chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hypoaesthesia, Migraine, Movement disorder
Clinical narrative: fainted as I was walking to my daughters room; I cannot move around quickly without getting dizzy.; I cannot move around quickly without getting dizzy.; woke up in the middle of the night in a terrible sweat; headache; Felt a massive migraine; I later felt numbness in both of my calves down to my toes; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 29Jul2021 (Batch/Lot number was not reported) (at the age of 31 years old) as single dose for Covid-19 immunisation. No other medical history reported. Patient had no known allergies. The patient was not pregnant at the time of vaccination. 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. Concomitant medications were reported as none. The patient received the first dose on 29Jul2021. She felt a massive migraine on 30Jul2021. She later felt numbness in both of her calves down to her toes. On 31Jul2021, she still had a migraine and then she woke up in the middle of the night in a terrible sweat worst she'd ever experienced. The patient then woke up on 01Aug2021 and fainted as she was walking to her daughter's room. On 01Aug2021, she cannot move around quickly without getting dizzy. She still has calf numbness and a headache which started on 30Jul2021. The patient did not receive any treatment for the adverse events. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent Covid-19 test nasal swab: negative on 02Aug2021. Outcome of the events was recovering at the time of the report.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, SARS-CoV-2 test, Syncope
Clinical narrative: fainted as I was walking to my daughters room; I cannot move around quickly without getting dizzy.; I cannot move around quickly without getting dizzy.; woke up in the middle of the night in a terrible sweat; headache; Felt a massive migraine; I later felt numbness in both of my calves down to my toes; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 29Jul2021 (Batch/Lot number was not reported) (at the age of 31 years old) as single dose for Covid-19 immunisation. No other medical history reported. Patient had no known allergies. The patient was not pregnant at the time of vaccination. 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. Concomitant medications were reported as none. The patient received the first dose on 29Jul2021. She felt a massive migraine on 30Jul2021. She later felt numbness in both of her calves down to her toes. On 31Jul2021, she still had a migraine and then she woke up in the middle of the night in a terrible sweat worst she'd ever experienced. The patient then woke up on 01Aug2021 and fainted as she was walking to her daughter's room. On 01Aug2021, she cannot move around quickly without getting dizzy. She still has calf numbness and a headache which started on 30Jul2021. The patient did not receive any treatment for the adverse events. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent Covid-19 test nasal swab: negative on 02Aug2021. Outcome of the events was recovering at the time of the report.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: I started having hear palpitations two days after vaccine they come and go; This is a spontaneous report received from a contactable consumer, the patient. A 52-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID VACCINE; Solution for injection, Batch/Lot number unknown), via an unspecified route of administration, administered in Arm Left on 30Jul2021 15:00 as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient heard palpitations two days after vaccine on 01Aug2021 16:00, they come and go. No treatment was received for the event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of event was not recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 test
Clinical narrative: took COVID test yesterday and tested positive with symptoms; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's mother) reported for a 16-year-old female patient (reporter's daughter). This is the second case out of the 2 cases.  A 16-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0198), dose 1 via an unspecified route of administration on 27Jul2021 (at the age of 16-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced "took COVID test yesterday and tested positive with symptoms" on 01Aug2021. The consumer took her daughter (patient), she got her shot, the vaccine on the 27. She thought it was the Tuesday or Wednesday of the previous week and the previous day. The consumer reported that unfortunately after taking the first dose her daughter experienced side effects. On the night of vaccination, the patient threw up. She was little nauseated and had body ache. She did not had lot of temperature like she was gone up to maybe 98 point something but that was or 99 but that was it. She was been getting to like middle cough and she just did not feel good. The consumer took her to get COVID shot and she tested positive for COVID. The patient underwent lab tests and procedures which included body temperature: gone up to 98 point something but that is or 99 (gone up to maybe 98 point something but that is or 99 but that is it) in Jul2021 and sars-cov-2 test: positive on 01Aug2021. So the consumer's question was what she from here on, she mean do they tested positive for COVID. Has to be (incomplete sentence). She also asked when do her daughter have to take the other shot. The outcome of the event was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This is a spontaneous report from a non-contactable consumer (patient). A 57-year-old adult male patient received 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 dose 1, single and second 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 dose 2, single for COVID-19 immunization.  Medical history included patient himself had never experienced Bell's palsy before, but a son had. The patient's concomitant medications were not reported.. About 3 days after vaccination on an unspecified date, the patient started experiencing symptoms of Bell's palsy. It was at the worst about 5 days after the first dose. He called telehealth and was given steroids and an antiviral and advised to postpone the 2nd dose. He received the 2nd dose approximately 6 weeks after the first, 2 weeks after stopping steroids. About 4 months later now, he has mostly recovered but has very mild lingering effects. Event took place after use of product. The outcome of event was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash papular
Clinical narrative: Rash on face/entire body red bumps appeared; entire body red bumps appeared; This is a spontaneous report from a contactable consumer (patient). A 14-year-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 vaccinev), dose 1 via an unspecified route of administration, administered in Arm Left on 02Aug2021 12:00 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 02Aug2021 14:00, the patient experienced rash on face/entire body red bumps appeared. The patient was treated with Benadryl and witch hazel. The outcome of the events was recovered on unspecified date in 2021.  Follow-up attempts are needed. Information on the lot/batch number is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Eczema, Oral pain, SARS-CoV-2 test, Skin sensitisation
Clinical narrative: Increase Eczema; Peanut allergy sensitivity. Skin; Peanut allergy sensitivity. Skin, mouth; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male 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 13Apr2021 at 13:15 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Medical history included allergy to peanuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. 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 an unknown date as a single dose for COVID-19 immunisation. On 19Jul2021, the patient underwent SARS-CoV-2 test (nasal swab) and the result was negative. On 23Jul2021, the patient experienced increase eczema and peanut allergy sensitivity, skin, mouth.  The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event increase eczema and peanut allergy sensitivity, skin, mouth were not resolved at the time of this report.     The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Itchy rash all over body; Dizziness; Nausea; Fever; Chills; Headache; This is a spontaneous report from a contactable consumer, the patient. A 34-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 in the left arm on 03Aug2021 at 09:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included anemic. The patient had no known allergies to medications, food or other products. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Aug2021 at 11:00, the patient experienced itchy rash all over body, dizziness, nausea, fever, chills and headache. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with Benadryl. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events itchy rash all over body, dizziness, nausea, fever, chills and headache was recovering at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy rash all over body; Dizziness; Nausea; Fever; Chills; Headache; This is a spontaneous report from a contactable consumer, the patient. A 34-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 in the left arm on 03Aug2021 at 09:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included anemic. The patient had no known allergies to medications, food or other products. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Aug2021 at 11:00, the patient experienced itchy rash all over body, dizziness, nausea, fever, chills and headache. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with Benadryl. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events itchy rash all over body, dizziness, nausea, fever, chills and headache was recovering at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Diabetes mellitus
Clinical narrative: diabetes; This is a spontaneous report from a non-contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2, on Jan2021 (Batch/Lot number was not reported) as dose 1, single, then on Feb2021 (Batch/Lot number was not reported) as dose 2, single, via an unspecified route of administration for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced diabetes 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.
Sex: U
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient). A female patient of unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on Jan2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE; and via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient experienced rheumatoid arthritis on unspecified date on 2021 with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Influenza like illness, Pain in extremity, SARS-CoV-2 test
Clinical narrative: sick with flu like symptoms for 2 days; Arm pain with both shots but worse with the first shot; This is a spontaneous report from a non-contactable consumer (patient). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on Jul2021 (Batch/Lot Number: FW0196) at the age of 45 years old, as DOSE 1, SINGLE for COVID-19 immunisation. Medical history was reported as none. Concomitant medications included calcium; vitamin d3; elderberry [sambucus nigra] and multivitamins; all taken for an unspecified indication, start and stop date were not reported. The patient reacted badly to the first shot on Jul2021 but was just sick with flu like symptoms for 2 days. No Asthma issues with the first shot. Arm pain with both shots but worse with the first shot on Jul2021. The patient underwent lab tests and procedures which included chest x-ray: clear on 2021 (no COVID and no pneumonia), and sars-cov-2 test: negative on 02Aug2021. The patient recovered from flu like symptoms, while recovering from arm pain.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chest X-ray, Cough, Lower respiratory tract infection, Pain in extremity
Clinical narrative: chest infection; Arm pain; cough; asthma attack; This is a spontaneous report from a non-contactable consumer (patient). A 45-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780), via an unspecified route of administration, administered in left arm on an unspecified date in Jul2021 (at the age of 45-years-old) as dose 2, single for COVID-19 immunisation. The patient previously took the first dose of bnt162b2 on an unsoecified date in Jul2021 and experienced arm pain and sick with flu like symptoms for 2 days. The patient medical history was not reported. The patient was not diagnosed with COVID before vaccination. Concomitant medication included multivitamin, vitamin d3, calcium and elderberry, all taken for an unspecified indication, start and stop date were not reported. On 28Jul2021 the patient experienced chest infection, arm pain, cough and asthma attack. It was reported that began with a cough, and it triggered a severe asthma attack by the second day after the vaccine. Patient has not suffered from asthma in 12 years until she took the covid shot. It became worse even after starting prednisone and taking prescribed cough medication. Ended up in the hospital for a chest X-ray and covid testing, all came back clear, no covid and no pneumonia. Just a severe chest infection that triggered outgrown asthma symptoms. Was them prescribed azithromycin and currently waiting to see if it will help with the reaction to the lungs and chest. Arm pain with both shots but worse with the first shot. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care visit. The treatment of events included ae treatment prednisone, Benzonatate and Azithromycin. On 02Aug2021 patient performed a covid test type post vaccination (Nasal Swab) with negative result. The outcome of events was recovering.    No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: chest infection; Arm pain; cough; asthma attack; This is a spontaneous report from a non-contactable consumer (patient). A 45-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780), via an unspecified route of administration, administered in left arm on an unspecified date in Jul2021 (at the age of 45-years-old) as dose 2, single for COVID-19 immunisation. The patient previously took the first dose of bnt162b2 on an unsoecified date in Jul2021 and experienced arm pain and sick with flu like symptoms for 2 days. The patient medical history was not reported. The patient was not diagnosed with COVID before vaccination. Concomitant medication included multivitamin, vitamin d3, calcium and elderberry, all taken for an unspecified indication, start and stop date were not reported. On 28Jul2021 the patient experienced chest infection, arm pain, cough and asthma attack. It was reported that began with a cough, and it triggered a severe asthma attack by the second day after the vaccine. Patient has not suffered from asthma in 12 years until she took the covid shot. It became worse even after starting prednisone and taking prescribed cough medication. Ended up in the hospital for a chest X-ray and covid testing, all came back clear, no covid and no pneumonia. Just a severe chest infection that triggered outgrown asthma symptoms. Was them prescribed azithromycin and currently waiting to see if it will help with the reaction to the lungs and chest. Arm pain with both shots but worse with the first shot. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care visit. The treatment of events included ae treatment prednisone, Benzonatate and Azithromycin. On 02Aug2021 patient performed a covid test type post vaccination (Nasal Swab) with negative result. The outcome of events was recovering.    No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Investigation, Magnetic resonance imaging, Post-acute COVID-19 syndrome, SARS-CoV-2 test
Clinical narrative: 1st date 21Dec2020; 2nd Date 13Apr2021; Post COVID Syndrome -possibly compounded by vaccine administered while asymptomatic+; Post COVID Syndrome -possibly compounded by vaccine administered while asymptomatic+; This is a spontaneous report from a contactable Nurse (patient) reported in response to HCP letter. A 51-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EP6955), via Intramuscular route of administration in Deltoid Left on 13Apr2021 10:00 (age at the time of vaccination 51-years-old), as a single dose for COVID-19 immunization. The patient's medical history included Obesity. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EJ1685), via Intramuscular route of administration in Deltoid Left on 21Dec2020 (age at the time of vaccination 51-years-old), as a single dose for COVID-19 immunization and experienced Post COVID headaches, fatigue, brainfog, and COVID onset date 28Dec2020, to ongoing. On an unspecified date, the patient experienced 1st date 21Dec2020; 2nd Date 13Apr2021; and Post COVID Syndrome -possibly compounded by vaccine administered while asymptomatic+. On 28Dec2020, the patient underwent lab tests and procedures which included SARS-CoV-2 test: COVID, COVID: Diagnosis 28Dec2020; and on 05Feb2021 Other radiological investigations: Normal, Other radiological investigations (MRI, Angiogram, V/Q scan); and Magnetic resonance imaging: Normal. The event requires the initiation of new medication or other treatment or procedure which included Aimovig, Topamax ubrelvy unable to work as RN. The patient was not hospitalized. The patient did not require supplement oxygen and not treated with immunomodulating or Immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. The outcome of the event was not recovered.  Follow-Up (11Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Balance disorder, Blood pressure measurement, Confusional state, Cough
Clinical narrative: blood pressure reaching 212/147 normally 108/60; Fever; migraine headache; rapid heartbeat; nausea; not hungry; coughing; sore throat; swollen neck and lymph nodes; looks like strep in the back of my throat; loss of voice; pain in kidneys; confusion; loss of balance when standing; swollen neck and lymph nodes; This is a spontaneous report from a non-contactable consumer (patient). A 32-year-old female patient (not pregnant) received the second dose of BNT162B2 via an unspecified route of administration on the left arm on 30Jul2021 at 19:00 at the age of 32-year-old as single dose for COVID-19 immunization. Medical history included Type 1 juvenile diabetes and morphine allergy. Prior to 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 COVID vaccine. Concomitant medication included insulin taken for type 1 juvenile diabetes. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 08Jul2021 at 05:00 PM at the age of 32-year-old as single dose for COVID-19 immunization. The patient previously taken morphine on an unspecified date and experienced known allergies. On 31Jul2021 at 07:00 am, the patient experienced fever, migraine headache, rapid heartbeat and blood pressure reaching 212/147 (normally 108/60), nausea, not hungry, coughing, sore throat, swollen neck and lymph nodes, looks like strep in the back of my throat, loss of voice, pain in kidneys, confusion and loss of balance when standing. No treatment was received. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Heart rate, Heart rate increased, Hypertension, Lymphadenopathy
Clinical narrative: blood pressure reaching 212/147 normally 108/60; Fever; migraine headache; rapid heartbeat; nausea; not hungry; coughing; sore throat; swollen neck and lymph nodes; looks like strep in the back of my throat; loss of voice; pain in kidneys; confusion; loss of balance when standing; swollen neck and lymph nodes; This is a spontaneous report from a non-contactable consumer (patient). A 32-year-old female patient (not pregnant) received the second dose of BNT162B2 via an unspecified route of administration on the left arm on 30Jul2021 at 19:00 at the age of 32-year-old as single dose for COVID-19 immunization. Medical history included Type 1 juvenile diabetes and morphine allergy. Prior to 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 COVID vaccine. Concomitant medication included insulin taken for type 1 juvenile diabetes. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 08Jul2021 at 05:00 PM at the age of 32-year-old as single dose for COVID-19 immunization. The patient previously taken morphine on an unspecified date and experienced known allergies. On 31Jul2021 at 07:00 am, the patient experienced fever, migraine headache, rapid heartbeat and blood pressure reaching 212/147 (normally 108/60), nausea, not hungry, coughing, sore throat, swollen neck and lymph nodes, looks like strep in the back of my throat, loss of voice, pain in kidneys, confusion and loss of balance when standing. No treatment was received. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Oropharyngeal pain, Pharyngitis, Pyrexia
Clinical narrative: blood pressure reaching 212/147 normally 108/60; Fever; migraine headache; rapid heartbeat; nausea; not hungry; coughing; sore throat; swollen neck and lymph nodes; looks like strep in the back of my throat; loss of voice; pain in kidneys; confusion; loss of balance when standing; swollen neck and lymph nodes; This is a spontaneous report from a non-contactable consumer (patient). A 32-year-old female patient (not pregnant) received the second dose of BNT162B2 via an unspecified route of administration on the left arm on 30Jul2021 at 19:00 at the age of 32-year-old as single dose for COVID-19 immunization. Medical history included Type 1 juvenile diabetes and morphine allergy. Prior to 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 COVID vaccine. Concomitant medication included insulin taken for type 1 juvenile diabetes. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 08Jul2021 at 05:00 PM at the age of 32-year-old as single dose for COVID-19 immunization. The patient previously taken morphine on an unspecified date and experienced known allergies. On 31Jul2021 at 07:00 am, the patient experienced fever, migraine headache, rapid heartbeat and blood pressure reaching 212/147 (normally 108/60), nausea, not hungry, coughing, sore throat, swollen neck and lymph nodes, looks like strep in the back of my throat, loss of voice, pain in kidneys, confusion and loss of balance when standing. No treatment was received. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Renal pain, Swelling
Clinical narrative: blood pressure reaching 212/147 normally 108/60; Fever; migraine headache; rapid heartbeat; nausea; not hungry; coughing; sore throat; swollen neck and lymph nodes; looks like strep in the back of my throat; loss of voice; pain in kidneys; confusion; loss of balance when standing; swollen neck and lymph nodes; This is a spontaneous report from a non-contactable consumer (patient). A 32-year-old female patient (not pregnant) received the second dose of BNT162B2 via an unspecified route of administration on the left arm on 30Jul2021 at 19:00 at the age of 32-year-old as single dose for COVID-19 immunization. Medical history included Type 1 juvenile diabetes and morphine allergy. Prior to 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 COVID vaccine. Concomitant medication included insulin taken for type 1 juvenile diabetes. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 08Jul2021 at 05:00 PM at the age of 32-year-old as single dose for COVID-19 immunization. The patient previously taken morphine on an unspecified date and experienced known allergies. On 31Jul2021 at 07:00 am, the patient experienced fever, migraine headache, rapid heartbeat and blood pressure reaching 212/147 (normally 108/60), nausea, not hungry, coughing, sore throat, swollen neck and lymph nodes, looks like strep in the back of my throat, loss of voice, pain in kidneys, confusion and loss of balance when standing. No treatment was received. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Headache, Heart rate, Heart rate increased, Menstruation irregular
Clinical narrative: Both doses have caused irregularities in menstrual cycle(bleeding and early period); headache; unable to lift arm in which received injection; whole body soreness; nausea; constipation; fever; Heart rate remains elevated; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown, at the age of 29 years), dose 2 via an unspecified route of administration, administered in Arm Left on 02Aug2021 09:30 as dose 2, single for covid-19 immunisation. Medical history included partial seizures (Other Medical History: Complex partial focal epilepsy). Concomitant medication(s) included bifidobacterium lactis (PROBIOTIC) and norethisterone (DEBLITANE) and Womens multi. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown, at the age of 29 years), dose 1 via an unspecified route of administration, administered in Arm Right on 12Jul2021 as dose 1, single for covid-19 immunisation and experienced Both doses have caused irregularities in menstrual cycle (bleeding and early period) and headache. The patient reported, both doses have caused irregularities in menstrual cycle (bleeding and early period), first dose caused headache but the second dose has caused headache, unable to lift arm in which received injection, whole body soreness, nausea, constipation, fever. Heart rate remains elevated. Worst part is the pain and soreness with inability to lift the arm and the racing heart on 02Aug2021 19:00 PM. The patient underwent lab tests and procedures which included heart rate: high on 02Aug2021 19:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any treatment for the event. Outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Nausea, Pain, Pyrexia
Clinical narrative: Both doses have caused irregularities in menstrual cycle(bleeding and early period); headache; unable to lift arm in which received injection; whole body soreness; nausea; constipation; fever; Heart rate remains elevated; This is a spontaneous report from a contactable consumer (patient). A 29-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown, at the age of 29 years), dose 2 via an unspecified route of administration, administered in Arm Left on 02Aug2021 09:30 as dose 2, single for covid-19 immunisation. Medical history included partial seizures (Other Medical History: Complex partial focal epilepsy). Concomitant medication(s) included bifidobacterium lactis (PROBIOTIC) and norethisterone (DEBLITANE) and Womens multi. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown, at the age of 29 years), dose 1 via an unspecified route of administration, administered in Arm Right on 12Jul2021 as dose 1, single for covid-19 immunisation and experienced Both doses have caused irregularities in menstrual cycle (bleeding and early period) and headache. The patient reported, both doses have caused irregularities in menstrual cycle (bleeding and early period), first dose caused headache but the second dose has caused headache, unable to lift arm in which received injection, whole body soreness, nausea, constipation, fever. Heart rate remains elevated. Worst part is the pain and soreness with inability to lift the arm and the racing heart on 02Aug2021 19:00 PM. The patient underwent lab tests and procedures which included heart rate: high on 02Aug2021 19:00. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any treatment for the event. Outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer or other non health care professional. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration, administered on an unspecified date in Jul2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got the first dose exactly 3 weeks ago (an unspecified date in Jul2021), after the first dose, she got Covid and was quarantined for 2 weeks. The patient was due for the second dose tomorrow. They wanted to know if she can take vaccine or not. On an unspecified date the patient underwent lab tests and procedures which included sars-cov-2 test and resulted positive for covid-19. The outcome of the event covid-19 was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myopericarditis; This is a spontaneous report from a contactable consumer. An adolescent patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as dose 2 single for COVID-19 immunization. Medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number, unknown) via an unspecified route of administration on an unspecified date as dose 1 single for COVID-19 immunization. On an unspecified date, patient experienced myopericarditis after the 2nd COVID 19 dose. Event took place after use of product. The outcome of the event was unknown.  Information about lot/batch number cannot be obtained. No further information expected. Sender's Comments: Limited information precludes a comprehensive causality assessment however with known safety profile of the drug the causal role of BNT162B2 vaccine cannot be excluded for the reported event of myocarditis.  The impact of this report on the benefit/risk profile of the product is evaluated as part of procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, as appropriate.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: hey had symptoms and that was why they tested; they had symptoms and that was why they tested; This is a spontaneous report from a contactable other health care professional. Caller is reporting on two patients and this report is for patient 2. A 33-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EP6955; Expiration Date: 30Jun2021) via an unspecified route of administration on 14Apr2021 (at the age of 33-year-old) as dose 2, single and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EP6955; Expiration Date: 30Jun2021) via an unspecified route of administration on 26Mar2021 (at the age of 33-year-old) as dose 1, single both for covid-19 immunisation. Caller said that the doses had the same lot numbers and expiry dates. The patient medical history and concomitant medications were not reported. On 02Aug2021, the patient experienced tested positive for covid and had received their covid vaccines. Caller said that the patients reported to her because they had to if they were sick on site or have COVID symptoms and that all had to go through her. She did not test them, but they had both tested outside and they have sent her the positive reports. They had symptoms and that was why they tested and they had family events a week prior to this. She received an email that was sent out today and it said she needed to call for the reason being for vaccine failure. The patient underwent lab tests and procedures which included SARS-CoV-2 test with result positive on 02Aug2021 (yesterday) report was from a nurse who had a patient that tested positive for COVID. The event outcome was unknown.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on the information provided in narrative, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. Linked Report(s): US-PFIZER INC-202100994257 same reporter, drug AE, different patient.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Hallucination, Headache, Malaise
Clinical narrative: Hallucinating; He was not feeling good; His vitals, is 97 over 133 and it keeps going up; His temp was 102.4; Felt weak; Headache; This is a spontaneous report from a contactable consumer (patient is the grandson).   A 14-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EW0153), via an unspecified route of administration, administered in left arm on 02Aug2021 in the afternoon (at the age of 14-years-old) as dose 2, single for COVID-19 immunisation. The patient preciously took first dose of bnt162b2 on 09Jul2021. The patient did not received any other vaccine within 4 weeks. Medical history included allergies. There were no concomitant medications.  On 03Aug2021 at about 01:00 the patient experienced hallucinating, he was not feeling good, his vitals were 97 over 133 and it kept going up, his temp was 102.4, he felt weak and he had headache. It was reported that patient got his Pfizer shot on 02Aug2021 afternoon and the morning of 03Aug2021 he told to reporter that he was not feeling good. So, they gave him the Tylenol 500 mg (treatment). The reporter went to check his vitals, was 97 over 133 and it kept going up and his temp was 102.4 and he was hallucinating and he got terrible headache and he felt weak. The outcome of events was not recovered.   No follow-up attempts are needed. No further information is expected
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vital capacity, Vital functions abnormal
Clinical narrative: Hallucinating; He was not feeling good; His vitals, is 97 over 133 and it keeps going up; His temp was 102.4; Felt weak; Headache; This is a spontaneous report from a contactable consumer (patient is the grandson).   A 14-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EW0153), via an unspecified route of administration, administered in left arm on 02Aug2021 in the afternoon (at the age of 14-years-old) as dose 2, single for COVID-19 immunisation. The patient preciously took first dose of bnt162b2 on 09Jul2021. The patient did not received any other vaccine within 4 weeks. Medical history included allergies. There were no concomitant medications.  On 03Aug2021 at about 01:00 the patient experienced hallucinating, he was not feeling good, his vitals were 97 over 133 and it kept going up, his temp was 102.4, he felt weak and he had headache. It was reported that patient got his Pfizer shot on 02Aug2021 afternoon and the morning of 03Aug2021 he told to reporter that he was not feeling good. So, they gave him the Tylenol 500 mg (treatment). The reporter went to check his vitals, was 97 over 133 and it kept going up and his temp was 102.4 and he was hallucinating and he got terrible headache and he felt weak. The outcome of events was not recovered.   No follow-up attempts are needed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling abnormal, Irritability
Clinical narrative: diarrhea; Irritability; just overall  been a breath and that is not like her; This is a spontaneous report from a contactable consumer (mother) reported for a female patient (daughter). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient's mother stated that her daughter got the COVID shot yesterday. She was literally having a reverse reaction, irritability and just diarrhea and just overall been a breath and that is not like her and she was a teenager so, the doctor said to call you guys to report the side effect. The outcome of the events was unknown.  Follow up attempts are needed, Information on lot/batch number has been requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Covid-19 positive test results; Covid-19 positive test results; This is a spontaneous report from a contactable consumer.   A 61-year-old male patient that the patient received bnt162b2 (Pfizer; formulation: solution for injection) dose 1 via intramuscular route administered in left arm on 12Mar2021 (Lot Number: EN6207) as dose 1, single and dose 2 via intramuscular route, administered in left arm on 02Apr2021 (Lot Number: ER8727) as dose 2, single (both doses at the age of 61 years) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccine in four weeks. Prior to vaccination, was the patient diagnosed with COVID-19. The patient covid-19 test showed positive results on 28Jul2021. Events are assessed as serious medically significant. Patient visited doctor or other healthcare professional office/clinic visit. The patient underwent lab tests which included Covid-19 test positive results on 28Jul2021, Rapid antigen test (nasal swab) showed positive on 02Aug2021. Patient did not receive any treatment for Covid-19. The outcome of the event Covid-19 was not recovered, and vaccination failure was unknown.  Follow-up attempts are completed. No further information is expected.