chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Appendicectomy, Appendicitis, Computerised tomogram abnormal
Clinical narrative: appendicitis; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports.  A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 27Mar2021 at 16:30 (batch/lot number: ER 870) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism from an unspecified date. The patient was not pregnant. Concomitant medications included levothyroxine sodium (SYNTHROID) and drospirenone (SLYND); both taken for an unspecified indication, start and stop date were not reported. Facility type vaccine was pharmacy or drug store. No other vaccine in four weeks. On 31Mar2021 at 12:00 AM, 4 days after receiving the first Pfizer shot, the patient was hospitalized with severe abdominal pain and diagnosed with appendicitis. A day later, she had surgery to remove her appendix. The woman in the hospital bed next to her had received the same shot on the same day and was hospitalized at the same time as her with the same diagnosis and surgery. The adverse event resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient was hospitalized for appendicitis from 31Mar2021 to 03Apr2021 for 3 days. No Covid prior to vaccination and was Covid tested post vaccination. Covid test post vaccination included nasal swab on 31Mar2021 with negative result. Therapeutic measures were taken as a result of appendicitis which included appendectomy. The outcome of the event was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021403551 same reporter, drug and event, different patient
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Appendicitis, SARS-CoV-2 test
Clinical narrative: appendicitis; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports.  A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the left arm on 27Mar2021 at 16:30 (batch/lot number: ER 870) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism from an unspecified date. The patient was not pregnant. Concomitant medications included levothyroxine sodium (SYNTHROID) and drospirenone (SLYND); both taken for an unspecified indication, start and stop date were not reported. Facility type vaccine was pharmacy or drug store. No other vaccine in four weeks. On 31Mar2021 at 12:00 AM, 4 days after receiving the first Pfizer shot, the patient was hospitalized with severe abdominal pain and diagnosed with appendicitis. A day later, she had surgery to remove her appendix. The woman in the hospital bed next to her had received the same shot on the same day and was hospitalized at the same time as her with the same diagnosis and surgery. The adverse event resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient was hospitalized for appendicitis from 31Mar2021 to 03Apr2021 for 3 days. No Covid prior to vaccination and was Covid tested post vaccination. Covid test post vaccination included nasal swab on 31Mar2021 with negative result. Therapeutic measures were taken as a result of appendicitis which included appendectomy. The outcome of the event was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021403551 same reporter, drug and event, different patient
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic shock, Burning sensation, Chest pain, Dyspnoea, Ear discomfort
Clinical narrative: anaphylactic shock; chest pains; tingling in extremities; shortness of breath/couldn't breath; wheezing; Throat closed; chest tightened; burning in arms that traveled down my arms then into my torso and legs/Scalp and ears also burning/still feeling the burning; Scalp and ears also burning; ears also burning; Itchy throat all days; couldn't breath or talk; This is a spontaneous report from contactable consumers. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 13:30 (Lot Number: EW0151) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Medical history included fish, tree nuts, peanuts allergy, in-door & outdoor environmental allergies, pet dander allergy, rheumatoid arthritis, asthma, GERD, chronic dry eye and ADHD; all from an unknown date and unknown if ongoing. Concomitant medications included albuterol, lifitegrast (XIIDRA), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), prednisone, cetirizine hydrochloride (ZYRTEC) and etanercept (ENBREL); all taken for an unspecified indication, start and stop date were not reported. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 31Mar2021 13:45, the patient began with chest pains, then tingling in extremities, then shortness of breath & wheezing.  Suddenly, was in anaphylactic shock. The patient experienced throat closed, chest tightened, couldn't breath or talk. Same symptoms came back on 01Apr2021. The patient went to emergency room/department or urgent care. The patient stated, "I went into anaphylactic shock again and back to hospital. The following day, anaphylaxis re-turned, but no anaphylactic shock. Shortness of breath, burning in arms that traveled down my arms then into my torso and legs. Itchy throat all days. Scalp and ears also burning. Today, on day 4, still feeling the burning and trouble breathing. Every time the Benadryl wears off, it feels like it's still attacking my body". Treatment for the events was received such as 3 epi-pen injections, EKG, IV of Benadryl and IV of steroids. The outcome of the event "burning in arms that traveled down my arms then into my torso and legs/Scalp and ears also burning/still feeling the burning" was unknown and the outcome of the rest of the events was not recovered. The patient was hospitalized due to event anaphylactic shock that was also reported as life threatening.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypopnoea, Paraesthesia, Paraesthesia oral, Pharyngeal paraesthesia, Skin burning sensation
Clinical narrative: anaphylactic shock; chest pains; tingling in extremities; shortness of breath/couldn't breath; wheezing; Throat closed; chest tightened; burning in arms that traveled down my arms then into my torso and legs/Scalp and ears also burning/still feeling the burning; Scalp and ears also burning; ears also burning; Itchy throat all days; couldn't breath or talk; This is a spontaneous report from contactable consumers. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 13:30 (Lot Number: EW0151) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Medical history included fish, tree nuts, peanuts allergy, in-door & outdoor environmental allergies, pet dander allergy, rheumatoid arthritis, asthma, GERD, chronic dry eye and ADHD; all from an unknown date and unknown if ongoing. Concomitant medications included albuterol, lifitegrast (XIIDRA), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), prednisone, cetirizine hydrochloride (ZYRTEC) and etanercept (ENBREL); all taken for an unspecified indication, start and stop date were not reported. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 31Mar2021 13:45, the patient began with chest pains, then tingling in extremities, then shortness of breath & wheezing.  Suddenly, was in anaphylactic shock. The patient experienced throat closed, chest tightened, couldn't breath or talk. Same symptoms came back on 01Apr2021. The patient went to emergency room/department or urgent care. The patient stated, "I went into anaphylactic shock again and back to hospital. The following day, anaphylaxis re-turned, but no anaphylactic shock. Shortness of breath, burning in arms that traveled down my arms then into my torso and legs. Itchy throat all days. Scalp and ears also burning. Today, on day 4, still feeling the burning and trouble breathing. Every time the Benadryl wears off, it feels like it's still attacking my body". Treatment for the events was received such as 3 epi-pen injections, EKG, IV of Benadryl and IV of steroids. The outcome of the event "burning in arms that traveled down my arms then into my torso and legs/Scalp and ears also burning/still feeling the burning" was unknown and the outcome of the rest of the events was not recovered. The patient was hospitalized due to event anaphylactic shock that was also reported as life threatening.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic shock, Burning sensation, Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: anaphylactic shock; chest pains; tingling in extremities; shortness of breath/couldn't breath; wheezing; Throat closed; chest tightened; burning in arms that traveled down my arms then into my torso and legs/Scalp and ears also burning/still feeling the burning; Scalp and ears also burning; ears also burning; Itchy throat all days; couldn't breath or talk; This is a spontaneous report from contactable consumers. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 13:30 (Lot Number: EW0151) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Medical history included fish, tree nuts, peanuts allergy, in-door & outdoor environmental allergies, pet dander allergy, rheumatoid arthritis, asthma, GERD, chronic dry eye and ADHD; all from an unknown date and unknown if ongoing. Concomitant medications included albuterol, lifitegrast (XIIDRA), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), prednisone, cetirizine hydrochloride (ZYRTEC) and etanercept (ENBREL); all taken for an unspecified indication, start and stop date were not reported. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 31Mar2021 13:45, the patient began with chest pains, then tingling in extremities, then shortness of breath & wheezing.  Suddenly, was in anaphylactic shock. The patient experienced throat closed, chest tightened, couldn't breath or talk. Same symptoms came back on 01Apr2021. The patient went to emergency room/department or urgent care. The patient stated, "I went into anaphylactic shock again and back to hospital. The following day, anaphylaxis re-turned, but no anaphylactic shock. Shortness of breath, burning in arms that traveled down my arms then into my torso and legs. Itchy throat all days. Scalp and ears also burning. Today, on day 4, still feeling the burning and trouble breathing. Every time the Benadryl wears off, it feels like it's still attacking my body". Treatment for the events was received such as 3 epi-pen injections, EKG, IV of Benadryl and IV of steroids. The outcome of the event "burning in arms that traveled down my arms then into my torso and legs/Scalp and ears also burning/still feeling the burning" was unknown and the outcome of the rest of the events was not recovered. The patient was hospitalized due to event anaphylactic shock that was also reported as life threatening.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Paraesthesia, Skin burning sensation, Speech disorder, Throat irritation
Clinical narrative: anaphylactic shock; chest pains; tingling in extremities; shortness of breath/couldn't breath; wheezing; Throat closed; chest tightened; burning in arms that traveled down my arms then into my torso and legs/Scalp and ears also burning/still feeling the burning; Scalp and ears also burning; ears also burning; Itchy throat all days; couldn't breath or talk; This is a spontaneous report from contactable consumers. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 13:30 (Lot Number: EW0151) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Medical history included fish, tree nuts, peanuts allergy, in-door & outdoor environmental allergies, pet dander allergy, rheumatoid arthritis, asthma, GERD, chronic dry eye and ADHD; all from an unknown date and unknown if ongoing. Concomitant medications included albuterol, lifitegrast (XIIDRA), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), prednisone, cetirizine hydrochloride (ZYRTEC) and etanercept (ENBREL); all taken for an unspecified indication, start and stop date were not reported. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 31Mar2021 13:45, the patient began with chest pains, then tingling in extremities, then shortness of breath & wheezing.  Suddenly, was in anaphylactic shock. The patient experienced throat closed, chest tightened, couldn't breath or talk. Same symptoms came back on 01Apr2021. The patient went to emergency room/department or urgent care. The patient stated, "I went into anaphylactic shock again and back to hospital. The following day, anaphylaxis re-turned, but no anaphylactic shock. Shortness of breath, burning in arms that traveled down my arms then into my torso and legs. Itchy throat all days. Scalp and ears also burning. Today, on day 4, still feeling the burning and trouble breathing. Every time the Benadryl wears off, it feels like it's still attacking my body". Treatment for the events was received such as 3 epi-pen injections, EKG, IV of Benadryl and IV of steroids. The outcome of the event "burning in arms that traveled down my arms then into my torso and legs/Scalp and ears also burning/still feeling the burning" was unknown and the outcome of the rest of the events was not recovered. The patient was hospitalized due to event anaphylactic shock that was also reported as life threatening.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness, Wheezing
Clinical narrative: anaphylactic shock; chest pains; tingling in extremities; shortness of breath/couldn't breath; wheezing; Throat closed; chest tightened; burning in arms that traveled down my arms then into my torso and legs/Scalp and ears also burning/still feeling the burning; Scalp and ears also burning; ears also burning; Itchy throat all days; couldn't breath or talk; This is a spontaneous report from contactable consumers. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 13:30 (Lot Number: EW0151) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Medical history included fish, tree nuts, peanuts allergy, in-door & outdoor environmental allergies, pet dander allergy, rheumatoid arthritis, asthma, GERD, chronic dry eye and ADHD; all from an unknown date and unknown if ongoing. Concomitant medications included albuterol, lifitegrast (XIIDRA), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), prednisone, cetirizine hydrochloride (ZYRTEC) and etanercept (ENBREL); all taken for an unspecified indication, start and stop date were not reported. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 31Mar2021 13:45, the patient began with chest pains, then tingling in extremities, then shortness of breath & wheezing.  Suddenly, was in anaphylactic shock. The patient experienced throat closed, chest tightened, couldn't breath or talk. Same symptoms came back on 01Apr2021. The patient went to emergency room/department or urgent care. The patient stated, "I went into anaphylactic shock again and back to hospital. The following day, anaphylaxis re-turned, but no anaphylactic shock. Shortness of breath, burning in arms that traveled down my arms then into my torso and legs. Itchy throat all days. Scalp and ears also burning. Today, on day 4, still feeling the burning and trouble breathing. Every time the Benadryl wears off, it feels like it's still attacking my body". Treatment for the events was received such as 3 epi-pen injections, EKG, IV of Benadryl and IV of steroids. The outcome of the event "burning in arms that traveled down my arms then into my torso and legs/Scalp and ears also burning/still feeling the burning" was unknown and the outcome of the rest of the events was not recovered. The patient was hospitalized due to event anaphylactic shock that was also reported as life threatening.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Blood pressure increased, Dizziness, Heart rate increased, Nausea
Clinical narrative: extremely dizzy; throat swelling; Anaphylactic response; This is a spontaneous report from a contactable consumer reporting for herself. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number Ep7533/expiration date: not provided), via an unspecified route of administration, on 31Mar2021 at 10:30 (at the age of 41 years old) as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Mar2021 at 11:15, the patient experienced extremely dizzy, throat swelling, and anaphylactic response. The clinical course of the events were as follows: 45 minutes after receiving COVID-19 vaccine, the patient was extremely dizzy, then had throat swelling, and anaphylactic response. The patient was admitted to ER and given treatment with epinephrine, steroids, albuterol, nubulizer, and blood. The events dizzy, throat swelling, and anaphylactic response were considered serious as requiring an emergency room visit and hospitalization for 1 day. The patient received treatment for these events. The outcome of the events dizzy, throat swelling, and anaphylactic response was recovering. Since the vaccination, the patient had not been tested for COVID-19.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash macular
Clinical narrative: extremely dizzy; throat swelling; Anaphylactic response; This is a spontaneous report from a contactable consumer reporting for herself. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number Ep7533/expiration date: not provided), via an unspecified route of administration, on 31Mar2021 at 10:30 (at the age of 41 years old) as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Mar2021 at 11:15, the patient experienced extremely dizzy, throat swelling, and anaphylactic response. The clinical course of the events were as follows: 45 minutes after receiving COVID-19 vaccine, the patient was extremely dizzy, then had throat swelling, and anaphylactic response. The patient was admitted to ER and given treatment with epinephrine, steroids, albuterol, nubulizer, and blood. The events dizzy, throat swelling, and anaphylactic response were considered serious as requiring an emergency room visit and hospitalization for 1 day. The patient received treatment for these events. The outcome of the events dizzy, throat swelling, and anaphylactic response was recovering. Since the vaccination, the patient had not been tested for COVID-19.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Dizziness, Pharyngeal swelling
Clinical narrative: extremely dizzy; throat swelling; Anaphylactic response; This is a spontaneous report from a contactable consumer reporting for herself. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number Ep7533/expiration date: not provided), via an unspecified route of administration, on 31Mar2021 at 10:30 (at the age of 41 years old) as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Mar2021 at 11:15, the patient experienced extremely dizzy, throat swelling, and anaphylactic response. The clinical course of the events were as follows: 45 minutes after receiving COVID-19 vaccine, the patient was extremely dizzy, then had throat swelling, and anaphylactic response. The patient was admitted to ER and given treatment with epinephrine, steroids, albuterol, nubulizer, and blood. The events dizzy, throat swelling, and anaphylactic response were considered serious as requiring an emergency room visit and hospitalization for 1 day. The patient received treatment for these events. The outcome of the events dizzy, throat swelling, and anaphylactic response was recovering. Since the vaccination, the patient had not been tested for COVID-19.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Flushing, Hyperventilation, Nausea, Paraesthesia
Clinical narrative: extremely dizzy; throat swelling; Anaphylactic response; This is a spontaneous report from a contactable consumer reporting for herself. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number Ep7533/expiration date: not provided), via an unspecified route of administration, on 31Mar2021 at 10:30 (at the age of 41 years old) as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Mar2021 at 11:15, the patient experienced extremely dizzy, throat swelling, and anaphylactic response. The clinical course of the events were as follows: 45 minutes after receiving COVID-19 vaccine, the patient was extremely dizzy, then had throat swelling, and anaphylactic response. The patient was admitted to ER and given treatment with epinephrine, steroids, albuterol, nubulizer, and blood. The events dizzy, throat swelling, and anaphylactic response were considered serious as requiring an emergency room visit and hospitalization for 1 day. The patient received treatment for these events. The outcome of the events dizzy, throat swelling, and anaphylactic response was recovering. Since the vaccination, the patient had not been tested for COVID-19.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash macular, Throat tightness
Clinical narrative: extremely dizzy; throat swelling; Anaphylactic response; This is a spontaneous report from a contactable consumer reporting for herself. A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number Ep7533/expiration date: not provided), via an unspecified route of administration, on 31Mar2021 at 10:30 (at the age of 41 years old) as a single dose for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 31Mar2021 at 11:15, the patient experienced extremely dizzy, throat swelling, and anaphylactic response. The clinical course of the events were as follows: 45 minutes after receiving COVID-19 vaccine, the patient was extremely dizzy, then had throat swelling, and anaphylactic response. The patient was admitted to ER and given treatment with epinephrine, steroids, albuterol, nubulizer, and blood. The events dizzy, throat swelling, and anaphylactic response were considered serious as requiring an emergency room visit and hospitalization for 1 day. The patient received treatment for these events. The outcome of the events dizzy, throat swelling, and anaphylactic response was recovering. Since the vaccination, the patient had not been tested for COVID-19.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Facial pain, Facial paralysis, Incomplete course of vaccination
Clinical narrative: bell palsy; Got shingles; This is a spontaneous report from a contactable consumer (patient).   A 56-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 15Mar2021 12:00 (Lot Number: En6208), at the age of 56-years at vaccination, as SINGLE DOSE for covid-19 immunisation.  Medical history was none. The patient previously took Advil and experienced allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included vitamins nos and 'Acid pill' taken for an unspecified indication, start and stop date were not reported.  On 2021, the patient experienced bell palsy and shingles. The event involved physician office visit. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): inconclusive on 31Mar2021.  The outcome of the events was not recovered.  Therapeutic measures were taken as a result of the events which includes viral pill and strides.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Herpes zoster, SARS-CoV-2 test
Clinical narrative: bell palsy; Got shingles; This is a spontaneous report from a contactable consumer (patient).   A 56-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 15Mar2021 12:00 (Lot Number: En6208), at the age of 56-years at vaccination, as SINGLE DOSE for covid-19 immunisation.  Medical history was none. The patient previously took Advil and experienced allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included vitamins nos and 'Acid pill' taken for an unspecified indication, start and stop date were not reported.  On 2021, the patient experienced bell palsy and shingles. The event involved physician office visit. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): inconclusive on 31Mar2021.  The outcome of the events was not recovered.  Therapeutic measures were taken as a result of the events which includes viral pill and strides.  Follow-up attempts are completed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Mobility decreased
Clinical narrative: Patient reported headache 2-4 hours after vaccination, followed by having to lie down 4-5 hours after vaccination. Overall, her AES she described as severe headache and nausea for about 3 days. She tried to take acetaminophen, but reported no relief. She also attempted to drink lots of water.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Hypokinesia, Mobility decreased
Clinical narrative: Patient reported headache 2-4 hours after vaccination, followed by having to lie down 4-5 hours after vaccination. Overall, her AES she described as severe headache and nausea for about 3 days. She tried to take acetaminophen, but reported no relief. She also attempted to drink lots of water.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Nausea
Clinical narrative: Patient reported headache 2-4 hours after vaccination, followed by having to lie down 4-5 hours after vaccination. Overall, her AES she described as severe headache and nausea for about 3 days. She tried to take acetaminophen, but reported no relief. She also attempted to drink lots of water.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Postictal state, Seizure, Tonic clonic movements
Clinical narrative: TONIC CLONIC SEIZURE; This spontaneous report received from a pharmacist concerned a 29 year old male. The patient's height, and weight were not reported.The patient's past medical history included seizure disorder, and epilepsy, and concurrent conditions included adjustment disorder with disturbance, intellectual and developmental disorder unspecified with behavioral, insomnia, right great toe wound, hyperlipidemia, hypertension, and allergic rhinitis, and other pre-existing medical conditions included patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, 1 total administered on 01-APR-202110:30 at arm for prophylactic vaccination Concomitant medications included hydroxyzine embonate for anxiety, levetiracetam for seizure, atorvastatin, fish oil, fluticasone, loratadine, melatonin, propranolol, and quetiapine.  On 02-APR-2021 10:00, the patient experienced tonic clonic seizure.Patient was asleep when convulsions were observed by roommate hospital staff alerted and seizure activity observed by nursing staff and medical students.Tonic clonic movements lasted approximately one minute, spontaneously resolved, then patient entered post-ictal state, and recovered approximately 5 minutes later. Vital signs were taken (WNL) and patient observed until return to being stable.Treatment medications (dates unspecified) included clonazepam.Patient did have a history of seizure occurrence and was on anti-epileptic medication, which he was compliant with. Patient was stable and seizure free for at least the previous six months per hospital records. Medications reviewed and levetiracetam dose was increased to 1,000mg PO. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tonic clonic seizure on 02-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210417369-covid-19 vaccine ad26.cov2.s-tonic clonic seizure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Generalised tonic-clonic seizure, Vital signs measurement
Clinical narrative: TONIC CLONIC SEIZURE; This spontaneous report received from a pharmacist concerned a 29 year old male. The patient's height, and weight were not reported.The patient's past medical history included seizure disorder, and epilepsy, and concurrent conditions included adjustment disorder with disturbance, intellectual and developmental disorder unspecified with behavioral, insomnia, right great toe wound, hyperlipidemia, hypertension, and allergic rhinitis, and other pre-existing medical conditions included patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, 1 total administered on 01-APR-202110:30 at arm for prophylactic vaccination Concomitant medications included hydroxyzine embonate for anxiety, levetiracetam for seizure, atorvastatin, fish oil, fluticasone, loratadine, melatonin, propranolol, and quetiapine.  On 02-APR-2021 10:00, the patient experienced tonic clonic seizure.Patient was asleep when convulsions were observed by roommate hospital staff alerted and seizure activity observed by nursing staff and medical students.Tonic clonic movements lasted approximately one minute, spontaneously resolved, then patient entered post-ictal state, and recovered approximately 5 minutes later. Vital signs were taken (WNL) and patient observed until return to being stable.Treatment medications (dates unspecified) included clonazepam.Patient did have a history of seizure occurrence and was on anti-epileptic medication, which he was compliant with. Patient was stable and seizure free for at least the previous six months per hospital records. Medications reviewed and levetiracetam dose was increased to 1,000mg PO. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tonic clonic seizure on 02-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210417369-covid-19 vaccine ad26.cov2.s-tonic clonic seizure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: TONIC CLONIC SEIZURE; This spontaneous report received from a pharmacist concerned a 29 year old male. The patient's height, and weight were not reported.The patient's past medical history included seizure disorder, and epilepsy, and concurrent conditions included adjustment disorder with disturbance, intellectual and developmental disorder unspecified with behavioral, insomnia, right great toe wound, hyperlipidemia, hypertension, and allergic rhinitis, and other pre-existing medical conditions included patient had no known drug allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, 1 total administered on 01-APR-202110:30 at arm for prophylactic vaccination Concomitant medications included hydroxyzine embonate for anxiety, levetiracetam for seizure, atorvastatin, fish oil, fluticasone, loratadine, melatonin, propranolol, and quetiapine.  On 02-APR-2021 10:00, the patient experienced tonic clonic seizure.Patient was asleep when convulsions were observed by roommate hospital staff alerted and seizure activity observed by nursing staff and medical students.Tonic clonic movements lasted approximately one minute, spontaneously resolved, then patient entered post-ictal state, and recovered approximately 5 minutes later. Vital signs were taken (WNL) and patient observed until return to being stable.Treatment medications (dates unspecified) included clonazepam.Patient did have a history of seizure occurrence and was on anti-epileptic medication, which he was compliant with. Patient was stable and seizure free for at least the previous six months per hospital records. Medications reviewed and levetiracetam dose was increased to 1,000mg PO. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tonic clonic seizure on 02-APR-2021. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210417369-covid-19 vaccine ad26.cov2.s-tonic clonic seizure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Dyspnoea, Pulmonary embolism, Thrombosis
Clinical narrative: She almost died from pulmonary edema; Lungs have blood clots in them; This is a spontaneous report from a contactable consumer (patient's husband). 74-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 intramuscular, administered in left upper arm muscle at age 74 years on 30Mar2021 (Batch/Lot Number: EP6955) as single dose, for COVID-19 immunisation. The patient medical history was reported as no. There were no concomitant medications. The patient historically took the first shot of BNT162B2 on an unspecified date for COVID-19 immunisation. It was reported that the patient took the shot of second dose of Pfizer BioNTech COVID Vaccine (Lot number: EP6955) shot on 30Mar2021 in her left upper arm muscle. Patient was in the hospital at the time of reporting hanging on to life. Patient got pulmonary edema and she almost died, her lungs are, have blood clots in them from 06Apr2021 then she went to the hospital on 07Apr2021, has to stay in the hospital for 4 days. Patient was not experiencing symptoms anymore, she has had blood thinners they administered blood thinners (treatment), she was improving. She has to stay 2 more days in the hospital taking the blood thinners. Laboratory test was done on  08Apr2021 which is in the hospital where she almost died. Vaccine was administered at a hospital. Patient was recovering at the time of report.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: X-ray
Clinical narrative: She almost died from pulmonary edema; Lungs have blood clots in them; This is a spontaneous report from a contactable consumer (patient's husband). 74-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 intramuscular, administered in left upper arm muscle at age 74 years on 30Mar2021 (Batch/Lot Number: EP6955) as single dose, for COVID-19 immunisation. The patient medical history was reported as no. There were no concomitant medications. The patient historically took the first shot of BNT162B2 on an unspecified date for COVID-19 immunisation. It was reported that the patient took the shot of second dose of Pfizer BioNTech COVID Vaccine (Lot number: EP6955) shot on 30Mar2021 in her left upper arm muscle. Patient was in the hospital at the time of reporting hanging on to life. Patient got pulmonary edema and she almost died, her lungs are, have blood clots in them from 06Apr2021 then she went to the hospital on 07Apr2021, has to stay in the hospital for 4 days. Patient was not experiencing symptoms anymore, she has had blood thinners they administered blood thinners (treatment), she was improving. She has to stay 2 more days in the hospital taking the blood thinners. Laboratory test was done on  08Apr2021 which is in the hospital where she almost died. Vaccine was administered at a hospital. Patient was recovering at the time of report.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Investigation, Pulmonary oedema, Pulmonary thrombosis
Clinical narrative: She almost died from pulmonary edema; Lungs have blood clots in them; This is a spontaneous report from a contactable consumer (patient's husband). 74-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 intramuscular, administered in left upper arm muscle at age 74 years on 30Mar2021 (Batch/Lot Number: EP6955) as single dose, for COVID-19 immunisation. The patient medical history was reported as no. There were no concomitant medications. The patient historically took the first shot of BNT162B2 on an unspecified date for COVID-19 immunisation. It was reported that the patient took the shot of second dose of Pfizer BioNTech COVID Vaccine (Lot number: EP6955) shot on 30Mar2021 in her left upper arm muscle. Patient was in the hospital at the time of reporting hanging on to life. Patient got pulmonary edema and she almost died, her lungs are, have blood clots in them from 06Apr2021 then she went to the hospital on 07Apr2021, has to stay in the hospital for 4 days. Patient was not experiencing symptoms anymore, she has had blood thinners they administered blood thinners (treatment), she was improving. She has to stay 2 more days in the hospital taking the blood thinners. Laboratory test was done on  08Apr2021 which is in the hospital where she almost died. Vaccine was administered at a hospital. Patient was recovering at the time of report.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: Slight fever and a small temperature; Soreness at the shot site; Body aches; This is a spontaneous report from a contactable consumer (patient). A 54-year female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9262, Expiration Date: May2021), via an unspecified route of administration in left arm, in Feb2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did have a reaction after the first dose. In Feb2021, the patient had slight fever and symptom with soreness at the shot site the day after. The reactions were expected including body aches, a slight fever, and a small temperature. It was nothing severe and it lasted for a day. On the second day, the patient still felt achy but better with paracetamol (TYLENOL). The reactions lasted a day. The patient recovered from the events in Feb2021.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Slight fever and a small temperature; Soreness at the shot site; Body aches; This is a spontaneous report from a contactable consumer (patient). A 54-year female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9262, Expiration Date: May2021), via an unspecified route of administration in left arm, in Feb2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did have a reaction after the first dose. In Feb2021, the patient had slight fever and symptom with soreness at the shot site the day after. The reactions were expected including body aches, a slight fever, and a small temperature. It was nothing severe and it lasted for a day. On the second day, the patient still felt achy but better with paracetamol (TYLENOL). The reactions lasted a day. The patient recovered from the events in Feb2021.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism, Thrombosis
Clinical narrative: developed blood clots in lungs; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: CP6955), via an unspecified route of administration into the left arm on 17Mar2021 as a single dose for COVID-19 immunisation. Medical history included allergies to sulfa. Patient was not pregnant. There were no concomitant medications. The patient previously took amoxicillin and experienced drug allergy. The patient developed blood clots in lungs on 27Mar2021 09:45. The patient was brought to the emergency room and was hospitalized for 3 days. The event was reported as life threatening. It was also reported that the patient was given treatment (unspecified). The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 27Mar2021. Outcome of event was recovering.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary thrombosis, SARS-CoV-2 test
Clinical narrative: developed blood clots in lungs; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: CP6955), via an unspecified route of administration into the left arm on 17Mar2021 as a single dose for COVID-19 immunisation. Medical history included allergies to sulfa. Patient was not pregnant. There were no concomitant medications. The patient previously took amoxicillin and experienced drug allergy. The patient developed blood clots in lungs on 27Mar2021 09:45. The patient was brought to the emergency room and was hospitalized for 3 days. The event was reported as life threatening. It was also reported that the patient was given treatment (unspecified). The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 27Mar2021. Outcome of event was recovering.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Axillary pain, Feeling hot, Hypoaesthesia, Injection site pain
Clinical narrative: NAUSEA; NUMBNESS OF FACE; TINGLING OF FACE; INJECTION SITE PAIN BUT PAIN UNDER  RIGHT ARM; ANAPHYLACTIC REACTION ( FEELING HOT, AND THROAT FELT CLOGGED); This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported.  The patient's height, and weight were not reported. The patient's past medical history included anaphylactic reactions with other vaccines, and concurrent conditions included antibiotic allergy (except ciprofloxacin), non-alcoholic, non-smoker, cancer, cerebral palsy, and pheochromocytoma.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, 1 total, administered on right arm on 27-MAR-2021 12:15 for prophylactic vaccination. No concomitant medications were reported.  On 27-MAR-2021 12:21, the patient experienced anaphylactic reaction (feeling hot and throat felt clogged and closing). The patient was taken to the emergency room and given epinephrine. Anaphylactic reaction continued during the transport to the emergency room. On 28-MAR-2021, the patient experienced injection site pain but pain under right arm, numbness of face and tingling of face. On an unspecified date, the patient experienced nausea. Patient also received a rapid COVID-19 test on 07-APR-2021 and waiting on lab results. The patient was worried about the cancer surgery planned after 5 days.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anaphylactic reaction ( feeling hot, and throat felt clogged) on 27-MAR-2021, was recovering from injection site pain but pain under right arm, numbness of face, and tingling of face, and the outcome of nausea was not reported. This report was serious (Life Threatening).; Sender's Comments: V0: A 54-year-old female experienced anaphylaxis 6 minutes after vaccine. Past medical history included anaphylactic reactions with other vaccines, and concurrent conditions included antibiotic allergy, cancer, cerebral palsy, and pheochromocytoma. Six minutes after vaccine she reporting feeling hot and throat felt clogged and closing. The patient was taken to the emergency room and given epinephrine and recovered the same day. Given the close temporal relationship, history of anaphylaxis to other vaccines as well as antibiotic allergy, the event is considered related.