chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Endocarditis, Pericarditis
Clinical narrative: Possible Endo Or Pericarditis; Possible Endo Or Pericarditis; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (Possible Endo Or Pericarditis) and ENDOCARDITIS (Possible Endo Or Pericarditis) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERICARDITIS (Possible Endo Or Pericarditis) (seriousness criterion medically significant) and ENDOCARDITIS (Possible Endo Or Pericarditis) (seriousness criterion medically significant). At the time of the report, PERICARDITIS (Possible Endo Or Pericarditis) and ENDOCARDITIS (Possible Endo Or Pericarditis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant and treatment information provided.  Company Comment: Very limited information regarding these events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 45.0
Sex: U
Vaccine: COVID19
Symptoms: General physical health deterioration, Impaired driving ability, Tremor
Clinical narrative: Body Shaking; After vaccination keeps deteriorating; I cannot drive; This spontaneous case was reported by an other and describes the occurrence of TREMOR (Body Shaking) and GENERAL PHYSICAL HEALTH DETERIORATION (After vaccination keeps deteriorating) in a 45-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (Body Shaking) (seriousness criterion hospitalization), GENERAL PHYSICAL HEALTH DETERIORATION (After vaccination keeps deteriorating) (seriousness criterion hospitalization) and IMPAIRED DRIVING ABILITY (I cannot drive). The patient was hospitalized for 5 days due to GENERAL PHYSICAL HEALTH DETERIORATION and TREMOR. At the time of the report, TREMOR (Body Shaking), GENERAL PHYSICAL HEALTH DETERIORATION (After vaccination keeps deteriorating) and IMPAIRED DRIVING ABILITY (I cannot drive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided by the reporter. No treatment information was provided by the reporter.  The patient reported that there was no definitive diagnosis about her condition after 5 days of stay at hospital. She had travelled 5600 miles to doctors trying to help. As of 01 May 2021, patient was healthy and was not on routine medicines. patient lost the job.  Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Heart rate
Clinical narrative: Patient developed an irregular heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Patient developed an irregular heartbeat) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced ARRHYTHMIA (Patient developed an irregular heartbeat) (seriousness criterion medically significant). At the time of the report, ARRHYTHMIA (Patient developed an irregular heartbeat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Heart rate: irregular (abnormal) irregular.         The concomitant medications were not reported. The treatment information was not provided.   The patient developed irregular heart beat around May 2021 post vaccination.  Company Comment: Very limited information regarding this event has been provided at this time.  Further information has been requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Limb discomfort, Vaccination site pain
Clinical narrative: She has trouble with right side and Can't use her right arm; Left injection arm is still very sore; Had a stroke that affected her right side; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Had a stroke that affected her right side) and LIMB DISCOMFORT (She has trouble with right side and Can't use her right arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 109B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Had a stroke that affected her right side) (seriousness criteria disability, medically significant and life threatening). On an unknown date, the patient experienced LIMB DISCOMFORT (She has trouble with right side and Can't use her right arm) (seriousness criterion disability) and VACCINATION SITE PAIN (Left injection arm is still very sore). At the time of the report, CEREBROVASCULAR ACCIDENT (Had a stroke that affected her right side), LIMB DISCOMFORT (She has trouble with right side and Can't use her right arm) and VACCINATION SITE PAIN (Left injection arm is still very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was not given. No laboratory was not given. No treatment information was not given.  Very limited information regarding this event/s has been provided at this time. Further information has been requested. Further information is not expected. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested. Further information is not expected. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cellulitis, Pyrexia
Clinical narrative: on her arm, a hot red rectangle that looks like cellulitis; fever of 102°F; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (on her arm, a hot red rectangle that looks like cellulitis) in a 73-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.     No Medical History information was reported.   On 13-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jul-2021, the patient experienced PYREXIA (fever of 102°F). On an unknown date, the patient experienced CELLULITIS (on her arm, a hot red rectangle that looks like cellulitis) (seriousness criterion medically significant). On 15-Jul-2021, PYREXIA (fever of 102°F) had resolved. At the time of the report, CELLULITIS (on her arm, a hot red rectangle that looks like cellulitis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 102°f (High) fever of 102°F.         No concomitant medications were reported. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Died of covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Died of covid) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Died of covid) (seriousness criterion death). The patient died on 16-Jul-2021. It is unknown if an autopsy was performed.            No concomitant medications were reported. No treatment information was reported. Very limited information regarding this event has been provided at this time. Further information has been requested. Further information is not expected.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested. Further information is not expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium, Cardiac arrest, Ventricular fibrillation
Clinical narrative: Cardiac arrest; Ventricular fibrillation; This spontaneous case was reported by a nurse and describes the occurrence of CARDIAC ARREST (Cardiac arrest) and VENTRICULAR FIBRILLATION (Ventricular fibrillation) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC ARREST (Cardiac arrest) (seriousness criteria hospitalization and medically significant) and VENTRICULAR FIBRILLATION (Ventricular fibrillation) (seriousness criteria hospitalization and medically significant). At the time of the report, CARDIAC ARREST (Cardiac arrest) and VENTRICULAR FIBRILLATION (Ventricular fibrillation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood potassium: decreased (Low) Decreased.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was a healthy person with no health issues. She had a cardiac arrest due to low level of potassium, 5 days after her 1st dose vaccination. It was not heart attack.There was no tumor found. She stated it was not adrenal gland related and there was nothing wrong with her kidney. Patient was in intensive care for 2 weeks and was given tons of medications.   No concomitant product information was provided.  No treatment information was provided.  Very limited information regarding the events onset dates has been provided at this time and insufficient to assess the temporal association. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Very limited information regarding the events onset dates has been provided at this time and insufficient to assess the temporal association. A causal relationship cannot be excluded. Further information has been requested.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Leukopenia, Vaccination site pain
Clinical narrative: Leucopenia/ white blood cell count was down; Felt like being stabbed with the needle; This spontaneous case was reported by a consumer and describes the occurrence of LEUKOPENIA (Leucopenia/ white blood cell count was down) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced VACCINATION SITE PAIN (Felt like being stabbed with the needle). On 08-Jul-2021, the patient experienced LEUKOPENIA (Leucopenia/ white blood cell count was down) (seriousness criterion medically significant). At the time of the report, LEUKOPENIA (Leucopenia/ white blood cell count was down) and VACCINATION SITE PAIN (Felt like being stabbed with the needle) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jul-2021, Blood test: everything was ok except for the white blood cell (abnormal) white blood cell count that was down.         Concomitant medications were not reported. Treatment information was not provided. Very limited information regarding the event has been provided at this time.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding the event has been provided at this time.
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: diagnosed with afib; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (diagnosed with afib) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced ATRIAL FIBRILLATION (diagnosed with afib) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (diagnosed with afib) outcome was unknown.            No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.   No Lab data was provided by the reporter.  Based on the 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.; Sender's Comments: Based on the 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: Dizziness, Loss of consciousness, Vision blurred
Clinical narrative: collapsed on kitchen floor; Dizzy; Blurred vision; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (collapsed on kitchen floor) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (collapsed on kitchen floor) (seriousness criterion medically significant), DIZZINESS (Dizzy) and VISION BLURRED (Blurred vision). At the time of the report, LOSS OF CONSCIOUSNESS (collapsed on kitchen floor), DIZZINESS (Dizzy) and VISION BLURRED (Blurred vision) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.  No concomitant or treatment medication has been reported.  Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Haemorrhagic stroke, Product dose omission issue
Clinical narrative: I was scheduled to get 2nd dose on 3/13/2.; Hemorrhagic stroke on 3/4/21; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGIC STROKE (Hemorrhagic stroke on 3/4/21) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced HAEMORRHAGIC STROKE (Hemorrhagic stroke on 3/4/21) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I was scheduled to get 2nd dose on 3/13/2.). At the time of the report, HAEMORRHAGIC STROKE (Hemorrhagic stroke on 3/4/21) and PRODUCT DOSE OMISSION ISSUE (I was scheduled to get 2nd dose on 3/13/2.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter. Treatment information was not provided.  Patient reported that experienced hemorrhagic stroke on 14-Mar-2021, and physician advised to him to not get 2nd dose vaccine.  Based on the current available information and temporal association between the use of the product and the start date of the event Hemorrhagic stroke, a causal relationship cannot be excluded. This report refers to a case of Product dose omission issue for mRNA-1273.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event Hemorrhagic stroke, a causal relationship cannot be excluded. This report refers to a case of Product dose omission issue for mRNA-1273.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Hyperhidrosis, Loss of consciousness, Vertigo
Clinical narrative: blacking out; sweating; falling out of chair; spinning; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacking out) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced LOSS OF CONSCIOUSNESS (blacking out) (seriousness criterion medically significant), HYPERHIDROSIS (sweating), FALL (falling out of chair) and VERTIGO (spinning). At the time of the report, LOSS OF CONSCIOUSNESS (blacking out), HYPERHIDROSIS (sweating), FALL (falling out of chair) and VERTIGO (spinning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient took Tylenol 1 hour before she got vaccination.  Concomitant product included Birth control medication.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No treatment information was provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Arrhythmia, Pneumonia
Clinical narrative: Fast or irregular heartbeats; Lungs were impacted; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Fast or irregular heartbeats) and PNEUMONIA (Lungs were impacted) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARRHYTHMIA (Fast or irregular heartbeats) (seriousness criterion medically significant) and PNEUMONIA (Lungs were impacted) (seriousness criterion medically significant). At the time of the report, ARRHYTHMIA (Fast or irregular heartbeats) and PNEUMONIA (Lungs were impacted) outcome was unknown.            The concomitant medications were not reported. The treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable   For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-117993 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Bronchial oedema, Bronchitis, Bronchospasm, Chest pain, Dysphonia
Clinical narrative: Acute respiratory illness; bronchial swelling; Acute bronchittis with bronchospasm; Voice was completely hoarse; chest pain; painful; Body ache; bronchospasm; Nasal congestion; Sore throat; Productive cough; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT INFECTION (Acute respiratory illness) and BRONCHIAL OEDEMA (bronchial swelling) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic bronchitis, Pneumonia and Asthma.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced NASAL CONGESTION (Nasal congestion), OROPHARYNGEAL PAIN (Sore throat) and PRODUCTIVE COUGH (Productive cough). On 02-Jun-2021, the patient experienced BRONCHOSPASM (bronchospasm). On 09-Jul-2021, the patient experienced DYSPHONIA (Voice was completely hoarse), CHEST PAIN (chest pain), PAIN (painful) and MYALGIA (Body ache). On an unknown date, the patient experienced RESPIRATORY TRACT INFECTION (Acute respiratory illness) (seriousness criterion medically significant), BRONCHIAL OEDEMA (bronchial swelling) (seriousness criterion medically significant) and BRONCHITIS (Acute bronchittis with bronchospasm). The patient was treated with ALBUTEROL [SALBUTAMOL] for Bronchospasm, at an unspecified dose and frequency; DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN (DEXTROMETHORPHAN HBR AND GUAIFENESIN) for Cough suppression, at an unspecified dose and frequency and NAPROXEN for Bronchial oedema, at an unspecified dose and frequency. At the time of the report, RESPIRATORY TRACT INFECTION (Acute respiratory illness) had not resolved, BRONCHIAL OEDEMA (bronchial swelling), NASAL CONGESTION (Nasal congestion), OROPHARYNGEAL PAIN (Sore throat), PRODUCTIVE COUGH (Productive cough), BRONCHITIS (Acute bronchittis with bronchospasm), DYSPHONIA (Voice was completely hoarse), BRONCHOSPASM (bronchospasm) and MYALGIA (Body ache) outcome was unknown and CHEST PAIN (chest pain) and PAIN (painful) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2021, SARS-CoV-2 test: negative (Negative) negative. On 02-Jun-2021, SARS-CoV-2 test: negative (Negative) negative.         Concomitant medications were not reported.  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.   This case was linked to MOD-2021-111160 (Patient Link).; Sender's Comments: 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: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nasal congestion, Oropharyngeal pain, Pain, Productive cough
Clinical narrative: Acute respiratory illness; bronchial swelling; Acute bronchittis with bronchospasm; Voice was completely hoarse; chest pain; painful; Body ache; bronchospasm; Nasal congestion; Sore throat; Productive cough; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT INFECTION (Acute respiratory illness) and BRONCHIAL OEDEMA (bronchial swelling) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic bronchitis, Pneumonia and Asthma.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced NASAL CONGESTION (Nasal congestion), OROPHARYNGEAL PAIN (Sore throat) and PRODUCTIVE COUGH (Productive cough). On 02-Jun-2021, the patient experienced BRONCHOSPASM (bronchospasm). On 09-Jul-2021, the patient experienced DYSPHONIA (Voice was completely hoarse), CHEST PAIN (chest pain), PAIN (painful) and MYALGIA (Body ache). On an unknown date, the patient experienced RESPIRATORY TRACT INFECTION (Acute respiratory illness) (seriousness criterion medically significant), BRONCHIAL OEDEMA (bronchial swelling) (seriousness criterion medically significant) and BRONCHITIS (Acute bronchittis with bronchospasm). The patient was treated with ALBUTEROL [SALBUTAMOL] for Bronchospasm, at an unspecified dose and frequency; DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN (DEXTROMETHORPHAN HBR AND GUAIFENESIN) for Cough suppression, at an unspecified dose and frequency and NAPROXEN for Bronchial oedema, at an unspecified dose and frequency. At the time of the report, RESPIRATORY TRACT INFECTION (Acute respiratory illness) had not resolved, BRONCHIAL OEDEMA (bronchial swelling), NASAL CONGESTION (Nasal congestion), OROPHARYNGEAL PAIN (Sore throat), PRODUCTIVE COUGH (Productive cough), BRONCHITIS (Acute bronchittis with bronchospasm), DYSPHONIA (Voice was completely hoarse), BRONCHOSPASM (bronchospasm) and MYALGIA (Body ache) outcome was unknown and CHEST PAIN (chest pain) and PAIN (painful) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2021, SARS-CoV-2 test: negative (Negative) negative. On 02-Jun-2021, SARS-CoV-2 test: negative (Negative) negative.         Concomitant medications were not reported.  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.   This case was linked to MOD-2021-111160 (Patient Link).; Sender's Comments: 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: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory tract infection, SARS-CoV-2 test
Clinical narrative: Acute respiratory illness; bronchial swelling; Acute bronchittis with bronchospasm; Voice was completely hoarse; chest pain; painful; Body ache; bronchospasm; Nasal congestion; Sore throat; Productive cough; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY TRACT INFECTION (Acute respiratory illness) and BRONCHIAL OEDEMA (bronchial swelling) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic bronchitis, Pneumonia and Asthma.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced NASAL CONGESTION (Nasal congestion), OROPHARYNGEAL PAIN (Sore throat) and PRODUCTIVE COUGH (Productive cough). On 02-Jun-2021, the patient experienced BRONCHOSPASM (bronchospasm). On 09-Jul-2021, the patient experienced DYSPHONIA (Voice was completely hoarse), CHEST PAIN (chest pain), PAIN (painful) and MYALGIA (Body ache). On an unknown date, the patient experienced RESPIRATORY TRACT INFECTION (Acute respiratory illness) (seriousness criterion medically significant), BRONCHIAL OEDEMA (bronchial swelling) (seriousness criterion medically significant) and BRONCHITIS (Acute bronchittis with bronchospasm). The patient was treated with ALBUTEROL [SALBUTAMOL] for Bronchospasm, at an unspecified dose and frequency; DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN (DEXTROMETHORPHAN HBR AND GUAIFENESIN) for Cough suppression, at an unspecified dose and frequency and NAPROXEN for Bronchial oedema, at an unspecified dose and frequency. At the time of the report, RESPIRATORY TRACT INFECTION (Acute respiratory illness) had not resolved, BRONCHIAL OEDEMA (bronchial swelling), NASAL CONGESTION (Nasal congestion), OROPHARYNGEAL PAIN (Sore throat), PRODUCTIVE COUGH (Productive cough), BRONCHITIS (Acute bronchittis with bronchospasm), DYSPHONIA (Voice was completely hoarse), BRONCHOSPASM (bronchospasm) and MYALGIA (Body ache) outcome was unknown and CHEST PAIN (chest pain) and PAIN (painful) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2021, SARS-CoV-2 test: negative (Negative) negative. On 02-Jun-2021, SARS-CoV-2 test: negative (Negative) negative.         Concomitant medications were not reported.  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.   This case was linked to MOD-2021-111160 (Patient Link).; Sender's Comments: 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: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis pain has worsened; This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis pain has worsened) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis.    On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis pain has worsened) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis pain has worsened) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the 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.; Sender's Comments: Based on the 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: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose abnormal
Clinical narrative: sugar level was 81 and then came back 552 after getting the vaccine.; This is a spontaneous report from a contactable consumer. An 86-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), (Lot number: EL9269 & Expiry date not reported) via unspecified route of administration in right arm on 04Feb2021 (age at the time of 86-year-old) as dose 1, single for COVID-19 Immunization. The patient's medical history include pacemaker, does not have both legs, he has had cankers and they had to cut them off, diabetes, heart surgery, he was in the house all the time, in a wheelchair. The patient's concomitant medications were not reported. On the 04Feb2021, the patient  got his first covid vaccine he was diabetic, controlled, when he went and had the breakfast, he had coffee and milk, and checked his sugar and it was 81, so he went to his house to get lunch, when he came back, his sugar was 552, really high, and he had to spend his whole day until 2AM checking his blood sugar every hour, and injected 42 units, then he was 152, at that hour, he injected 48 units and had 516, then he injected 28 of insulin, he was checking every hour, then he had 486, 477, and he injected again, he had 500, at 500, he got another 36 units at 14:00 it got lowered to 311, so normally he is between 108-120, 125, 130, and usually, this exaggeration could cause sugar attack. On 5Feb2021 (one day after vaccination) his sugar was normal, he thinks it was caused because of the vaccine, he never had this. More than 500, you must go to the hospital, to avoid attack, he has 30 years with diabetes. On 06Feb2021 (two days after vaccination) he went to have breakfast he was only 75. Patient took vaccine he was scared because all of complications he had, does not want to get infected. Other sicknesses are under control, all this time, he had surgery of his heart, they replaced his aorta with pork aorta, in the past 12 years ago, and since then he has had no problems with his heart. He was sure this was because of the injection, it was 2 hours after that he got the shot, his sugar went up 500 points, he did not eat anything, this was before the lunch. Treatment received by patient with novalog, lot/expiry unknown; they are syringes he has, once empty, they are thrown out, this one injection lasts one day, they usually last 10-12 days, he threw it away. When he feels his eyelids hot, he knows his sugar was high, but he does not feel any pain. His normal sugar level was 108-130.Caller was unsure if he will go to his second dose of the vaccine that is scheduled 25Feb2021. Patient underwent lab test and procedure include blood glucose level on 04Feb2021 as 81,552,152,516,486,477,500,311 and it was normal on 5Feb2021, on 06Feb2021 blood glucose level was 75. The outcome of event was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had a sore arm for 1 day after vaccination; This is a spontaneous report from a contactable Physician communicated to a Pfizer Sales Representative. This Physician reported for an elderly male patient. A 9-decade-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced had a sore arm for 1 day after vaccination. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: I noticed there is a lot of red liquid in that round little circle.; This is a spontaneous report from a contactable consumer (patient) and Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in Arm on 10Mar2021 (Batch/Lot number was not reported, expiry date: unknown) as dose 1, single for covid-19 immunization. The medical history and concomitant medications were not reported. The patient stated when she came home, she was looking at her arm and she still had that little square bandage that the gentleman put on her arm. But in the middle, there was a clear plastic circle and she noticed there was a lot of red liquid in that round little circle. The outcome of event was unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amenorrhoea, Headache, Hot flush, Ovulation pain, Pregnancy test
Clinical narrative: No menstrual cycle since receiving vaccines; Evening hot flashes; Pms symptoms; Nc Lusine ovulation pain; Headaches; This is a spontaneous report from a contactable other hcp (patient). A 46-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration in Arm Left on an unspecified date (Batch/Lot number and expiration date was not reported) as dose 2, single for covid-19 immunization. The patient medical history was not reported. Concomitant medications included eletriptan hydrobromide (RELPAX) and ibuprofen (ADVIL [IBUPROFEN]) taken for headache, start and stop date were not reported. The patient had not received any other vaccines in four weeks. COVID prior vaccination and post vaccination was mentioned as no. on 11Feb2021 12:00 AM, the patient had no menstrual cycle since receiving vaccines. Evening hot flashes. Pregnancy test so far negative, Pms symptoms include Nc Lusine ovulation pain, and headaches. Had a headache for 3 days which would not resolve with typical regimen of Relpax and Advil. The patient underwent lab tests and procedures which included pregnancy test: negative on an unspecified date. Therapeutic measures were taken as a result of headaches (headache). The outcome of event headache was not recovered, and other events was unknown.  No follow-up attempts are possible; information about lot/batch number could not be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Premenstrual syndrome
Clinical narrative: No menstrual cycle since receiving vaccines; Evening hot flashes; Pms symptoms; Nc Lusine ovulation pain; Headaches; This is a spontaneous report from a contactable other hcp (patient). A 46-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration in Arm Left on an unspecified date (Batch/Lot number and expiration date was not reported) as dose 2, single for covid-19 immunization. The patient medical history was not reported. Concomitant medications included eletriptan hydrobromide (RELPAX) and ibuprofen (ADVIL [IBUPROFEN]) taken for headache, start and stop date were not reported. The patient had not received any other vaccines in four weeks. COVID prior vaccination and post vaccination was mentioned as no. on 11Feb2021 12:00 AM, the patient had no menstrual cycle since receiving vaccines. Evening hot flashes. Pregnancy test so far negative, Pms symptoms include Nc Lusine ovulation pain, and headaches. Had a headache for 3 days which would not resolve with typical regimen of Relpax and Advil. The patient underwent lab tests and procedures which included pregnancy test: negative on an unspecified date. Therapeutic measures were taken as a result of headaches (headache). The outcome of event headache was not recovered, and other events was unknown.  No follow-up attempts are possible; information about lot/batch number could not be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Pain, Pruritus
Clinical narrative: No menstrual cycle since receiving vaccines; Evening hot flashes; Pms symptoms; Nc Lusine ovulation pain; Headaches; This is a spontaneous report from a contactable other hcp (patient). A 46-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration in Arm Left on an unspecified date (Batch/Lot number and expiration date was not reported) as dose 2, single for covid-19 immunization. The patient medical history was not reported. Concomitant medications included eletriptan hydrobromide (RELPAX) and ibuprofen (ADVIL [IBUPROFEN]) taken for headache, start and stop date were not reported. The patient had not received any other vaccines in four weeks. COVID prior vaccination and post vaccination was mentioned as no. on 11Feb2021 12:00 AM, the patient had no menstrual cycle since receiving vaccines. Evening hot flashes. Pregnancy test so far negative, Pms symptoms include Nc Lusine ovulation pain, and headaches. Had a headache for 3 days which would not resolve with typical regimen of Relpax and Advil. The patient underwent lab tests and procedures which included pregnancy test: negative on an unspecified date. Therapeutic measures were taken as a result of headaches (headache). The outcome of event headache was not recovered, and other events was unknown.  No follow-up attempts are possible; information about lot/batch number could not be obtained.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Pruritus, Vaccination site abscess, Vaccination site erythema, Vaccination site swelling
Clinical narrative: red, swollen knot appeared at the injection site last night; red, swollen knot appeared at the injection site last night; red, swollen knot appeared at the injection site last night; the red welt is the size of a small arrowhead and itched really bad last night/ had a red welt pop up in that area; he can still feel a raised place like a welt under the skin and it is like a small bruise under the skin; This is a spontaneous report from a contactable consumer (patient). A 69-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: FN6207), via an unspecified route of administration, administered in Arm Left on 11Mar2021 15:30 (Age at vaccination 69 years) as dose 1, single for covid-19 immunization. Medical history included ongoing rheumatoid arthritis. Patient stated that he was diagnosed with rheumatoid arthritis about 10 years ago and has been on Methotrexate for a long time and little overweight. No family Medical History relevant to adverse events. Concomitant medications included methotrexate (METHOTREXATE) taken for rheumatoid arthritis. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not visited to emergency room and physician office. Vaccine was not administered at military facility (Hospital staff). Additional vaccines were not administered on same date of the Pfizer Suspect. On 21Mar2021, Patient reported that a red, swollen knot appeared at the injection site last night. This morning the swelling has went down, the knot can be felt under the skin and is in the shape of an "arrow head". He states you can only see a red whelp now. stated this morning the red welt is the size of a small arrowhead and itched really bad last night but does not itch this morning. Patient stated that the red welt is just like a little arrowhead and is like a little heart and it is kind of weird. He wants to know if this reported event was a common occurrence after receiving the Pfizer COVID Vaccine. He states the red welt was improved and was not near as swollen as it was and it had swelled up to a big knot and he could visibly see the knot but he cannot see the knot now. Patient stated his appointment for the 2nd dose of the Pfizer COVID19 Vaccine was scheduled for 01Apr2021. Patient did not received treatment for events. No lab test was performed. The clinical outcome of event red, swollen knot appeared at the injection site last night was recovering; the red welt is the size of a small arrowhead and itched really bad last night/ had a red welt pop up in that area was recovered on 22Mar2021 and he can still feel a raised place like a welt under the skin and it is like a small bruise under the skin unknown.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Flatulence, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: little gassy; I experienced severe abdominal cramping; A little soreness in arm; dose 2 administration date 24Mar2021/dose 1 administration date 08Mar2021; This is a spontaneous report from a non-contactable consumer, the patient. A 47-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER- BIONTECH COVID-19 mRNA Vaccine, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 24Mar2021 at 13:30 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. The patient did not report any medical history. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA Vaccine, Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 08Mar2021 at 13:30 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. The patient received dose 2 administration date 24Mar2021/dose 1 administration date 08Mar2021 (Inappropriate schedule of vaccine administered); the patient experienced a little soreness in arm but last night after shot approximately 10 hours after, the patient reported "I experienced severe abdominal cramping",  on 24Mar2021. It lasted for several hours approximately 3 and then patient felt asleep. Woke up next day morning without cramps but a little gassy on 25Mar2021. The clinical outcome of the little soreness in arm and severe abdominal cramping and little gassy were unknown at the time of reporting.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Description as reported updated from "Inappropriate schedule of vaccine administered" to "dose 2 administration date 24Mar2021/dose 1 administration date 08Mar2021", Medication error checked in product details, Lead sentence updated as "non-contactable consumer", Final sentence updated.