINA. 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 four weeks prior to the vaccination. On unknown date after first dose, patient experienced delayed period. Therapeutic measures were unknown as a result of the event. The clinical outcome of event delayed period was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Neck pain, Pain in extremity
Clinical narrative: Arm numbness/Arm and neck still sore and numb/Left foot was numb; Left neck pain; Arm and neck still sore and numb; This is a spontaneous report from a contactable consumer or other non-HCP (Patient). A female of an unspecified age was received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on 15Jan2021 as dose number unknown, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced arm numbness, left neck pain and left foot was numb. Arm and neck still sore and numb. Now it is intermittent and even if I am standing my left foot goes numb. Question asked Creating this report transmit the AE details" caller states she has spoken to the authorities in regards to the side effects 6 hours arm numbness, left neck pain and left foot was numb. Arm and neck still sore and numb. Now it is intermittent and even if I am standing my left foot goes numb. Outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Fatigue, Lip swelling, Pyrexia
Clinical narrative: Fatague; Soreness at injection sight; Low fever; Swelling of lips, tongue; Tightness in throat; Body rashes; Dizziness; Swelling of lips, tongue; This is a spontaneous report from a contactable consumer (patient). A 67-years-old non-pregnant female patient received bnt162b2 (Solution, injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 30Mar2021 at 18:30 (at the age of 67-years-old) as dose number unknown, single dose for covid-19 immunization. Medical history included lactose intolerance. Patient was diagnosed with covid prior to vaccination. There were no concomitant medications. Patient did not receive any other vaccine in 4 weeks. On 31Mar2021, patient experienced fatague, soreness at injection sight, low fever, swelling of lips, tongue, tightness in throat, body rashes and dizziness. Therapeutic measures were taken as a result of fatague, soreness at injection sight, low fever, swelling of lips, tongue, tightness in throat, body rashes and dizziness and patient was treated with steroid. Lab test includes was Low fever on 31Mar2021. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swollen tongue, Throat tightness, Vaccination site pain
Clinical narrative: Fatague; Soreness at injection sight; Low fever; Swelling of lips, tongue; Tightness in throat; Body rashes; Dizziness; Swelling of lips, tongue; This is a spontaneous report from a contactable consumer (patient). A 67-years-old non-pregnant female patient received bnt162b2 (Solution, injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 30Mar2021 at 18:30 (at the age of 67-years-old) as dose number unknown, single dose for covid-19 immunization. Medical history included lactose intolerance. Patient was diagnosed with covid prior to vaccination. There were no concomitant medications. Patient did not receive any other vaccine in 4 weeks. On 31Mar2021, patient experienced fatague, soreness at injection sight, low fever, swelling of lips, tongue, tightness in throat, body rashes and dizziness. Therapeutic measures were taken as a result of fatague, soreness at injection sight, low fever, swelling of lips, tongue, tightness in throat, body rashes and dizziness and patient was treated with steroid. Lab test includes was Low fever on 31Mar2021. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: Administered 0.5 mL of vaccine, not 0.3 mL; This is a spontaneous report from a contactable healthcare professional.   A 23-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162), intramuscularly in the left arm on 08Apr2021 (at the age of 23-years-old) as a  0.5 ml single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On 08Apr2021, the patient was administered 0.5 ml of BNT162b2 vaccine, not instead of 0.3 ml. No therapeutic measures were taken as a result of the event. The clinical outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: reaction data (updated event to overdose), treatment (NO), and outcome (UNKNOWN).
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Haemoglobin, Haemoglobin decreased, Red blood cell count, Red blood cell count decreased, White blood cell count
Clinical narrative: DROP IN HEMOGLOBIN; DROP IN HEMOGLOBIN AND WHITE AND RED BLOOD CELL COUNTS; DROP IN HEMOGLOBIN AND WHITE AND RED BLOOD CELL COUNTS; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot Number: EN6202), via an unspecified route of administration in left arm on 26Feb2021 at 15:00 (at the age of 53-year-old) at single dose for COVID-19 immunisation. Medical history included Crohn's. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Feb2021, the patient experienced drop in hemoglobin, white blood cell and red blood cell counts. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the reported events included iron infusion. The clinical outcome of the events was recovering. The patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6207) via an unspecified route of administration in left arm on 22Mar2021 at 11:00 at single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: lab data added.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count decreased
Clinical narrative: DROP IN HEMOGLOBIN; DROP IN HEMOGLOBIN AND WHITE AND RED BLOOD CELL COUNTS; DROP IN HEMOGLOBIN AND WHITE AND RED BLOOD CELL COUNTS; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot Number: EN6202), via an unspecified route of administration in left arm on 26Feb2021 at 15:00 (at the age of 53-year-old) at single dose for COVID-19 immunisation. Medical history included Crohn's. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Feb2021, the patient experienced drop in hemoglobin, white blood cell and red blood cell counts. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the reported events included iron infusion. The clinical outcome of the events was recovering. The patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6207) via an unspecified route of administration in left arm on 22Mar2021 at 11:00 at single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: lab data added.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: administered 0.5 ml of BNT162b2 vaccine, instead of 0.3 ml; This is a spontaneous report from a contactable healthcare professional.   A 26-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162), intramuscularly in the left arm on 08Apr2021 (at the age of 26-years-old) as a  0.5 ml single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On 08Apr2021, the patient was administered 0.5 ml of BNT162b2 vaccine, instead of 0.3 ml. The event did not result in doctor or other healthcare professional office/clinic visit or emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: reaction data (updated event to overdose), treatment (NO), and outcome (UNKNOWN).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: Administered 0.5 mL of vaccine, not 0.3 mL; This is a spontaneous report from a contactable healthcare professional.   A 30-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162), intramuscularly in the left arm on 08Apr2021 (at the age of 30-years-old) as a  0.5 ml single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On 08Apr2021, the patient was administered 0.5 ml of BNT162b2 vaccine, instead of 0.3 ml. The event did not result in doctor or other healthcare professional office/clinic visit or emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: reaction data (updated event to overdose), treatment (NO), and outcome (UNKNOWN).
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: Administered 0.5 mL of vaccine, not 0.3 mL; This is a spontaneous report from a contactable healthcare professional.   A 20-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162), intramuscularly in the left arm on 08Apr2021 (at the age of 20-years-old) as a  0.5 ml single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On 08Apr2021, the patient was administered 0.5 ml of BNT162b2 vaccine, instead of 0.3 ml. The event did not result in doctor or other healthcare professional office/clinic visit or emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: reaction data (updated event to overdose), treatment (NO), and outcome (UNKNOWN).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Fatigue, Feeling abnormal, Malaise
Clinical narrative: Arm pain near injection site.; Body aches; Malaise; Tired; Slight brain fog; Diarrhea; stomach upset; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the right arm on 04May2021 at 11:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not provided. The patient received unspecified medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05May2021, the patient experienced arm pain near injection site, body aches, malaise, tired, slight brain fog, diarrhea and stomach upset. Patient didn't receive treatment for events. The adverse events didn't result in doctor or other healthcare professional office/clinic visit, or emergency room/department or urgent care. The clinical outcome of the events arm pain near injection site, body aches, malaise, tired, slight brain fog, diarrhea and stomach upset were unknown 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: added information that patient didn't receive treatment for events.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Arm pain near injection site.; Body aches; Malaise; Tired; Slight brain fog; Diarrhea; stomach upset; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the right arm on 04May2021 at 11:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not provided. The patient received unspecified medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05May2021, the patient experienced arm pain near injection site, body aches, malaise, tired, slight brain fog, diarrhea and stomach upset. Patient didn't receive treatment for events. The adverse events didn't result in doctor or other healthcare professional office/clinic visit, or emergency room/department or urgent care. The clinical outcome of the events arm pain near injection site, body aches, malaise, tired, slight brain fog, diarrhea and stomach upset were unknown 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: added information that patient didn't receive treatment for events.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Feeling hot, Heart rate increased, Herpes virus infection
Clinical narrative: heart rate elevated; body temp elevated; can't sleep well; tired; felt hot all the time; 1st herpes outbreak in 9 months; This is a spontaneous report from a contactable consumer, the patient. This is the first of two reports. A 41-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN0171) via an unspecified route of administration in the left arm on 20Apr2021 at 12:00 (at the age of 41-year-old), as dose 2, single for COVID-19 immunisation. Medical history included chronic constipation, herpes, allergic to contrast dye, red dyes, milk products and penicillin. Concomitant medications included linaclotide (LINZESS), lysine (MANUFACTURER UNKNOWN) and linum usitatissimum seed oil (FLAX OIL), all for unknown indication from unknown date. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8732) via an unspecified route of administration in the left arm on 23Mar2021 at 12:00 (at the age of 41-year-old), as dose 1, single for COVID-19 immunisation and experienced constipation and bad menstrual cycle. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021, the patient experienced heart rate elevated, body temp elevated, could not sleep well, felt tired, felt hot all the time and experienced 1st herpes outbreak in 9 months. No therapeutic measures were taken as a result of the events. The patient underwent lab tests and procedures which included: heart rate elevated, result: elevated and body temp elevated, result: elevated on 21Apr2021. The clinical outcome of the event heart rate elevated, body temp elevated, could not sleep well, tired, hot all the time and 1st herpes outbreak in 9 months was not recovered at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality sleep
Clinical narrative: heart rate elevated; body temp elevated; can't sleep well; tired; felt hot all the time; 1st herpes outbreak in 9 months; This is a spontaneous report from a contactable consumer, the patient. This is the first of two reports. A 41-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN0171) via an unspecified route of administration in the left arm on 20Apr2021 at 12:00 (at the age of 41-year-old), as dose 2, single for COVID-19 immunisation. Medical history included chronic constipation, herpes, allergic to contrast dye, red dyes, milk products and penicillin. Concomitant medications included linaclotide (LINZESS), lysine (MANUFACTURER UNKNOWN) and linum usitatissimum seed oil (FLAX OIL), all for unknown indication from unknown date. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8732) via an unspecified route of administration in the left arm on 23Mar2021 at 12:00 (at the age of 41-year-old), as dose 1, single for COVID-19 immunisation and experienced constipation and bad menstrual cycle. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Apr2021, the patient experienced heart rate elevated, body temp elevated, could not sleep well, felt tired, felt hot all the time and experienced 1st herpes outbreak in 9 months. No therapeutic measures were taken as a result of the events. The patient underwent lab tests and procedures which included: heart rate elevated, result: elevated and body temp elevated, result: elevated on 21Apr2021. The clinical outcome of the event heart rate elevated, body temp elevated, could not sleep well, tired, hot all the time and 1st herpes outbreak in 9 months was not recovered at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: patient was administered 0.5 ml of BNT162b2 vaccine, instead of 0.3 ml; This is a spontaneous report from a contactable healthcare professional. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162), intramuscularly in the left arm on 08Apr2021 (at the age of 34-years-old) as a  0.5 ml single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 08Apr2021, the patient was administered 0.5 ml of BNT162b2 vaccine, instead of 0.3 ml. The event did not result in doctor or other healthcare professional office/clinic visit or emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event was unknown.   No follow-up attempts are needed. No further information is expected.  This follow-up report is being submitted to amend previously reported information: reaction data updated event to overdose, treatment none, and outcome was UNKNOWN.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Pain
Clinical narrative: General body pain; Chills; Headache; Nausea; fever over 100 degrees Farenheit; This is a spontaneous report from a non-contactable consumer. A male patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 30Apr2021 as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On 01May2021 the patient experienced general body aches/chills, nausea, headache and fever over 100 degrees Farenheit. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether the patient received any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event general body aches/ chills, nausea, headache and fever over 100 degrees Farenheit was recovered on an unknown date in May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: General body pain; Chills; Headache; Nausea; fever over 100 degrees Farenheit; This is a spontaneous report from a non-contactable consumer. A male patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 30Apr2021 as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On 01May2021 the patient experienced general body aches/chills, nausea, headache and fever over 100 degrees Farenheit. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether the patient received any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event general body aches/ chills, nausea, headache and fever over 100 degrees Farenheit was recovered on an unknown date in May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Hypoaesthesia
Clinical narrative: Numbness in the hand after the second dose; When she lays on that side it gets worse; This is a spontaneous report from a Non-contactable nurse. This nurse (patient's son) reported for a 60-year-old female patient (reporter's mother).  A 60-year-old female patient received second dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as dose 2, single for COVID-19 immunization. Patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date 2021, after the vaccination, the patient experienced numbness in the hand and When she lays on that side, she has it gets worse, when lays on the other side it doesn't get any worse, stays the same. The events assessed as non-serious. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Dizziness, Hypertension, Nausea
Clinical narrative: severe dizziness; nausea; Blood pressure was unusually high during this period; Dehydrated; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the arm right on 06Apr2021 at 16:00(at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included Stage 3 kidney failure, obesity, idiopathic (likely gluten) peripheral neuropathy, and Raynaud's syndrome. Concomitant medications included pregabalin (LYRICA), losartan (MANUFACTURER UNKNOWN) and paracetamol (TYLENOL); all from unknown date for unspecified indication. The past drug history was reported that patient had many drugs reaction. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the arm right on 16Mar2021 at 14:15(at the age of 60-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Apr2021 at 10:00 approximately 32 hours after the vaccination, the patient experienced severe dizziness and nausea and Blood pressure was unusually high during this period. On an unknown date in Apr2021 the patient experienced dehydrated. It was reported approximately 32 hours post vaccine severe dizziness and nausea, had to return to bed. Somewhat improved approx. 8 hours later, could carefully move about. Less severe but remained approximately 6 days. Did continue 3 more days before the patient realized he was dehydrated and that was likely reason it continued. The patient had a history of drug reactions to a great number of medications. The patient was very drug sensitive. Blood pressure was unusually high during this period. The patient did not bother the physician as he never felt anything more than inconvenience after the first day of onset. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of dizziness, nausea, dehydrated and blood pressure high were resolving.   No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Fall, Fatigue, Feeling cold, Hyperhidrosis
Clinical narrative: shot was given in the am...around 8-9 pm started feeling achy, tired, fever, freezing...took ibuprofen, put on socks, sweatshirt and gloves because I couldn't get warm...went to bed...woke up at 2-3am drenched in sweat....took off gloves, socks, sweatshirt, went to bathroom...stood to pull up pants with right arm (still very sore from injection)...everything went dark...my husband came into the bathroom and I was laying on the floor....I couldn't stand... I had to crawl to the living room where my husband helped me into a chair...he got me cold wet towel, more ibuprofen and water....I slept most of the day...I was scheduled to work the weekend but missed all three days (F, Sa and Su)