chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Respiratory disorder
Clinical narrative: Respiratory issues; This case was reported by a physician via sales rep and described the occurrence of respiratory disorder in a female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced respiratory disorder. On an unknown date, the outcome of the respiratory disorder was unknown.   It was unknown if the reporter considered the respiratory disorder to be related to Pediarix and Pediarix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. No patient identifiers were provided. Health care professional reported that the patient experienced respiratory issue after receiving Pediarix. The dates of the event, the lot number or expiration dates were unknown. No further details were known. The health care professional gave permission to be contacted concerning event. The reporter consented to follow up. This case is one of the 10 cases reported by same reporter.
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Respiratory disorder
Clinical narrative: Respiratory issues; This case was reported by a physician via sales rep and described the occurrence of respiratory disorder in a female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced respiratory disorder. On an unknown date, the outcome of the respiratory disorder was unknown.   It was unknown if the reporter considered the respiratory disorder to be related to Pediarix and Pediarix Pre-Filled Syringe Device.  This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. Health care professional reported that the patient experienced respiratory issue after receiving Pediarix. The dates of the event, the lot number or expiration dates were unknown. The health care professional gave permission to be contacted concerning event. The reporter consented to follow up. No further details were known. This case is one of the 10 cases reported by same reporter.
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Respiratory disorder
Clinical narrative: Respiratory issues; This case was reported by a physician via sales rep and described the occurrence of respiratory disorder in a female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced respiratory disorder. On an unknown date, the outcome of the respiratory disorder was unknown.   It was unknown if the reporter considered the respiratory disorder to be related to Pediarix and Pediarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. Health care professional reported that the patient experienced respiratory issue after receiving Pediarix. The dates of the event, the lot number or expiration dates were unknown. The health care professional gave permission to be contacted concerning event. The reporter consented to follow up. No further details were known. This case is one of the 10 cases reported by same reporter.
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Respiratory disorder
Clinical narrative: Respiratory issues; This case was reported by a physician via sales rep and described the occurrence of respiratory disorder in a female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced respiratory disorder. On an unknown date, the outcome of the respiratory disorder was unknown.   It was unknown if the reporter considered the respiratory disorder to be related to Pediarix and Pediarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: This case was reported by the physician. The age at vaccination was not reported. Health care professional reported that the patient experienced respiratory issue after receiving Pediarix. The dates of the event, the lot number or expiration dates were unknown. No further details were known. The health care professional gave permission to be contacted concerning event. The reporter consented to follow up. This case is one of the 10 cases reported by same reporter.
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Respiratory disorder
Clinical narrative: Respiratory issues; This case was reported by a physician via sales rep and described the occurrence of respiratory disorder in a female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced respiratory disorder. On an unknown date, the outcome of the respiratory disorder was unknown.   It was unknown if the reporter considered the respiratory disorder to be related to Pediarix and Pediarix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. Health care professional (HCP) reported that, the patient (no patient identifiers) experienced respiratory issues after receiving Pediarix.  The date of this events was unknown.  The field representative found out about the event yesterday at 12:30 from the date of reporting. No Lot number or Expiration dates were known.   No further details are known.   The reporter consented to follow up. This case was 1 of 10 case reported by the same reporter.
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Respiratory disorder
Clinical narrative: Respiratory issues; This case was reported by a physician via sales rep and described the occurrence of respiratory disorder in a female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced respiratory disorder. On an unknown date, the outcome of the respiratory disorder was unknown.   It was unknown if the reporter considered the respiratory disorder to be related to Pediarix and Pediarix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. Health care professional (HCP) reported that a patient (no patient identifiers) experienced respiratory issues after receiving Pediarix. The date of this events was unknown.  The field representative found out about the event yesterday at 12:30 from the date of reporting. No Lot number or Expiration dates were known.  No further details are known.  The reporter consented to follow up. This case was 1 of 10 case reported by the same reporter.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cheilitis, Eye irritation, Lip swelling
Clinical narrative: lips and eyes were swollen and irritated; lips and eyes were swollen and irritated; lips and eyes were swollen and irritated; lips and eyes were swollen and irritated; lips still sensitive and tingling; lips still sensitive and tingling; This is a spontaneous report from a contactable consumer (patient).   A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in right arm on 04Mar2021 14:30 (at the age of 58-years-old) as dose 1, single for covid-19 immunization.  Medical history included , polyarteritis nodosa, coronary artery disease, hypertension, myocardial infarction in 2017 and seasonal allergy g. Concomitant medications included metoprolol (METOPROLOL); losartan (LOSARTAN) and aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]). The patient previously took Rituxan every 4 months (last dose was on 12Mar2020) and experienced allergy with sulfonamide and nickel. Prior to vaccination, the patient was not pregnant, not diagnosed with COVID-19, did not receive any other vaccines within 4 weeks. Since the vaccination, has the patient has not been tested for COVID-19.  Patient lips and eyes were swollen and irritated 24 hours after vaccination. She took treatment and swelling improved but lips still sensitive and tingling. Treatment was taken with Benadryl. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cheilitis, Eye irritation, Eye swelling, Lip pain, Lip swelling
Clinical narrative: lips and eyes were swollen and irritated; lips and eyes were swollen and irritated; lips and eyes were swollen and irritated; lips and eyes were swollen and irritated; lips still sensitive and tingling; lips still sensitive and tingling; This is a spontaneous report from a contactable consumer (patient).   A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in right arm on 04Mar2021 14:30 (at the age of 58-years-old) as dose 1, single for covid-19 immunization.  Medical history included , polyarteritis nodosa, coronary artery disease, hypertension, myocardial infarction in 2017 and seasonal allergy g. Concomitant medications included metoprolol (METOPROLOL); losartan (LOSARTAN) and aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]). The patient previously took Rituxan every 4 months (last dose was on 12Mar2020) and experienced allergy with sulfonamide and nickel. Prior to vaccination, the patient was not pregnant, not diagnosed with COVID-19, did not receive any other vaccines within 4 weeks. Since the vaccination, has the patient has not been tested for COVID-19.  Patient lips and eyes were swollen and irritated 24 hours after vaccination. She took treatment and swelling improved but lips still sensitive and tingling. Treatment was taken with Benadryl. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral
Clinical narrative: lips and eyes were swollen and irritated; lips and eyes were swollen and irritated; lips and eyes were swollen and irritated; lips and eyes were swollen and irritated; lips still sensitive and tingling; lips still sensitive and tingling; This is a spontaneous report from a contactable consumer (patient).   A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/Lot Number: EN6203), via an unspecified route of administration, administered in right arm on 04Mar2021 14:30 (at the age of 58-years-old) as dose 1, single for covid-19 immunization.  Medical history included , polyarteritis nodosa, coronary artery disease, hypertension, myocardial infarction in 2017 and seasonal allergy g. Concomitant medications included metoprolol (METOPROLOL); losartan (LOSARTAN) and aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]). The patient previously took Rituxan every 4 months (last dose was on 12Mar2020) and experienced allergy with sulfonamide and nickel. Prior to vaccination, the patient was not pregnant, not diagnosed with COVID-19, did not receive any other vaccines within 4 weeks. Since the vaccination, has the patient has not been tested for COVID-19.  Patient lips and eyes were swollen and irritated 24 hours after vaccination. She took treatment and swelling improved but lips still sensitive and tingling. Treatment was taken with Benadryl. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Decreased appetite, Fatigue, Headache, Malaise
Clinical narrative: feeling unwell; excessive fatigue; headache; joint pain; This is a spontaneous report from a contactable consumer (patient).   A non-pregnant 62-year-old female patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6198) via an unspecified route of administration, administered in arm right on 23Feb2021 15:15 (at the age of 62 years old) as dose 1, single for COVID-19 immunisation. Medical history included lung/bone cancer, and allergy to Bactrim. Concomitant medications included omeprazole, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), nebivolol hydrochloride (BYSTOLIC). On 25Feb2021 12:30, the patient experienced feeling unwell, excessive fatigue, headache, and joint pain. Patient had no other vaccines in four weeks, no COVID prior vaccination and not COVID tested post vaccination. There was no treatment received for the events. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Headache, Malaise
Clinical narrative: feeling unwell; excessive fatigue; headache; joint pain; This is a spontaneous report from a contactable consumer (patient).   A non-pregnant 62-year-old female patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6198) via an unspecified route of administration, administered in arm right on 23Feb2021 15:15 (at the age of 62 years old) as dose 1, single for COVID-19 immunisation. Medical history included lung/bone cancer, and allergy to Bactrim. Concomitant medications included omeprazole, aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), nebivolol hydrochloride (BYSTOLIC). On 25Feb2021 12:30, the patient experienced feeling unwell, excessive fatigue, headache, and joint pain. Patient had no other vaccines in four weeks, no COVID prior vaccination and not COVID tested post vaccination. There was no treatment received for the events. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Analgesic drug level, Analgesic drug level therapeutic, Blood bicarbonate decreased, Blood glucose increased, Blood ketone body
Clinical narrative: Received vaccine on 3/9/21 with progressive development of headache, back pain, and light-headedness upon standing that dissipated over the week.  Then sudden onset of vomiting on 3/16 that worsened throughout the day with cardiopulmonary arrest on 3/17.  Admitted to hospital with severe hyperglycemia (1041mg/dL) and elevated lipase level.  Developed sepsis and aspiration pneumonia before passing away on 3/22.  T-cell lymphocytic pancreatitis found at autopsy.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pH decreased, Brain death, Diabetic ketoacidosis, Drug screen negative, Glycosylated haemoglobin
Clinical narrative: Received vaccine on 3/9/21 with progressive development of headache, back pain, and light-headedness upon standing that dissipated over the week.  Then sudden onset of vomiting on 3/16 that worsened throughout the day with cardiopulmonary arrest on 3/17.  Admitted to hospital with severe hyperglycemia (1041mg/dL) and elevated lipase level.  Developed sepsis and aspiration pneumonia before passing away on 3/22.  T-cell lymphocytic pancreatitis found at autopsy.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lipase increased, Mechanical ventilation, Metabolic encephalopathy, PCO2 decreased, PO2 increased
Clinical narrative: Received vaccine on 3/9/21 with progressive development of headache, back pain, and light-headedness upon standing that dissipated over the week.  Then sudden onset of vomiting on 3/16 that worsened throughout the day with cardiopulmonary arrest on 3/17.  Admitted to hospital with severe hyperglycemia (1041mg/dL) and elevated lipase level.  Developed sepsis and aspiration pneumonia before passing away on 3/22.  T-cell lymphocytic pancreatitis found at autopsy.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pneumonia aspiration
Clinical narrative: Received vaccine on 3/9/21 with progressive development of headache, back pain, and light-headedness upon standing that dissipated over the week.  Then sudden onset of vomiting on 3/16 that worsened throughout the day with cardiopulmonary arrest on 3/17.  Admitted to hospital with severe hyperglycemia (1041mg/dL) and elevated lipase level.  Developed sepsis and aspiration pneumonia before passing away on 3/22.  T-cell lymphocytic pancreatitis found at autopsy.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Autopsy, Back pain, Bandaemia, Blood creatinine increased, Blood glucose increased
Clinical narrative: Received vaccine on 3/9/21 with progressive development of headache, back pain, and light-headedness upon standing that dissipated over the week.  Then sudden onset of vomiting on 3/16 that worsened throughout the day with cardiopulmonary arrest on 3/17.  Admitted to hospital with severe hyperglycemia (1041mg/dL) and elevated lipase level.  Developed sepsis and aspiration pneumonia before passing away on 3/22.  T-cell lymphocytic pancreatitis found at autopsy.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood ketone body, Blood osmolarity increased, Blood potassium increased, Blood urea increased, Cardio-respiratory arrest
Clinical narrative: Received vaccine on 3/9/21 with progressive development of headache, back pain, and light-headedness upon standing that dissipated over the week.  Then sudden onset of vomiting on 3/16 that worsened throughout the day with cardiopulmonary arrest on 3/17.  Admitted to hospital with severe hyperglycemia (1041mg/dL) and elevated lipase level.  Developed sepsis and aspiration pneumonia before passing away on 3/22.  T-cell lymphocytic pancreatitis found at autopsy.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Dizziness, Headache, Hyperglycaemia, Lipase increased
Clinical narrative: Received vaccine on 3/9/21 with progressive development of headache, back pain, and light-headedness upon standing that dissipated over the week.  Then sudden onset of vomiting on 3/16 that worsened throughout the day with cardiopulmonary arrest on 3/17.  Admitted to hospital with severe hyperglycemia (1041mg/dL) and elevated lipase level.  Developed sepsis and aspiration pneumonia before passing away on 3/22.  T-cell lymphocytic pancreatitis found at autopsy.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pancreatitis, Pneumonia aspiration, Sepsis, Vomiting, White blood cell count increased
Clinical narrative: Received vaccine on 3/9/21 with progressive development of headache, back pain, and light-headedness upon standing that dissipated over the week.  Then sudden onset of vomiting on 3/16 that worsened throughout the day with cardiopulmonary arrest on 3/17.  Admitted to hospital with severe hyperglycemia (1041mg/dL) and elevated lipase level.  Developed sepsis and aspiration pneumonia before passing away on 3/22.  T-cell lymphocytic pancreatitis found at autopsy.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Periorbital swelling, Tachycardia
Clinical narrative: I normally have Mast Cell Immediate Anaphylactic reactions and within a few minutes of the vaccine I started to have a reaction and my lips were swollen and I started to feel spaced out. I had pretreated with some antihistamines. I used my own EpiPen when I started to have a reaction. I was observed for a short while but then I started to feel itchy. I was given some Intramuscular Benadryl and I felt better and then I went home. A few hours later I felt extremely itchy again all over for about 24 hours. Twelve days after the shot I and been feeling bad the whole time and my system seemed to be out of control. I did not have any of my intramuscular Benadryl and IV Pepcid like I would have preferred. I went to Urgent Care and I was sent to the ER where I got the IV. I felt like I was swollen, and I was prescribed some Prednisone and experienced Prednisone Psychosis for a few weeks. Over the next two months I visited the ER and Urgent Care and I got a Xolair infusion which I reacted to in the infusion center. I was admitted to the hospital over night in May 2021. My immune system seeded to be in overdrive, and I was having trouble functioning mentally. Any noise or light was affecting me, so I completely shut down. I needed care giving full for two weeks. My joints became extremely inflamed, and my depth perception is not functioning. I have had pattern of extreme nausea in 14?15-hour bouts five times over the last five months. My Lymphatic system seems to be malfunctioning and I have fatty lumps that seem to move around. I had a lack of menstruation from 03/13/2021 for 90 days. The first three times after that were super heavy and intense. Currently it has been six months since the vaccine and I have not been able to work. I have a caregiver that has to help me take care of myself.  I am scheduled to see a cardiologist and I have been experiencing new symptoms. My condition was controlled before this but it was not bad to this extreme.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Altered visual depth perception, Amenorrhoea, Arthritis, Blood test, Feeling abnormal
Clinical narrative: I normally have Mast Cell Immediate Anaphylactic reactions and within a few minutes of the vaccine I started to have a reaction and my lips were swollen and I started to feel spaced out. I had pretreated with some antihistamines. I used my own EpiPen when I started to have a reaction. I was observed for a short while but then I started to feel itchy. I was given some Intramuscular Benadryl and I felt better and then I went home. A few hours later I felt extremely itchy again all over for about 24 hours. Twelve days after the shot I and been feeling bad the whole time and my system seemed to be out of control. I did not have any of my intramuscular Benadryl and IV Pepcid like I would have preferred. I went to Urgent Care and I was sent to the ER where I got the IV. I felt like I was swollen, and I was prescribed some Prednisone and experienced Prednisone Psychosis for a few weeks. Over the next two months I visited the ER and Urgent Care and I got a Xolair infusion which I reacted to in the infusion center. I was admitted to the hospital over night in May 2021. My immune system seeded to be in overdrive, and I was having trouble functioning mentally. Any noise or light was affecting me, so I completely shut down. I needed care giving full for two weeks. My joints became extremely inflamed, and my depth perception is not functioning. I have had pattern of extreme nausea in 14?15-hour bouts five times over the last five months. My Lymphatic system seems to be malfunctioning and I have fatty lumps that seem to move around. I had a lack of menstruation from 03/13/2021 for 90 days. The first three times after that were super heavy and intense. Currently it has been six months since the vaccine and I have not been able to work. I have a caregiver that has to help me take care of myself.  I am scheduled to see a cardiologist and I have been experiencing new symptoms. My condition was controlled before this but it was not bad to this extreme.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Impaired work ability, Infusion, Lip swelling, Loss of personal independence in daily activities
Clinical narrative: I normally have Mast Cell Immediate Anaphylactic reactions and within a few minutes of the vaccine I started to have a reaction and my lips were swollen and I started to feel spaced out. I had pretreated with some antihistamines. I used my own EpiPen when I started to have a reaction. I was observed for a short while but then I started to feel itchy. I was given some Intramuscular Benadryl and I felt better and then I went home. A few hours later I felt extremely itchy again all over for about 24 hours. Twelve days after the shot I and been feeling bad the whole time and my system seemed to be out of control. I did not have any of my intramuscular Benadryl and IV Pepcid like I would have preferred. I went to Urgent Care and I was sent to the ER where I got the IV. I felt like I was swollen, and I was prescribed some Prednisone and experienced Prednisone Psychosis for a few weeks. Over the next two months I visited the ER and Urgent Care and I got a Xolair infusion which I reacted to in the infusion center. I was admitted to the hospital over night in May 2021. My immune system seeded to be in overdrive, and I was having trouble functioning mentally. Any noise or light was affecting me, so I completely shut down. I needed care giving full for two weeks. My joints became extremely inflamed, and my depth perception is not functioning. I have had pattern of extreme nausea in 14?15-hour bouts five times over the last five months. My Lymphatic system seems to be malfunctioning and I have fatty lumps that seem to move around. I had a lack of menstruation from 03/13/2021 for 90 days. The first three times after that were super heavy and intense. Currently it has been six months since the vaccine and I have not been able to work. I have a caregiver that has to help me take care of myself.  I am scheduled to see a cardiologist and I have been experiencing new symptoms. My condition was controlled before this but it was not bad to this extreme.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphatic disorder, Magnetic resonance imaging, Mental impairment, Nausea, Oversensing
Clinical narrative: I normally have Mast Cell Immediate Anaphylactic reactions and within a few minutes of the vaccine I started to have a reaction and my lips were swollen and I started to feel spaced out. I had pretreated with some antihistamines. I used my own EpiPen when I started to have a reaction. I was observed for a short while but then I started to feel itchy. I was given some Intramuscular Benadryl and I felt better and then I went home. A few hours later I felt extremely itchy again all over for about 24 hours. Twelve days after the shot I and been feeling bad the whole time and my system seemed to be out of control. I did not have any of my intramuscular Benadryl and IV Pepcid like I would have preferred. I went to Urgent Care and I was sent to the ER where I got the IV. I felt like I was swollen, and I was prescribed some Prednisone and experienced Prednisone Psychosis for a few weeks. Over the next two months I visited the ER and Urgent Care and I got a Xolair infusion which I reacted to in the infusion center. I was admitted to the hospital over night in May 2021. My immune system seeded to be in overdrive, and I was having trouble functioning mentally. Any noise or light was affecting me, so I completely shut down. I needed care giving full for two weeks. My joints became extremely inflamed, and my depth perception is not functioning. I have had pattern of extreme nausea in 14?15-hour bouts five times over the last five months. My Lymphatic system seems to be malfunctioning and I have fatty lumps that seem to move around. I had a lack of menstruation from 03/13/2021 for 90 days. The first three times after that were super heavy and intense. Currently it has been six months since the vaccine and I have not been able to work. I have a caregiver that has to help me take care of myself.  I am scheduled to see a cardiologist and I have been experiencing new symptoms. My condition was controlled before this but it was not bad to this extreme.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Photophobia, Pruritus, Psychotic disorder, Swelling, X-ray
Clinical narrative: I normally have Mast Cell Immediate Anaphylactic reactions and within a few minutes of the vaccine I started to have a reaction and my lips were swollen and I started to feel spaced out. I had pretreated with some antihistamines. I used my own EpiPen when I started to have a reaction. I was observed for a short while but then I started to feel itchy. I was given some Intramuscular Benadryl and I felt better and then I went home. A few hours later I felt extremely itchy again all over for about 24 hours. Twelve days after the shot I and been feeling bad the whole time and my system seemed to be out of control. I did not have any of my intramuscular Benadryl and IV Pepcid like I would have preferred. I went to Urgent Care and I was sent to the ER where I got the IV. I felt like I was swollen, and I was prescribed some Prednisone and experienced Prednisone Psychosis for a few weeks. Over the next two months I visited the ER and Urgent Care and I got a Xolair infusion which I reacted to in the infusion center. I was admitted to the hospital over night in May 2021. My immune system seeded to be in overdrive, and I was having trouble functioning mentally. Any noise or light was affecting me, so I completely shut down. I needed care giving full for two weeks. My joints became extremely inflamed, and my depth perception is not functioning. I have had pattern of extreme nausea in 14?15-hour bouts five times over the last five months. My Lymphatic system seems to be malfunctioning and I have fatty lumps that seem to move around. I had a lack of menstruation from 03/13/2021 for 90 days. The first three times after that were super heavy and intense. Currently it has been six months since the vaccine and I have not been able to work. I have a caregiver that has to help me take care of myself.  I am scheduled to see a cardiologist and I have been experiencing new symptoms. My condition was controlled before this but it was not bad to this extreme.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Chest discomfort, Chest pain, Dizziness, Fatigue
Clinical narrative: My right eye lid swelled shut; had a red rash; sun burn; Sores in my mouth; Chest pains; trouble breathing; BAD headache; loss of appetite; Fatigue; Couldn't lift my arm at all from my side; This is a spontaneous report from a contactable consumer(patient, self reported). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date was not reported), via an unspecified route of administration in Arm left, on 08Apr2021 11:15AM (at the of 45-year-old), as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included Fibromyalgia, chronic fatigue, known allergies: penicillin and the patient was diagnosed with covid prior vaccination. Concomitant medications included Adderall, Tylenol, Vitamins, Zinc, Vitamin c. The patient did not receive any other vaccine in four weeks. The patient had other medications in two weeks. On 08Apr2021 12:00AM, The patient reported that her right eye lid swelled shut and had a red rash/ sun burn, sores in her mouth and Chest pains, trouble breathing, BAD headache, loss of appetite, Fatigue and Could not lift her arm at all from her side. The patient did not received any treatment for the events. The patient was diagnosed with COVID prior vaccination. The patient was tested for COVID post vaccination. The patient underwent SARS-CoV-2 test Nasal swab with the result of positive on 29Jan2021. Outcome of the events were not recovered.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Movement disorder, Pain, Petechiae, Swelling of eyelid, Tension headache
Clinical narrative: My right eye lid swelled shut; had a red rash; sun burn; Sores in my mouth; Chest pains; trouble breathing; BAD headache; loss of appetite; Fatigue; Couldn't lift my arm at all from my side; This is a spontaneous report from a contactable consumer(patient, self reported). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date was not reported), via an unspecified route of administration in Arm left, on 08Apr2021 11:15AM (at the of 45-year-old), as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included Fibromyalgia, chronic fatigue, known allergies: penicillin and the patient was diagnosed with covid prior vaccination. Concomitant medications included Adderall, Tylenol, Vitamins, Zinc, Vitamin c. The patient did not receive any other vaccine in four weeks. The patient had other medications in two weeks. On 08Apr2021 12:00AM, The patient reported that her right eye lid swelled shut and had a red rash/ sun burn, sores in her mouth and Chest pains, trouble breathing, BAD headache, loss of appetite, Fatigue and Could not lift her arm at all from her side. The patient did not received any treatment for the events. The patient was diagnosed with COVID prior vaccination. The patient was tested for COVID post vaccination. The patient underwent SARS-CoV-2 test Nasal swab with the result of positive on 29Jan2021. Outcome of the events were not recovered.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Decreased appetite, Dyspnoea, Fatigue, Headache
Clinical narrative: My right eye lid swelled shut; had a red rash; sun burn; Sores in my mouth; Chest pains; trouble breathing; BAD headache; loss of appetite; Fatigue; Couldn't lift my arm at all from my side; This is a spontaneous report from a contactable consumer(patient, self reported). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date was not reported), via an unspecified route of administration in Arm left, on 08Apr2021 11:15AM (at the of 45-year-old), as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included Fibromyalgia, chronic fatigue, known allergies: penicillin and the patient was diagnosed with covid prior vaccination. Concomitant medications included Adderall, Tylenol, Vitamins, Zinc, Vitamin c. The patient did not receive any other vaccine in four weeks. The patient had other medications in two weeks. On 08Apr2021 12:00AM, The patient reported that her right eye lid swelled shut and had a red rash/ sun burn, sores in her mouth and Chest pains, trouble breathing, BAD headache, loss of appetite, Fatigue and Could not lift her arm at all from her side. The patient did not received any treatment for the events. The patient was diagnosed with COVID prior vaccination. The patient was tested for COVID post vaccination. The patient underwent SARS-CoV-2 test Nasal swab with the result of positive on 29Jan2021. Outcome of the events were not recovered.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Rash, SARS-CoV-2 test, Stomatitis, Sunburn
Clinical narrative: My right eye lid swelled shut; had a red rash; sun burn; Sores in my mouth; Chest pains; trouble breathing; BAD headache; loss of appetite; Fatigue; Couldn't lift my arm at all from my side; This is a spontaneous report from a contactable consumer(patient, self reported). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date was not reported), via an unspecified route of administration in Arm left, on 08Apr2021 11:15AM (at the of 45-year-old), as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included Fibromyalgia, chronic fatigue, known allergies: penicillin and the patient was diagnosed with covid prior vaccination. Concomitant medications included Adderall, Tylenol, Vitamins, Zinc, Vitamin c. The patient did not receive any other vaccine in four weeks. The patient had other medications in two weeks. On 08Apr2021 12:00AM, The patient reported that her right eye lid swelled shut and had a red rash/ sun burn, sores in her mouth and Chest pains, trouble breathing, BAD headache, loss of appetite, Fatigue and Could not lift her arm at all from her side. The patient did not received any treatment for the events. The patient was diagnosed with COVID prior vaccination. The patient was tested for COVID post vaccination. The patient underwent SARS-CoV-2 test Nasal swab with the result of positive on 29Jan2021. Outcome of the events were not recovered.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling of eyelid
Clinical narrative: My right eye lid swelled shut; had a red rash; sun burn; Sores in my mouth; Chest pains; trouble breathing; BAD headache; loss of appetite; Fatigue; Couldn't lift my arm at all from my side; This is a spontaneous report from a contactable consumer(patient, self reported). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date was not reported), via an unspecified route of administration in Arm left, on 08Apr2021 11:15AM (at the of 45-year-old), as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history included Fibromyalgia, chronic fatigue, known allergies: penicillin and the patient was diagnosed with covid prior vaccination. Concomitant medications included Adderall, Tylenol, Vitamins, Zinc, Vitamin c. The patient did not receive any other vaccine in four weeks. The patient had other medications in two weeks. On 08Apr2021 12:00AM, The patient reported that her right eye lid swelled shut and had a red rash/ sun burn, sores in her mouth and Chest pains, trouble breathing, BAD headache, loss of appetite, Fatigue and Could not lift her arm at all from her side. The patient did not received any treatment for the events. The patient was diagnosed with COVID prior vaccination. The patient was tested for COVID post vaccination. The patient underwent SARS-CoV-2 test Nasal swab with the result of positive on 29Jan2021. Outcome of the events were not recovered.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Nausea, Palpitations, Paraesthesia
Clinical narrative: Symptoms: numbness in left arm and fingers, dizziness, racing pulse, racing heart, elevated blood pressure Time: symptoms occurred within 15 min after vaccine administration Treatment: 30 min of observation and monitoring blood pressure  by on-site EMT, recommended to f/u with PCP or return home to rest Outcome: D/C from vaccination site once blood pressure <140/90
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness, Heart rate increased, Hypoaesthesia, Palpitations
Clinical narrative: Symptoms: numbness in left arm and fingers, dizziness, racing pulse, racing heart, elevated blood pressure Time: symptoms occurred within 15 min after vaccine administration Treatment: 30 min of observation and monitoring blood pressure  by on-site EMT, recommended to f/u with PCP or return home to rest Outcome: D/C from vaccination site once blood pressure <140/90
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast pain, Rash, Skin discolouration
Clinical narrative: Partial numbness in legs; Swelling; Sharp pain in left breast.; Subcutaneous reticular spots, some red, some violet on the calves of both legs. In one legs spots extending to the thigh.; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8730) via an unspecified route of administration in left arm on 25Mar2021 at 12:30 (at the age of 60-year-old) as single dose for COVID-19 immunization. Patient had no medical history or known allergies. The patient did not receive any concomitant/other medications within 2 weeks of vaccination and 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. On 26Mar2021 at 19:00, the patient experienced subcutaneous reticular spots, some red, some violet on the calves of both legs. In one leg spots extending to the thigh. On 28Mar2021 at 20:00, patient had partial numbness in legs, Swelling, sharp pain in left breast. Reportedly, red, and blue spots all over calves in the back of patient legs and spots were still visible 2 months later. Since the vaccination, the patient was tested for COVID-19. On 05May2021, the patient underwent a lab test name NAAT [Nasal Swab] with result as negative. Patient did not receive any treatment in response to the adverse event. Outcome of the events were not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast pain, Hypoaesthesia, Pigmentation disorder, SARS-CoV-2 test, Swelling
Clinical narrative: Partial numbness in legs; Swelling; Sharp pain in left breast.; Subcutaneous reticular spots, some red, some violet on the calves of both legs. In one legs spots extending to the thigh.; This is a spontaneous report from a contactable consumer (patient). A 60-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8730) via an unspecified route of administration in left arm on 25Mar2021 at 12:30 (at the age of 60-year-old) as single dose for COVID-19 immunization. Patient had no medical history or known allergies. The patient did not receive any concomitant/other medications within 2 weeks of vaccination and 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. On 26Mar2021 at 19:00, the patient experienced subcutaneous reticular spots, some red, some violet on the calves of both legs. In one leg spots extending to the thigh. On 28Mar2021 at 20:00, patient had partial numbness in legs, Swelling, sharp pain in left breast. Reportedly, red, and blue spots all over calves in the back of patient legs and spots were still visible 2 months later. Since the vaccination, the patient was tested for COVID-19. On 05May2021, the patient underwent a lab test name NAAT [Nasal Swab] with result as negative. Patient did not receive any treatment in response to the adverse event. Outcome of the events were not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: The vaccine did not work properly. My body did not develop antibodies which is supposed to. I had 2 of the proper blood tests done and they were negative. One on 06/02/2021 and another on 07/20/2021. I have somewhat of an immune deficiency. 3 doctors have said that I need to get another shot and I have been waiting and waiting and waiting for another shot, but I have not heard anything yet. It has caused me immense stress and worry. I have been to 2 immunologist and several doctors visits because of this problem. It is all because I am waiting for a booster shot. I do not feel protected. I only leave my house for urgent matters. Basically, I shut my life down. I am just hoping this helps expedite the authorization of the booster shot because there are a lot of people with immune problems who definitely need a a second shot. This could save lives.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 antibody test negative, Vaccine induced antibody absent
Clinical narrative: The vaccine did not work properly. My body did not develop antibodies which is supposed to. I had 2 of the proper blood tests done and they were negative. One on 06/02/2021 and another on 07/20/2021. I have somewhat of an immune deficiency. 3 doctors have said that I need to get another shot and I have been waiting and waiting and waiting for another shot, but I have not heard anything yet. It has caused me immense stress and worry. I have been to 2 immunologist and several doctors visits because of this problem. It is all because I am waiting for a booster shot. I do not feel protected. I only leave my house for urgent matters. Basically, I shut my life down. I am just hoping this helps expedite the authorization of the booster shot because there are a lot of people with immune problems who definitely need a a second shot. This could save lives.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Alopecia
Clinical narrative: My hair is falling out!; This is a spontaneous report from a contactable consumer. This 41-year-old female consumer reported that:  A 41-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine; Solution for injection; Lot number: EW0169), via an unspecified route of administration, administered in left arm as dose 1, single on 23Apr2021 15:15 (at the age of 41-year-old) for covid-19 immunization. Medical history included covid-19 from an unknown date and unknown if ongoing and no known allergies. Patient had been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine and received no other medications within two weeks of vaccination. On 25Apr2021, patient reported that her hair is falling out. No treatment was received as a result of adverse event. The outcome of event was not recovered.  No follow up attempts are possible; No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Loss of consciousness, Nausea
Clinical narrative: Mental confusion, tingling in the fingers, racing pulse, rapid heartbeat, dizziness, nausea, dry vomiting, fainting, elevated blood pressure, muscular weakness.  Symptoms occurred within 15-20 min after receiving the vaccine The Treatment included person removed to a resting area and then transported to the nearest ER for observation and testing. Released home after a couple hours, rest, f/u with PCP.