chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood potassium normal, Blood sodium normal, Blood urea normal, Carbon dioxide normal, Globulin
Clinical narrative: Acute hemolytic anemia; Felt pale and tachycardic; Felt pale and tachycardic; This is a spontaneous report from a contactable pharmacist. A 37-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), intramuscularly on 06Jan2021 12:30 on Left arm at single dose for COVID-19 immunization, facility where the most recent COVID-19 vaccine was administered in Hospital; pembrolizumab (KEYTRUDA), via unspecified route of administration from 01Dec2020 and from 22Dec2020 at unspecified dosage for unspecified indication. Medical history included thymic carcinoma stage IV, Allergy to adhesive tape. Concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 (lot number=EJ1685) intramuscularly on 18Dec2020 14:15 on Left arm for COVID-19 immunization. It was reported that patient was receiving Keytruda (01Dec2020 and 22Dec2020) which could cause hemolytic anemia. Labs were stable on 22Dec2020. Patient felt pale and tachycardic the next day (07Jan2021) but didn't notify us. He had follow-up on 1/12/2021 at the cancer center. The labs were consistent with acute hemolytic anemia (12Jan2021 at 08:00 AM), and patient was closely followed by hematology. He was on immunotherapy for cancer treatment, but there was concern for COVID vaccine contributing the hemolytic anemia. Events were result in doctor or other healthcare professional office/clinic visit. Treatment received for acute hemolytic anemia included blood transfusion. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The action taken for pembrolizumab was unknown. The outcome of the events were not resolved.; Sender's Comments: Based on the available information, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of reported events acute hemolytic anemia, pallor and tachycardia cannot be completely excluded. concomitant use of KEYTRUDA and patient's underlying medical condition may have also contributed to reported events. The case will be reevaluated should additional information become 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: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haematocrit decreased, Haemoglobin decreased, Haemolytic anaemia, Pallor, Platelet count
Clinical narrative: Acute hemolytic anemia; Felt pale and tachycardic; Felt pale and tachycardic; This is a spontaneous report from a contactable pharmacist. A 37-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), intramuscularly on 06Jan2021 12:30 on Left arm at single dose for COVID-19 immunization, facility where the most recent COVID-19 vaccine was administered in Hospital; pembrolizumab (KEYTRUDA), via unspecified route of administration from 01Dec2020 and from 22Dec2020 at unspecified dosage for unspecified indication. Medical history included thymic carcinoma stage IV, Allergy to adhesive tape. Concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 (lot number=EJ1685) intramuscularly on 18Dec2020 14:15 on Left arm for COVID-19 immunization. It was reported that patient was receiving Keytruda (01Dec2020 and 22Dec2020) which could cause hemolytic anemia. Labs were stable on 22Dec2020. Patient felt pale and tachycardic the next day (07Jan2021) but didn't notify us. He had follow-up on 1/12/2021 at the cancer center. The labs were consistent with acute hemolytic anemia (12Jan2021 at 08:00 AM), and patient was closely followed by hematology. He was on immunotherapy for cancer treatment, but there was concern for COVID vaccine contributing the hemolytic anemia. Events were result in doctor or other healthcare professional office/clinic visit. Treatment received for acute hemolytic anemia included blood transfusion. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The action taken for pembrolizumab was unknown. The outcome of the events were not resolved.; Sender's Comments: Based on the available information, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of reported events acute hemolytic anemia, pallor and tachycardia cannot be completely excluded. concomitant use of KEYTRUDA and patient's underlying medical condition may have also contributed to reported events. The case will be reevaluated should additional information become 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: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tachycardia, White blood cell count decreased
Clinical narrative: Acute hemolytic anemia; Felt pale and tachycardic; Felt pale and tachycardic; This is a spontaneous report from a contactable pharmacist. A 37-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), intramuscularly on 06Jan2021 12:30 on Left arm at single dose for COVID-19 immunization, facility where the most recent COVID-19 vaccine was administered in Hospital; pembrolizumab (KEYTRUDA), via unspecified route of administration from 01Dec2020 and from 22Dec2020 at unspecified dosage for unspecified indication. Medical history included thymic carcinoma stage IV, Allergy to adhesive tape. Concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 (lot number=EJ1685) intramuscularly on 18Dec2020 14:15 on Left arm for COVID-19 immunization. It was reported that patient was receiving Keytruda (01Dec2020 and 22Dec2020) which could cause hemolytic anemia. Labs were stable on 22Dec2020. Patient felt pale and tachycardic the next day (07Jan2021) but didn't notify us. He had follow-up on 1/12/2021 at the cancer center. The labs were consistent with acute hemolytic anemia (12Jan2021 at 08:00 AM), and patient was closely followed by hematology. He was on immunotherapy for cancer treatment, but there was concern for COVID vaccine contributing the hemolytic anemia. Events were result in doctor or other healthcare professional office/clinic visit. Treatment received for acute hemolytic anemia included blood transfusion. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The action taken for pembrolizumab was unknown. The outcome of the events were not resolved.; Sender's Comments: Based on the available information, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of reported events acute hemolytic anemia, pallor and tachycardia cannot be completely excluded. concomitant use of KEYTRUDA and patient's underlying medical condition may have also contributed to reported events. The case will be reevaluated should additional information become 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: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haemolytic anaemia, Inappropriate schedule of product administration, Laboratory test abnormal, Pallor, Tachycardia
Clinical narrative: Acute hemolytic anemia; Felt pale and tachycardic; Felt pale and tachycardic; This is a spontaneous report from a contactable pharmacist. A 37-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), intramuscularly on 06Jan2021 12:30 on Left arm at single dose for COVID-19 immunization, facility where the most recent COVID-19 vaccine was administered in Hospital; pembrolizumab (KEYTRUDA), via unspecified route of administration from 01Dec2020 and from 22Dec2020 at unspecified dosage for unspecified indication. Medical history included thymic carcinoma stage IV, Allergy to adhesive tape. Concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 (lot number=EJ1685) intramuscularly on 18Dec2020 14:15 on Left arm for COVID-19 immunization. It was reported that patient was receiving Keytruda (01Dec2020 and 22Dec2020) which could cause hemolytic anemia. Labs were stable on 22Dec2020. Patient felt pale and tachycardic the next day (07Jan2021) but didn't notify us. He had follow-up on 1/12/2021 at the cancer center. The labs were consistent with acute hemolytic anemia (12Jan2021 at 08:00 AM), and patient was closely followed by hematology. He was on immunotherapy for cancer treatment, but there was concern for COVID vaccine contributing the hemolytic anemia. Events were result in doctor or other healthcare professional office/clinic visit. Treatment received for acute hemolytic anemia included blood transfusion. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The action taken for pembrolizumab was unknown. The outcome of the events were not resolved.; Sender's Comments: Based on the available information, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of reported events acute hemolytic anemia, pallor and tachycardia cannot be completely excluded. concomitant use of KEYTRUDA and patient's underlying medical condition may have also contributed to reported events. The case will be reevaluated should additional information become 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: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Transfusion
Clinical narrative: Acute hemolytic anemia; Felt pale and tachycardic; Felt pale and tachycardic; This is a spontaneous report from a contactable pharmacist. A 37-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), intramuscularly on 06Jan2021 12:30 on Left arm at single dose for COVID-19 immunization, facility where the most recent COVID-19 vaccine was administered in Hospital; pembrolizumab (KEYTRUDA), via unspecified route of administration from 01Dec2020 and from 22Dec2020 at unspecified dosage for unspecified indication. Medical history included thymic carcinoma stage IV, Allergy to adhesive tape. Concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 (lot number=EJ1685) intramuscularly on 18Dec2020 14:15 on Left arm for COVID-19 immunization. It was reported that patient was receiving Keytruda (01Dec2020 and 22Dec2020) which could cause hemolytic anemia. Labs were stable on 22Dec2020. Patient felt pale and tachycardic the next day (07Jan2021) but didn't notify us. He had follow-up on 1/12/2021 at the cancer center. The labs were consistent with acute hemolytic anemia (12Jan2021 at 08:00 AM), and patient was closely followed by hematology. He was on immunotherapy for cancer treatment, but there was concern for COVID vaccine contributing the hemolytic anemia. Events were result in doctor or other healthcare professional office/clinic visit. Treatment received for acute hemolytic anemia included blood transfusion. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The action taken for pembrolizumab was unknown. The outcome of the events were not resolved.; Sender's Comments: Based on the available information, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of reported events acute hemolytic anemia, pallor and tachycardia cannot be completely excluded. concomitant use of KEYTRUDA and patient's underlying medical condition may have also contributed to reported events. The case will be reevaluated should additional information become 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: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Injection site erythema, Injection site papule, Injection site pruritus, Injection site rash
Clinical narrative: red, bumpy, itchy, scaling rash developed around injection site within two hours of receiving vaccine; red, bumpy, itchy, scaling rash developed around injection site within two hours of receiving vaccine; red, bumpy, itchy, scaling rash developed around injection site within two hours of receiving vaccine; red, bumpy, itchy, scaling rash developed around injection site within two hours of receiving vaccine, spreading to entire trunk, including face, bilateral arms, chest, abdomen, and thighs; This is a spontaneous report from a contactable nurse, reporting for herself.  A 28-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EK9231, via an unspecified route of administration on 15Jan2021 at 11:00 (at the age of 28 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history included crohn's disease from  an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Ustekinumab (STELARA), sertraline, imipramine, colestipol, and B12, all from an unknown date for unknown indications. The patient did not receive any other vaccines within four weeks prior to the vaccination,  The vaccine was given at a Hospital. On 15Jan2021 at 13:30, the patient experienced red, bumpy, itchy, scaling rash around injection site within two hours of receiving vaccine, spreading to entire trunk, including face, bilateral arms, chest, abdomen, and thighs within 24 hours. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the events which included Medrol dose pack. The clinical outcome of red, bumpy, itchy, scaling rash around injection site within two hours of receiving vaccine, spreading to entire trunk, including face, bilateral arms, chest, abdomen, and thighs within 24 hours was recovered on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: red, bumpy, itchy, scaling rash developed around injection site within two hours of receiving vaccine; red, bumpy, itchy, scaling rash developed around injection site within two hours of receiving vaccine; red, bumpy, itchy, scaling rash developed around injection site within two hours of receiving vaccine; red, bumpy, itchy, scaling rash developed around injection site within two hours of receiving vaccine, spreading to entire trunk, including face, bilateral arms, chest, abdomen, and thighs; This is a spontaneous report from a contactable nurse, reporting for herself.  A 28-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EK9231, via an unspecified route of administration on 15Jan2021 at 11:00 (at the age of 28 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history included crohn's disease from  an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Ustekinumab (STELARA), sertraline, imipramine, colestipol, and B12, all from an unknown date for unknown indications. The patient did not receive any other vaccines within four weeks prior to the vaccination,  The vaccine was given at a Hospital. On 15Jan2021 at 13:30, the patient experienced red, bumpy, itchy, scaling rash around injection site within two hours of receiving vaccine, spreading to entire trunk, including face, bilateral arms, chest, abdomen, and thighs within 24 hours. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the events which included Medrol dose pack. The clinical outcome of red, bumpy, itchy, scaling rash around injection site within two hours of receiving vaccine, spreading to entire trunk, including face, bilateral arms, chest, abdomen, and thighs within 24 hours was recovered on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: red, bumpy, itchy, scaling rash developed around injection site within two hours of receiving vaccine; red, bumpy, itchy, scaling rash developed around injection site within two hours of receiving vaccine; red, bumpy, itchy, scaling rash developed around injection site within two hours of receiving vaccine; red, bumpy, itchy, scaling rash developed around injection site within two hours of receiving vaccine, spreading to entire trunk, including face, bilateral arms, chest, abdomen, and thighs; This is a spontaneous report from a contactable nurse, reporting for herself.  A 28-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EK9231, via an unspecified route of administration on 15Jan2021 at 11:00 (at the age of 28 years old) as a single dose in the right arm for COVID-19 vaccination. Medical history included crohn's disease from  an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included Ustekinumab (STELARA), sertraline, imipramine, colestipol, and B12, all from an unknown date for unknown indications. The patient did not receive any other vaccines within four weeks prior to the vaccination,  The vaccine was given at a Hospital. On 15Jan2021 at 13:30, the patient experienced red, bumpy, itchy, scaling rash around injection site within two hours of receiving vaccine, spreading to entire trunk, including face, bilateral arms, chest, abdomen, and thighs within 24 hours. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the events which included Medrol dose pack. The clinical outcome of red, bumpy, itchy, scaling rash around injection site within two hours of receiving vaccine, spreading to entire trunk, including face, bilateral arms, chest, abdomen, and thighs within 24 hours was recovered on an unspecified date in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Myalgia, Neck pain
Clinical narrative: Body and muscle aches; muscle ache; Neck pain; Pounding headache; This is a spontaneous report from a contactable health care professional (patient).  A 38-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3302), via an unspecified route of administration on 20Jan2021 at 08:30 on the left arm at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) for COVID-19 immunization. The patient has not been tested for COVID-19 since the vaccination. The patient experienced body and muscle aches, neck pain and pounding headache on 20Jan2021 at 08:30. The patient did not receive treatment for the events. The outcome of the events was unknown. The events were reported as non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Myalgia, Neck pain, Pain
Clinical narrative: Body and muscle aches; muscle ache; Neck pain; Pounding headache; This is a spontaneous report from a contactable health care professional (patient).  A 38-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3302), via an unspecified route of administration on 20Jan2021 at 08:30 on the left arm at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) for COVID-19 immunization. The patient has not been tested for COVID-19 since the vaccination. The patient experienced body and muscle aches, neck pain and pounding headache on 20Jan2021 at 08:30. The patient did not receive treatment for the events. The outcome of the events was unknown. The events were reported as non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bruxism, Erythema, Gait disturbance, Hypoaesthesia, Muscle spasms
Clinical narrative: bilateral leg paralysis; nauseous; hardly walk; muscles were so tight/jaws felt locked, like a tightness; numbness on the left side of [her] face, right under the eye; temporary rash she had on the left side of her face, under her cheek; toes crowded back; This is a spontaneous report from a contactable consumer (patient).  A 54-year-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose "on the left side" for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  She stated feeling nauseous right after the shot and mentioned not eating breakfast. She described having bilateral leg paralysis which she also qualified as locked to the point where she could hardly walk. She added that her leg muscles were so tight that her toes crowded back. She then explained having numbness on the left side of her face, right under the eye and that her jaws felt locked, like a tightness. She specified she didn't know if she really felt tightness in her jaws because of the intensity of her bilateral leg paralysis. She then described a temporary rash she had on the left side of her face, under her cheek. She said her experience occurred two hours post injection on 21Jan2021 and was resolved in Jan2021 after taking a muscle relaxer.  She asked if shellfish is in the vaccine.    Information about lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in jaw, Paraesthesia oral
Clinical narrative: bilateral leg paralysis; nauseous; hardly walk; muscles were so tight/jaws felt locked, like a tightness; numbness on the left side of [her] face, right under the eye; temporary rash she had on the left side of her face, under her cheek; toes crowded back; This is a spontaneous report from a contactable consumer (patient).  A 54-year-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose "on the left side" for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  She stated feeling nauseous right after the shot and mentioned not eating breakfast. She described having bilateral leg paralysis which she also qualified as locked to the point where she could hardly walk. She added that her leg muscles were so tight that her toes crowded back. She then explained having numbness on the left side of her face, right under the eye and that her jaws felt locked, like a tightness. She specified she didn't know if she really felt tightness in her jaws because of the intensity of her bilateral leg paralysis. She then described a temporary rash she had on the left side of her face, under her cheek. She said her experience occurred two hours post injection on 21Jan2021 and was resolved in Jan2021 after taking a muscle relaxer.  She asked if shellfish is in the vaccine.    Information about lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Diplegia, Hypoaesthesia, Immediate post-injection reaction, Mobility decreased, Muscle tightness
Clinical narrative: bilateral leg paralysis; nauseous; hardly walk; muscles were so tight/jaws felt locked, like a tightness; numbness on the left side of [her] face, right under the eye; temporary rash she had on the left side of her face, under her cheek; toes crowded back; This is a spontaneous report from a contactable consumer (patient).  A 54-year-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose "on the left side" for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  She stated feeling nauseous right after the shot and mentioned not eating breakfast. She described having bilateral leg paralysis which she also qualified as locked to the point where she could hardly walk. She added that her leg muscles were so tight that her toes crowded back. She then explained having numbness on the left side of her face, right under the eye and that her jaws felt locked, like a tightness. She specified she didn't know if she really felt tightness in her jaws because of the intensity of her bilateral leg paralysis. She then described a temporary rash she had on the left side of her face, under her cheek. She said her experience occurred two hours post injection on 21Jan2021 and was resolved in Jan2021 after taking a muscle relaxer.  She asked if shellfish is in the vaccine.    Information about lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Rash, Trismus
Clinical narrative: bilateral leg paralysis; nauseous; hardly walk; muscles were so tight/jaws felt locked, like a tightness; numbness on the left side of [her] face, right under the eye; temporary rash she had on the left side of her face, under her cheek; toes crowded back; This is a spontaneous report from a contactable consumer (patient).  A 54-year-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose "on the left side" for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  She stated feeling nauseous right after the shot and mentioned not eating breakfast. She described having bilateral leg paralysis which she also qualified as locked to the point where she could hardly walk. She added that her leg muscles were so tight that her toes crowded back. She then explained having numbness on the left side of her face, right under the eye and that her jaws felt locked, like a tightness. She specified she didn't know if she really felt tightness in her jaws because of the intensity of her bilateral leg paralysis. She then described a temporary rash she had on the left side of her face, under her cheek. She said her experience occurred two hours post injection on 21Jan2021 and was resolved in Jan2021 after taking a muscle relaxer.  She asked if shellfish is in the vaccine.    Information about lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Gait inability, Hypoaesthesia, Muscle spasms, Muscle tightness
Clinical narrative: bilateral leg paralysis; nauseous; hardly walk; muscles were so tight/jaws felt locked, like a tightness; numbness on the left side of [her] face, right under the eye; temporary rash she had on the left side of her face, under her cheek; toes crowded back; This is a spontaneous report from a contactable consumer (patient).  A 54-year-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose "on the left side" for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  She stated feeling nauseous right after the shot and mentioned not eating breakfast. She described having bilateral leg paralysis which she also qualified as locked to the point where she could hardly walk. She added that her leg muscles were so tight that her toes crowded back. She then explained having numbness on the left side of her face, right under the eye and that her jaws felt locked, like a tightness. She specified she didn't know if she really felt tightness in her jaws because of the intensity of her bilateral leg paralysis. She then described a temporary rash she had on the left side of her face, under her cheek. She said her experience occurred two hours post injection on 21Jan2021 and was resolved in Jan2021 after taking a muscle relaxer.  She asked if shellfish is in the vaccine.    Information about lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in jaw, Paraesthesia
Clinical narrative: bilateral leg paralysis; nauseous; hardly walk; muscles were so tight/jaws felt locked, like a tightness; numbness on the left side of [her] face, right under the eye; temporary rash she had on the left side of her face, under her cheek; toes crowded back; This is a spontaneous report from a contactable consumer (patient).  A 54-year-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose "on the left side" for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  She stated feeling nauseous right after the shot and mentioned not eating breakfast. She described having bilateral leg paralysis which she also qualified as locked to the point where she could hardly walk. She added that her leg muscles were so tight that her toes crowded back. She then explained having numbness on the left side of her face, right under the eye and that her jaws felt locked, like a tightness. She specified she didn't know if she really felt tightness in her jaws because of the intensity of her bilateral leg paralysis. She then described a temporary rash she had on the left side of her face, under her cheek. She said her experience occurred two hours post injection on 21Jan2021 and was resolved in Jan2021 after taking a muscle relaxer.  She asked if shellfish is in the vaccine.    Information about lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Headache, Insomnia, Myalgia
Clinical narrative: 102.8 F fever; aches in muscles and joints; aches in muscles and joints; chills; headache; This is a spontaneous report from a contactable consumer, the patient. This 51-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EL9262), first dose, via an unspecified route of administration in the left arm on 21Jan2021 at 12:00 (at the age of 51-years-old) as a single dose for COVID-19 vaccination. Medical history included migraine from an unknown date and unknown if ongoing, cow's milk protein allergy from an unknown date and unknown if ongoing, lactose allergy from an unknown date and unknown if ongoing, peppermint allergy from an unknown date and unknown if ongoing and Penicillin allergy from an unknown date and unknown if ongoing. Concomitant medication included butalbital (BUTALBITAL), zolmitriptan (ZOMIG), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), benzonatate (BENZONATATE) and levocetirizine dihydrochloride (XYZAL). The patient previously took bactrim and experienced drug hypersensitivity, ultram er and experienced drug hypersensitivity. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. On 21Jan2021 at 04:00, the patient experienced 102.8 degree Fahrenheit fever, aches in muscle and joints, headache and chills. No therapeutic measures were taken as a result of the events. The clinical outcome of the 102.8 degree Fahrenheit fever, aches in muscle and joints, headache and chills was resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: 102.8 F fever; aches in muscles and joints; aches in muscles and joints; chills; headache; This is a spontaneous report from a contactable consumer, the patient. This 51-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EL9262), first dose, via an unspecified route of administration in the left arm on 21Jan2021 at 12:00 (at the age of 51-years-old) as a single dose for COVID-19 vaccination. Medical history included migraine from an unknown date and unknown if ongoing, cow's milk protein allergy from an unknown date and unknown if ongoing, lactose allergy from an unknown date and unknown if ongoing, peppermint allergy from an unknown date and unknown if ongoing and Penicillin allergy from an unknown date and unknown if ongoing. Concomitant medication included butalbital (BUTALBITAL), zolmitriptan (ZOMIG), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), benzonatate (BENZONATATE) and levocetirizine dihydrochloride (XYZAL). The patient previously took bactrim and experienced drug hypersensitivity, ultram er and experienced drug hypersensitivity. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. On 21Jan2021 at 04:00, the patient experienced 102.8 degree Fahrenheit fever, aches in muscle and joints, headache and chills. No therapeutic measures were taken as a result of the events. The clinical outcome of the 102.8 degree Fahrenheit fever, aches in muscle and joints, headache and chills was resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Myalgia
Clinical narrative: 102.8 F fever; aches in muscles and joints; aches in muscles and joints; chills; headache; This is a spontaneous report from a contactable consumer, the patient. This 51-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EL9262), first dose, via an unspecified route of administration in the left arm on 21Jan2021 at 12:00 (at the age of 51-years-old) as a single dose for COVID-19 vaccination. Medical history included migraine from an unknown date and unknown if ongoing, cow's milk protein allergy from an unknown date and unknown if ongoing, lactose allergy from an unknown date and unknown if ongoing, peppermint allergy from an unknown date and unknown if ongoing and Penicillin allergy from an unknown date and unknown if ongoing. Concomitant medication included butalbital (BUTALBITAL), zolmitriptan (ZOMIG), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), benzonatate (BENZONATATE) and levocetirizine dihydrochloride (XYZAL). The patient previously took bactrim and experienced drug hypersensitivity, ultram er and experienced drug hypersensitivity. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. On 21Jan2021 at 04:00, the patient experienced 102.8 degree Fahrenheit fever, aches in muscle and joints, headache and chills. No therapeutic measures were taken as a result of the events. The clinical outcome of the 102.8 degree Fahrenheit fever, aches in muscle and joints, headache and chills was resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: 102.8 F fever; aches in muscles and joints; aches in muscles and joints; chills; headache; This is a spontaneous report from a contactable consumer, the patient. This 51-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EL9262), first dose, via an unspecified route of administration in the left arm on 21Jan2021 at 12:00 (at the age of 51-years-old) as a single dose for COVID-19 vaccination. Medical history included migraine from an unknown date and unknown if ongoing, cow's milk protein allergy from an unknown date and unknown if ongoing, lactose allergy from an unknown date and unknown if ongoing, peppermint allergy from an unknown date and unknown if ongoing and Penicillin allergy from an unknown date and unknown if ongoing. Concomitant medication included butalbital (BUTALBITAL), zolmitriptan (ZOMIG), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), benzonatate (BENZONATATE) and levocetirizine dihydrochloride (XYZAL). The patient previously took bactrim and experienced drug hypersensitivity, ultram er and experienced drug hypersensitivity. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. On 21Jan2021 at 04:00, the patient experienced 102.8 degree Fahrenheit fever, aches in muscle and joints, headache and chills. No therapeutic measures were taken as a result of the events. The clinical outcome of the 102.8 degree Fahrenheit fever, aches in muscle and joints, headache and chills was resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Pulse absent, Resuscitation
Clinical narrative: Passed out; Pulseless for 30 seconds; Feel dizzy and nauseous; Feel dizzy and nauseous; This is a spontaneous report from a contactable Other Health Professional (patient).  A 25-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown since not available/provided to reporter at the time of report completion), via an unspecified route of administration at left arm on 22Jan2021 11:45 at single dose for COVID-19 immunization at a Nursing Home/Senior Living Facility. The patient's medical history included known allergies: Sulfa and poppy seed. No other known medical history/conditions. For concomitant medications, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took amoxicillin, clarithromycin (BIAXIN) and cefaclor (CECLOR), and experienced drug allergy. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for COVID-19 since the vaccination. After receiving the vaccine, the patient was sitting in the observation area for about 10 minutes when she started to feel dizzy and nauseous. She raised her hand up and called for the nurse to come over. She passed out. She was pulseless for 30 seconds and they had to begin giving her CPR chest compressions. She woke up lying on the ground and was taken to the emergency room (ER) where they ran tests to see how she was doing and for observation for several hours. The patient was "discharged" this afternoon and was doing better. The events result in emergency room/department or urgent care. Treatment was received for the events, ER observation and care, and CPR chest compressions. The patient underwent lab tests and procedures which included test on 22Jan2021: unknown results. The outcome of events at the time of last observation was recovering. The reporter's assessment of the events was non-serious, no results in death, no life threatening, not causing/prolonging hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect.  Information on the lot/batch number has been requested.; Sender's Comments: The reported passed out and pulseless for 30 seconds were likely related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship.   However, considering the clinical course and medical history, other cause(s)/confounding factors cannot be excluded.  The case will be reassessed should additional information become 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: 25.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Dizziness, Electrocardiogram, Glucose tolerance test, Loss of consciousness
Clinical narrative: Passed out; Pulseless for 30 seconds; Feel dizzy and nauseous; Feel dizzy and nauseous; This is a spontaneous report from a contactable Other Health Professional (patient).  A 25-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number and expiration date unknown since not available/provided to reporter at the time of report completion), via an unspecified route of administration at left arm on 22Jan2021 11:45 at single dose for COVID-19 immunization at a Nursing Home/Senior Living Facility. The patient's medical history included known allergies: Sulfa and poppy seed. No other known medical history/conditions. For concomitant medications, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took amoxicillin, clarithromycin (BIAXIN) and cefaclor (CECLOR), and experienced drug allergy. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for COVID-19 since the vaccination. After receiving the vaccine, the patient was sitting in the observation area for about 10 minutes when she started to feel dizzy and nauseous. She raised her hand up and called for the nurse to come over. She passed out. She was pulseless for 30 seconds and they had to begin giving her CPR chest compressions. She woke up lying on the ground and was taken to the emergency room (ER) where they ran tests to see how she was doing and for observation for several hours. The patient was "discharged" this afternoon and was doing better. The events result in emergency room/department or urgent care. Treatment was received for the events, ER observation and care, and CPR chest compressions. The patient underwent lab tests and procedures which included test on 22Jan2021: unknown results. The outcome of events at the time of last observation was recovering. The reporter's assessment of the events was non-serious, no results in death, no life threatening, not causing/prolonging hospitalization, no disabling/incapacitating, no congenital anomaly/birth defect.  Information on the lot/batch number has been requested.; Sender's Comments: The reported passed out and pulseless for 30 seconds were likely related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship.   However, considering the clinical course and medical history, other cause(s)/confounding factors cannot be excluded.  The case will be reassessed should additional information become 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.