chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Malaise, Pain, Throat tightness, Urticaria
Clinical narrative: approximately 52 hours after Injectionit felt like throat was tightening/closingup; Hives; overall feeling unwell; body aches; chills; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL9262), via an unspecified route of administration in the left arm on 10Mar2021 at 14:30 (at the age of 25-years-old), as a single dose for COVID-19 immunisation. Medical history included CAH (congenital adrenal hyperplasia), asthma, steroid dependent, adrenal insufficiency, shellfish allergy and allergy to sulpha medications. Concomitant medications included hydrocortisone (CORTEF), montelukast sodium (SINGULAIR), levothyroxine sodium (SYNTHROID), metformin (MANUFACTURER UNKNOWN), fexofenadine hydrochloride (ALLEGRA); all for unspecified indications from unknown date. 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. The patient had not been tested for COVID-19, since the vaccination. On 10Mar2021 at 15:15, the patient experienced hives within 45 minutes, overall feeling unwell, body aches, chills and on 12Mar2021, approximately 52 hours after injection, the patient felt like throat was tightening/closing up. The adverse events result in a visit to the doctors or other healthcare professional office/clinic visit. The patient did not receive treatment for the reported events. The clinical outcome of hives, overall feeling unwell, body aches, chills, throat tightening/closing up was recovered on an unspecified date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dermatitis bullous, Lymphadenopathy
Clinical narrative: axillary lymphadenopathy; a rash on chest; This is a spontaneous report from a contactable physician. A 33-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via intramuscular route of administration in the left arm on 17Feb2021 (at the age 33 -years-old), as a single dose for COVID-19 immunisation. Medical history included depression. Concomitant medications included escitalopram (LEXAPRO), nitrofurantoin (MACROBID) both received within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via intramuscular route of administration in the left arm on 27Jan2021 (at the age 33 -years-old), as a single dose for COVID-19 immunisation. It was reported that patient had known allergies (unspecified) to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03Mar2021, the patient experienced axillary lymphadenopathy started 2 weeks after the second vaccination and persisted even six weeks after and also had a rash on chest about 2 weeks after which was not itchy and lasted about 5 days (also reported as not recovered). The adverse events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcomes of the events, axillary lymphadenopathy and rash on chest were not recovered at the time of the report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Rash
Clinical narrative: axillary lymphadenopathy; a rash on chest; This is a spontaneous report from a contactable physician. A 33-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via intramuscular route of administration in the left arm on 17Feb2021 (at the age 33 -years-old), as a single dose for COVID-19 immunisation. Medical history included depression. Concomitant medications included escitalopram (LEXAPRO), nitrofurantoin (MACROBID) both received within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via intramuscular route of administration in the left arm on 27Jan2021 (at the age 33 -years-old), as a single dose for COVID-19 immunisation. It was reported that patient had known allergies (unspecified) to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03Mar2021, the patient experienced axillary lymphadenopathy started 2 weeks after the second vaccination and persisted even six weeks after and also had a rash on chest about 2 weeks after which was not itchy and lasted about 5 days (also reported as not recovered). The adverse events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. The clinical outcomes of the events, axillary lymphadenopathy and rash on chest were not recovered at the time of the report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Swelling face
Clinical narrative: Swelling of left jaw gland/enlarged lymph nodes; This is a spontaneous report from contactable consumer, the patient. A 59-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA; Lot Number: En6208), via an unspecified route of administration in left arm on 10Mar2021 at 09:30 (at the age of 59-year-old) as single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications included atorvastatin calcium 20mg (MANUFACTURER UNKNOWN) indicated for cholesterol. 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-19 vaccine. On 12Mar2021 at 13:30, the patient experienced swelling of left jaw gland/enlarged lymph nodes. The adverse event resulted in patients visit to emergency room/department or urgent care. Therapeutic measures taken for the event were reported that the patient received Medrol Pak 4mg (methylprednisolone) 6da as a treatment for the event. The clinical outcome of the event of swelling of left jaw gland/enlarged lymph nodes was resolved at the time of reporting. No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swelling of left jaw gland/enlarged lymph nodes; This is a spontaneous report from contactable consumer, the patient. A 59-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA; Lot Number: En6208), via an unspecified route of administration in left arm on 10Mar2021 at 09:30 (at the age of 59-year-old) as single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications included atorvastatin calcium 20mg (MANUFACTURER UNKNOWN) indicated for cholesterol. 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-19 vaccine. On 12Mar2021 at 13:30, the patient experienced swelling of left jaw gland/enlarged lymph nodes. The adverse event resulted in patients visit to emergency room/department or urgent care. Therapeutic measures taken for the event were reported that the patient received Medrol Pak 4mg (methylprednisolone) 6da as a treatment for the event. The clinical outcome of the event of swelling of left jaw gland/enlarged lymph nodes was resolved at the time of reporting. No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Myocardial infarction, Pulse absent
Clinical narrative: Death.  Patient received vaccine on 3/17/2021.  Patient died on 3/22/2021. Initially presumed cause of death was heart attack.  Patient collapsed at home, spouse called 911. Never revived with CPR or ACLS. Pronounced dead in emergency department.  (No physician at that point have been informed of his COVID-19 immunization? The patient?s spouse informed me of his COVID-19 immunization today 7/13/2021)
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Myocardial infarction, Syncope
Clinical narrative: Death.  Patient received vaccine on 3/17/2021.  Patient died on 3/22/2021. Initially presumed cause of death was heart attack.  Patient collapsed at home, spouse called 911. Never revived with CPR or ACLS. Pronounced dead in emergency department.  (No physician at that point have been informed of his COVID-19 immunization? The patient?s spouse informed me of his COVID-19 immunization today 7/13/2021)
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain, Vaccination site pain
Clinical narrative: Lymph node swelling in left armpit.; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP6955) via an unspecified route of administration on left arm on 24Mar2021 at 13:15 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. The patient had medical history of high blood pressure (controlled via medication). Concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247) via an unspecified route of administration in the left arm on 04Mar2021 at 13:15 (at the age of 57-year-old) as a 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. On 27Mar2021 at 19: 30, the patient experienced lymph node swelling in left armpit. Patient did not receive any treatment for the adverse event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event swollen lymph node was recovering at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph node swelling in left armpit.; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EP6955) via an unspecified route of administration on left arm on 24Mar2021 at 13:15 (at the age of 57-year-old) as a single dose for COVID-19 immunisation. The patient had medical history of high blood pressure (controlled via medication). Concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3247) via an unspecified route of administration in the left arm on 04Mar2021 at 13:15 (at the age of 57-year-old) as a 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. On 27Mar2021 at 19: 30, the patient experienced lymph node swelling in left armpit. Patient did not receive any treatment for the adverse event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event swollen lymph node was recovering at the time of reporting.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Syncope
Clinical narrative: Severe Nausea; Extreme joint pain; Headache; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW6204) via an unspecified route of administration on 25Mar2021 at 14:00 (at the age of vaccination 55-years-old) in the right arm as a single dose for COVID-19 immunisation. Medical history included barrettes oesophagus. The patient did not have a history of allergies to medications, food, or other products. Concomitant medications included spironolactone (MANUFACTURER UNKNOWN) for unknown indication, estradiol (ESTROGEN) for unknown indication, progesterone (MANUFACTURER UNKNOWN) for unknown indication, esomeprazole magnesium (NEXIUM) for unknown indication which were received within two weeks of vaccination. 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 right arm on 04Mar2021 at 14:00 (at the age of vaccination 55-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 02:00, the patient had experienced severe nausea, extreme joint pain, headache and fatigue. The patient did not receive any treatment for the reported events. Adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events severe nausea, extreme joint pain, headache and fatigue was resolved in Mar2021 at the time of report. No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Headache, Nausea
Clinical narrative: Severe Nausea; Extreme joint pain; Headache; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW6204) via an unspecified route of administration on 25Mar2021 at 14:00 (at the age of vaccination 55-years-old) in the right arm as a single dose for COVID-19 immunisation. Medical history included barrettes oesophagus. The patient did not have a history of allergies to medications, food, or other products. Concomitant medications included spironolactone (MANUFACTURER UNKNOWN) for unknown indication, estradiol (ESTROGEN) for unknown indication, progesterone (MANUFACTURER UNKNOWN) for unknown indication, esomeprazole magnesium (NEXIUM) for unknown indication which were received within two weeks of vaccination. 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 right arm on 04Mar2021 at 14:00 (at the age of vaccination 55-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 02:00, the patient had experienced severe nausea, extreme joint pain, headache and fatigue. The patient did not receive any treatment for the reported events. Adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events severe nausea, extreme joint pain, headache and fatigue was resolved in Mar2021 at the time of report. No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anti-thyroid antibody, Asthenia, Blood iron, Blood thyroid stimulating hormone, Electrocardiogram
Clinical narrative: BLOOD PRESSURE HIGH; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; DIZZINESS; HEADACHES; NAUSEA; WEAKNESS; This spontaneous report received from a patient concerned a 72 year old female. Initial information was processed along with additional information received on 04-JUL-2021, 08-JUL-2021 and 09-JUL-2021. The patient's weight was 64.86 kilograms, and height was 165 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 and expiry: unknown) dose was not reported, 1 total administered to upper left arm on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, (5 days after vaccination) the patient had a strong reaction to the vaccine and experienced headaches, dizziness, nausea, and weakness which persisted for several weeks. On an unspecified date, the patient experienced high blood pressure and started using losartan, and metoprolol from 30-MAR-2021 as treatment. On 22-JUN-2021, the patient's physician got tested her for the spike protein immunoglobulin G (IgG Antibody) test and its results came negative (confirmed immunological vaccine failure). The patient wanted to know whether it was okay to get another vaccine as a booster dose to boost her immunity because she felt if she did not do that, she would be at risk of catching a virus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, headaches, nausea, and weakness, had not recovered from blood pressure high, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000185416. The suspected product quality complaint has been confirmed to be not voided (meet pqc criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0 - 20210710887-COVID-19 VACCINE AD26.COV2.S -Confirmed Immunological Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Full blood count, Headache, Lipids, Metabolic function test, Muscle twitching
Clinical narrative: BLOOD PRESSURE HIGH; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; DIZZINESS; HEADACHES; NAUSEA; WEAKNESS; This spontaneous report received from a patient concerned a 72 year old female. Initial information was processed along with additional information received on 04-JUL-2021, 08-JUL-2021 and 09-JUL-2021. The patient's weight was 64.86 kilograms, and height was 165 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 and expiry: unknown) dose was not reported, 1 total administered to upper left arm on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, (5 days after vaccination) the patient had a strong reaction to the vaccine and experienced headaches, dizziness, nausea, and weakness which persisted for several weeks. On an unspecified date, the patient experienced high blood pressure and started using losartan, and metoprolol from 30-MAR-2021 as treatment. On 22-JUN-2021, the patient's physician got tested her for the spike protein immunoglobulin G (IgG Antibody) test and its results came negative (confirmed immunological vaccine failure). The patient wanted to know whether it was okay to get another vaccine as a booster dose to boost her immunity because she felt if she did not do that, she would be at risk of catching a virus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, headaches, nausea, and weakness, had not recovered from blood pressure high, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000185416. The suspected product quality complaint has been confirmed to be not voided (meet pqc criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0 - 20210710887-COVID-19 VACCINE AD26.COV2.S -Confirmed Immunological Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Neurological examination, Palpitations, Serum ferritin, Thyroxine free
Clinical narrative: BLOOD PRESSURE HIGH; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; DIZZINESS; HEADACHES; NAUSEA; WEAKNESS; This spontaneous report received from a patient concerned a 72 year old female. Initial information was processed along with additional information received on 04-JUL-2021, 08-JUL-2021 and 09-JUL-2021. The patient's weight was 64.86 kilograms, and height was 165 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 and expiry: unknown) dose was not reported, 1 total administered to upper left arm on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, (5 days after vaccination) the patient had a strong reaction to the vaccine and experienced headaches, dizziness, nausea, and weakness which persisted for several weeks. On an unspecified date, the patient experienced high blood pressure and started using losartan, and metoprolol from 30-MAR-2021 as treatment. On 22-JUN-2021, the patient's physician got tested her for the spike protein immunoglobulin G (IgG Antibody) test and its results came negative (confirmed immunological vaccine failure). The patient wanted to know whether it was okay to get another vaccine as a booster dose to boost her immunity because she felt if she did not do that, she would be at risk of catching a virus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, headaches, nausea, and weakness, had not recovered from blood pressure high, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000185416. The suspected product quality complaint has been confirmed to be not voided (meet pqc criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0 - 20210710887-COVID-19 VACCINE AD26.COV2.S -Confirmed Immunological Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urine analysis, Vision blurred
Clinical narrative: BLOOD PRESSURE HIGH; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; DIZZINESS; HEADACHES; NAUSEA; WEAKNESS; This spontaneous report received from a patient concerned a 72 year old female. Initial information was processed along with additional information received on 04-JUL-2021, 08-JUL-2021 and 09-JUL-2021. The patient's weight was 64.86 kilograms, and height was 165 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 and expiry: unknown) dose was not reported, 1 total administered to upper left arm on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, (5 days after vaccination) the patient had a strong reaction to the vaccine and experienced headaches, dizziness, nausea, and weakness which persisted for several weeks. On an unspecified date, the patient experienced high blood pressure and started using losartan, and metoprolol from 30-MAR-2021 as treatment. On 22-JUN-2021, the patient's physician got tested her for the spike protein immunoglobulin G (IgG Antibody) test and its results came negative (confirmed immunological vaccine failure). The patient wanted to know whether it was okay to get another vaccine as a booster dose to boost her immunity because she felt if she did not do that, she would be at risk of catching a virus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, headaches, nausea, and weakness, had not recovered from blood pressure high, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000185416. The suspected product quality complaint has been confirmed to be not voided (meet pqc criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0 - 20210710887-COVID-19 VACCINE AD26.COV2.S -Confirmed Immunological Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Blood immunoglobulin G, Blood pressure measurement, Dizziness, Headache
Clinical narrative: BLOOD PRESSURE HIGH; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; DIZZINESS; HEADACHES; NAUSEA; WEAKNESS; This spontaneous report received from a patient concerned a 72 year old female. Initial information was processed along with additional information received on 04-JUL-2021, 08-JUL-2021 and 09-JUL-2021. The patient's weight was 64.86 kilograms, and height was 165 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 and expiry: unknown) dose was not reported, 1 total administered to upper left arm on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, (5 days after vaccination) the patient had a strong reaction to the vaccine and experienced headaches, dizziness, nausea, and weakness which persisted for several weeks. On an unspecified date, the patient experienced high blood pressure and started using losartan, and metoprolol from 30-MAR-2021 as treatment. On 22-JUN-2021, the patient's physician got tested her for the spike protein immunoglobulin G (IgG Antibody) test and its results came negative (confirmed immunological vaccine failure). The patient wanted to know whether it was okay to get another vaccine as a booster dose to boost her immunity because she felt if she did not do that, she would be at risk of catching a virus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, headaches, nausea, and weakness, had not recovered from blood pressure high, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000185416. The suspected product quality complaint has been confirmed to be not voided (meet pqc criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0 - 20210710887-COVID-19 VACCINE AD26.COV2.S -Confirmed Immunological Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypertension, Nausea, Therapy non-responder
Clinical narrative: BLOOD PRESSURE HIGH; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; DIZZINESS; HEADACHES; NAUSEA; WEAKNESS; This spontaneous report received from a patient concerned a 72 year old female. Initial information was processed along with additional information received on 04-JUL-2021, 08-JUL-2021 and 09-JUL-2021. The patient's weight was 64.86 kilograms, and height was 165 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 and expiry: unknown) dose was not reported, 1 total administered to upper left arm on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, (5 days after vaccination) the patient had a strong reaction to the vaccine and experienced headaches, dizziness, nausea, and weakness which persisted for several weeks. On an unspecified date, the patient experienced high blood pressure and started using losartan, and metoprolol from 30-MAR-2021 as treatment. On 22-JUN-2021, the patient's physician got tested her for the spike protein immunoglobulin G (IgG Antibody) test and its results came negative (confirmed immunological vaccine failure). The patient wanted to know whether it was okay to get another vaccine as a booster dose to boost her immunity because she felt if she did not do that, she would be at risk of catching a virus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, headaches, nausea, and weakness, had not recovered from blood pressure high, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000185416. The suspected product quality complaint has been confirmed to be not voided (meet pqc criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0 - 20210710887-COVID-19 VACCINE AD26.COV2.S -Confirmed Immunological Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Chills, Coagulation time prolonged, Computerised tomogram head, Dizziness
Clinical narrative: BLOOD PRESSURE HIGH; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; DIZZINESS; HEADACHES; NAUSEA; WEAKNESS; This spontaneous report received from a patient concerned a 72 year old female. Initial information was processed along with additional information received on 04-JUL-2021, 08-JUL-2021 and 09-JUL-2021. The patient's weight was 64.86 kilograms, and height was 165 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 and expiry: unknown) dose was not reported, 1 total administered to upper left arm on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, (5 days after vaccination) the patient had a strong reaction to the vaccine and experienced headaches, dizziness, nausea, and weakness which persisted for several weeks. On an unspecified date, the patient experienced high blood pressure and started using losartan, and metoprolol from 30-MAR-2021 as treatment. On 22-JUN-2021, the patient's physician got tested her for the spike protein immunoglobulin G (IgG Antibody) test and its results came negative (confirmed immunological vaccine failure). The patient wanted to know whether it was okay to get another vaccine as a booster dose to boost her immunity because she felt if she did not do that, she would be at risk of catching a virus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, headaches, nausea, and weakness, had not recovered from blood pressure high, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000185416. The suspected product quality complaint has been confirmed to be not voided (meet pqc criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0 - 20210710887-COVID-19 VACCINE AD26.COV2.S -Confirmed Immunological Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Heart rate increased, Hypertension, Investigation, Muscle twitching
Clinical narrative: BLOOD PRESSURE HIGH; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; DIZZINESS; HEADACHES; NAUSEA; WEAKNESS; This spontaneous report received from a patient concerned a 72 year old female. Initial information was processed along with additional information received on 04-JUL-2021, 08-JUL-2021 and 09-JUL-2021. The patient's weight was 64.86 kilograms, and height was 165 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 and expiry: unknown) dose was not reported, 1 total administered to upper left arm on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, (5 days after vaccination) the patient had a strong reaction to the vaccine and experienced headaches, dizziness, nausea, and weakness which persisted for several weeks. On an unspecified date, the patient experienced high blood pressure and started using losartan, and metoprolol from 30-MAR-2021 as treatment. On 22-JUN-2021, the patient's physician got tested her for the spike protein immunoglobulin G (IgG Antibody) test and its results came negative (confirmed immunological vaccine failure). The patient wanted to know whether it was okay to get another vaccine as a booster dose to boost her immunity because she felt if she did not do that, she would be at risk of catching a virus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, headaches, nausea, and weakness, had not recovered from blood pressure high, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000185416. The suspected product quality complaint has been confirmed to be not voided (meet pqc criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0 - 20210710887-COVID-19 VACCINE AD26.COV2.S -Confirmed Immunological Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: BLOOD PRESSURE HIGH; CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; DIZZINESS; HEADACHES; NAUSEA; WEAKNESS; This spontaneous report received from a patient concerned a 72 year old female. Initial information was processed along with additional information received on 04-JUL-2021, 08-JUL-2021 and 09-JUL-2021. The patient's weight was 64.86 kilograms, and height was 165 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 and expiry: unknown) dose was not reported, 1 total administered to upper left arm on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, (5 days after vaccination) the patient had a strong reaction to the vaccine and experienced headaches, dizziness, nausea, and weakness which persisted for several weeks. On an unspecified date, the patient experienced high blood pressure and started using losartan, and metoprolol from 30-MAR-2021 as treatment. On 22-JUN-2021, the patient's physician got tested her for the spike protein immunoglobulin G (IgG Antibody) test and its results came negative (confirmed immunological vaccine failure). The patient wanted to know whether it was okay to get another vaccine as a booster dose to boost her immunity because she felt if she did not do that, she would be at risk of catching a virus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, headaches, nausea, and weakness, had not recovered from blood pressure high, and the outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000185416. The suspected product quality complaint has been confirmed to be not voided (meet pqc criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0 - 20210710887-COVID-19 VACCINE AD26.COV2.S -Confirmed Immunological Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness
Clinical narrative: dizziness; weakness; headache; chills; nausea; tiredness; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the left arm on 25Mar2021 at 08:30 (at the age of 55-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19 and reported that the patient had known environmental and food allergies. Concomitant medications included penicillin (MANUFACTURER UNKNOWN), probiotic (MANUFACTURER UNKNOWN) and naproxen sodium (ALEVE), all for unknown indication from unknown date. 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. On 25Mar2021 at 20:30 (12 hours later), the patient experienced dizziness, weakness, headache, chills, nausea and tiredness. The events did not result in 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 the events dizziness, weakness, headache, chills, nausea and tiredness was resolving (also reported that all the events lasted for 48 hours).   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: dizziness; weakness; headache; chills; nausea; tiredness; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the left arm on 25Mar2021 at 08:30 (at the age of 55-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19 and reported that the patient had known environmental and food allergies. Concomitant medications included penicillin (MANUFACTURER UNKNOWN), probiotic (MANUFACTURER UNKNOWN) and naproxen sodium (ALEVE), all for unknown indication from unknown date. 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. On 25Mar2021 at 20:30 (12 hours later), the patient experienced dizziness, weakness, headache, chills, nausea and tiredness. The events did not result in 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 the events dizziness, weakness, headache, chills, nausea and tiredness was resolving (also reported that all the events lasted for 48 hours).   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: dizziness; weakness; headache; chills; nausea; tiredness; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration in the left arm on 25Mar2021 at 08:30 (at the age of 55-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19 and reported that the patient had known environmental and food allergies. Concomitant medications included penicillin (MANUFACTURER UNKNOWN), probiotic (MANUFACTURER UNKNOWN) and naproxen sodium (ALEVE), all for unknown indication from unknown date. 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. On 25Mar2021 at 20:30 (12 hours later), the patient experienced dizziness, weakness, headache, chills, nausea and tiredness. The events did not result in 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 the events dizziness, weakness, headache, chills, nausea and tiredness was resolving (also reported that all the events lasted for 48 hours).   No follow-up attempts are needed. No further information is expected.
Age: 15.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Patient Too Young for Vaccine Administered-
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Fatigue, Muscular weakness, Tremor, Vertigo
Clinical narrative: developing gradually worsening symptoms of vertigo, speech difficulty, and weakness a few weeks after 2nd vaccine.  Specifically, vertigo was the first symptoms starting 3 weeks after the second shot. Then 2-3 weeks after that, she noticed a slower cadence of speech and difficulty with fine motor movement (holding pencils, etc). Shortly thereafter, she developed numbness/tingling in hands and feet and then eventually weakness in legs. Weakness/imbalance issues continued to progress over the past few months to the point where she has now been using a walker for the past month or so.   She now came in to the ER due to markedly worsening weakness to the point where she is falling.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram cerebral normal, Arteriogram carotid normal, Asthenia, Balance disorder, CSF protein increased
Clinical narrative: developing gradually worsening symptoms of vertigo, speech difficulty, and weakness a few weeks after 2nd vaccine.  Specifically, vertigo was the first symptoms starting 3 weeks after the second shot. Then 2-3 weeks after that, she noticed a slower cadence of speech and difficulty with fine motor movement (holding pencils, etc). Shortly thereafter, she developed numbness/tingling in hands and feet and then eventually weakness in legs. Weakness/imbalance issues continued to progress over the past few months to the point where she has now been using a walker for the past month or so.   She now came in to the ER due to markedly worsening weakness to the point where she is falling.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Demyelination, Electromyogram abnormal, Fall, Fine motor skill dysfunction, Hypoaesthesia
Clinical narrative: developing gradually worsening symptoms of vertigo, speech difficulty, and weakness a few weeks after 2nd vaccine.  Specifically, vertigo was the first symptoms starting 3 weeks after the second shot. Then 2-3 weeks after that, she noticed a slower cadence of speech and difficulty with fine motor movement (holding pencils, etc). Shortly thereafter, she developed numbness/tingling in hands and feet and then eventually weakness in legs. Weakness/imbalance issues continued to progress over the past few months to the point where she has now been using a walker for the past month or so.   She now came in to the ER due to markedly worsening weakness to the point where she is falling.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lumbar puncture abnormal, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal abnormal, Muscular weakness, Paraesthesia
Clinical narrative: developing gradually worsening symptoms of vertigo, speech difficulty, and weakness a few weeks after 2nd vaccine.  Specifically, vertigo was the first symptoms starting 3 weeks after the second shot. Then 2-3 weeks after that, she noticed a slower cadence of speech and difficulty with fine motor movement (holding pencils, etc). Shortly thereafter, she developed numbness/tingling in hands and feet and then eventually weakness in legs. Weakness/imbalance issues continued to progress over the past few months to the point where she has now been using a walker for the past month or so.   She now came in to the ER due to markedly worsening weakness to the point where she is falling.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Slow speech, Speech disorder, Spinal osteoarthritis, Vertebral foraminal stenosis, Vertigo
Clinical narrative: developing gradually worsening symptoms of vertigo, speech difficulty, and weakness a few weeks after 2nd vaccine.  Specifically, vertigo was the first symptoms starting 3 weeks after the second shot. Then 2-3 weeks after that, she noticed a slower cadence of speech and difficulty with fine motor movement (holding pencils, etc). Shortly thereafter, she developed numbness/tingling in hands and feet and then eventually weakness in legs. Weakness/imbalance issues continued to progress over the past few months to the point where she has now been using a walker for the past month or so.   She now came in to the ER due to markedly worsening weakness to the point where she is falling.