chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Intentional dose omission, Pancreatitis acute
Clinical narrative: Acute pancreatitis; Missed her second shot as she was hospitalized due to Abdominal problem; This spontaneous case was reported by a consumer and describes the occurrence of PANCREATITIS ACUTE (Acute pancreatitis) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PANCREATITIS ACUTE (Acute pancreatitis) (seriousness criterion hospitalization). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (Missed her second shot as she was hospitalized due to Abdominal problem ). The patient was hospitalized from 08-Mar-2021 to 21-Mar-2021 due to PANCREATITIS ACUTE. On 21-Mar-2021, PANCREATITIS ACUTE (Acute pancreatitis) had resolved. At the time of the report, INTENTIONAL DOSE OMISSION (Missed her second shot as she was hospitalized due to Abdominal problem ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitants were not provided.  Additional information:She missed her second shot as she was hospitalized due to Abdominal problem - acute pancreatitis. She was hospitalized on 8Mar2021 and discharged on 21Mar2021; Sender's Comments: Very limited information has been provided at this time. Further information ahs been requested. Based on the current information and temporal association between the use of the product and the start date of the event a causal relationship cannot be excluded.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Ill-defined disorder, Loss of personal independence in daily activities
Clinical narrative: Body started to shut down/ Can't open the eyes; Can't do anything, can't feed herself and can't go to bathroom; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of ILL-DEFINED DISORDER (Body started to shut down/ Can't open the eyes) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't do anything, can't feed herself and can't go to bathroom) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. ).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILL-DEFINED DISORDER (Body started to shut down/ Can't open the eyes) (seriousness criteria hospitalization and life threatening) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't do anything, can't feed herself and can't go to bathroom) (seriousness criteria hospitalization and life threatening). At the time of the report, ILL-DEFINED DISORDER (Body started to shut down/ Can't open the eyes) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't do anything, can't feed herself and can't go to bathroom) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case concerns a 92-year-old female hospitalized with serious unexpected events of ill-defined disorder and loss of personal independence in daily activities. Event onset with unknown latency after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: This case concerns a 92-year-old female hospitalized with serious unexpected events of ill-defined disorder and loss of personal independence in daily activities. Event onset with unknown latency after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Tetanus
Clinical narrative: Tetanus shot after first dose; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Due for her second shot on 1April2021, of which we was denied) and TETANUS (Tetanus shot after first dose) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history). Concomitant products included TETANUS VACCINE TOXOID (TETANUS VACCIN) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Due for her second shot on 1April2021, of which we was denied) and TETANUS (Tetanus shot after first dose). At the time of the report, OFF LABEL USE (Due for her second shot on 1April2021, of which we was denied) had resolved and TETANUS (Tetanus shot after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.; Sender's Comments: Based on reporter's causality the event is assessed as non-applicable to mRNA-1273.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia, Haematochezia
Clinical narrative: Also she had blood in her stool; Her urine was really yellow and then she hydrated and was still yellow; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Also she had blood in her stool) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported.). Concomitant products included AMLODIPINE, METFORMIN, PRAVASTATIN, CETIRIZINE, METOPROLOL, HYDROCHLOROTHIAZIDE and TOCOPHEROL (VIT E [TOCOPHEROL]) for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced HAEMATOCHEZIA (Also she had blood in her stool) (seriousness criterion medically significant) and CHROMATURIA (Her urine was really yellow and then she hydrated and was still yellow). At the time of the report, HAEMATOCHEZIA (Also she had blood in her stool) and CHROMATURIA (Her urine was really yellow and then she hydrated and was still yellow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  The case refers to a 58-year-old female who received Covid-19 vaccination.  Based on the current available information and temporal association between the use of the product and the start date of the events, Hematochezia and chromaturia, a causal relationship cannot be excluded.; Sender's Comments: The case refers to a 58-year-old female who received Covid-19 vaccination.  Based on the current available information and temporal association between the use of the product and the start date of the events, Hematochezia and chromaturia, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Bell's palsy, Hair injury, Hypoaesthesia, Oral pain
Clinical narrative: It swells my face; I have numbness; Tingling of the whole thing in my lip; pins and needles in the left side of my mouth/sometimes it goes across my lip and into my right side; she did not get the second dose because her face is bad/more than 36 days after the first dose without receiving the second dose; hair loss; a hole in her hair; bells palsy; This spontaneous case was reported by a nurse and describes the occurrence of FACIAL PARALYSIS (bells palsy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in 2020. Previously administered products included for an unreported indication: ZOSTAVAX (Shingles vaccine).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced FACIAL PARALYSIS (bells palsy) (seriousness criterion medically significant). On an unknown date, the patient experienced SWELLING FACE (It swells my face), HYPOAESTHESIA (I have numbness), PARAESTHESIA ORAL (Tingling of the whole thing in my lip), ORAL PAIN (pins and needles in the left side of my mouth/sometimes it goes across my lip and into my right side), PRODUCT DOSE OMISSION ISSUE (she did not get the second dose because her face is bad/more than 36 days after the first dose without receiving the second dose), ALOPECIA (hair loss) and HAIR INJURY (a hole in her hair). At the time of the report, FACIAL PARALYSIS (bells palsy), SWELLING FACE (It swells my face), HYPOAESTHESIA (I have numbness), PARAESTHESIA ORAL (Tingling of the whole thing in my lip) and ORAL PAIN (pins and needles in the left side of my mouth/sometimes it goes across my lip and into my right side) had not resolved and PRODUCT DOSE OMISSION ISSUE (she did not get the second dose because her face is bad/more than 36 days after the first dose without receiving the second dose), ALOPECIA (hair loss) and HAIR INJURY (a hole in her hair) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   She stated that on the third week after the vaccine, she experienced bells palsy.; Sender's Comments: This case concerns a 71-year-old female with a serious unexpected event of facial paralysis, along with nonserious unexpected swelling face, oral paraesthesia, hypoesthesia, oral pain, alopecia, hair injury and product dose omission issue. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Product dose omission issue, Swelling face
Clinical narrative: It swells my face; I have numbness; Tingling of the whole thing in my lip; pins and needles in the left side of my mouth/sometimes it goes across my lip and into my right side; she did not get the second dose because her face is bad/more than 36 days after the first dose without receiving the second dose; hair loss; a hole in her hair; bells palsy; This spontaneous case was reported by a nurse and describes the occurrence of FACIAL PARALYSIS (bells palsy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in 2020. Previously administered products included for an unreported indication: ZOSTAVAX (Shingles vaccine).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced FACIAL PARALYSIS (bells palsy) (seriousness criterion medically significant). On an unknown date, the patient experienced SWELLING FACE (It swells my face), HYPOAESTHESIA (I have numbness), PARAESTHESIA ORAL (Tingling of the whole thing in my lip), ORAL PAIN (pins and needles in the left side of my mouth/sometimes it goes across my lip and into my right side), PRODUCT DOSE OMISSION ISSUE (she did not get the second dose because her face is bad/more than 36 days after the first dose without receiving the second dose), ALOPECIA (hair loss) and HAIR INJURY (a hole in her hair). At the time of the report, FACIAL PARALYSIS (bells palsy), SWELLING FACE (It swells my face), HYPOAESTHESIA (I have numbness), PARAESTHESIA ORAL (Tingling of the whole thing in my lip) and ORAL PAIN (pins and needles in the left side of my mouth/sometimes it goes across my lip and into my right side) had not resolved and PRODUCT DOSE OMISSION ISSUE (she did not get the second dose because her face is bad/more than 36 days after the first dose without receiving the second dose), ALOPECIA (hair loss) and HAIR INJURY (a hole in her hair) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   She stated that on the third week after the vaccine, she experienced bells palsy.; Sender's Comments: This case concerns a 71-year-old female with a serious unexpected event of facial paralysis, along with nonserious unexpected swelling face, oral paraesthesia, hypoesthesia, oral pain, alopecia, hair injury and product dose omission issue. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram, Headache, Heart injury, Myalgia
Clinical narrative: Significant elevation of troponin of 12; chest pain; Vaccine induced myocardial injury; headache; myalgia; fever; This is a spontaneous report from a contactable physician. A 28-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6205), intramuscular, administered in left arm on 24Mar2021 at 1:00 pm as single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included keppra, lamictal same dose for more than 5 years. The patient previously took bnt162b2 on 03Mar2021 for covid-19 immunization at the age of 28-year-old at 1:00 pm. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient stated 1-2 days after vaccine he developed headache, myalgia, fever, chest pain. Chest pain progressively worsened. He was presented to the hospital 3 days after onset. There was significant elevation of troponin of 12, ECG unremarkable. No prior history of hypertension/ hyperlipidemia or diabetes. On 25Mar2021, the patient was diagnosed with vaccine induced myocardial injury. Treatment for events was inpatient monitoring, Heparin infusion while awaiting results of cardiac work up. Outcome of events was recovering.  Follow up attempts are needed and Information on lot/batch number was available.; Sender's Comments: Based on temporal association and profile of the product, the contributory role of the suspect product  bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6205),  to reported events is possible.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative, Troponin, Troponin increased
Clinical narrative: Significant elevation of troponin of 12; chest pain; Vaccine induced myocardial injury; headache; myalgia; fever; This is a spontaneous report from a contactable physician. A 28-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6205), intramuscular, administered in left arm on 24Mar2021 at 1:00 pm as single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included keppra, lamictal same dose for more than 5 years. The patient previously took bnt162b2 on 03Mar2021 for covid-19 immunization at the age of 28-year-old at 1:00 pm. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient stated 1-2 days after vaccine he developed headache, myalgia, fever, chest pain. Chest pain progressively worsened. He was presented to the hospital 3 days after onset. There was significant elevation of troponin of 12, ECG unremarkable. No prior history of hypertension/ hyperlipidemia or diabetes. On 25Mar2021, the patient was diagnosed with vaccine induced myocardial injury. Treatment for events was inpatient monitoring, Heparin infusion while awaiting results of cardiac work up. Outcome of events was recovering.  Follow up attempts are needed and Information on lot/batch number was available.; Sender's Comments: Based on temporal association and profile of the product, the contributory role of the suspect product  bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EN6205),  to reported events is possible.
Age: 1.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: A patient received an expired vaccine , no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional (Reference number- 00527670) and transmitted to Sanofi on 19-Mar-2021.  This case involves a one-year-old female patient who received an expired 0.5 mL of 3rd dose of IPV (VERO) [IPOL] (lot R1B251M and expiry date: 13-Mar-2021) via an intramuscular route in the thigh for prophylactic vaccination on 19-Mar-2021 (Expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   This was a case of actual medication error case due to expired vaccine used (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 1.33
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received expired ActHIB vaccine with no adverse event; Initial information regarding an unsolicited valid non-serious was received from a Physician (Reference number- 00527706) and transmitted to Sanofi on 19-Mar-2021.  This case involves a 16 months old female patient who received a fourth 0.5 mL expired dose HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ182AA and expiration date: 08-Mar-2021) via intramuscular route in the right thigh (right leg) (expired product administered) for prophylactic vaccination on 19-Mar-2021.  Medical history, past medical treatments, past vaccinations and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) and INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation.  It was actual medication error due to expired vaccine used (on same day).  It was reported that after administration it was later discovered that the vaccine was expired by 11 days. The reporter would like to know if the patient must be revaccinated.  At the time of report, the patients experienced no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 10.0
Sex: F
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: Patient received an Ipol vaccine that was later noted to be expired, with no adverse event; Initial information received on 31-Mar-2021 regarding an unsolicited valid non-serious case from other health professional and physician.  This case involves a 10 years old female patient who received 0.5 ml  IPV (VERO) [IPOL] vaccine (lot R18251M and expiration date: 13-Mar-2021), that was later noted to be expired (expired product administered). Vaccine was given via intramuscular route in the left arm for prophylactic vaccination on 31-Mar-2021.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No concomitant medications were given to the patient.  It was a case of an actual medication error due to expired vaccine used (same day latency).  It was not reported whether the patient had any adverse event.  Reporter reported that she would like to find out about next steps and if the patient would need to be re-vaccinated.  It was also reported that treatment will be repeated.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Hyperhidrosis, Nausea, Pallor, Syncope
Clinical narrative: Approx 6 mins after vaccination pt fainted.  She recovered on her own within a minute and was very diaphoretic and pale, but was alert and oriented x 3.  Pt then stated she was feeling very nauseous and proceeded to vomit.  911 was called and B/P 87/58, HR 91 and O2 99.   EMS arrived B/P was fluctuating and pt was brought to ED for evaluation
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Approx 6 mins after vaccination pt fainted.  She recovered on her own within a minute and was very diaphoretic and pale, but was alert and oriented x 3.  Pt then stated she was feeling very nauseous and proceeded to vomit.  911 was called and B/P 87/58, HR 91 and O2 99.   EMS arrived B/P was fluctuating and pt was brought to ED for evaluation
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Brain fog for a total of 2 days after receiving vaccination, starting on day 1 post-vaccination
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Colonoscopy, Computerised tomogram, Diarrhoea, Endoscopy
Clinical narrative: Call receive Madonna vaccine at approximately 10 AM while driving home around 12:30 PM I started having severe stomach cramps those lasted until February 5 when I woke my husband up saying I needed to go to the emergency room I was vomiting severe diarrhea heart rate accelerated scared tingling all over couldn?t keep anything down this lasted the entire month of February I had to emergency room visits CT scans done bloodwork a colonoscopy endoscopy and I can?t find anything wrong I?m miserable I still can?t eat or drink anything my life is just terrible all because of the vaccine
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Laboratory test, Paraesthesia, Vomiting
Clinical narrative: Call receive Madonna vaccine at approximately 10 AM while driving home around 12:30 PM I started having severe stomach cramps those lasted until February 5 when I woke my husband up saying I needed to go to the emergency room I was vomiting severe diarrhea heart rate accelerated scared tingling all over couldn?t keep anything down this lasted the entire month of February I had to emergency room visits CT scans done bloodwork a colonoscopy endoscopy and I can?t find anything wrong I?m miserable I still can?t eat or drink anything my life is just terrible all because of the vaccine
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Dizziness, Electrocardiogram normal, Feeling abnormal, Laboratory test
Clinical narrative: Feeling like I was going to pass out at work with continued vertigo like feeling and fluttering in chest. Went to ER and received labs and EkG with nothing outstanding. Dizziness continued for a total of 3 hours on 4/9. 4/10 I felt a brain fog and vertigo feeling for most of the day. 4/11 I felt better. 4/12 I had another episode of feeling like I was going to pass out along with brain fog. I went to urgent care and got more labs drawn.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Feeling like I was going to pass out at work with continued vertigo like feeling and fluttering in chest. Went to ER and received labs and EkG with nothing outstanding. Dizziness continued for a total of 3 hours on 4/9. 4/10 I felt a brain fog and vertigo feeling for most of the day. 4/11 I felt better. 4/12 I had another episode of feeling like I was going to pass out along with brain fog. I went to urgent care and got more labs drawn.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Patient reports numbness to left thumb-the same side she had the vaccine administered. Patient denies chest pain, shortness of breath, abdominal pain, dizziness. Vital signs obtained: BP 182/110, 160/98, HR 84, 78; RR 18, 18, SpO2 98% on RA. Patient monitored for 15 minutes with no changes reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Nervousness, Swollen tongue
Clinical narrative: 29 min after 2nd Moderna vaccine, pt started to feel shaky and said her "tongue felt swollen". Denies difficulty breathing. VS 150/84, HR 70, SpO2 97% RA.  5 minutes later this started to get better 25 min after onset pt said she was feeling better , "just anxious". She does have hx of anxiety.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Rash macular
Clinical narrative: Swelling of both elbows sores on both arms red blotchy skin on both arms itching severe fatigue
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Dizziness, Fatigue, Nausea
Clinical narrative: Extreme nausea and vomiting Fever Dizziness Fatigue Diarrhea Fainting No appetite Symptoms listed above lasted 56 hours. Treated at home, no visit to doctor. Injection site was sore 24 hours.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Syncope, Vomiting
Clinical narrative: Extreme nausea and vomiting Fever Dizziness Fatigue Diarrhea Fainting No appetite Symptoms listed above lasted 56 hours. Treated at home, no visit to doctor. Injection site was sore 24 hours.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness
Clinical narrative: Vaccine administered at 9:30am. At 9:36am patient reported lightheadedness, dizziness, and feeling clammy. HR 50, RR 17, BP 100/70, O2 100%. Phone call to regional medical director, instructed to give patient food and water and monitor for 30 minutes. At 10:05am patient stated she was feeling well. HR 88, RR 15, BP 110/80, O2 98% at 10:05am. Patient left via personal vehicle with spouse driving.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia, Paraesthesia, Pyrexia
Clinical narrative: Numbness and Tingling in both arms and legs in addition to fever and chills at around 12:00am on 4/2. It continued for about 2 hours until I took Tylenol and Xyzal (antihistamine). In addition, I was not able to  sleep during that time.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Almost immediately after giving the injection  for the janssen covid vaccine, the patient felt light headed and dizzy.  After asking if it was ok,  I rolled up her jacket and put it on the floor and assisted her in laying down with her feet up on a chair.  After less than 5 minutes the patient felt better, got up, and sat in one of our designated post-vaccine chairs to finish out the 15 minutes. When asked, she stated that she had a similar reaction to another injectable at the dr office and she wasn't too concerned.  Before leaving, her husband had come to meet her (he was already in the store) and she said she was feeling fine.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: PATIENT FAINTED AFTER LEAVING IMMUNIZATION ROOM
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Blood fibrinogen decreased, Blood lactic acid, Disseminated intravascular coagulation, Fibrin D dimer
Clinical narrative: Patient presented with acute abdominal pain, DIC , thrombocytopenia and found have small bowel gangrene due to SMA thrombosis. Underwent Laparotomy with small bowel resection. Was in the ICU and currently on TPN and IV antibiotics.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Intensive care, Laparotomy, Mesenteric artery thrombosis, Platelet count decreased, Small intestinal resection
Clinical narrative: Patient presented with acute abdominal pain, DIC , thrombocytopenia and found have small bowel gangrene due to SMA thrombosis. Underwent Laparotomy with small bowel resection. Was in the ICU and currently on TPN and IV antibiotics.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Small intestine gangrene, Thrombocytopenia
Clinical narrative: Patient presented with acute abdominal pain, DIC , thrombocytopenia and found have small bowel gangrene due to SMA thrombosis. Underwent Laparotomy with small bowel resection. Was in the ICU and currently on TPN and IV antibiotics.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Computerised tomogram, Cytopenia, Disseminated intravascular coagulation, Gastrointestinal necrosis
Clinical narrative: Patient presented with acute abdominal pain, DIC , thrombocytopenia and found have small bowel gangrene due to SMA thrombosis. Underwent Laparotomy with small bowel resection. Was in the ICU and currently on TPN and IV antibiotics.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Intestinal gangrene, Mesenteric artery thrombosis, Small intestinal obstruction
Clinical narrative: Patient presented with acute abdominal pain, DIC , thrombocytopenia and found have small bowel gangrene due to SMA thrombosis. Underwent Laparotomy with small bowel resection. Was in the ICU and currently on TPN and IV antibiotics.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Disseminated intravascular coagulation
Clinical narrative: Patient presented with acute abdominal pain, DIC , thrombocytopenia and found have small bowel gangrene due to SMA thrombosis. Underwent Laparotomy with small bowel resection. Was in the ICU and currently on TPN and IV antibiotics.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests normal, Tinnitus
Clinical narrative: Ears starting ringing two weeks after the first Moderna vaccine. Symptoms became significantly worse after the second vaccine and continue 10 days after.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pruritus, Fatigue, Formication, Injection site dryness, Injection site erythema
Clinical narrative: 2/2/2021 Fatigue and itching right ear 2/3/2021 Feels like something crawling in Right ear. 2/4/2021 Intermittent right ear itch 2/5/2021 Slept 14 hours, "crawly "itch right ear, injection site raised and red with a knot at site. 2/6/2021  2/7/2021right ear and vaccine site itch 2/8/2021 Right ear is warm and itches, occasional ringing in ear bump on vaccine site. Feels like something is wiggling in both ears and at injection site. S 2/9/2021 Headache, right ear is warm and itches, ringing in ear occasionally. Bump at injection site. Skin peeling at injection site. 2/10/2021 Itch in ear and injection site.. red raised bumps at site. Still feels wiggly, ear warm. 2/11/2021 Arm is still sore , red and itchy. Raisedbumps at injection site. Ear feels crawly.  3/4/2021 right arm became ulcerated at the injection site and skin peeled. Small carter at site ans still itches. Tinnitus of right ear last 20 days.  3/26/2021 Second Vaccine given  3/29/2021 Muscle ache/pain, headache, fatigue, itching/rash at injection site, small blisters at site
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site nodule, Injection site oedema, Pain in extremity, Skin warm, Tinnitus
Clinical narrative: 2/2/2021 Fatigue and itching right ear 2/3/2021 Feels like something crawling in Right ear. 2/4/2021 Intermittent right ear itch 2/5/2021 Slept 14 hours, "crawly "itch right ear, injection site raised and red with a knot at site. 2/6/2021  2/7/2021right ear and vaccine site itch 2/8/2021 Right ear is warm and itches, occasional ringing in ear bump on vaccine site. Feels like something is wiggling in both ears and at injection site. S 2/9/2021 Headache, right ear is warm and itches, ringing in ear occasionally. Bump at injection site. Skin peeling at injection site. 2/10/2021 Itch in ear and injection site.. red raised bumps at site. Still feels wiggly, ear warm. 2/11/2021 Arm is still sore , red and itchy. Raisedbumps at injection site. Ear feels crawly.  3/4/2021 right arm became ulcerated at the injection site and skin peeled. Small carter at site ans still itches. Tinnitus of right ear last 20 days.  3/26/2021 Second Vaccine given  3/29/2021 Muscle ache/pain, headache, fatigue, itching/rash at injection site, small blisters at site
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Vaccine was given to patient that was under 18 years of age.  Patient had no adverse issues. Troubleshooting: The vaccinator checked ID but did not catch age < 18.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Lymphadenopathy, Nausea
Clinical narrative: Dizziness started 1 hr after, shaking/chills started 5 hours after. 103 degree fever for 3 days (even while taking ibuprofen and tylenol), headache, body aches, swollen lymph nodes, rash, extreme nausea and vomiting.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Rash, Tremor, Vomiting
Clinical narrative: Dizziness started 1 hr after, shaking/chills started 5 hours after. 103 degree fever for 3 days (even while taking ibuprofen and tylenol), headache, body aches, swollen lymph nodes, rash, extreme nausea and vomiting.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram normal, Electrocardiogram abnormal, Fibrin D dimer increased, Heart rate increased, Palpitations
Clinical narrative: 12 hours after vaccine administered experienced heart palpitations ranging from 140-160bpm at about 1am Sunday Morning.  At 4pm Sunday I was admitted to the emergency room where I was given diltiazem in an IV which did not bring my heart rate down. I was then given another heart medication which brought my heart rate down but I had to stay overnight.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus tachycardia
Clinical narrative: 12 hours after vaccine administered experienced heart palpitations ranging from 140-160bpm at about 1am Sunday Morning.  At 4pm Sunday I was admitted to the emergency room where I was given diltiazem in an IV which did not bring my heart rate down. I was then given another heart medication which brought my heart rate down but I had to stay overnight.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza virus test negative, Nausea, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Fever, nausea,  tiredness for 3 weeks.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count normal
Clinical narrative: Fever, nausea,  tiredness for 3 weeks.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Eye irritation, Heavy exposure to ultraviolet light, Lacrimation increased
Clinical narrative: HPI: Patient is a * year old * who presents following administration of a single dose of J&J COVID19 vaccine in the left deltoid.  Patient states she started to experience ocular burning and tearing about 20 minutes following administration of the vaccine.  She denies ocular pain.  Patient denies wearing contacts, eye makeup, and face products at this time.  She relates that she spent most of her day outside in the sun today but has never experienced these symptoms in the past.  She reports an allergy to amoxicillin and numerous food sensitivities.  She has never required epinephrine for treatment of aforementioned allergies.  She denies a history of seasonal allergies.  She relates that she has a past medical history of PCOS.  She does not take medication on a daily basis.  She denies chest pain, difficulty breathing, swelling of the face/lips/tongue/throat, skin rash/itching, cramping abdominal pain, nausea, and vomiting.     Exam (update as needed): GEN: Alert and oriented x 4, NAD. HEAD: NCAT EYES: Conjunctival injection bilaterally.  Tearing noted in the bilateral eyes.  No purulence noted.  No foreign body noted.  Surrounding tissue nonedematous.  Visual acuity grossly intact.  PERRL, EOMI ENT: Ears normal, Nose normal, OP normal, no evidence of angioedema NECK: Supple, without LAD.  CV: RRR, no m/r/g PULM: Clear to auscultation bilaterally, no accessory muscle use ABD: Soft, no tenderness. SKIN: No rashes, skin warm and dry.  No erythema or edema of the injection site. MSK: FROM, MS 5/5 NEURO: Alert and oriented x 4, CN 2-12 grossly intact, no ataxia, gait steady   Clinical Impression/Field Tx: Possible allergic conjunctivitis, bilateral eyes.  Patient not displaying active signs or symptoms of anaphylaxis, to include facial edema and patient demonstrated ability to control airway.  No foreign body was noted in the orbi to explain symptomst, nor was purulence noted, thus decreasing likelihood of infection origin.  Visual acuity was not compromised at the time of exam.  Conjunctival injection and epiphora, in addition to consistent sun and wind exposure, makes an allergic conjunctivitis more likely.   Instructed patient to consult their PCP or follow up with urgent care regarding the post-vaccination reaction.  Also instructed patient to consult an ophthalmologist if they are able to should the eye symptoms not improve.  Recommended patient utilize visine or other normal saline eye drops for burning sensation relief, in addition to OTC antihistamine medication per package directions..  Patient instructed to go to emergency department should they develop chest pain, difficulty breathing, swelling of the face/lips/mouth/tongue/throat, or cramping abdominal pain with nausea/vomiting, as these are signs of possible anaphylaxis that requires immediate intervention.     Medications administered: None   Disposition:  Home
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Alcohol withdrawal syndrome, COVID-19, Chest X-ray abnormal, Hypoxia, Lung infiltration
Clinical narrative: 4/11/21 pt with pleurtic chest pain and worsening hypoxia.  chest x-ray w/ bilateral pulmonary infiltrates. covid pcr + 4/11.  pt admitted to hospital on 4/7 for alcohol withdrawal, minimal o2 requirements on admit.  on 4/10 pt with low grade temperature and 02 requirements were increasing then, started on azithro 500mg daily x 3 days, patient did have chest ray that day with bilateral opacities.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Lung opacity, Pleuritic pain, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: 4/11/21 pt with pleurtic chest pain and worsening hypoxia.  chest x-ray w/ bilateral pulmonary infiltrates. covid pcr + 4/11.  pt admitted to hospital on 4/7 for alcohol withdrawal, minimal o2 requirements on admit.  on 4/10 pt with low grade temperature and 02 requirements were increasing then, started on azithro 500mg daily x 3 days, patient did have chest ray that day with bilateral opacities.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Nausea
Clinical narrative: Did the adverse event start after the first or second vaccination?  only one dose (after the shot 5min after his arm completely went numb) when waiting at the site for 15min he experienced nausea and dizziness  Recommendation:  Please make sure he drinks lots of fluids he could take Pedialyte and if symptoms worsen please contact doctor and go the nearest ER. Mother would like a follow up call tomorrow at 10:00am I told her we would try to call her back at that time if its not busy, if not expect a call later in the afternoon.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Awoke in the morning with tinnitus in left ear only.  Tinnitus has been present continuously since first onset.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Chills, Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient received dose #2 of Moderna vaccine on April 1, 2021. The patient reported that the shot felt like a bee sting and she had fever and chills for 2-3 days. The patient stated that by "day 3," she had swelling and redness of her right arm which continued to get worse, despite using ice. By 4/7, the patient's arm was 2.5 times larger than the other one, swollen down the entire arm and hand. It was red, splotchy, had lesions, and was painful. The patient went to the ER and was admitted to the hospital. The patient was diagnosed with cellulitis. The providers told the patient the vaccine did not go all the way into the muscle but "ran into the tissue." The patient received IV cefazolin x3 days then switched to cephalexin. She was hospitalized for 3 days. The patient is healing and doing better at the time she reported this adverse event to us.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Pyrexia, Rash macular, Skin lesion
Clinical narrative: Patient received dose #2 of Moderna vaccine on April 1, 2021. The patient reported that the shot felt like a bee sting and she had fever and chills for 2-3 days. The patient stated that by "day 3," she had swelling and redness of her right arm which continued to get worse, despite using ice. By 4/7, the patient's arm was 2.5 times larger than the other one, swollen down the entire arm and hand. It was red, splotchy, had lesions, and was painful. The patient went to the ER and was admitted to the hospital. The patient was diagnosed with cellulitis. The providers told the patient the vaccine did not go all the way into the muscle but "ran into the tissue." The patient received IV cefazolin x3 days then switched to cephalexin. She was hospitalized for 3 days. The patient is healing and doing better at the time she reported this adverse event to us.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: A lymph node on the base of my neck on the left side swelled painfully.  The lymph node is tender to the touch. It does not hurt when it is not touched, but when touched the pain level is about a 4. Today is day 2 of the painful swelling. I have never experienced swelling or pain in this particular lymph node before.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Erythema, Fatigue, Lymph node pain
Clinical narrative: pain, tenderness, swelling, hardness, redness and sore under arm pit in lymph nodes. fatigue, body aches, chills, nausea and slight fever. I almost passed out while driving.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Swelling, Tenderness
Clinical narrative: pain, tenderness, swelling, hardness, redness and sore under arm pit in lymph nodes. fatigue, body aches, chills, nausea and slight fever. I almost passed out while driving.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dyspnoea, Malaise, Myalgia
Clinical narrative: Feeling unwell, dizziness/weakness, muscle pain, and difficulty breathing. Onset of symptoms under 1 hour from time of vaccination. EMS on site monitored patient and later released. No need for additional care or treatment.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Hot flush
Clinical narrative: Headache, dizziness, weakness, fatigue, body aches, hot flashes
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Headache, dizziness, weakness, fatigue, body aches, hot flashes
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Nausea
Clinical narrative: 13 hours after the injection, I experienced chills, nausea, then sweats, headache, muscle ache.  Next day, tired and got chills for a couple hours in the evening.  Following day, felt okay.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: 13 hours after the injection, I experienced chills, nausea, then sweats, headache, muscle ache.  Next day, tired and got chills for a couple hours in the evening.  Following day, felt okay.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Aura, Dizziness, Dysphagia, Feeling abnormal, Headache
Clinical narrative: Approximately 10 min after receiving vaccine, patient obtained a headache proceeding with tingling in both hands, difficulty swallowing, and feeling funny. She states as soon as she got it she developed an immediate headache, on her drive home she became lightheaded and had pins and needles sensation in her face and got a strange aura that lasted all her way home.  She said for a while she felt like she couldn't swallow.  She feels that she might have had a panic attack versus an adverse reaction to the vaccine and is declining any further evaluation.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Approximately 10 min after receiving vaccine, patient obtained a headache proceeding with tingling in both hands, difficulty swallowing, and feeling funny. She states as soon as she got it she developed an immediate headache, on her drive home she became lightheaded and had pins and needles sensation in her face and got a strange aura that lasted all her way home.  She said for a while she felt like she couldn't swallow.  She feels that she might have had a panic attack versus an adverse reaction to the vaccine and is declining any further evaluation.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Developed shingles 17 days later.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Insomnia, Nausea, Pain of skin
Clinical narrative: about 12 hours after the shot, I got a week headache and was very restless and couldn't get comfortable going to sleep. Took 600 mg of IBprophen which helped.  When I woke up at 7:30 next morning, I didn't feel good...my skin hurt to touch (like when you have the flu), nauseated and felt weak.  This ended around 8pm of 4/6.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Restlessness
Clinical narrative: about 12 hours after the shot, I got a week headache and was very restless and couldn't get comfortable going to sleep. Took 600 mg of IBprophen which helped.  When I woke up at 7:30 next morning, I didn't feel good...my skin hurt to touch (like when you have the flu), nauseated and felt weak.  This ended around 8pm of 4/6.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, COVID-19, Cough, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: I experienced after my vaccine, after a few days I had a runny nose, head cold and I thought it as hay fever.  At the end of my day it would clear up, my runny nose was back again. On the next morning I also experienced sore throat and a runny nose. This lasted about one week.  I went to my PCP, and they did a COVID test and I tested positive.  I can not taste anything, my nose is not runny and I have to blow up a few times a day. I have no fever 96.7F. I also get a minor phlegm when coughing.  At this time I can say my symptoms are a bit better when taking OTC Tylenol medication though I still can not taste anything.   I am taking fluids and taking Tylenol for my Covid symptoms.