chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Echocardiogram
Clinical narrative: Chest pain; This literature-non-study case was reported in a literature article and describes the occurrence of CHEST PAIN (Chest pain) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE:  No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion hospitalization). At the time of the report, CHEST PAIN (Chest pain) had resolved. Possible    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 1:80 (Inconclusive) An autoimmune  workup showed an anti-nuclear antibody titer of 1:80 in a speckled  pattern. On an unknown date, Antinuclear antibody: negative (Negative) negative, negative (Negative) negative and negative (Negative) negative. On an unknown date, Blood immunoglobulin G: negative (Negative) ribonucleic protein IgG negative. On an unknown date, C-reactive protein: 14 mg/l (High) CRP was notably elevated. On an unknown date, DNA antibody: negative (Negative) Negative double stranded DNA. On an unknown date, Echocardiogram: unknown (Inconclusive) Left Ventricular Ejection Fraction (LVEF) 55%, no regional wall motion abnormalities. On an unknown date, Electrocardiogram: abnormal (abnormal) Down-sloping PR depressions, diffuse ST elevations. On an unknown date, Rheumatoid factor: negative (Negative) Negative Rheumatoid factor. On an unknown date, Troponin I: 3785 pg/ml (High) Troponin-I peaked and 6802 pg/ml (High) Troponin-I peaked.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered CHEST PAIN (Chest pain) to be possibly related.    No concomitant medication was provided by the reporter  Patient was presented with chest pain 4 days after receiving his second dose of the Moderna vaccine. His chest pain resolved on the first day of his hospitalization, and he was discharged the following day.  No treatment medication information 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.   This case was linked to MOD-2021-293732, MOD-2021-293677 (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 event, a causal relationship cannot be excluded.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac aneurysm
Clinical narrative: Afib; An aneurysm in mu heart; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Afib) and CARDIAC ANEURYSM (An aneurysm in mu heart) in an 86-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (Afib) (seriousness criterion medically significant) and CARDIAC ANEURYSM (An aneurysm in mu heart) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (Afib) and CARDIAC ANEURYSM (An aneurysm in mu heart) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication information provided. No relevant treatment medication information provided.  Company Comment: Very limited information regarding this events has been provided at this time.  Further information can't be requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information can't be requested.
Age: 81.0
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction, Joint dislocation, Parkinson's disease, Tremor
Clinical narrative: side effects from the Parkinson's medication; diagnosed with Parkinson's disease; a worsening on the tremors more on her hands and her thumb; got off balanced; This spontaneous case was reported by a physician and describes the occurrence of PARKINSON'S DISEASE (diagnosed with Parkinson's disease) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unkwon) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Clot blood and Tremor (1 year ago patient started with tremors but on Jun 2021 patient experienced a worsening on the tremors more on her hands and her thumb and she got off balanced). Concurrent medical conditions included Parkinson's disease (2 months ago patient was diagnosed with Parkinson's disease) in June 2021, Diabetes and Hypertension. Concomitant products included APIXABAN (ELIQUIS) for Clot blood, CARBIDOPA, LEVODOPA (CARBIDOPA LEVODOPA) from 14-Jun-2021 to an unknown date for Parkinson's disease.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2021, the patient experienced PARKINSON'S DISEASE (diagnosed with Parkinson's disease) (seriousness criterion medically significant), TREMOR (a worsening on the tremors more on her hands and her thumb) and JOINT DISLOCATION (got off balanced). On an unknown date, the patient experienced ADVERSE DRUG REACTION (side effects from the Parkinson's medication). At the time of the report, PARKINSON'S DISEASE (diagnosed with Parkinson's disease), TREMOR (a worsening on the tremors more on her hands and her thumb), JOINT DISLOCATION (got off balanced) and ADVERSE DRUG REACTION (side effects from the Parkinson's medication) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications are reported.  There was no information on lot numbers on the patients vaccination card.  Patient would like to receive a third dose .  One year ago patient started with tremors but on Jun 2021 patient experienced a worsening on the tremors more on her hands and her thumb and she got off balanced  Company Comment : Based on the current available information a temporal association between the use of the product and the start date of the events is unlikely, however, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information a temporal association between the use of the product and the start date of the events is unlikely, however, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Off label use
Clinical narrative: Severe heart pain; Shortness of breath; Got her third vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CHEST PAIN (Severe heart pain) and DYSPNOEA (Shortness of breath) 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.     The patient's past medical history included Leukopenia.    On 18-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Severe heart pain) (seriousness criterion medically significant), DYSPNOEA (Shortness of breath) (seriousness criterion medically significant) and OFF LABEL USE (Got her third vaccine). At the time of the report, CHEST PAIN (Severe heart pain) and DYSPNOEA (Shortness of breath) outcome was unknown and OFF LABEL USE (Got her third vaccine) had resolved.            Concomitant product use was not provider by the reporter.  Treatment information was not provided.   The patient received vaccine in  a Wednesday.  Company 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.  The causality for OFF LABEL USE  is not applicable. Further information is expected.; 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.  The causality for OFF LABEL USE  is not applicable. Further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old by chance gets moderna; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old by chance gets moderna) in a 17-year-old patient of an unknown 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old by chance gets moderna). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old by chance gets moderna) had resolved.        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.   No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Face injury, Syncope
Clinical narrative: faint; dizzy; Injured her face and chin/wound up doing a face plant on the side walk; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (faint) 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 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Aug-2021, the patient experienced SYNCOPE (faint) (seriousness criterion medically significant), DIZZINESS (dizzy) and FACE INJURY (Injured her face and chin/wound up doing a face plant on the side walk). At the time of the report, SYNCOPE (faint), DIZZINESS (dizzy) and FACE INJURY (Injured her face and chin/wound up doing a face plant on the side walk) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  The reactions occurred 45-60 minutes after receiving the shot.  No treatment information was provided by the reporter.  Company Comment:Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Product quality issue
Clinical narrative: usually have a space between the frozen liquid and the vial stopper, but with this one, she; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT QUALITY ISSUE (usually have a space between the frozen liquid and the vial stopper, but with this one, she) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059A21A) for COVID-19 vaccination.     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 PRODUCT QUALITY ISSUE (usually have a space between the frozen liquid and the vial stopper, but with this one, she). At the time of the report, PRODUCT QUALITY ISSUE (usually have a space between the frozen liquid and the vial stopper, but with this one, she) had resolved. 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.   No concomitant medication was reported.                   No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: Admited in the hospital because of positive covid test; Did not received the 2nd dose yet; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Admited in the hospital because of positive covid test) 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 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced COVID-19 (Admited in the hospital because of positive covid test) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not received the 2nd dose yet). The patient was hospitalized from 08-Mar-2021 to 09-Jul-2021 due to COVID-19. On 09-Jul-2021, COVID-19 (Admited in the hospital because of positive covid test) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not received the 2nd dose yet) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company comment: This report refers to a case of Product dose omission issue with associated AEs. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of COVID 19 is assessed as not applicable.; Sender's Comments: This report refers to a case of Product dose omission issue with associated AEs. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of COVID 19 is assessed as not applicable.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Off label use
Clinical narrative: severe case of COVID/chills/shivers; received his third; Lack of efficacy; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (severe case of COVID/chills/shivers) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A, 011M20A and 066D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Vasculitis (Presumed to be giant cell arteritis but not seen in biopsy.) and Steroid therapy since 2013. Concomitant products included PREDNISONE for Vasculitis, DULAGLUTIDE (TRULICITY), ISOPHANE INSULIN (NPH INSULIN) and GLYCERYL TRINITRATE (NITROGLYCERIN) for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jul-2021, the patient experienced COVID-19 (severe case of COVID/chills/shivers) (seriousness criterion hospitalization) and DRUG INEFFECTIVE (Lack of efficacy). On 17-Aug-2021, the patient experienced OFF LABEL USE (received his third). The patient was hospitalized on 28-Jul-2021 due to COVID-19. At the time of the report, COVID-19 (severe case of COVID/chills/shivers), DRUG INEFFECTIVE (Lack of efficacy) and OFF LABEL USE (received his third) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided by the reporter.  Patient was on unspecified regular insulin. The patient received a booster (third dose of the product), which had been captured as off label use; after, the reported event of COVID-19. So, the third dose of product was not suspect for the event lack of drug effect.  Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the event Drug ineffective a causal relationship cannot be excluded. The patient received a third dose of the product, which was captured as off-label use.    This case was linked to MOD-2021-294409 (Patient Link).; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the event Drug ineffective a causal relationship cannot be excluded. The patient received a third dose of the product, which was captured as off-label use. Further information has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cardiac disorder, Cardiac flutter, Chest discomfort, Feeling abnormal
Clinical narrative: 2 days ago 21Aug2021 she had to stop her walk / she did not feel correct, she did not feel right/she has had unusual effects/; since the vaccine, it is messing with her heart/having heart symptoms right now.; Heart fluttering; Heart palpitations; tightening in the middle of the chest; This spontaneous case was reported by an other health care professional and describes the occurrence of CARDIAC FLUTTER (Heart fluttering), PALPITATIONS (Heart palpitations), CHEST DISCOMFORT (tightening in the middle of the chest), FEELING ABNORMAL (2 days ago 21Aug2021 she had to stop her walk / she did not feel correct, she did not feel right/she has had unusual effects/) and CARDIAC DISORDER (since the vaccine, it is messing with her heart/having heart symptoms right now) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced CARDIAC FLUTTER (Heart fluttering) (seriousness criteria medically significant and life threatening), PALPITATIONS (Heart palpitations) (seriousness criteria medically significant and life threatening), CHEST DISCOMFORT (tightening in the middle of the chest) (seriousness criteria medically significant and life threatening) and CARDIAC DISORDER (since the vaccine, it is messing with her heart/having heart symptoms right now.) (seriousness criterion life threatening). On 21-Aug-2021, the patient experienced FEELING ABNORMAL (2 days ago 21Aug2021 she had to stop her walk / she did not feel correct, she did not feel right/she has had unusual effects/) (seriousness criteria medically significant and life threatening). At the time of the report, CARDIAC FLUTTER (Heart fluttering), PALPITATIONS (Heart palpitations), CHEST DISCOMFORT (tightening in the middle of the chest), FEELING ABNORMAL (2 days ago 21Aug2021 she had to stop her walk / she did not feel correct, she did not feel right/she has had unusual effects/) and CARDIAC DISORDER (since the vaccine, it is messing with her heart/having heart symptoms right now.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Aug-2021, Blood pressure measurement (70-90-120): 150/90 (High) patient  BP was 150/90 (baseline usually 120/70-90).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter.  Treatment medication not reported.  Company comment: Very limited information regarding this event/s has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: 2 days ago 21Aug2021 she had to stop her walk / she did not feel correct, she did not feel right/she has had unusual effects/; since the vaccine, it is messing with her heart/having heart symptoms right now.; Heart fluttering; Heart palpitations; tightening in the middle of the chest; This spontaneous case was reported by an other health care professional and describes the occurrence of CARDIAC FLUTTER (Heart fluttering), PALPITATIONS (Heart palpitations), CHEST DISCOMFORT (tightening in the middle of the chest), FEELING ABNORMAL (2 days ago 21Aug2021 she had to stop her walk / she did not feel correct, she did not feel right/she has had unusual effects/) and CARDIAC DISORDER (since the vaccine, it is messing with her heart/having heart symptoms right now) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced CARDIAC FLUTTER (Heart fluttering) (seriousness criteria medically significant and life threatening), PALPITATIONS (Heart palpitations) (seriousness criteria medically significant and life threatening), CHEST DISCOMFORT (tightening in the middle of the chest) (seriousness criteria medically significant and life threatening) and CARDIAC DISORDER (since the vaccine, it is messing with her heart/having heart symptoms right now.) (seriousness criterion life threatening). On 21-Aug-2021, the patient experienced FEELING ABNORMAL (2 days ago 21Aug2021 she had to stop her walk / she did not feel correct, she did not feel right/she has had unusual effects/) (seriousness criteria medically significant and life threatening). At the time of the report, CARDIAC FLUTTER (Heart fluttering), PALPITATIONS (Heart palpitations), CHEST DISCOMFORT (tightening in the middle of the chest), FEELING ABNORMAL (2 days ago 21Aug2021 she had to stop her walk / she did not feel correct, she did not feel right/she has had unusual effects/) and CARDIAC DISORDER (since the vaccine, it is messing with her heart/having heart symptoms right now.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Aug-2021, Blood pressure measurement (70-90-120): 150/90 (High) patient  BP was 150/90 (baseline usually 120/70-90).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter.  Treatment medication not reported.  Company comment: Very limited information regarding this event/s has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Cough, Muscle tightness, Pruritus, Rash
Clinical narrative: Anaphylaxis reaction; Broke out in hives; Itching; Cough on and off/still has a cough; Tightness in her neck; Broke out with rash; This spontaneous case was reported by an other health care professional and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis reaction), URTICARIA (Broke out in hives), PRURITUS (Itching), COUGH (Cough on and off/still has a cough), MUSCLE TIGHTNESS (Tightness in her neck) and RASH (Broke out with rash) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Allergy. Concomitant products included EPINEPHRINE (EPIPEN) for Allergy.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis reaction) (seriousness criteria medically significant and life threatening), URTICARIA (Broke out in hives) (seriousness criterion life threatening), PRURITUS (Itching) (seriousness criterion life threatening), COUGH (Cough on and off/still has a cough) (seriousness criterion life threatening), MUSCLE TIGHTNESS (Tightness in her neck) (seriousness criterion life threatening) and RASH (Broke out with rash) (seriousness criterion life threatening). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 25 milligram. At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis reaction), URTICARIA (Broke out in hives), PRURITUS (Itching), COUGH (Cough on and off/still has a cough), MUSCLE TIGHTNESS (Tightness in her neck) and RASH (Broke out with rash) outcome was unknown.        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.   Concomitant included some unknown medications for blood pressure. Treatment medication was not reported.  Company Comment : 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. However, patient's medical history of allergies treated with EpiPen remains a contributory factor. Though symptoms were reported separately, they could all be subsumed under the anaphylactic reaction experienced by this patient.; 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. However, patient's medical history of allergies treated with EpiPen remains a contributory factor. Though symptoms were reported separately, they could all be subsumed under the anaphylactic reaction experienced by this patient.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Anaphylaxis reaction; Broke out in hives; Itching; Cough on and off/still has a cough; Tightness in her neck; Broke out with rash; This spontaneous case was reported by an other health care professional and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis reaction), URTICARIA (Broke out in hives), PRURITUS (Itching), COUGH (Cough on and off/still has a cough), MUSCLE TIGHTNESS (Tightness in her neck) and RASH (Broke out with rash) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Allergy. Concomitant products included EPINEPHRINE (EPIPEN) for Allergy.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis reaction) (seriousness criteria medically significant and life threatening), URTICARIA (Broke out in hives) (seriousness criterion life threatening), PRURITUS (Itching) (seriousness criterion life threatening), COUGH (Cough on and off/still has a cough) (seriousness criterion life threatening), MUSCLE TIGHTNESS (Tightness in her neck) (seriousness criterion life threatening) and RASH (Broke out with rash) (seriousness criterion life threatening). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 25 milligram. At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis reaction), URTICARIA (Broke out in hives), PRURITUS (Itching), COUGH (Cough on and off/still has a cough), MUSCLE TIGHTNESS (Tightness in her neck) and RASH (Broke out with rash) outcome was unknown.        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.   Concomitant included some unknown medications for blood pressure. Treatment medication was not reported.  Company Comment : 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. However, patient's medical history of allergies treated with EpiPen remains a contributory factor. Though symptoms were reported separately, they could all be subsumed under the anaphylactic reaction experienced by this patient.; 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. However, patient's medical history of allergies treated with EpiPen remains a contributory factor. Though symptoms were reported separately, they could all be subsumed under the anaphylactic reaction experienced by this patient.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Sore throat Runny nose Cough
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Nasal congestion, SARS-CoV-2 test
Clinical narrative: Cough Nasal congestion Shortness of breath
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Tinnitus, Vertigo
Clinical narrative: Hissing on my ears  and sometimes dizziness or vertigo
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Cough, Nasal congestion, Pyrexia
Clinical narrative: nasal and chest congestion, runny nose, fever, loss of taste/smell, and cough.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: nasal and chest congestion, runny nose, fever, loss of taste/smell, and cough.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Mass
Clinical narrative: I have an internal lump in my right armpit. It was disappearing for a few days but came back by the week's end following the Covid-19 vaccine.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Injection site swelling, Pain, Pyrexia
Clinical narrative: Pain and swelling near at injection site.  Body aches and chills.  High fever (103)
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, SARS-CoV-2 test
Clinical narrative: Cough
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test positive
Clinical narrative: asymptomatic  Tested positive for COVID-19
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Sternal chest pain
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Balance disorder, Body temperature increased, Chest X-ray, Chills, Computerised tomogram head
Clinical narrative: My son woke up the next morning with horrible headaches, chills, temperature elevation (37.8C), loss of balance, nausea, vomiting. I took him to the emergency room. Labs were done and an emergency CT scan of the head. Later on, he saw a neurologist, a neurosurgeon, and an endocrinologist. He was sick for a month and was unable to go to school.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Headache, Illness, Magnetic resonance imaging head, Nausea, Vomiting
Clinical narrative: My son woke up the next morning with horrible headaches, chills, temperature elevation (37.8C), loss of balance, nausea, vomiting. I took him to the emergency room. Labs were done and an emergency CT scan of the head. Later on, he saw a neurologist, a neurosurgeon, and an endocrinologist. He was sick for a month and was unable to go to school.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Condition aggravated, Decreased appetite, Dizziness, Nausea
Clinical narrative: Pneumonia due to 2019 novel coronavirus nausea decreased appetite dizziness
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Respiratory viral panel
Clinical narrative: Pneumonia due to 2019 novel coronavirus nausea decreased appetite dizziness
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: Within a few hours I began to hear a ringing in both ears. It became progressively worse. After Tylenol due to headache I developed from the noise,  I was able to sleep a few hours .  However, it is back in full force this morning.   I?ve had no prior issues with hearing, no prior ENT visits, and have never had anything like this.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Cough, Headache, Respiratory tract congestion
Clinical narrative: headache, loss of taste and smell, cough, congestion
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: headache, loss of taste and smell, cough, congestion
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Injection site bruising, Peripheral swelling, Rash, Urticaria
Clinical narrative: Site: Bruising at Injection Site-Mild, Additional Details: Pt recieved vaccine at 12pm, was monitored for 15 min and no reaction developed. She noticed burning and swelling of her hands and feet, followed by a full body rash/hives between 11-1:30pm. She took 1 diphenhydramine 25mg followed by 3 separate doses after. She went to urgent care for eval and was given famotidine and prednisone. She was advised to not recieve any further doses of vaccine and proceed to ER if problems.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Sex: F
Vaccine: COVID19, UNK
Symptoms: Feeling abnormal, Mobility decreased
Clinical narrative: barely move; have had a terrible terrible time but I'm feeling better today; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 08Jul2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a Pfizer-sponsored program XELSOURCE from a contactable consumer (patient). This 71-year-old female patient received bnt162b2, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation; tofacitinib citrate (XELJANZ XR) (strength: 11 mg), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 11 mg for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient due for a refill. patient stated she was out of the tofacitinib citrate. She got the second dose of the vaccine and she can barely move. She got the vaccine and she have had a terrible terrible time but she was feeling better at the time of report. The patient was prescribed tofacitinib citrate 11mg. The action taken with tofacitinib citrate was unknown. The outcome of event barely move was unknown. The outcome of other event was recovered.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: Morning nausea; Mild pain at injection site 48 and 72 hours later; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 14Jul2021 at 19:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 since prior to the vaccination, the patient was diagnosed with COVID-19 on an unknown date. The patient did not have any allergies to medications, food, or other products. Concomitant medications included levothyroxine sodium (SYNTHROID) 100 mcg and amitriptyline hydrochloride (ELAVIL) 25 mg. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 16Jul2021 at 04:00, 48 hours after vaccination, the patient experienced mild pain at injection site. On 17Jul2021, 72 hours after vaccination, the patient experienced morning nausea. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events mild pain at injection site and nausea was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, SARS-CoV-2 test
Clinical narrative: Blister has been developing on right arm where the patient received a shot; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the right arm on an unknown date in 2021 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. Medical history included allergy to peanuts and sulfonamide allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included atenolol (MANUFACTURER UNKNOWN) 25 mg once daily from an unknown date for an unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 01Apr2021 at 15:00 (at the age of 54-years-old), as a single dose for COVID-19 immunisation. On 07May2021, the patient experienced blister has been developing on right arm where the patient received a shot. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. On 09Jun2021, the patient underwent SARS-CoV-2 test (nasal swab) and the result was negative. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event blister has been developing on right arm where the patient received a shot was unknown at the time of this report.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Limb discomfort, Pain in extremity
Clinical narrative: Hard time raising arm; Pain in left arm and upper back left side that lasted few days; Upper back leftside; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 08:00(at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included thyroid disease and allergy to penicillin and sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included escitalopram oxalate (LEXAPRO), pravastatin (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and lorazepam (MANUFACTURER UNKNOWN); all for unspecified indication and unknown start date. The patient previously took codeine (MANUFACTURER UNKNOWN) and methocarbamol (MYOCIN) and experienced drug allergy. On 01Apr2021, the day the patient received her 2nd dose, she had pain in her left arm and upper back left side that lasted few days. Pain in left arm never went away. Hard time raising arm or using arm and without pain still existed. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of event she had pain in her left arm, hard time raising arm or using arm and without pain still existed was not recovered and she had pain in upper back left side was recovering at the time of this report.  The batch/lot numbers for BNT162b2, were not provided and will be requested during follow up.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Burning sensation, CSF culture, Hypoaesthesia, Lumbar puncture
Clinical narrative: nerve pain; numbness and tingling in hands feet; numbness and tingling in hands feet; weakness on legs and arms; burning in face; polyneuropathy increased 10- fold after the Pfizer vaccine for the first 2 days after shot; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 64-year-old female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, dose 1 intramuscular, administered in arm left on 25Jun2021 09:00 (Batch/Lot Number: EW0173) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included breast cancer from Aug2015 to Jul2016 (right mastectomy reconstruction), lung cancer from Jan2020 to Jan2020 (lung resection), guillain barre from Oct1986 to Apr1987 (paralyzed waist down), polyneuropathy from 04Jul2017, muscular weakness from 04Jul2017. Patient is not pregnant at time of vaccination. Concomitant medications included atenolol; ramipril; potassium; and hydrochlorothiazide. The patient previously received tetanus boost on 04Jun2017 for immunization and experienced polyneuropathy and muscle weakness at age of 60 years old, and previously took duloxetine hydrochloride (CYMBALTA), baclofen and gabapentin and none of these medications have been effective. The patient experienced nerve pain, numbness and tingling in hands feet, weakness on legs and arms, burning in face after first dose. Adverse event start date was reported as 14Jun2021 (pending clarify). The patient underwent lab tests and procedures which included mamograme biopsy: positive on Aug2015, Celebro spinal fluid culture imagine: negative on 2017, negative on 2019, negative on 2020, spinal tap: negative on Oct1986, Diagnostic X-Ray: negative on Oct1986, X-Ray biopsy: positive on Jan2020. Patient was considered this event as not serious. Patient developed Guillain barre syndrome in 1986 after her young children had the flu. Patient was hospitalized for 2 weeks. She was unable to walk for several months. She had residual visible weakness on one side of her face which has persisted to the present. Patient developed polyneuropathy after an emergency tetanus shot in Jul2017. Patient had persistent numbness, tingling and muscle weakness in her hand, face, legs, feet, and arms. She had been prescribed Cymbalta, gabapentin, baclofen; none of these medications have been effective in managing the symptoms. She had never taken the flu, shingles, or pneumonia vaccine to avoid the risk of negative reaction. The polyneuropathy increased 10- fold after the Pfizer vaccine for the first 2 days after shot and even worse after the 2nd shot. No treatment was received. The outcomes of events were recovering.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Neuralgia, Paraesthesia, Polyneuropathy, X-ray
Clinical narrative: nerve pain; numbness and tingling in hands feet; numbness and tingling in hands feet; weakness on legs and arms; burning in face; polyneuropathy increased 10- fold after the Pfizer vaccine for the first 2 days after shot; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 64-year-old female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, dose 1 intramuscular, administered in arm left on 25Jun2021 09:00 (Batch/Lot Number: EW0173) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included breast cancer from Aug2015 to Jul2016 (right mastectomy reconstruction), lung cancer from Jan2020 to Jan2020 (lung resection), guillain barre from Oct1986 to Apr1987 (paralyzed waist down), polyneuropathy from 04Jul2017, muscular weakness from 04Jul2017. Patient is not pregnant at time of vaccination. Concomitant medications included atenolol; ramipril; potassium; and hydrochlorothiazide. The patient previously received tetanus boost on 04Jun2017 for immunization and experienced polyneuropathy and muscle weakness at age of 60 years old, and previously took duloxetine hydrochloride (CYMBALTA), baclofen and gabapentin and none of these medications have been effective. The patient experienced nerve pain, numbness and tingling in hands feet, weakness on legs and arms, burning in face after first dose. Adverse event start date was reported as 14Jun2021 (pending clarify). The patient underwent lab tests and procedures which included mamograme biopsy: positive on Aug2015, Celebro spinal fluid culture imagine: negative on 2017, negative on 2019, negative on 2020, spinal tap: negative on Oct1986, Diagnostic X-Ray: negative on Oct1986, X-Ray biopsy: positive on Jan2020. Patient was considered this event as not serious. Patient developed Guillain barre syndrome in 1986 after her young children had the flu. Patient was hospitalized for 2 weeks. She was unable to walk for several months. She had residual visible weakness on one side of her face which has persisted to the present. Patient developed polyneuropathy after an emergency tetanus shot in Jul2017. Patient had persistent numbness, tingling and muscle weakness in her hand, face, legs, feet, and arms. She had been prescribed Cymbalta, gabapentin, baclofen; none of these medications have been effective in managing the symptoms. She had never taken the flu, shingles, or pneumonia vaccine to avoid the risk of negative reaction. The polyneuropathy increased 10- fold after the Pfizer vaccine for the first 2 days after shot and even worse after the 2nd shot. No treatment was received. The outcomes of events were recovering.