chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Injection site erythema, Injection site pruritus, Injection site reaction, Limb discomfort
Clinical narrative: Received Moderna Covid -19 vaccine to the LD at 8:27 a.m. At 8:39 a.m. patient complaint of "tight" left arm. At 8:44 a.m. complaint of a sore left arm and the need to take deeper breaths, stated chest felt heavy. RN in practice consulted with Nurse practitioner and directed PO Benadryl 25 mg (10ml) administered at 8:47 a.m.  At 8:52 a.m. bilateral hands are tight, swollen, bilateral upper arms are red, blotchy, and itchy. Patient reports a "weird" taste in her mouth perhaps from the oral Benadryl suspension. 9:02 a.m. patient ambulated to the ED with the RN, who was present with the patient through the duration of the above incident until she was taken to a room in the Hospital ED. Patient did have a co-worker present before she was taken to the ED.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling, Taste disorder
Clinical narrative: Received Moderna Covid -19 vaccine to the LD at 8:27 a.m. At 8:39 a.m. patient complaint of "tight" left arm. At 8:44 a.m. complaint of a sore left arm and the need to take deeper breaths, stated chest felt heavy. RN in practice consulted with Nurse practitioner and directed PO Benadryl 25 mg (10ml) administered at 8:47 a.m.  At 8:52 a.m. bilateral hands are tight, swollen, bilateral upper arms are red, blotchy, and itchy. Patient reports a "weird" taste in her mouth perhaps from the oral Benadryl suspension. 9:02 a.m. patient ambulated to the ED with the RN, who was present with the patient through the duration of the above incident until she was taken to a room in the Hospital ED. Patient did have a co-worker present before she was taken to the ED.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Red, warm, slightly itchy "rash" encircling  left axilla. Also sore left arm and some fatigue. Started 01/18/2021 & resolved 01/22/2021
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Fatigue, Pain in extremity, Rash pruritic, Skin warm
Clinical narrative: Red, warm, slightly itchy "rash" encircling  left axilla. Also sore left arm and some fatigue. Started 01/18/2021 & resolved 01/22/2021
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Erythema, Flushing, Paraesthesia
Clinical narrative: About one to two minutes after receiving the vaccine, I felt dizzy and lightheaded. Nurses came to help me and put me on the floor. I felt flushed throughout my whole body and the nurse said my face and chest was very red.  My blood pressure went up and I remember at one point the top number was in the 180s and bottom number in the 110s. My heart rate was fast, but I don't recall what it was from the monitor. At one point my jaw got tight, my face felt numb, and my fingers were tingly.  They  gave me a 50mg shot of Benadryl. One of the nurses wanted to give me an Epipen, but the other nurse said to wait and monitor me for a few more minutes to see if the Benadryl would take effect, which thankfully it did.  I would say the entire episode lasted about 20 minutes.  I never had a problem with breathing, throat closing up, or wheezing and the nurse told me after that my oxygen levels never went down.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness, Erythema, Flushing, Heart rate increased
Clinical narrative: About one to two minutes after receiving the vaccine, I felt dizzy and lightheaded. Nurses came to help me and put me on the floor. I felt flushed throughout my whole body and the nurse said my face and chest was very red.  My blood pressure went up and I remember at one point the top number was in the 180s and bottom number in the 110s. My heart rate was fast, but I don't recall what it was from the monitor. At one point my jaw got tight, my face felt numb, and my fingers were tingly.  They  gave me a 50mg shot of Benadryl. One of the nurses wanted to give me an Epipen, but the other nurse said to wait and monitor me for a few more minutes to see if the Benadryl would take effect, which thankfully it did.  I would say the entire episode lasted about 20 minutes.  I never had a problem with breathing, throat closing up, or wheezing and the nurse told me after that my oxygen levels never went down.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Muscle tightness, Paraesthesia
Clinical narrative: About one to two minutes after receiving the vaccine, I felt dizzy and lightheaded. Nurses came to help me and put me on the floor. I felt flushed throughout my whole body and the nurse said my face and chest was very red.  My blood pressure went up and I remember at one point the top number was in the 180s and bottom number in the 110s. My heart rate was fast, but I don't recall what it was from the monitor. At one point my jaw got tight, my face felt numb, and my fingers were tingly.  They  gave me a 50mg shot of Benadryl. One of the nurses wanted to give me an Epipen, but the other nurse said to wait and monitor me for a few more minutes to see if the Benadryl would take effect, which thankfully it did.  I would say the entire episode lasted about 20 minutes.  I never had a problem with breathing, throat closing up, or wheezing and the nurse told me after that my oxygen levels never went down.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Dyspnoea, Electrocardiogram normal, Influenza like illness
Clinical narrative: Mild symptoms - cold chills, achy on the night of vaccine. At about 24 hrs after vaccine administration, developed high fever(102), rapid heart rate, low o2 sat, eventually passed out and EMS had to be called.  Was not transported to hospital per pt request.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Pain, Pyrexia, Syncope
Clinical narrative: Mild symptoms - cold chills, achy on the night of vaccine. At about 24 hrs after vaccine administration, developed high fever(102), rapid heart rate, low o2 sat, eventually passed out and EMS had to be called.  Was not transported to hospital per pt request.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Dyspnoea, Electrocardiogram normal, Feeling cold, Heart rate increased
Clinical narrative: Mild symptoms - cold chills, achy on the night of vaccine. At about 24 hrs after vaccine administration, developed high fever(102), rapid heart rate, low o2 sat, eventually passed out and EMS had to be called.  Was not transported to hospital per pt request.
Age: 41.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Pain, Pyrexia
Clinical narrative: Mild symptoms - cold chills, achy on the night of vaccine. At about 24 hrs after vaccine administration, developed high fever(102), rapid heart rate, low o2 sat, eventually passed out and EMS had to be called.  Was not transported to hospital per pt request.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness, Heart rate increased, Pallor
Clinical narrative: 15 minutes after receiving vaccine, patient went back to work.  He is 47 year old urgent care physician.  Exactly at the 30 minute mark, patient started feeling faint and not right.  Felt like he was going to be unconscious. Patient yelled for his nurse to get the crash cart.  He was experiencing anaphylaxis.  Was admitted to Medical Center where he was seen by physician and RN.  Patient was finally discharged at 9:30 pm.  Patient is continuing to have ongoing cardiac issues including abnormal readings and heart palpitations.  Patient went to Cardiologist last week and an allergist last week to try and resolve these ongoing issues.  Patient got prescribed Ativan, Busprirone, Hydroxyzine Clonazepam.  He asked for the hydroxyzine Clonazepam to be switched to Diltizem as it was not making him feel better.  He is also experiencing additional pain in his neck that has worsened.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Cardiac disorder, Depressed level of consciousness, Dizziness, Electrocardiogram abnormal
Clinical narrative: 15 minutes after receiving vaccine, patient went back to work.  He is 47 year old urgent care physician.  Exactly at the 30 minute mark, patient started feeling faint and not right.  Felt like he was going to be unconscious. Patient yelled for his nurse to get the crash cart.  He was experiencing anaphylaxis.  Was admitted to Medical Center where he was seen by physician and RN.  Patient was finally discharged at 9:30 pm.  Patient is continuing to have ongoing cardiac issues including abnormal readings and heart palpitations.  Patient went to Cardiologist last week and an allergist last week to try and resolve these ongoing issues.  Patient got prescribed Ativan, Busprirone, Hydroxyzine Clonazepam.  He asked for the hydroxyzine Clonazepam to be switched to Diltizem as it was not making him feel better.  He is also experiencing additional pain in his neck that has worsened.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Neck pain, Palpitations
Clinical narrative: 15 minutes after receiving vaccine, patient went back to work.  He is 47 year old urgent care physician.  Exactly at the 30 minute mark, patient started feeling faint and not right.  Felt like he was going to be unconscious. Patient yelled for his nurse to get the crash cart.  He was experiencing anaphylaxis.  Was admitted to Medical Center where he was seen by physician and RN.  Patient was finally discharged at 9:30 pm.  Patient is continuing to have ongoing cardiac issues including abnormal readings and heart palpitations.  Patient went to Cardiologist last week and an allergist last week to try and resolve these ongoing issues.  Patient got prescribed Ativan, Busprirone, Hydroxyzine Clonazepam.  He asked for the hydroxyzine Clonazepam to be switched to Diltizem as it was not making him feel better.  He is also experiencing additional pain in his neck that has worsened.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Resuscitation, Unresponsive to stimuli
Clinical narrative: Systemic: Other- Patient passed away 1 day after vaccine - unknown if cause of death related to immunization-Severe; 1 day symptoms
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Systemic: Other- Patient passed away 1 day after vaccine - unknown if cause of death related to immunization-Severe; 1 day symptoms
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Syncope
Clinical narrative: As I was leaving the clinic, roughly 20 minutes after receiving the vaccine, I because very nauseous and returned to tell the nurse I didn't feel well.  I then had an episode of syncope and was unconscious for around 40 seconds.  I was transported to the hospital via ambulance.  In the ambulance I had a second syncopal episode while the EKG monitored that my HR dropped to 30 bpm.  I was unconscious the 2nd time for around 1 minute.  Upon arrival to the ER I vomited uncontrollably for a few minutes.   For the last 3 weeks following the vaccine I've had a fever of 99.8, headaches, mild diarrhea and nausea.  For 10 days following the vaccine I had trouble with thinking clearly and "brain fog".  Beginning 2 days post-vaccination my left supraclavicular lymph nodes became very swollen and hard and have remained that way since.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Diarrhoea, Feeling abnormal, Headache, Heart rate decreased
Clinical narrative: As I was leaving the clinic, roughly 20 minutes after receiving the vaccine, I because very nauseous and returned to tell the nurse I didn't feel well.  I then had an episode of syncope and was unconscious for around 40 seconds.  I was transported to the hospital via ambulance.  In the ambulance I had a second syncopal episode while the EKG monitored that my HR dropped to 30 bpm.  I was unconscious the 2nd time for around 1 minute.  Upon arrival to the ER I vomited uncontrollably for a few minutes.   For the last 3 weeks following the vaccine I've had a fever of 99.8, headaches, mild diarrhea and nausea.  For 10 days following the vaccine I had trouble with thinking clearly and "brain fog".  Beginning 2 days post-vaccination my left supraclavicular lymph nodes became very swollen and hard and have remained that way since.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Induration, Loss of consciousness, Lymphadenopathy, Mental impairment, Nausea
Clinical narrative: As I was leaving the clinic, roughly 20 minutes after receiving the vaccine, I because very nauseous and returned to tell the nurse I didn't feel well.  I then had an episode of syncope and was unconscious for around 40 seconds.  I was transported to the hospital via ambulance.  In the ambulance I had a second syncopal episode while the EKG monitored that my HR dropped to 30 bpm.  I was unconscious the 2nd time for around 1 minute.  Upon arrival to the ER I vomited uncontrollably for a few minutes.   For the last 3 weeks following the vaccine I've had a fever of 99.8, headaches, mild diarrhea and nausea.  For 10 days following the vaccine I had trouble with thinking clearly and "brain fog".  Beginning 2 days post-vaccination my left supraclavicular lymph nodes became very swollen and hard and have remained that way since.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Syncope, Vomiting
Clinical narrative: As I was leaving the clinic, roughly 20 minutes after receiving the vaccine, I because very nauseous and returned to tell the nurse I didn't feel well.  I then had an episode of syncope and was unconscious for around 40 seconds.  I was transported to the hospital via ambulance.  In the ambulance I had a second syncopal episode while the EKG monitored that my HR dropped to 30 bpm.  I was unconscious the 2nd time for around 1 minute.  Upon arrival to the ER I vomited uncontrollably for a few minutes.   For the last 3 weeks following the vaccine I've had a fever of 99.8, headaches, mild diarrhea and nausea.  For 10 days following the vaccine I had trouble with thinking clearly and "brain fog".  Beginning 2 days post-vaccination my left supraclavicular lymph nodes became very swollen and hard and have remained that way since.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Intensive care
Clinical narrative: Employee presented for 2nd dose of COVID Moderna vaccine and experienced swelling of her lips and tongue.  She was taken to the ED for monitoring and therapeutic intervention and was discharged home.  She presented to the ED approximately 12 hours later as well on 1/16/21 and was admitted for angioedema.  was discharged home on 1/17/21.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Lip swelling, Swollen tongue
Clinical narrative: Employee presented for 2nd dose of COVID Moderna vaccine and experienced swelling of her lips and tongue.  She was taken to the ED for monitoring and therapeutic intervention and was discharged home.  She presented to the ED approximately 12 hours later as well on 1/16/21 and was admitted for angioedema.  was discharged home on 1/17/21.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Rash on torso; Passed out; Laceration to back of skull requiring staples; Severe chills; Feeling unwell; Difficulty sleeping; Dizziness; Weakness; Joint pain neck; Joint pain neck; Mild injection site pain; This is a spontaneous report from a contactable nurse reporting for self. A 67-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation.  Medical history included Covid, Hypothyroidism, Arthritis, Chronic Neck R shoulder pain, Migraines, Submaxillary gland removal, Tubal ligation.  Concomitant medication included amitriptyline, ibuprofen, levothyroxine sodium (LEVOTHYROXIN), ibuprofen (MOTRIN [IBUPROFEN]), vitamin d3.  Patient received first dose of bnt162b2 on 30Dec2020 and experienced injection site pain. Patient had allergies to Amoxicillin, Duricef, Mobic, Nexium. The patient experienced severe chills, feeling unwell, difficulty sleeping, dizziness and weakness, passed out, laceration to back of skull requiring staples, joint pain neck, mild injection site pain, on 22Jan2021 01:00 AM, 24 hours later rash on torso. Patient underwent CT head neck, EKG, Chest XRAY, Labs, results all unknown. Events resulted in Emergency room/department or urgent care. Outcome of event rash was unknown, of other events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for passed out and chills.  Laceration is subsequent to passed out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Chest X-ray, Chills, Computerised tomogram head
Clinical narrative: Rash on torso; Passed out; Laceration to back of skull requiring staples; Severe chills; Feeling unwell; Difficulty sleeping; Dizziness; Weakness; Joint pain neck; Joint pain neck; Mild injection site pain; This is a spontaneous report from a contactable nurse reporting for self. A 67-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation.  Medical history included Covid, Hypothyroidism, Arthritis, Chronic Neck R shoulder pain, Migraines, Submaxillary gland removal, Tubal ligation.  Concomitant medication included amitriptyline, ibuprofen, levothyroxine sodium (LEVOTHYROXIN), ibuprofen (MOTRIN [IBUPROFEN]), vitamin d3.  Patient received first dose of bnt162b2 on 30Dec2020 and experienced injection site pain. Patient had allergies to Amoxicillin, Duricef, Mobic, Nexium. The patient experienced severe chills, feeling unwell, difficulty sleeping, dizziness and weakness, passed out, laceration to back of skull requiring staples, joint pain neck, mild injection site pain, on 22Jan2021 01:00 AM, 24 hours later rash on torso. Patient underwent CT head neck, EKG, Chest XRAY, Labs, results all unknown. Events resulted in Emergency room/department or urgent care. Outcome of event rash was unknown, of other events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for passed out and chills.  Laceration is subsequent to passed out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram neck, Condition aggravated, Dizziness, Electrocardiogram, Injection site pain
Clinical narrative: Rash on torso; Passed out; Laceration to back of skull requiring staples; Severe chills; Feeling unwell; Difficulty sleeping; Dizziness; Weakness; Joint pain neck; Joint pain neck; Mild injection site pain; This is a spontaneous report from a contactable nurse reporting for self. A 67-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation.  Medical history included Covid, Hypothyroidism, Arthritis, Chronic Neck R shoulder pain, Migraines, Submaxillary gland removal, Tubal ligation.  Concomitant medication included amitriptyline, ibuprofen, levothyroxine sodium (LEVOTHYROXIN), ibuprofen (MOTRIN [IBUPROFEN]), vitamin d3.  Patient received first dose of bnt162b2 on 30Dec2020 and experienced injection site pain. Patient had allergies to Amoxicillin, Duricef, Mobic, Nexium. The patient experienced severe chills, feeling unwell, difficulty sleeping, dizziness and weakness, passed out, laceration to back of skull requiring staples, joint pain neck, mild injection site pain, on 22Jan2021 01:00 AM, 24 hours later rash on torso. Patient underwent CT head neck, EKG, Chest XRAY, Labs, results all unknown. Events resulted in Emergency room/department or urgent care. Outcome of event rash was unknown, of other events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for passed out and chills.  Laceration is subsequent to passed out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Laboratory test, Loss of consciousness, Malaise, Neck pain
Clinical narrative: Rash on torso; Passed out; Laceration to back of skull requiring staples; Severe chills; Feeling unwell; Difficulty sleeping; Dizziness; Weakness; Joint pain neck; Joint pain neck; Mild injection site pain; This is a spontaneous report from a contactable nurse reporting for self. A 67-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation.  Medical history included Covid, Hypothyroidism, Arthritis, Chronic Neck R shoulder pain, Migraines, Submaxillary gland removal, Tubal ligation.  Concomitant medication included amitriptyline, ibuprofen, levothyroxine sodium (LEVOTHYROXIN), ibuprofen (MOTRIN [IBUPROFEN]), vitamin d3.  Patient received first dose of bnt162b2 on 30Dec2020 and experienced injection site pain. Patient had allergies to Amoxicillin, Duricef, Mobic, Nexium. The patient experienced severe chills, feeling unwell, difficulty sleeping, dizziness and weakness, passed out, laceration to back of skull requiring staples, joint pain neck, mild injection site pain, on 22Jan2021 01:00 AM, 24 hours later rash on torso. Patient underwent CT head neck, EKG, Chest XRAY, Labs, results all unknown. Events resulted in Emergency room/department or urgent care. Outcome of event rash was unknown, of other events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for passed out and chills.  Laceration is subsequent to passed out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Skin laceration, Suture insertion
Clinical narrative: Rash on torso; Passed out; Laceration to back of skull requiring staples; Severe chills; Feeling unwell; Difficulty sleeping; Dizziness; Weakness; Joint pain neck; Joint pain neck; Mild injection site pain; This is a spontaneous report from a contactable nurse reporting for self. A 67-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation.  Medical history included Covid, Hypothyroidism, Arthritis, Chronic Neck R shoulder pain, Migraines, Submaxillary gland removal, Tubal ligation.  Concomitant medication included amitriptyline, ibuprofen, levothyroxine sodium (LEVOTHYROXIN), ibuprofen (MOTRIN [IBUPROFEN]), vitamin d3.  Patient received first dose of bnt162b2 on 30Dec2020 and experienced injection site pain. Patient had allergies to Amoxicillin, Duricef, Mobic, Nexium. The patient experienced severe chills, feeling unwell, difficulty sleeping, dizziness and weakness, passed out, laceration to back of skull requiring staples, joint pain neck, mild injection site pain, on 22Jan2021 01:00 AM, 24 hours later rash on torso. Patient underwent CT head neck, EKG, Chest XRAY, Labs, results all unknown. Events resulted in Emergency room/department or urgent care. Outcome of event rash was unknown, of other events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be excluded for passed out and chills.  Laceration is subsequent to passed out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Headache, Muscular weakness, Myalgia, Pyrexia
Clinical narrative: Cellulitis in the arm; Fever; strong muscle pain; chills; headache; muscle weakness; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EL1283), intramuscularly on 25Jan2021 at 10:00 AM in Left arm at single dose for COVID-19 immunization. The patient medical history included Hypothyroidism and COVID prior vaccination. No known allergies, no allergies to medications, food, or other products. The patient's concomitant medications reported as no. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Ek4176), on 07Jan2021 in Left Arm at single dose for COVID-19 immunization at age of 47-year-old. The patient experienced fever, strong muscle pain, chills, headache and muscle weakness on 26Jan2021 at 03:00 AM; Cellulitis in the arm on 27Jan2021 at 08:00 AM. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of the events fever, strong muscle pain, chills, headache and muscle weakness included Acetaminophen, ibuprofen; no treatment was received for the event Cellulitis in the arm. The outcome of the events was not recovered. The report was reported as non-serious for event "Cellulitis in the arm", with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cellulitis, Chills, Headache, Muscular weakness, Myalgia
Clinical narrative: Cellulitis in the arm; Fever; strong muscle pain; chills; headache; muscle weakness; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EL1283), intramuscularly on 25Jan2021 at 10:00 AM in Left arm at single dose for COVID-19 immunization. The patient medical history included Hypothyroidism and COVID prior vaccination. No known allergies, no allergies to medications, food, or other products. The patient's concomitant medications reported as no. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Ek4176), on 07Jan2021 in Left Arm at single dose for COVID-19 immunization at age of 47-year-old. The patient experienced fever, strong muscle pain, chills, headache and muscle weakness on 26Jan2021 at 03:00 AM; Cellulitis in the arm on 27Jan2021 at 08:00 AM. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of the events fever, strong muscle pain, chills, headache and muscle weakness included Acetaminophen, ibuprofen; no treatment was received for the event Cellulitis in the arm. The outcome of the events was not recovered. The report was reported as non-serious for event "Cellulitis in the arm", with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Cellulitis in the arm; Fever; strong muscle pain; chills; headache; muscle weakness; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EL1283), intramuscularly on 25Jan2021 at 10:00 AM in Left arm at single dose for COVID-19 immunization. The patient medical history included Hypothyroidism and COVID prior vaccination. No known allergies, no allergies to medications, food, or other products. The patient's concomitant medications reported as no. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Ek4176), on 07Jan2021 in Left Arm at single dose for COVID-19 immunization at age of 47-year-old. The patient experienced fever, strong muscle pain, chills, headache and muscle weakness on 26Jan2021 at 03:00 AM; Cellulitis in the arm on 27Jan2021 at 08:00 AM. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of the events fever, strong muscle pain, chills, headache and muscle weakness included Acetaminophen, ibuprofen; no treatment was received for the event Cellulitis in the arm. The outcome of the events was not recovered. The report was reported as non-serious for event "Cellulitis in the arm", with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cellulitis
Clinical narrative: Cellulitis in the arm; Fever; strong muscle pain; chills; headache; muscle weakness; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EL1283), intramuscularly on 25Jan2021 at 10:00 AM in Left arm at single dose for COVID-19 immunization. The patient medical history included Hypothyroidism and COVID prior vaccination. No known allergies, no allergies to medications, food, or other products. The patient's concomitant medications reported as no. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Ek4176), on 07Jan2021 in Left Arm at single dose for COVID-19 immunization at age of 47-year-old. The patient experienced fever, strong muscle pain, chills, headache and muscle weakness on 26Jan2021 at 03:00 AM; Cellulitis in the arm on 27Jan2021 at 08:00 AM. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of the events fever, strong muscle pain, chills, headache and muscle weakness included Acetaminophen, ibuprofen; no treatment was received for the event Cellulitis in the arm. The outcome of the events was not recovered. The report was reported as non-serious for event "Cellulitis in the arm", with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose normal, Blood pressure increased, Chills, Dizziness, Dry mouth
Clinical narrative: faint; feeling off; feel dizzy/light headed; dry mouth; hard to swallow; They took my BP upon arrival and it was 141/93; chills; low grade fever 100 degrees; This is a spontaneous report from a contactable 45-year-old female other health professional reported for herself that she received 1st dose of bnt162b2 (lot number EL8982) on 15Jan2021 08:00 AM at left arm for Covid-19 immunization. Medical history included hereditary angioedema from unknown date (last episode 2015). The patient had not received other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant drug included caffeine, paracetamol (ACETAMINOPHEN AND CAFFEINE).  The patient reported that after waiting the 15 minutes, she walked to her car, and started feeling off. She thought about sitting in the hospital parking lot, but started to drive home. She started to feel dizzy, light headed, faint, dry mouth, hard to swallow so she drove herself to the fire station. They took her blood pressure (BP) upon arrival and it was 141/93 and blood sugar was 90 on 15Jan2021. She was 120 pounds and her normal BP was 116/63. The event onset time was reported as 15Jan2021 08:30 AM.  Later on 15Jan2021, the patient had chills and low grade fever 100 degrees. Treatment was received for the events. The events were resolved on unknown date. Events were reported non-serious. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event syncope cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Feeling abnormal, Malaise, Pyrexia
Clinical narrative: faint; feeling off; feel dizzy/light headed; dry mouth; hard to swallow; They took my BP upon arrival and it was 141/93; chills; low grade fever 100 degrees; This is a spontaneous report from a contactable 45-year-old female other health professional reported for herself that she received 1st dose of bnt162b2 (lot number EL8982) on 15Jan2021 08:00 AM at left arm for Covid-19 immunization. Medical history included hereditary angioedema from unknown date (last episode 2015). The patient had not received other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant drug included caffeine, paracetamol (ACETAMINOPHEN AND CAFFEINE).  The patient reported that after waiting the 15 minutes, she walked to her car, and started feeling off. She thought about sitting in the hospital parking lot, but started to drive home. She started to feel dizzy, light headed, faint, dry mouth, hard to swallow so she drove herself to the fire station. They took her blood pressure (BP) upon arrival and it was 141/93 and blood sugar was 90 on 15Jan2021. She was 120 pounds and her normal BP was 116/63. The event onset time was reported as 15Jan2021 08:30 AM.  Later on 15Jan2021, the patient had chills and low grade fever 100 degrees. Treatment was received for the events. The events were resolved on unknown date. Events were reported non-serious. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event syncope cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Feeling abnormal, Pyrexia, Syncope
Clinical narrative: faint; feeling off; feel dizzy/light headed; dry mouth; hard to swallow; They took my BP upon arrival and it was 141/93; chills; low grade fever 100 degrees; This is a spontaneous report from a contactable 45-year-old female other health professional reported for herself that she received 1st dose of bnt162b2 (lot number EL8982) on 15Jan2021 08:00 AM at left arm for Covid-19 immunization. Medical history included hereditary angioedema from unknown date (last episode 2015). The patient had not received other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant drug included caffeine, paracetamol (ACETAMINOPHEN AND CAFFEINE).  The patient reported that after waiting the 15 minutes, she walked to her car, and started feeling off. She thought about sitting in the hospital parking lot, but started to drive home. She started to feel dizzy, light headed, faint, dry mouth, hard to swallow so she drove herself to the fire station. They took her blood pressure (BP) upon arrival and it was 141/93 and blood sugar was 90 on 15Jan2021. She was 120 pounds and her normal BP was 116/63. The event onset time was reported as 15Jan2021 08:30 AM.  Later on 15Jan2021, the patient had chills and low grade fever 100 degrees. Treatment was received for the events. The events were resolved on unknown date. Events were reported non-serious. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event syncope cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Dizziness, Malaise
Clinical narrative: Patient died the following day after getting vaccinated - documented but not believed to be due to vaccine per patients wife (Told another pharmacist at our store this).
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient died the following day after getting vaccinated - documented but not believed to be due to vaccine per patients wife (Told another pharmacist at our store this).
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder, Chest pain, Dyspnoea, Fatigue, Pain in extremity
Clinical narrative: Systemic: generalized body aches -Severe, Systemic: unable to sleep-Severe, Systemic: abdominal pain-Severe, Systemic: Other- pain in chest under ribs and swelling around collar bone-Severe; symptoms lasted 7 days.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vascular pain
Clinical narrative: Systemic: generalized body aches -Severe, Systemic: unable to sleep-Severe, Systemic: abdominal pain-Severe, Systemic: Other- pain in chest under ribs and swelling around collar bone-Severe; symptoms lasted 7 days.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Chest pain, Insomnia, Pain
Clinical narrative: Systemic: generalized body aches -Severe, Systemic: unable to sleep-Severe, Systemic: abdominal pain-Severe, Systemic: Other- pain in chest under ribs and swelling around collar bone-Severe; symptoms lasted 7 days.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: I notified agency of my severe penicillin allergy and need to wait the 30 minutes. About after 10 minutes after I had vaccine I became very hot, skin on my face and cheeks became bright red. Nurse monitored me quickly rushed and brought me to another area and checked my heart beat, lungs and vitals every 5 minutes. Skin became blotchy, very itchy and bright red on face first then it went to my back, butt and legs. At first nurse wanted to ems me but since vitals were stable I was released after an hour and had to get Benadryl.  I was monitored by a family member as suggested by nurse for 4 hours after. Arm was extremely painful for a week and i was very itchy.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Feeling hot, Pain in extremity, Pruritus, Rash macular
Clinical narrative: I notified agency of my severe penicillin allergy and need to wait the 30 minutes. About after 10 minutes after I had vaccine I became very hot, skin on my face and cheeks became bright red. Nurse monitored me quickly rushed and brought me to another area and checked my heart beat, lungs and vitals every 5 minutes. Skin became blotchy, very itchy and bright red on face first then it went to my back, butt and legs. At first nurse wanted to ems me but since vitals were stable I was released after an hour and had to get Benadryl.  I was monitored by a family member as suggested by nurse for 4 hours after. Arm was extremely painful for a week and i was very itchy.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site erythema, Lip swelling, Lymphadenopathy
Clinical narrative: Upper and Lower Lip Swelling, swollen lymph node left axillary.  Resolved after 36 hours Used Benadryl 25mg every 8 hours I have had lip filler approximately 14 months prior
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Lymphadenopathy
Clinical narrative: Upper and Lower Lip Swelling, swollen lymph node left axillary.  Resolved after 36 hours Used Benadryl 25mg every 8 hours I have had lip filler approximately 14 months prior
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Chest pain, Dyspnoea, Dyspnoea exertional, Headache
Clinical narrative: Acute pericarditis complicated by atrial flutter
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Imaging procedure abnormal, Myalgia, Pericarditis
Clinical narrative: Acute pericarditis complicated by atrial flutter
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Cardiac imaging procedure abnormal, Cardiovascular evaluation, Chest pain, Dyspnoea
Clinical narrative: Acute pericarditis complicated by atrial flutter
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Myalgia, Pericarditis, SARS-CoV-2 test negative, Sleep disorder
Clinical narrative: Acute pericarditis complicated by atrial flutter
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Asthenia, Atrial flutter, Chest pain, Echocardiogram, Electrocardiogram
Clinical narrative: Acute pericarditis complicated by atrial flutter
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Pain, Pericardial effusion, Pericarditis
Clinical narrative: Acute pericarditis complicated by atrial flutter
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Sleep disorder, Systemic inflammatory response syndrome
Clinical narrative: Acute pericarditis complicated by atrial flutter
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Atrial flutter, Brain natriuretic peptide increased, C-reactive protein increased, Computerised tomogram aorta, Echocardiogram
Clinical narrative: Acute pericarditis complicated by atrial flutter
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Ejection fraction normal, Pericardial effusion, Pericarditis, Red blood cell sedimentation rate increased
Clinical narrative: Acute pericarditis complicated by atrial flutter