chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Hypoaesthesia oral, Iron deficiency, Muscular weakness, Oral discomfort
Clinical narrative: Iron deficiency; arm soreness; tingling in her toes that gradually kind of was in her legs then her arms too; weakness in her legs; altered sense of touch; Numbness of tongue; trouble moving her lips; This is a spontaneous report from a contactable consumer(patient). A 20-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration, administered in left arm on 09Feb2021 13:00 as SINGLE DOSE for covid-19 immunization. Patient was 20 years old at the time of vaccination. Patient medical history and concomitant medications were not reported. On 12Jan2021 at 07:30PM patient received her first dose of Bnt162b2 and experienced sore arm. On an unspecified date patient stated that her arm was sore again after the second dose, then she started having tingling in her toes that gradually kind of was in her legs then her arms too. She said that she has weakness in her legs , and an altered sense of touch, when she kind of touches her skin it feels not normal, like an altered kind of touch, she says her tongue is numb, and her mouth has trouble moving. She says that when she rubs her lips together like to swish mouthwash, it is difficult. She says she saw someone yesterday, a nurse practitioner, who got labs and her blood work came back, and the nurse practitioner said she had a possible iron deficiency and recommended a supplement. The patient underwent lab tests and procedures which included blood test: unknown. Outcome of the events was unknown.  Information about lot/ batch number has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Iron deficiency; arm soreness; tingling in her toes that gradually kind of was in her legs then her arms too; weakness in her legs; altered sense of touch; Numbness of tongue; trouble moving her lips; This is a spontaneous report from a contactable consumer(patient). A 20-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration, administered in left arm on 09Feb2021 13:00 as SINGLE DOSE for covid-19 immunization. Patient was 20 years old at the time of vaccination. Patient medical history and concomitant medications were not reported. On 12Jan2021 at 07:30PM patient received her first dose of Bnt162b2 and experienced sore arm. On an unspecified date patient stated that her arm was sore again after the second dose, then she started having tingling in her toes that gradually kind of was in her legs then her arms too. She said that she has weakness in her legs , and an altered sense of touch, when she kind of touches her skin it feels not normal, like an altered kind of touch, she says her tongue is numb, and her mouth has trouble moving. She says that when she rubs her lips together like to swish mouthwash, it is difficult. She says she saw someone yesterday, a nurse practitioner, who got labs and her blood work came back, and the nurse practitioner said she had a possible iron deficiency and recommended a supplement. The patient underwent lab tests and procedures which included blood test: unknown. Outcome of the events was unknown.  Information about lot/ batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram, Electrocardiogram, Facial pain, Nausea, Neck pain
Clinical narrative: stroke; heart attack; nauseated; normal bp of 110/65 was 204/110; pain in my jaw and neck; pain in my jaw and neck; entire left side of my face and left side of my neck felt like they were being jack-hammered; my teeth on my left side started to hurt; This is a spontaneous report from a contactable consumer.   A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history and concomitant medications were not reported. Per the patient, I was eager to get my doses. I received the first dose on 28Jan, and the second dose was received 15Feb, which was a Monday. In the evening of Wednesday, 17Feb, my teeth on my left side started to hurt. Top and bottom. At 2:00 am, Thursday, 18Feb, I called an ambulance because the entire left side of my face and left side of my neck felt like they were being jack-hammered. I was extremely nauseated. My normal bp of 110/65 was 204/110. The paramedic thought I was having a heart attack. My cholesterol is 129. I went to the ER on Friday, 19Feb, because a doctor thought I was having a stroke. I finally went to my primary care doctor the next week, He believes I had a very strong antibody response so that I have a high level of protection. It took a month to get the side effects under control. Even now, 11Apr2021, I have pain in my jaw and neck that comes and goes throughout the day. If I had known that I would have such awful side effects, I would not have taken it. My doctor says when it is time for a booster, he wants me to have a different vaccine. I don't think I can make myself do it. I will continue to wear my medical grade masks and shield instead." The outcome of the events was not reported.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Toothache
Clinical narrative: stroke; heart attack; nauseated; normal bp of 110/65 was 204/110; pain in my jaw and neck; pain in my jaw and neck; entire left side of my face and left side of my neck felt like they were being jack-hammered; my teeth on my left side started to hurt; This is a spontaneous report from a contactable consumer.   A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history and concomitant medications were not reported. Per the patient, I was eager to get my doses. I received the first dose on 28Jan, and the second dose was received 15Feb, which was a Monday. In the evening of Wednesday, 17Feb, my teeth on my left side started to hurt. Top and bottom. At 2:00 am, Thursday, 18Feb, I called an ambulance because the entire left side of my face and left side of my neck felt like they were being jack-hammered. I was extremely nauseated. My normal bp of 110/65 was 204/110. The paramedic thought I was having a heart attack. My cholesterol is 129. I went to the ER on Friday, 19Feb, because a doctor thought I was having a stroke. I finally went to my primary care doctor the next week, He believes I had a very strong antibody response so that I have a high level of protection. It took a month to get the side effects under control. Even now, 11Apr2021, I have pain in my jaw and neck that comes and goes throughout the day. If I had known that I would have such awful side effects, I would not have taken it. My doctor says when it is time for a booster, he wants me to have a different vaccine. I don't think I can make myself do it. I will continue to wear my medical grade masks and shield instead." The outcome of the events was not reported.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood cholesterol, Blood pressure increased, Blood pressure measurement, Cerebrovascular accident, Facial pain
Clinical narrative: stroke; heart attack; nauseated; normal bp of 110/65 was 204/110; pain in my jaw and neck; pain in my jaw and neck; entire left side of my face and left side of my neck felt like they were being jack-hammered; my teeth on my left side started to hurt; This is a spontaneous report from a contactable consumer.   A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history and concomitant medications were not reported. Per the patient, I was eager to get my doses. I received the first dose on 28Jan, and the second dose was received 15Feb, which was a Monday. In the evening of Wednesday, 17Feb, my teeth on my left side started to hurt. Top and bottom. At 2:00 am, Thursday, 18Feb, I called an ambulance because the entire left side of my face and left side of my neck felt like they were being jack-hammered. I was extremely nauseated. My normal bp of 110/65 was 204/110. The paramedic thought I was having a heart attack. My cholesterol is 129. I went to the ER on Friday, 19Feb, because a doctor thought I was having a stroke. I finally went to my primary care doctor the next week, He believes I had a very strong antibody response so that I have a high level of protection. It took a month to get the side effects under control. Even now, 11Apr2021, I have pain in my jaw and neck that comes and goes throughout the day. If I had known that I would have such awful side effects, I would not have taken it. My doctor says when it is time for a booster, he wants me to have a different vaccine. I don't think I can make myself do it. I will continue to wear my medical grade masks and shield instead." The outcome of the events was not reported.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocardial infarction, Nausea, Neck pain, Pain in jaw, Toothache
Clinical narrative: stroke; heart attack; nauseated; normal bp of 110/65 was 204/110; pain in my jaw and neck; pain in my jaw and neck; entire left side of my face and left side of my neck felt like they were being jack-hammered; my teeth on my left side started to hurt; This is a spontaneous report from a contactable consumer.   A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history and concomitant medications were not reported. Per the patient, I was eager to get my doses. I received the first dose on 28Jan, and the second dose was received 15Feb, which was a Monday. In the evening of Wednesday, 17Feb, my teeth on my left side started to hurt. Top and bottom. At 2:00 am, Thursday, 18Feb, I called an ambulance because the entire left side of my face and left side of my neck felt like they were being jack-hammered. I was extremely nauseated. My normal bp of 110/65 was 204/110. The paramedic thought I was having a heart attack. My cholesterol is 129. I went to the ER on Friday, 19Feb, because a doctor thought I was having a stroke. I finally went to my primary care doctor the next week, He believes I had a very strong antibody response so that I have a high level of protection. It took a month to get the side effects under control. Even now, 11Apr2021, I have pain in my jaw and neck that comes and goes throughout the day. If I had known that I would have such awful side effects, I would not have taken it. My doctor says when it is time for a booster, he wants me to have a different vaccine. I don't think I can make myself do it. I will continue to wear my medical grade masks and shield instead." The outcome of the events was not reported.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure measurement, Cerebrovascular accident, Feeling abnormal, Hypertension, Myocardial infarction
Clinical narrative: stroke; heart attack; nauseated; normal bp of 110/65 was 204/110; pain in my jaw and neck; pain in my jaw and neck; entire left side of my face and left side of my neck felt like they were being jack-hammered; my teeth on my left side started to hurt; This is a spontaneous report from a contactable consumer.   A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history and concomitant medications were not reported. Per the patient, I was eager to get my doses. I received the first dose on 28Jan, and the second dose was received 15Feb, which was a Monday. In the evening of Wednesday, 17Feb, my teeth on my left side started to hurt. Top and bottom. At 2:00 am, Thursday, 18Feb, I called an ambulance because the entire left side of my face and left side of my neck felt like they were being jack-hammered. I was extremely nauseated. My normal bp of 110/65 was 204/110. The paramedic thought I was having a heart attack. My cholesterol is 129. I went to the ER on Friday, 19Feb, because a doctor thought I was having a stroke. I finally went to my primary care doctor the next week, He believes I had a very strong antibody response so that I have a high level of protection. It took a month to get the side effects under control. Even now, 11Apr2021, I have pain in my jaw and neck that comes and goes throughout the day. If I had known that I would have such awful side effects, I would not have taken it. My doctor says when it is time for a booster, he wants me to have a different vaccine. I don't think I can make myself do it. I will continue to wear my medical grade masks and shield instead." The outcome of the events was not reported.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Neck pain, Pain in jaw, Toothache
Clinical narrative: stroke; heart attack; nauseated; normal bp of 110/65 was 204/110; pain in my jaw and neck; pain in my jaw and neck; entire left side of my face and left side of my neck felt like they were being jack-hammered; my teeth on my left side started to hurt; This is a spontaneous report from a contactable consumer.   A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history and concomitant medications were not reported. Per the patient, I was eager to get my doses. I received the first dose on 28Jan, and the second dose was received 15Feb, which was a Monday. In the evening of Wednesday, 17Feb, my teeth on my left side started to hurt. Top and bottom. At 2:00 am, Thursday, 18Feb, I called an ambulance because the entire left side of my face and left side of my neck felt like they were being jack-hammered. I was extremely nauseated. My normal bp of 110/65 was 204/110. The paramedic thought I was having a heart attack. My cholesterol is 129. I went to the ER on Friday, 19Feb, because a doctor thought I was having a stroke. I finally went to my primary care doctor the next week, He believes I had a very strong antibody response so that I have a high level of protection. It took a month to get the side effects under control. Even now, 11Apr2021, I have pain in my jaw and neck that comes and goes throughout the day. If I had known that I would have such awful side effects, I would not have taken it. My doctor says when it is time for a booster, he wants me to have a different vaccine. I don't think I can make myself do it. I will continue to wear my medical grade masks and shield instead." The outcome of the events was not reported.   Information about lot/batch number has been requested.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood fibrinogen decreased, Cerebral haemorrhage, Cerebral mass effect, Computerised tomogram head abnormal, Disseminated intravascular coagulation
Clinical narrative: On unspecified date complained about a headache.  The following day, patient collapsed due to an acute intracerebral hemorrhage, acute thrombocytopenia and acute tonic-clonic seizures.  On unspecified date, he passed.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Endotracheal intubation, Fibrin D dimer, Platelet count decreased, Platelet transfusion, Seizure
Clinical narrative: On unspecified date complained about a headache.  The following day, patient collapsed due to an acute intracerebral hemorrhage, acute thrombocytopenia and acute tonic-clonic seizures.  On unspecified date, he passed.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebral haemorrhage
Clinical narrative: On unspecified date complained about a headache.  The following day, patient collapsed due to an acute intracerebral hemorrhage, acute thrombocytopenia and acute tonic-clonic seizures.  On unspecified date, he passed.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cerebral haemorrhage, Death, Deep vein thrombosis, Generalised tonic-clonic seizure, Headache
Clinical narrative: On unspecified date complained about a headache.  The following day, patient collapsed due to an acute intracerebral hemorrhage, acute thrombocytopenia and acute tonic-clonic seizures.  On unspecified date, he passed.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Platelet count decreased, Syncope, Thrombocytopenia, Thrombosis
Clinical narrative: On unspecified date complained about a headache.  The following day, patient collapsed due to an acute intracerebral hemorrhage, acute thrombocytopenia and acute tonic-clonic seizures.  On unspecified date, he passed.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Blood pressure decreased, Blood pressure increased, Blood pressure measurement, Chest discomfort
Clinical narrative: Anaphylaxis. Patient with a  h/o anaphylaxis with sulfa experienced itchiness, hives, neck swelling, lightheadedness, hoarse voice, cough, and shortness of breath that began minutes after the 1st Pfizer vaccine dose, lot EN6208. Patient was seen in ED on 3/17 and treated with prednisone and Pepcid. Patient had a return of symptoms of throat closing and shortness of breath and self-medicated with epiPen at home and was then seen by PCP on 3/18. Restarted Singulair and added Pepcid. Patient came back to ED on 3/19 with continued symptoms. On 3/19 ED visit, patient was given Benadryl, Pepcid, Solu-medrol, epinephrine IM, and albuterol inhalation. Patient was admitted to ICU for observation. Continued Benadryl, Pepcid, and Solu-medrol scheduled doses. In ICU x 48 hours without further escalation in care. No lip swelling, stridor or wheezes noted. Urticarial rash has improved. Discharged home on tapered prednisone and Pepcid.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cough, Dyspnoea, Ear swelling, Heart rate, Heart rate increased
Clinical narrative: Anaphylaxis. Patient with a  h/o anaphylaxis with sulfa experienced itchiness, hives, neck swelling, lightheadedness, hoarse voice, cough, and shortness of breath that began minutes after the 1st Pfizer vaccine dose, lot EN6208. Patient was seen in ED on 3/17 and treated with prednisone and Pepcid. Patient had a return of symptoms of throat closing and shortness of breath and self-medicated with epiPen at home and was then seen by PCP on 3/18. Restarted Singulair and added Pepcid. Patient came back to ED on 3/19 with continued symptoms. On 3/19 ED visit, patient was given Benadryl, Pepcid, Solu-medrol, epinephrine IM, and albuterol inhalation. Patient was admitted to ICU for observation. Continued Benadryl, Pepcid, and Solu-medrol scheduled doses. In ICU x 48 hours without further escalation in care. No lip swelling, stridor or wheezes noted. Urticarial rash has improved. Discharged home on tapered prednisone and Pepcid.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Palpitations, Pharyngeal swelling, Pruritus, Urticaria
Clinical narrative: Anaphylaxis. Patient with a  h/o anaphylaxis with sulfa experienced itchiness, hives, neck swelling, lightheadedness, hoarse voice, cough, and shortness of breath that began minutes after the 1st Pfizer vaccine dose, lot EN6208. Patient was seen in ED on 3/17 and treated with prednisone and Pepcid. Patient had a return of symptoms of throat closing and shortness of breath and self-medicated with epiPen at home and was then seen by PCP on 3/18. Restarted Singulair and added Pepcid. Patient came back to ED on 3/19 with continued symptoms. On 3/19 ED visit, patient was given Benadryl, Pepcid, Solu-medrol, epinephrine IM, and albuterol inhalation. Patient was admitted to ICU for observation. Continued Benadryl, Pepcid, and Solu-medrol scheduled doses. In ICU x 48 hours without further escalation in care. No lip swelling, stridor or wheezes noted. Urticarial rash has improved. Discharged home on tapered prednisone and Pepcid.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Blood pressure measurement, Heart rate
Clinical narrative: Anaphylaxis. Patient with a  h/o anaphylaxis with sulfa experienced itchiness, hives, neck swelling, lightheadedness, hoarse voice, cough, and shortness of breath that began minutes after the 1st Pfizer vaccine dose, lot EN6208. Patient was seen in ED on 3/17 and treated with prednisone and Pepcid. Patient had a return of symptoms of throat closing and shortness of breath and self-medicated with epiPen at home and was then seen by PCP on 3/18. Restarted Singulair and added Pepcid. Patient came back to ED on 3/19 with continued symptoms. On 3/19 ED visit, patient was given Benadryl, Pepcid, Solu-medrol, epinephrine IM, and albuterol inhalation. Patient was admitted to ICU for observation. Continued Benadryl, Pepcid, and Solu-medrol scheduled doses. In ICU x 48 hours without further escalation in care. No lip swelling, stridor or wheezes noted. Urticarial rash has improved. Discharged home on tapered prednisone and Pepcid.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Cough, Dizziness, Dysphonia, Dyspnoea
Clinical narrative: Anaphylaxis. Patient with a  h/o anaphylaxis with sulfa experienced itchiness, hives, neck swelling, lightheadedness, hoarse voice, cough, and shortness of breath that began minutes after the 1st Pfizer vaccine dose, lot EN6208. Patient was seen in ED on 3/17 and treated with prednisone and Pepcid. Patient had a return of symptoms of throat closing and shortness of breath and self-medicated with epiPen at home and was then seen by PCP on 3/18. Restarted Singulair and added Pepcid. Patient came back to ED on 3/19 with continued symptoms. On 3/19 ED visit, patient was given Benadryl, Pepcid, Solu-medrol, epinephrine IM, and albuterol inhalation. Patient was admitted to ICU for observation. Continued Benadryl, Pepcid, and Solu-medrol scheduled doses. In ICU x 48 hours without further escalation in care. No lip swelling, stridor or wheezes noted. Urticarial rash has improved. Discharged home on tapered prednisone and Pepcid.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Full blood count normal, Intensive care, Metabolic function test normal, Pruritus, Swelling
Clinical narrative: Anaphylaxis. Patient with a  h/o anaphylaxis with sulfa experienced itchiness, hives, neck swelling, lightheadedness, hoarse voice, cough, and shortness of breath that began minutes after the 1st Pfizer vaccine dose, lot EN6208. Patient was seen in ED on 3/17 and treated with prednisone and Pepcid. Patient had a return of symptoms of throat closing and shortness of breath and self-medicated with epiPen at home and was then seen by PCP on 3/18. Restarted Singulair and added Pepcid. Patient came back to ED on 3/19 with continued symptoms. On 3/19 ED visit, patient was given Benadryl, Pepcid, Solu-medrol, epinephrine IM, and albuterol inhalation. Patient was admitted to ICU for observation. Continued Benadryl, Pepcid, and Solu-medrol scheduled doses. In ICU x 48 hours without further escalation in care. No lip swelling, stridor or wheezes noted. Urticarial rash has improved. Discharged home on tapered prednisone and Pepcid.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Throat tightness, Urticaria
Clinical narrative: Anaphylaxis. Patient with a  h/o anaphylaxis with sulfa experienced itchiness, hives, neck swelling, lightheadedness, hoarse voice, cough, and shortness of breath that began minutes after the 1st Pfizer vaccine dose, lot EN6208. Patient was seen in ED on 3/17 and treated with prednisone and Pepcid. Patient had a return of symptoms of throat closing and shortness of breath and self-medicated with epiPen at home and was then seen by PCP on 3/18. Restarted Singulair and added Pepcid. Patient came back to ED on 3/19 with continued symptoms. On 3/19 ED visit, patient was given Benadryl, Pepcid, Solu-medrol, epinephrine IM, and albuterol inhalation. Patient was admitted to ICU for observation. Continued Benadryl, Pepcid, and Solu-medrol scheduled doses. In ICU x 48 hours without further escalation in care. No lip swelling, stridor or wheezes noted. Urticarial rash has improved. Discharged home on tapered prednisone and Pepcid.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Arthropod bite, Blood test, Condition aggravated, Hypersensitivity
Clinical narrative: Anaphylaxis. Patient with a  h/o anaphylaxis with sulfa experienced itchiness, hives, neck swelling, lightheadedness, hoarse voice, cough, and shortness of breath that began minutes after the 1st Pfizer vaccine dose, lot EN6208. Patient was seen in ED on 3/17 and treated with prednisone and Pepcid. Patient had a return of symptoms of throat closing and shortness of breath and self-medicated with epiPen at home and was then seen by PCP on 3/18. Restarted Singulair and added Pepcid. Patient came back to ED on 3/19 with continued symptoms. On 3/19 ED visit, patient was given Benadryl, Pepcid, Solu-medrol, epinephrine IM, and albuterol inhalation. Patient was admitted to ICU for observation. Continued Benadryl, Pepcid, and Solu-medrol scheduled doses. In ICU x 48 hours without further escalation in care. No lip swelling, stridor or wheezes noted. Urticarial rash has improved. Discharged home on tapered prednisone and Pepcid.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Immediate post-injection reaction, Intensive care
Clinical narrative: Anaphylaxis. Patient with a  h/o anaphylaxis with sulfa experienced itchiness, hives, neck swelling, lightheadedness, hoarse voice, cough, and shortness of breath that began minutes after the 1st Pfizer vaccine dose, lot EN6208. Patient was seen in ED on 3/17 and treated with prednisone and Pepcid. Patient had a return of symptoms of throat closing and shortness of breath and self-medicated with epiPen at home and was then seen by PCP on 3/18. Restarted Singulair and added Pepcid. Patient came back to ED on 3/19 with continued symptoms. On 3/19 ED visit, patient was given Benadryl, Pepcid, Solu-medrol, epinephrine IM, and albuterol inhalation. Patient was admitted to ICU for observation. Continued Benadryl, Pepcid, and Solu-medrol scheduled doses. In ICU x 48 hours without further escalation in care. No lip swelling, stridor or wheezes noted. Urticarial rash has improved. Discharged home on tapered prednisone and Pepcid.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: AE: FEELING FAINT/LIGHTHEADED, NAUSEOUS APPROX 5 MIN POST-VACCINATION  TX: LAID SUPINE, EMS EVALUATION, VITALS  OC: PT. REFUSED EMS TRANSPORT + FURTHER CARE. REFUSED AMA
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Nausea, Syncope
Clinical narrative: AE: FEELING FAINT/LIGHTHEADED, NAUSEOUS APPROX 5 MIN POST-VACCINATION  TX: LAID SUPINE, EMS EVALUATION, VITALS  OC: PT. REFUSED EMS TRANSPORT + FURTHER CARE. REFUSED AMA
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: patient reported chest pain and tingling of lips 30 minutes after vaccination, refused furthered evaluation/transport
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Paraesthesia oral
Clinical narrative: patient reported chest pain and tingling of lips 30 minutes after vaccination, refused furthered evaluation/transport
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Headache, Inappropriate schedule of product administration, Vomiting
Clinical narrative: Patient given 2nd dose 8 days after first dose. Patient states nausea and vomiting pain in head and sides.  SOB, Epinephrin 1mg IM offender states that helped.
Age: 29.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Headache, Inappropriate schedule of product administration, Nausea, Vomiting
Clinical narrative: Patient given 2nd dose 8 days after first dose. Patient states nausea and vomiting pain in head and sides.  SOB, Epinephrin 1mg IM offender states that helped.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Cough, Dermatitis acneiform, Dyspnoea, Electrocardiogram
Clinical narrative: Approximately 30 minutes after vaccination, patient complained of rash on chest and "felt tight in the chest". Patient used albuterol inhaler. BP 170/100, HR 85. Symptoms did not improve, IM Benadryl administered at 1212, at 1214 patient stated her "throat felt tight" and began coughing. 1215 BP 150/90, 0.5mL EPI administered, EMS called. EMS arrived on scene and transported the patient to the local hospital.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Rash, Throat tightness
Clinical narrative: Approximately 30 minutes after vaccination, patient complained of rash on chest and "felt tight in the chest". Patient used albuterol inhaler. BP 170/100, HR 85. Symptoms did not improve, IM Benadryl administered at 1212, at 1214 patient stated her "throat felt tight" and began coughing. 1215 BP 150/90, 0.5mL EPI administered, EMS called. EMS arrived on scene and transported the patient to the local hospital.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Cough, Rash, Throat tightness
Clinical narrative: Approximately 30 minutes after vaccination, patient complained of rash on chest and "felt tight in the chest". Patient used albuterol inhaler. BP 170/100, HR 85. Symptoms did not improve, IM Benadryl administered at 1212, at 1214 patient stated her "throat felt tight" and began coughing. 1215 BP 150/90, 0.5mL EPI administered, EMS called. EMS arrived on scene and transported the patient to the local hospital.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy
Clinical narrative: enlarged lymph nodes under left arm; This is a spontaneous report received from a contactable healthcare professional (patient). A 63-year-old male patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6207) via an unspecified route of administration on 17Mar2021 at 09:00 (at the age of 63-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included high blood pressure, pre-diabetes, and high BMI. Prior to the vaccine, the patient had not been diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications were none. The patient previously received dose 1 of BNT162B2 (lot number EN6198) on 24Feb2021 at 09:00 as a single dose in the left arm for COVID-19 immunization. The patient did not have any allergies to medications, food, or other products. On 19Mar2021, the patient experienced enlarged lymph nodes under left arm. The event was reported as non-serious. The patient was not hospitalized for the event. The patient visited a doctor or other healthcare professional office/clinic as a result of the event. The patient did not receive any treatment for the event. The outcome of enlarged lymph nodes under left arm was recovered. It was also reported since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Confusional state, Dizziness, Injection site pain, Nausea
Clinical narrative: This is a spontaneous report from a contactable consumer. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 12:30 (at the age of 60-years-old) (Batch/Lot Number: ER-8730) as SINGLE DOSE for covid-19 immunization. Medical history included Hypothyroid, High Blood Pressure. Concomitant medications included levothyroxine sodium (SYNTHROID); losartan potassium (LOSARTIN); amlodipine; hydrochlorothiazide; all taken for unspecified indications, start and stop dates were not reported. On 27Mar2021 13:30, the patient experienced Bleeding at the site, fainting and vomiting while passed out for 5 minutes. The patient believes the injection was too high and she hit a vein. It was further reported that the patient is not a squeamish person and have never had reactions to any shots or blood draws in the past. The event fainting and passed out was assessed as serious (medically significant). Therapeutic measures were taken as a result of bleeding at the site. The patient did not receive treatment for the events fainting, passed out, and vomiting. The outcome of the events was recovered.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Syncope, Tremor, Unresponsive to stimuli, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 12:30 (at the age of 60-years-old) (Batch/Lot Number: ER-8730) as SINGLE DOSE for covid-19 immunization. Medical history included Hypothyroid, High Blood Pressure. Concomitant medications included levothyroxine sodium (SYNTHROID); losartan potassium (LOSARTIN); amlodipine; hydrochlorothiazide; all taken for unspecified indications, start and stop dates were not reported. On 27Mar2021 13:30, the patient experienced Bleeding at the site, fainting and vomiting while passed out for 5 minutes. The patient believes the injection was too high and she hit a vein. It was further reported that the patient is not a squeamish person and have never had reactions to any shots or blood draws in the past. The event fainting and passed out was assessed as serious (medically significant). Therapeutic measures were taken as a result of bleeding at the site. The patient did not receive treatment for the events fainting, passed out, and vomiting. The outcome of the events was recovered.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site haemorrhage, Syncope, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 12:30 (at the age of 60-years-old) (Batch/Lot Number: ER-8730) as SINGLE DOSE for covid-19 immunization. Medical history included Hypothyroid, High Blood Pressure. Concomitant medications included levothyroxine sodium (SYNTHROID); losartan potassium (LOSARTIN); amlodipine; hydrochlorothiazide; all taken for unspecified indications, start and stop dates were not reported. On 27Mar2021 13:30, the patient experienced Bleeding at the site, fainting and vomiting while passed out for 5 minutes. The patient believes the injection was too high and she hit a vein. It was further reported that the patient is not a squeamish person and have never had reactions to any shots or blood draws in the past. The event fainting and passed out was assessed as serious (medically significant). Therapeutic measures were taken as a result of bleeding at the site. The patient did not receive treatment for the events fainting, passed out, and vomiting. The outcome of the events was recovered.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Incorrect route of product administration, Loss of consciousness, Syncope, Vaccination site haemorrhage, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 27Mar2021 12:30 (at the age of 60-years-old) (Batch/Lot Number: ER-8730) as SINGLE DOSE for covid-19 immunization. Medical history included Hypothyroid, High Blood Pressure. Concomitant medications included levothyroxine sodium (SYNTHROID); losartan potassium (LOSARTIN); amlodipine; hydrochlorothiazide; all taken for unspecified indications, start and stop dates were not reported. On 27Mar2021 13:30, the patient experienced Bleeding at the site, fainting and vomiting while passed out for 5 minutes. The patient believes the injection was too high and she hit a vein. It was further reported that the patient is not a squeamish person and have never had reactions to any shots or blood draws in the past. The event fainting and passed out was assessed as serious (medically significant). Therapeutic measures were taken as a result of bleeding at the site. The patient did not receive treatment for the events fainting, passed out, and vomiting. The outcome of the events was recovered.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Contusion, Deep vein thrombosis, Haematuria, Paraesthesia, Peripheral artery occlusion
Clinical narrative: Reported to be "In hospital ICU  several weeks after vaccine with blood clots"
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Peripheral artery thrombosis, Peripheral swelling, Platelet transfusion, Skin discolouration, Stent placement
Clinical narrative: Reported to be "In hospital ICU  several weeks after vaccine with blood clots"
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thrombectomy, Thrombocytopenia, Ultrasound scan abnormal, Vena cava filter insertion
Clinical narrative: Reported to be "In hospital ICU  several weeks after vaccine with blood clots"
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Peripheral swelling, Platelet count, Platelet count decreased, Thrombosis
Clinical narrative: Reported to be "In hospital ICU  several weeks after vaccine with blood clots"
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Intensive care, Thrombosis
Clinical narrative: Reported to be "In hospital ICU  several weeks after vaccine with blood clots"
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Diabetes; back pain; This is a spontaneous report from a contactable consumer. A 68-years-old female patient (no pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 10Mar2021 as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were unspecified product.   The Patient died in her sleep on 10Mar2021, per death certificate, diabetes. The Patient had back pain in Mar2021 with outcome of unknown. No treatment for the events.  The patient died on 10Mar2021.  An autopsy was not performed. The outcome of event diabetes was fatal.No covid prior vaccination; No covid tested post vaccination.  Information on the lot/ batch number has been requested.; Reported Cause(s) of Death: Per death certificate, Diabetes
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Diabetes mellitus
Clinical narrative: Diabetes; back pain; This is a spontaneous report from a contactable consumer. A 68-years-old female patient (no pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 10Mar2021 as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported.  The patient's concomitant medications were unspecified product.   The Patient died in her sleep on 10Mar2021, per death certificate, diabetes. The Patient had back pain in Mar2021 with outcome of unknown. No treatment for the events.  The patient died on 10Mar2021.  An autopsy was not performed. The outcome of event diabetes was fatal.No covid prior vaccination; No covid tested post vaccination.  Information on the lot/ batch number has been requested.; Reported Cause(s) of Death: Per death certificate, Diabetes
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram, Blood pressure increased, Dizziness, Headache, Heart rate decreased
Clinical narrative: blood pressure has been off charts/her blood pressure was over 200.; chills; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 78, no unit) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8737), via an unspecified route of administration on 01Apr2021 as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated she received the first dose of the vaccine on 01Apr2021. Ever since then, her blood pressure has been off the charts. She received the vaccine at the hospital and they had to take her to the Emergency Department right after the vaccine. She went to the Emergency Room last Monday (05Apr2021) because her blood pressure was over 200. She also has had chills everyday since then. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Nausea, Oropharyngeal discomfort, Palpitations
Clinical narrative: blood pressure has been off charts/her blood pressure was over 200.; chills; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 78, no unit) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8737), via an unspecified route of administration on 01Apr2021 as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated she received the first dose of the vaccine on 01Apr2021. Ever since then, her blood pressure has been off the charts. She received the vaccine at the hospital and they had to take her to the Emergency Department right after the vaccine. She went to the Emergency Room last Monday (05Apr2021) because her blood pressure was over 200. She also has had chills everyday since then. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chills
Clinical narrative: blood pressure has been off charts/her blood pressure was over 200.; chills; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 78, no unit) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8737), via an unspecified route of administration on 01Apr2021 as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated she received the first dose of the vaccine on 01Apr2021. Ever since then, her blood pressure has been off the charts. She received the vaccine at the hospital and they had to take her to the Emergency Department right after the vaccine. She went to the Emergency Room last Monday (05Apr2021) because her blood pressure was over 200. She also has had chills everyday since then. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a covid blog via a company representative concerned a 25 year old patient of unspecified sex. The patient's height, and weight were not reported.The patient received Covid-19 vaccine ad26.cov2.s(suspension for injection,route of admin not reported,expiration date was not reported)dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported.The Company is unable to perform follow-up to request batch/lot number.No concomitant medications were reported. On an unspecified date,the patient died from unknown cause of death.It was reported that, the patient death and other 3 deaths occurred after receiving the vaccine.It was unknown whether the autopsy was performed.  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked.    .; Sender's Comments: V0: -covid-19 vaccine ad26.cov2.s-death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Myocardial infarction
Clinical narrative: heart attack; severe diarrhea; This is a spontaneous report from a contactable consumer reported for himself. A 61-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204) via unspecified route of administration on 11Mar2021 01:15 PM in the left arm at 61-year-old at single dose for COVID-19 immunization. Patient had known allergies to CT scan dye. And other medical history included heart. Patient had no covid prior vaccination. There is no other vaccine in four weeks. Concomitant medications in two weeks included: atorvastatin, metoprolol, clopidogrel bisulfate (PLAVIX), amlodipine. Patient got severe diarrhea within 4 hours that was so sever and it was every 10 minutes in frequency first day on 11Mar2021 04:45 PM. He still had diarrhea now 6 weeks after the 1st dose of Pfizer COVID vaccine on 11Mar2021. Also, he had a heart attack 39 hours later on 13Mar2021 which he was hospitalized for 5 days at the hospital. The adverse events resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Patient received treatment for events included heart emergency drugs, catherization for the heart. Patient received covid tested post vaccination, Nasal Swab (PCR) negative. Blood test (covid antigen test): negative. Patient was not recovered. Patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8729) on 01Apr2021 01:30 PM in the right arm at single dose for COVID-19 immunization.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Myocardial infarction, SARS-CoV-2 test
Clinical narrative: heart attack; severe diarrhea; This is a spontaneous report from a contactable consumer reported for himself. A 61-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204) via unspecified route of administration on 11Mar2021 01:15 PM in the left arm at 61-year-old at single dose for COVID-19 immunization. Patient had known allergies to CT scan dye. And other medical history included heart. Patient had no covid prior vaccination. There is no other vaccine in four weeks. Concomitant medications in two weeks included: atorvastatin, metoprolol, clopidogrel bisulfate (PLAVIX), amlodipine. Patient got severe diarrhea within 4 hours that was so sever and it was every 10 minutes in frequency first day on 11Mar2021 04:45 PM. He still had diarrhea now 6 weeks after the 1st dose of Pfizer COVID vaccine on 11Mar2021. Also, he had a heart attack 39 hours later on 13Mar2021 which he was hospitalized for 5 days at the hospital. The adverse events resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. Patient received treatment for events included heart emergency drugs, catherization for the heart. Patient received covid tested post vaccination, Nasal Swab (PCR) negative. Blood test (covid antigen test): negative. Patient was not recovered. Patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8729) on 01Apr2021 01:30 PM in the right arm at single dose for COVID-19 immunization.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Fever 100.6 - given tylenol  Near fainting - mother called medical facility and spoke and was advised by a Triage nurse