chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: some delirium episodes x2 days; BP of 200-210/100- 110; irregular heart palpitations; severe headaches; left sided neck and shoulder stiffness; acute weakness; tiredness; severe chills throughout my whole body; generalized severe body aches; extreme joint pains; her upper left arm, at the injection site and beyond-up and down the right arm, began to hurt something fierce with pains; numbness; tingling sensations; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm on 05Apr2021 15:30 (Batch/Lot Number: ER 8737) as single dose, for covid-19 immunization. Medical history included chronic interstitial cystitis, hypertension, COVID-19 flu in Jan2021. Concomitant medications included telmisartan (MICARDIS) taken for an unspecified indication, start and stop date were not reported; metoprolol succinate (TOPROL) taken for an unspecified indication, start and stop date were not reported. within the first 15 minutes of observation, the patient did not have any anaphylactic symptoms from the covid-19 flu shot. But as patient was driving home, at around 15:45, her upper left arm, at the injection site and beyond-up and down the right arm, began to hurt something fierce with pains and numbness and tingling sensations. By around 19:00 that same day, she began having severe headaches, left sided neck and shoulder stiffness, acute weakness and tiredness, severe chills throughout my whole body, with generalized severe body aches, and extreme joint pains, BP of 200-210/100- 110, irregular heart palpitations and some delirium episodes x 2 days. The outcome of events was reported as recovering. The patient has been treating herself with OTC Tylenol and motrin as the result of the events.  No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the delirium, hypertension and other reported events  due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer 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, Ethics Committees and Investigators, as appropriate.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Blood pressure measurement, Chills, Delirium
Clinical narrative: some delirium episodes x2 days; BP of 200-210/100- 110; irregular heart palpitations; severe headaches; left sided neck and shoulder stiffness; acute weakness; tiredness; severe chills throughout my whole body; generalized severe body aches; extreme joint pains; her upper left arm, at the injection site and beyond-up and down the right arm, began to hurt something fierce with pains; numbness; tingling sensations; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm on 05Apr2021 15:30 (Batch/Lot Number: ER 8737) as single dose, for covid-19 immunization. Medical history included chronic interstitial cystitis, hypertension, COVID-19 flu in Jan2021. Concomitant medications included telmisartan (MICARDIS) taken for an unspecified indication, start and stop date were not reported; metoprolol succinate (TOPROL) taken for an unspecified indication, start and stop date were not reported. within the first 15 minutes of observation, the patient did not have any anaphylactic symptoms from the covid-19 flu shot. But as patient was driving home, at around 15:45, her upper left arm, at the injection site and beyond-up and down the right arm, began to hurt something fierce with pains and numbness and tingling sensations. By around 19:00 that same day, she began having severe headaches, left sided neck and shoulder stiffness, acute weakness and tiredness, severe chills throughout my whole body, with generalized severe body aches, and extreme joint pains, BP of 200-210/100- 110, irregular heart palpitations and some delirium episodes x 2 days. The outcome of events was reported as recovering. The patient has been treating herself with OTC Tylenol and motrin as the result of the events.  No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the delirium, hypertension and other reported events  due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer 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, Ethics Committees and Investigators, as appropriate.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Hypertension, Hypoaesthesia, Musculoskeletal stiffness
Clinical narrative: some delirium episodes x2 days; BP of 200-210/100- 110; irregular heart palpitations; severe headaches; left sided neck and shoulder stiffness; acute weakness; tiredness; severe chills throughout my whole body; generalized severe body aches; extreme joint pains; her upper left arm, at the injection site and beyond-up and down the right arm, began to hurt something fierce with pains; numbness; tingling sensations; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm on 05Apr2021 15:30 (Batch/Lot Number: ER 8737) as single dose, for covid-19 immunization. Medical history included chronic interstitial cystitis, hypertension, COVID-19 flu in Jan2021. Concomitant medications included telmisartan (MICARDIS) taken for an unspecified indication, start and stop date were not reported; metoprolol succinate (TOPROL) taken for an unspecified indication, start and stop date were not reported. within the first 15 minutes of observation, the patient did not have any anaphylactic symptoms from the covid-19 flu shot. But as patient was driving home, at around 15:45, her upper left arm, at the injection site and beyond-up and down the right arm, began to hurt something fierce with pains and numbness and tingling sensations. By around 19:00 that same day, she began having severe headaches, left sided neck and shoulder stiffness, acute weakness and tiredness, severe chills throughout my whole body, with generalized severe body aches, and extreme joint pains, BP of 200-210/100- 110, irregular heart palpitations and some delirium episodes x 2 days. The outcome of events was reported as recovering. The patient has been treating herself with OTC Tylenol and motrin as the result of the events.  No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the delirium, hypertension and other reported events  due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer 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, Ethics Committees and Investigators, as appropriate.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pain in extremity, Palpitations, Paraesthesia
Clinical narrative: some delirium episodes x2 days; BP of 200-210/100- 110; irregular heart palpitations; severe headaches; left sided neck and shoulder stiffness; acute weakness; tiredness; severe chills throughout my whole body; generalized severe body aches; extreme joint pains; her upper left arm, at the injection site and beyond-up and down the right arm, began to hurt something fierce with pains; numbness; tingling sensations; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in the left arm on 05Apr2021 15:30 (Batch/Lot Number: ER 8737) as single dose, for covid-19 immunization. Medical history included chronic interstitial cystitis, hypertension, COVID-19 flu in Jan2021. Concomitant medications included telmisartan (MICARDIS) taken for an unspecified indication, start and stop date were not reported; metoprolol succinate (TOPROL) taken for an unspecified indication, start and stop date were not reported. within the first 15 minutes of observation, the patient did not have any anaphylactic symptoms from the covid-19 flu shot. But as patient was driving home, at around 15:45, her upper left arm, at the injection site and beyond-up and down the right arm, began to hurt something fierce with pains and numbness and tingling sensations. By around 19:00 that same day, she began having severe headaches, left sided neck and shoulder stiffness, acute weakness and tiredness, severe chills throughout my whole body, with generalized severe body aches, and extreme joint pains, BP of 200-210/100- 110, irregular heart palpitations and some delirium episodes x 2 days. The outcome of events was reported as recovering. The patient has been treating herself with OTC Tylenol and motrin as the result of the events.  No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the delirium, hypertension and other reported events  due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient.   There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer 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, Ethics Committees and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Enlarged uvula, Pharyngeal swelling, Swelling face
Clinical narrative: throat swelling; uvula swelling; facial swelling; tongue swelling; This is a spontaneous report from a contactable healthcare professional. A non-pregnant 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in right arm on 08Apr2021 at 10:00 (at the age of 33 years old) (Lot Number: EW0150, unknown expiration) as a single dose for COVID-19 immunisation.  Medical history included diabetes, HTN heart failure, migraine, and hypertension (HTN). Concomitant medications included medroxyprogesterone acetate (DEPO PROVERA) taken from 07Apr2021 to an unspecified stop date; omeprazole (PRILOSEC); clarithromycin (CLARITIN); allopurinol (ELAVIL); magnesium; venlafaxine hydrochloride (EFFEXOR); warfarin sodium (COUMADIN); digoxin; metoprolol tartrate (LOPRESSOR); torsemide; acyclovir; aspirin; topiramate (TOPAMAX); insulin aspart (NOVOLOG); and atorvastatin.  The patient previously took bactrim and experienced allergies.  The patient experienced throat swelling, uvula swelling, facial swelling, and tongue swelling on 08Apr2021 at 10:00 AM. The events resulted in emergency room/department or urgent care visit. The patient received epinephirine, solumedrol, Pepcid, and Benadryl for the events.  It was unknown if the patient has COVID prior to vaccination and unknown if the patient was tested for COVID post vaccination. The patient did not have other vaccine in four weeks. The patient is recovering from the events.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events pharyngeal swelling, enlarged uvula, swelling face and swollen tongue cannot be excluded. While a diagnosis was not provided, the clinical picture and treatment received by the patient point to the likelihood of an allergic reaction. The information available in this report is limited. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer 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, Ethics Committees, and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Enlarged uvula, Pharyngeal swelling, Swelling face, Swollen tongue
Clinical narrative: throat swelling; uvula swelling; facial swelling; tongue swelling; This is a spontaneous report from a contactable healthcare professional. A non-pregnant 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in right arm on 08Apr2021 at 10:00 (at the age of 33 years old) (Lot Number: EW0150, unknown expiration) as a single dose for COVID-19 immunisation.  Medical history included diabetes, HTN heart failure, migraine, and hypertension (HTN). Concomitant medications included medroxyprogesterone acetate (DEPO PROVERA) taken from 07Apr2021 to an unspecified stop date; omeprazole (PRILOSEC); clarithromycin (CLARITIN); allopurinol (ELAVIL); magnesium; venlafaxine hydrochloride (EFFEXOR); warfarin sodium (COUMADIN); digoxin; metoprolol tartrate (LOPRESSOR); torsemide; acyclovir; aspirin; topiramate (TOPAMAX); insulin aspart (NOVOLOG); and atorvastatin.  The patient previously took bactrim and experienced allergies.  The patient experienced throat swelling, uvula swelling, facial swelling, and tongue swelling on 08Apr2021 at 10:00 AM. The events resulted in emergency room/department or urgent care visit. The patient received epinephirine, solumedrol, Pepcid, and Benadryl for the events.  It was unknown if the patient has COVID prior to vaccination and unknown if the patient was tested for COVID post vaccination. The patient did not have other vaccine in four weeks. The patient is recovering from the events.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events pharyngeal swelling, enlarged uvula, swelling face and swollen tongue cannot be excluded. While a diagnosis was not provided, the clinical picture and treatment received by the patient point to the likelihood of an allergic reaction. The information available in this report is limited. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer 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, Ethics Committees, and Investigators, as appropriate.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry mouth, Dysgeusia, Heart rate increased, Immediate post-injection reaction, Oropharyngeal discomfort
Clinical narrative: felt like precursor to an anaphylactic response; Rapid heart rate; metallic taste; throat pressure; dry mouth; This is a spontaneous report from a contactable consumer (Patient herself). A 56-Year-old female (non-pregnant) patient received BNT162B2 (BNT162B2, Formulation: solution for injection, Batch/Lot was not reported) via unspecified route of administration and administered in left arm on 07Apr2021 14:00 as single dose for COVID-19 immunization. The patient no medical history and known allergies includes shellfish allergy and penicillin allergy, Levaquin, doxycycline were reported. The patient concomitant medications within two weeks included as Linzess, Prilosec, miralax, vitamin D were reported. Patient was not on other vaccines within four weeks. Patient had no Covid prior to vaccination and not tested for covid post vaccination. On 07Apr202 14:00 PM, the patient experienced rapid heart rate and metallic taste and dry mouth and throat pressure- felt like precursor to an anaphylactic response. Symptom onset was immediate and was decreased in 8 hours but still present 24 hours later. No therapeutic measures were taken. The outcome of the events was recovering.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Dry mouth, Dysgeusia, Heart rate, Heart rate increased
Clinical narrative: felt like precursor to an anaphylactic response; Rapid heart rate; metallic taste; throat pressure; dry mouth; This is a spontaneous report from a contactable consumer (Patient herself). A 56-Year-old female (non-pregnant) patient received BNT162B2 (BNT162B2, Formulation: solution for injection, Batch/Lot was not reported) via unspecified route of administration and administered in left arm on 07Apr2021 14:00 as single dose for COVID-19 immunization. The patient no medical history and known allergies includes shellfish allergy and penicillin allergy, Levaquin, doxycycline were reported. The patient concomitant medications within two weeks included as Linzess, Prilosec, miralax, vitamin D were reported. Patient was not on other vaccines within four weeks. Patient had no Covid prior to vaccination and not tested for covid post vaccination. On 07Apr202 14:00 PM, the patient experienced rapid heart rate and metallic taste and dry mouth and throat pressure- felt like precursor to an anaphylactic response. Symptom onset was immediate and was decreased in 8 hours but still present 24 hours later. No therapeutic measures were taken. The outcome of the events was recovering.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal discomfort
Clinical narrative: felt like precursor to an anaphylactic response; Rapid heart rate; metallic taste; throat pressure; dry mouth; This is a spontaneous report from a contactable consumer (Patient herself). A 56-Year-old female (non-pregnant) patient received BNT162B2 (BNT162B2, Formulation: solution for injection, Batch/Lot was not reported) via unspecified route of administration and administered in left arm on 07Apr2021 14:00 as single dose for COVID-19 immunization. The patient no medical history and known allergies includes shellfish allergy and penicillin allergy, Levaquin, doxycycline were reported. The patient concomitant medications within two weeks included as Linzess, Prilosec, miralax, vitamin D were reported. Patient was not on other vaccines within four weeks. Patient had no Covid prior to vaccination and not tested for covid post vaccination. On 07Apr202 14:00 PM, the patient experienced rapid heart rate and metallic taste and dry mouth and throat pressure- felt like precursor to an anaphylactic response. Symptom onset was immediate and was decreased in 8 hours but still present 24 hours later. No therapeutic measures were taken. The outcome of the events was recovering.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pyrexia, Vomiting projectile
Clinical narrative: This is a spontaneous report from a contactable consumer. A 36-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration, administered in left arm on 07Apr2021 16:20 as single dose for Covid-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD) was advised because she has been in her house so long that she is basically an agoraphobe and psychologist qualified because diagnosed with ADHD and profound anxiety at the fear of dying from COVID, anxiety and Covid-19, Concomitant medications were not reported. The patient stated that yesterday 07Apr2021 she got her first round of Pfizer COVID-19 vaccine and came home and got the worst headache she ever had in her life. She states then she projectile vomited and started uncontrollably shaking. The patient stated that she was shaking uncontrollably so bad she had to take a bath. She once she took a bath, in the bath she was shaking, it was not until she raised her body temperature high enough that her body was like okay, it could let go a little bit, then she got into bed and the shaking started again. She stated she had to use her heating blanket and stayed in bed all night with it and she is still using it now. She doesn't know how she would be if she wasn't warm, she thinks the fact that she is warm, the shaking has subsided. Later, last night, around 2 or 3 the headache was piercing, her head was hurting so bad like someone was taking a nail in her left temple. If it was a stroke she would have dealt with it if she had someone there with her to help her deal with it. She has a horrible headache today. The patient stated that now it is like a regular migraine. It sounded crazy to say , but now it she stated that it was like a regular migraine, it has improved and no longer feels like she is having a stroke. The patient took two Tylenol yesterday for the headache and vomited pretty quickly after so she doesn't think she got much of it. She has not taken anything else because she does not have anything on her stomach so she does not want to take more Advil or whatever but she would like to, her head hurts really bad, she would love some pain relief. The projectile vomiting went until there was just bile. She did not eat very much yesterday. She is no longer actively vomiting, but she felt herself wanting to dry heave but feels there is nothing else to give. The patient stated that she hasn't eaten anything today so she does not know if she can keep anything down and doesn't have much water in her system. The outcome of the event headache was recovering while the outcome of other events was unknown. Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Headache, Migraine, Tremor, Vomiting projectile
Clinical narrative: This is a spontaneous report from a contactable consumer. A 36-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration, administered in left arm on 07Apr2021 16:20 as single dose for Covid-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD) was advised because she has been in her house so long that she is basically an agoraphobe and psychologist qualified because diagnosed with ADHD and profound anxiety at the fear of dying from COVID, anxiety and Covid-19, Concomitant medications were not reported. The patient stated that yesterday 07Apr2021 she got her first round of Pfizer COVID-19 vaccine and came home and got the worst headache she ever had in her life. She states then she projectile vomited and started uncontrollably shaking. The patient stated that she was shaking uncontrollably so bad she had to take a bath. She once she took a bath, in the bath she was shaking, it was not until she raised her body temperature high enough that her body was like okay, it could let go a little bit, then she got into bed and the shaking started again. She stated she had to use her heating blanket and stayed in bed all night with it and she is still using it now. She doesn't know how she would be if she wasn't warm, she thinks the fact that she is warm, the shaking has subsided. Later, last night, around 2 or 3 the headache was piercing, her head was hurting so bad like someone was taking a nail in her left temple. If it was a stroke she would have dealt with it if she had someone there with her to help her deal with it. She has a horrible headache today. The patient stated that now it is like a regular migraine. It sounded crazy to say , but now it she stated that it was like a regular migraine, it has improved and no longer feels like she is having a stroke. The patient took two Tylenol yesterday for the headache and vomited pretty quickly after so she doesn't think she got much of it. She has not taken anything else because she does not have anything on her stomach so she does not want to take more Advil or whatever but she would like to, her head hurts really bad, she would love some pain relief. The projectile vomiting went until there was just bile. She did not eat very much yesterday. She is no longer actively vomiting, but she felt herself wanting to dry heave but feels there is nothing else to give. The patient stated that she hasn't eaten anything today so she does not know if she can keep anything down and doesn't have much water in her system. The outcome of the event headache was recovering while the outcome of other events was unknown. Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Fall, Fatigue, Headache, Injection site pain
Clinical narrative: lost my consciousness; My upper front teeth was broken; fell down to the front on floor; injuries with my lip and teeth; injuries with my lip and teeth; chills; headache; nausea; injection site pain; muscle pain; unwell; This is a spontaneous report from a contactable consumer.   A non-pregnant 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 06Apr2021 17:30 (Batch/Lot Number: EW0151) as single dose (at the age of 40 years old) for COVID-19 immunisation.  The patient medical history was not reported. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2, dose 1, (lot number=EN6204), on 13Mar2021 04:00 PM, administered on left arm for COVID-19 immunisation. The patient stated, "I got various symptoms such as chills, headache, nausea, injection site pain, muscle pain, unwell, and one day after getting the shot (on 06Apr2021 20:00) and on 07Apr2021, I lost my consciousness and fell down to the front on floor and it caused injuries with my lip and teeth. My upper front teeth was broken". The patient received no treatment. The patient was rushed to the emergency room and physician was visited. The outcome of the events was not recovered.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lip injury, Loss of consciousness, Malaise, Myalgia, Nausea
Clinical narrative: lost my consciousness; My upper front teeth was broken; fell down to the front on floor; injuries with my lip and teeth; injuries with my lip and teeth; chills; headache; nausea; injection site pain; muscle pain; unwell; This is a spontaneous report from a contactable consumer.   A non-pregnant 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 06Apr2021 17:30 (Batch/Lot Number: EW0151) as single dose (at the age of 40 years old) for COVID-19 immunisation.  The patient medical history was not reported. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2, dose 1, (lot number=EN6204), on 13Mar2021 04:00 PM, administered on left arm for COVID-19 immunisation. The patient stated, "I got various symptoms such as chills, headache, nausea, injection site pain, muscle pain, unwell, and one day after getting the shot (on 06Apr2021 20:00) and on 07Apr2021, I lost my consciousness and fell down to the front on floor and it caused injuries with my lip and teeth. My upper front teeth was broken". The patient received no treatment. The patient was rushed to the emergency room and physician was visited. The outcome of the events was not recovered.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tooth injury
Clinical narrative: lost my consciousness; My upper front teeth was broken; fell down to the front on floor; injuries with my lip and teeth; injuries with my lip and teeth; chills; headache; nausea; injection site pain; muscle pain; unwell; This is a spontaneous report from a contactable consumer.   A non-pregnant 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 06Apr2021 17:30 (Batch/Lot Number: EW0151) as single dose (at the age of 40 years old) for COVID-19 immunisation.  The patient medical history was not reported. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2, dose 1, (lot number=EN6204), on 13Mar2021 04:00 PM, administered on left arm for COVID-19 immunisation. The patient stated, "I got various symptoms such as chills, headache, nausea, injection site pain, muscle pain, unwell, and one day after getting the shot (on 06Apr2021 20:00) and on 07Apr2021, I lost my consciousness and fell down to the front on floor and it caused injuries with my lip and teeth. My upper front teeth was broken". The patient received no treatment. The patient was rushed to the emergency room and physician was visited. The outcome of the events was not recovered.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Fall, Headache, Lip injury, Loss of consciousness
Clinical narrative: lost my consciousness; My upper front teeth was broken; fell down to the front on floor; injuries with my lip and teeth; injuries with my lip and teeth; chills; headache; nausea; injection site pain; muscle pain; unwell; This is a spontaneous report from a contactable consumer.   A non-pregnant 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 06Apr2021 17:30 (Batch/Lot Number: EW0151) as single dose (at the age of 40 years old) for COVID-19 immunisation.  The patient medical history was not reported. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2, dose 1, (lot number=EN6204), on 13Mar2021 04:00 PM, administered on left arm for COVID-19 immunisation. The patient stated, "I got various symptoms such as chills, headache, nausea, injection site pain, muscle pain, unwell, and one day after getting the shot (on 06Apr2021 20:00) and on 07Apr2021, I lost my consciousness and fell down to the front on floor and it caused injuries with my lip and teeth. My upper front teeth was broken". The patient received no treatment. The patient was rushed to the emergency room and physician was visited. The outcome of the events was not recovered.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, Myalgia, Nausea, Tooth fracture, Tooth injury
Clinical narrative: lost my consciousness; My upper front teeth was broken; fell down to the front on floor; injuries with my lip and teeth; injuries with my lip and teeth; chills; headache; nausea; injection site pain; muscle pain; unwell; This is a spontaneous report from a contactable consumer.   A non-pregnant 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 06Apr2021 17:30 (Batch/Lot Number: EW0151) as single dose (at the age of 40 years old) for COVID-19 immunisation.  The patient medical history was not reported. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2, dose 1, (lot number=EN6204), on 13Mar2021 04:00 PM, administered on left arm for COVID-19 immunisation. The patient stated, "I got various symptoms such as chills, headache, nausea, injection site pain, muscle pain, unwell, and one day after getting the shot (on 06Apr2021 20:00) and on 07Apr2021, I lost my consciousness and fell down to the front on floor and it caused injuries with my lip and teeth. My upper front teeth was broken". The patient received no treatment. The patient was rushed to the emergency room and physician was visited. The outcome of the events was not recovered.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: lost my consciousness; My upper front teeth was broken; fell down to the front on floor; injuries with my lip and teeth; injuries with my lip and teeth; chills; headache; nausea; injection site pain; muscle pain; unwell; This is a spontaneous report from a contactable consumer.   A non-pregnant 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered on left arm on 06Apr2021 17:30 (Batch/Lot Number: EW0151) as single dose (at the age of 40 years old) for COVID-19 immunisation.  The patient medical history was not reported. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2, dose 1, (lot number=EN6204), on 13Mar2021 04:00 PM, administered on left arm for COVID-19 immunisation. The patient stated, "I got various symptoms such as chills, headache, nausea, injection site pain, muscle pain, unwell, and one day after getting the shot (on 06Apr2021 20:00) and on 07Apr2021, I lost my consciousness and fell down to the front on floor and it caused injuries with my lip and teeth. My upper front teeth was broken". The patient received no treatment. The patient was rushed to the emergency room and physician was visited. The outcome of the events was not recovered.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: Dizziness/ extreme dizziness/ Some degree of dizziness every day/ Varies from daily light headedness to extreme dizziness; had extreme fatigue; Almost fainted once; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6199), via an unspecified route of administration, administered in right arm on 03Mar2021 19:30 at single dose for COVID-19 immunisation. The patient's medical history included Hashimoto's autoimmune, and known allergies to penicillin. The patient's concomitant medications included liothyronine, and levothyroxine, both taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination and was tested for COVID post vaccination. The facility type vaccine was Pharmacy or Drug Store. The patient experienced dizziness on 10Mar2021 at 12:00 and has not ceased. It varies from daily light headedness to extreme dizziness. The patient almost fainted once on an unspecified date in Mar2021. The patient had some degree of dizziness every day. The patient also had extreme fatigue since 09Mar2021. The patient was completely normal and physically active before the first dose, and she have not felt normal since. Events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included nasal swab, with both negative test results on 17Mar2021 and on 31Mar2021. No treatment was received for the events. The outcome of the events were not recovered.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Fatigue, SARS-CoV-2 test, Syncope
Clinical narrative: Dizziness/ extreme dizziness/ Some degree of dizziness every day/ Varies from daily light headedness to extreme dizziness; had extreme fatigue; Almost fainted once; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6199), via an unspecified route of administration, administered in right arm on 03Mar2021 19:30 at single dose for COVID-19 immunisation. The patient's medical history included Hashimoto's autoimmune, and known allergies to penicillin. The patient's concomitant medications included liothyronine, and levothyroxine, both taken for an unspecified indication, start and stop date were not reported. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination and was tested for COVID post vaccination. The facility type vaccine was Pharmacy or Drug Store. The patient experienced dizziness on 10Mar2021 at 12:00 and has not ceased. It varies from daily light headedness to extreme dizziness. The patient almost fainted once on an unspecified date in Mar2021. The patient had some degree of dizziness every day. The patient also had extreme fatigue since 09Mar2021. The patient was completely normal and physically active before the first dose, and she have not felt normal since. Events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included nasal swab, with both negative test results on 17Mar2021 and on 31Mar2021. No treatment was received for the events. The outcome of the events were not recovered.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dysgeusia, Feeling hot, Flushing, Tachycardia
Clinical narrative: strong metallic taste; flushing; a warm sensation from her head to her toes; lightheaded; fast heartbeat; 2 hives appeared on her chest; This is a spontaneous report from a contactable consumer (patient). The 32-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced strong metallic taste, flushing, a warm sensation from her head to her toes, lightheaded, fast heartbeat, 2 hives appeared on her chest on 06Apr2021. Reported as: immediately after receiving the vaccine she experienced a strong metallic taste, flushing and a warm sensation from her head to her toes, she also felt lightheaded, and a fast heartbeat; after 5 minutes she felt better and these symptoms subsided. In the afternoon 2 hives appeared on her chest. She's not experiencing these symportoms currently. Patient states that she already talked to her HCP and she's most likely not gonna proceed with the second dose of the vaccine at this time, so she will not have increased immunity against Sars-CoV-2, she would like to know if this is true, and the efficacy after one dose of the vaccine. The outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: strong metallic taste; flushing; a warm sensation from her head to her toes; lightheaded; fast heartbeat; 2 hives appeared on her chest; This is a spontaneous report from a contactable consumer (patient). The 32-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced strong metallic taste, flushing, a warm sensation from her head to her toes, lightheaded, fast heartbeat, 2 hives appeared on her chest on 06Apr2021. Reported as: immediately after receiving the vaccine she experienced a strong metallic taste, flushing and a warm sensation from her head to her toes, she also felt lightheaded, and a fast heartbeat; after 5 minutes she felt better and these symptoms subsided. In the afternoon 2 hives appeared on her chest. She's not experiencing these symportoms currently. Patient states that she already talked to her HCP and she's most likely not gonna proceed with the second dose of the vaccine at this time, so she will not have increased immunity against Sars-CoV-2, she would like to know if this is true, and the efficacy after one dose of the vaccine. The outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dysgeusia, Feeling hot, Flushing, Presyncope
Clinical narrative: strong metallic taste; flushing; a warm sensation from her head to her toes; lightheaded; fast heartbeat; 2 hives appeared on her chest; This is a spontaneous report from a contactable consumer (patient). The 32-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced strong metallic taste, flushing, a warm sensation from her head to her toes, lightheaded, fast heartbeat, 2 hives appeared on her chest on 06Apr2021. Reported as: immediately after receiving the vaccine she experienced a strong metallic taste, flushing and a warm sensation from her head to her toes, she also felt lightheaded, and a fast heartbeat; after 5 minutes she felt better and these symptoms subsided. In the afternoon 2 hives appeared on her chest. She's not experiencing these symportoms currently. Patient states that she already talked to her HCP and she's most likely not gonna proceed with the second dose of the vaccine at this time, so she will not have increased immunity against Sars-CoV-2, she would like to know if this is true, and the efficacy after one dose of the vaccine. The outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tachycardia, Urticaria
Clinical narrative: strong metallic taste; flushing; a warm sensation from her head to her toes; lightheaded; fast heartbeat; 2 hives appeared on her chest; This is a spontaneous report from a contactable consumer (patient). The 32-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced strong metallic taste, flushing, a warm sensation from her head to her toes, lightheaded, fast heartbeat, 2 hives appeared on her chest on 06Apr2021. Reported as: immediately after receiving the vaccine she experienced a strong metallic taste, flushing and a warm sensation from her head to her toes, she also felt lightheaded, and a fast heartbeat; after 5 minutes she felt better and these symptoms subsided. In the afternoon 2 hives appeared on her chest. She's not experiencing these symportoms currently. Patient states that she already talked to her HCP and she's most likely not gonna proceed with the second dose of the vaccine at this time, so she will not have increased immunity against Sars-CoV-2, she would like to know if this is true, and the efficacy after one dose of the vaccine. The outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dysgeusia, Feeling hot, Flushing, Heart rate
Clinical narrative: strong metallic taste; flushing; a warm sensation from her head to her toes; lightheaded; fast heartbeat; 2 hives appeared on her chest; This is a spontaneous report from a contactable consumer (patient). The 32-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced strong metallic taste, flushing, a warm sensation from her head to her toes, lightheaded, fast heartbeat, 2 hives appeared on her chest on 06Apr2021. Reported as: immediately after receiving the vaccine she experienced a strong metallic taste, flushing and a warm sensation from her head to her toes, she also felt lightheaded, and a fast heartbeat; after 5 minutes she felt better and these symptoms subsided. In the afternoon 2 hives appeared on her chest. She's not experiencing these symportoms currently. Patient states that she already talked to her HCP and she's most likely not gonna proceed with the second dose of the vaccine at this time, so she will not have increased immunity against Sars-CoV-2, she would like to know if this is true, and the efficacy after one dose of the vaccine. The outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.