chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test, SARS-CoV-2 test positive, Urinary tract infection
Clinical narrative: tested positive for Covid-19; I took her in to see the Dr for a urinary tract infection; sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 30-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) (seriousness criterion medically significant) and URINARY TRACT INFECTION (I took her in to see the Dr for a urinary tract infection). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid-19), URINARY TRACT INFECTION (I took her in to see the Dr for a urinary tract infection) and PAIN IN EXTREMITY (sore arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  It was reported that the patient had been feeling weak a few days before getting the vaccine.  Patient was treated with one dose of IV Bamlanivimab etesevimab to treat Covid.and was sent home.  Company comment: SARS-CoV-2 test: positive is assessed as unlikely related to mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the rest of the events, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-138839, US-MODERNATX, INC.-MOD-2021-138859 (E2B Linked Report).; Sender's Comments: SARS-CoV-2 test: positive is assessed as unlikely related to mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the rest of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-138859: US-MODERNATX, INC.-MOD-2021-138839:Crosslink
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Multiple sclerosis, Pain, Paraesthesia, Vaccination complication
Clinical narrative: MS symptoms; tingling; pain; feeling like crap; constantly tired; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS (MS symptoms) in a 62-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.     Concurrent medical conditions included Psoriatic arthritis. Concomitant products included ADALIMUMAB (HUMIRA) for Psoriatic arthritis.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced MULTIPLE SCLEROSIS (MS symptoms) (seriousness criterion medically significant), PARAESTHESIA (tingling), PAIN (pain), VACCINATION COMPLICATION (feeling like crap) and FATIGUE (constantly tired). At the time of the report, MULTIPLE SCLEROSIS (MS symptoms), PARAESTHESIA (tingling), PAIN (pain), VACCINATION COMPLICATION (feeling like crap) and FATIGUE (constantly tired) had not resolved.            No laboratory data was provided. No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  Company comment: Very limited information regarding these events have been provided at this time. No further information is expected.   This case was linked to MOD-2021-139228 (Patient Link).; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Hospitalisation, Incorrect dose administered
Clinical narrative: hospitalized after the first dose for over a month; Patient received three doses of Moderna Covid 19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of HOSPITALISATION (hospitalized after the first dose for over a month) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A, 045A21A and 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FLUTICASONE, TRAZODONE, PROPRANOLOL HYDROCHLORIDE (PROPRANOLOL [PROPRANOLOL HYDROCHLORIDE]), LITHIUM CARBONATE, NORTRIPTYLINE, BENZONATATE (TESSALON PERLE), HALOPERIDOL and CLONAZEPAM for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced HOSPITALISATION (hospitalized after the first dose for over a month) (seriousness criterion hospitalization). On 13-May-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Patient received three doses of Moderna Covid 19 vaccine). The patient was hospitalized from sometime in 2021 to sometime in 2021 due to HOSPITALISATION. On 13-May-2021, INCORRECT DOSE ADMINISTERED (Patient received three doses of Moderna Covid 19 vaccine) had resolved. At the time of the report, HOSPITALISATION (hospitalized after the first dose for over a month) outcome was unknown.        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.   Reason for hospital admission was not reported.  Company comment: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: )  with the event of "Hospitalisation'. Very limited information regarding Hospitalisation has been provided at this time.  Further information is not expected  no associated adverse events.   This case was linked to MOD-2021-141479 (Patient Link).; Sender's Comments: This report refers to a case of Expired Product Administered for mRNA-1273 (Lot #: )  with the event of "Hospitalisation'. Very limited information regarding Hospitalisation has been provided at this time.  Further information is not expected  no associated adverse events.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Hospitalisation, Overdose
Clinical narrative: hospitalized after the first dose for over a month; Patient received three doses of Moderna Covid 19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of HOSPITALISATION (hospitalized after the first dose for over a month) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A, 045A21A and 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported by the reporter.  Concomitant products included FLUTICASONE, TRAZODONE, PROPRANOLOL (PROPANOLOL [PROPRANOLOL]), LITHIUM CARBONATE, NORTRIPTYLINE, BENZONATATE, HALOPERIDOL and CLONAZEPAM for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-May-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced HOSPITALISATION (hospitalized after the first dose for over a month) (seriousness criterion hospitalization). On 13-May-2021, the patient experienced OVERDOSE (Patient received three doses of Moderna Covid 19 vaccine). On 13-May-2021, OVERDOSE (Patient received three doses of Moderna Covid 19 vaccine) had resolved. At the time of the report, HOSPITALISATION (hospitalized after the first dose for over a month) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information were not provided. Action taken with mRNA-1273 in response to the event was not applicable.  Company comment: This report refers to a case of Overdose for mRNA-1273 (Lot #: 031M20A, 045A21A and 027C21A)  with the event of "Hospitalisation'. Very limited information regarding Hospitalisation has been provided at this time.  Further information is not expected   This case was linked to MOD-2021-141444 (Patient Link).; Sender's Comments: This report refers to a case of Overdose for mRNA-1273 (Lot #: 031M20A, 045A21A and 027C21A)  with the event of "Hospitalisation'. Very limited information regarding Hospitalisation has been provided at this time.  Further information is not expected
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Brain oedema, Gait disturbance, Magnetic resonance imaging head, Muscular weakness, Vision blurred
Clinical narrative: Swelling in the brain; Blurred vision; Weakness in the hand; Difficulty walking; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRAIN OEDEMA (Swelling in the brain), VISION BLURRED (Blurred vision), MUSCULAR WEAKNESS (Weakness in the hand) and GAIT DISTURBANCE (Difficulty walking) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced BRAIN OEDEMA (Swelling in the brain) (seriousness criteria hospitalization and medically significant), VISION BLURRED (Blurred vision) (seriousness criterion hospitalization), MUSCULAR WEAKNESS (Weakness in the hand) (seriousness criterion hospitalization) and GAIT DISTURBANCE (Difficulty walking) (seriousness criterion hospitalization). At the time of the report, BRAIN OEDEMA (Swelling in the brain), VISION BLURRED (Blurred vision), MUSCULAR WEAKNESS (Weakness in the hand) and GAIT DISTURBANCE (Difficulty walking) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Magnetic resonance imaging head: abnormal (abnormal) He had a brain MRI which shows swelling in the brain.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not taken by the patient. Treatment information was not provided.  The patient has weakness in his hand, difficulty walking, blurred vision. The patient started experiencing symptoms 3 days later, and they are ongoing. The patient was hospitalized for these symptoms, and was given steroids to reduce the swelling.  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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Possible stroke symptoms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Possible stroke symptoms) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Possible stroke symptoms) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 12-May-2021 to 15-May-2021 due to CEREBROVASCULAR ACCIDENT. The patient was treated with ACICLOVIR SODIUM (ACYCLOVIR [ACICLOVIR SODIUM]) ongoing since an unknown date for Stroke, at a dose of 800 milligram; ATORVASTATIN CALCIUM (LIPITOR) ongoing since an unknown date for Stroke, at a dose of UNK dosage form; FENOFIBRATE ongoing since an unknown date for Stroke, at a dose of 54 milligram and PREDNISONE ongoing since an unknown date for Stroke, at a dose of 10 milligram. At the time of the report, CEREBROVASCULAR ACCIDENT (Possible stroke symptoms) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Company comment: 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: FLUX
Symptoms: Malaise
Clinical narrative: sick; Based on information previously received, the case was classified as valid, gender, age group, event coding, listedness and values for combination product was corrected  Initial information was received on 10-Nov-2020 regarding an unsolicited non-valid non-serious case from a consumer via Social Media. This case is linked to case 2021SA173404 (male patient).  This case involves a female patient (age unspecified) who was sick (llness) after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient was sick (illness, non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE.  The reporter asked why the parents got sick almost every year after getting the vaccine   No laboratory data was provided.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: sick; Initial information was received on 10-Nov-2020 regarding an unsolicited valid non-serious case from a consumer via Social Media. This case is linked to case 2020SA317914 (female patient).  This case involves a male patient (age unspecified) who was sick (llness) after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient was sick (illness, non-serious event) (unknown latency) following the administration of INFLUENZA VACCINE.  The reporter asked why the parents got sick almost every year after getting the vaccine   No laboratory data was provided.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product preparation issue
Clinical narrative: Only one component of the vaccine was given to patient, the solution component which as the Tdap/ no AE; Based on information previously received on 21-Jan-2021, the following information [case classification from Non-Valid to Valid Agency with no AE and update in narrative accordingly; company drug code Pentacel from 242 to 520 updated and latency as one day in the field and update in narrative accordingly] have been amended.  Initial information was received on 21-Jan-2021 regarding an unsolicited valid non-serious case via Agency (Reference number- 00439658) from a pharmacist.  This case involves a patient of unknown age and gender who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] however, only one component of the vaccine was given, the solution component which as the Tdap (product preparation issue) via an unknown route at an unknown administration site on an unknown date for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate reconstitution technique (latency was on same day).  At the time of reporting, no adverse event reported.  The reporter said that whether they can reconstitute the powder portion of the vaccine and was it safe to give another dose to patient.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: Thrombosis
Clinical narrative: Idiopathic blood clot; This spontaneous case  was received on 18-May-2021 from other non-health professional (patient's mom) with additional information received on the same day via Med Communications (reference number: SEQW21-01337) and additional document received on 19-May-2021 (being processed together) and concerned a male patient of an unknown age.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; indication, dose, route of administration and anatomical location: not reported). Batch number was not reported.  On an unspecified date, an unknown amount of time after receiving influenza virus vaccine polyvalent, the patient developed idiopathic blood clot.   The outcome of the event was not reported.  The reporter did not provide a causality assessment to influenza virus vaccine polyvalent.  The event of 'clot blood' was considered to be medically significant by a Physician within regulatory authority. Company comment: A male patient of unreported age developed thrombosis an unknown amount of time after vaccination with the suspect product, influenza virus vaccine polyvalent. Chronology is unassessable. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Due to lack of information regarding chronology and diagnostic data, causality for the reported event is unassessable.; Sender's Comments: A male patient of unreported age developed thrombosis an unknown amount of time after vaccination with the suspect product, influenza virus vaccine polyvalent. Chronology is unassessable. Information regarding the underlying medical history, related diagnostic findings and concomitant medications have not been provided. Due to lack of information regarding chronology and diagnostic data, causality for the reported event is unassessable.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID19
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Patient was feeling light headed b/p was 108/70; Patient refused to be transported.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram abnormal, Angiogram cerebral abnormal, Aphasia, Arteriogram carotid abnormal, Basal ganglia infarction
Clinical narrative: Received COVID vaccine on 5/17/21 5/25/21 around 0100 patient collapsed with acute onset right sided weakness and expressive aphasia. Brought to an ED where CTA found an occlusion of the L MCA which was confirmed as a ischemic stroke. He received TPA and underwent a IR guided thrombectomy. Patient continues to be admitted to the PICU with intermittent expressive aphasia and mild right sided weakness.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Basal ganglia stroke, Cerebral artery occlusion, Computerised tomogram head abnormal, Hemiparesis, Intensive care
Clinical narrative: Received COVID vaccine on 5/17/21 5/25/21 around 0100 patient collapsed with acute onset right sided weakness and expressive aphasia. Brought to an ED where CTA found an occlusion of the L MCA which was confirmed as a ischemic stroke. He received TPA and underwent a IR guided thrombectomy. Patient continues to be admitted to the PICU with intermittent expressive aphasia and mild right sided weakness.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Ischaemic stroke, Magnetic resonance imaging head abnormal, Syncope, Thrombectomy
Clinical narrative: Received COVID vaccine on 5/17/21 5/25/21 around 0100 patient collapsed with acute onset right sided weakness and expressive aphasia. Brought to an ED where CTA found an occlusion of the L MCA which was confirmed as a ischemic stroke. He received TPA and underwent a IR guided thrombectomy. Patient continues to be admitted to the PICU with intermittent expressive aphasia and mild right sided weakness.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Cold sweat, Depressed level of consciousness, Dyskinesia, Eye movement disorder
Clinical narrative: Less than 1 minute after received the shot, patient became clammy and pale while sitting in chair. Her eyes rolled back in her head and her body went slack. Myself (parent) and the nurse who had given the shot braced her on either side while she appeared to fade in and out of consciousness for several minutes (she seemed to occasionally interact with us, mumbling responses to 'yes' or 'no' questions). The nurse did not want to lower her to the floor, but wanted to keep her propped on the chair. Her head kept rolling to the side. At one point, she began to jerk rhythmically.  Just as I was about to bring this to the attention of the nurse, the patient returned to consciousness. Patient was moved to a rolling recliner chair and taken to a recovery area where I (parent) did not see her for another 30 minutes as I was receiving my own shot. The chair she had sat in was wet, but it was assumed this was due to sweat (patient had sweated profusely).  On the way out of the clinic, noticing a wet stain on the back side of patient's pants, I asked if she had wet her pants (quietly) two separate times. Patient denied it both times. However, upon returning home, patient confirmed that she had wet her pants.  Patient was monitored during the evening for similar adverse events ; none noted.  Patient ate lunch approximately 1 hour before receiving shot and was given crackers while at clinic. Patient is a well-hydrated individual, and also drank water while on-site. No fever either before or after shot. A slightly elevated BP the next day (135/83). However, patient complained of headache, fatigue, and pain at injection location; elevated BP may be related to headache and/or ordeal from day of the shot.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Immediate post-injection reaction, Injection site pain
Clinical narrative: Less than 1 minute after received the shot, patient became clammy and pale while sitting in chair. Her eyes rolled back in her head and her body went slack. Myself (parent) and the nurse who had given the shot braced her on either side while she appeared to fade in and out of consciousness for several minutes (she seemed to occasionally interact with us, mumbling responses to 'yes' or 'no' questions). The nurse did not want to lower her to the floor, but wanted to keep her propped on the chair. Her head kept rolling to the side. At one point, she began to jerk rhythmically.  Just as I was about to bring this to the attention of the nurse, the patient returned to consciousness. Patient was moved to a rolling recliner chair and taken to a recovery area where I (parent) did not see her for another 30 minutes as I was receiving my own shot. The chair she had sat in was wet, but it was assumed this was due to sweat (patient had sweated profusely).  On the way out of the clinic, noticing a wet stain on the back side of patient's pants, I asked if she had wet her pants (quietly) two separate times. Patient denied it both times. However, upon returning home, patient confirmed that she had wet her pants.  Patient was monitored during the evening for similar adverse events ; none noted.  Patient ate lunch approximately 1 hour before receiving shot and was given crackers while at clinic. Patient is a well-hydrated individual, and also drank water while on-site. No fever either before or after shot. A slightly elevated BP the next day (135/83). However, patient complained of headache, fatigue, and pain at injection location; elevated BP may be related to headache and/or ordeal from day of the shot.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Urinary incontinence
Clinical narrative: Less than 1 minute after received the shot, patient became clammy and pale while sitting in chair. Her eyes rolled back in her head and her body went slack. Myself (parent) and the nurse who had given the shot braced her on either side while she appeared to fade in and out of consciousness for several minutes (she seemed to occasionally interact with us, mumbling responses to 'yes' or 'no' questions). The nurse did not want to lower her to the floor, but wanted to keep her propped on the chair. Her head kept rolling to the side. At one point, she began to jerk rhythmically.  Just as I was about to bring this to the attention of the nurse, the patient returned to consciousness. Patient was moved to a rolling recliner chair and taken to a recovery area where I (parent) did not see her for another 30 minutes as I was receiving my own shot. The chair she had sat in was wet, but it was assumed this was due to sweat (patient had sweated profusely).  On the way out of the clinic, noticing a wet stain on the back side of patient's pants, I asked if she had wet her pants (quietly) two separate times. Patient denied it both times. However, upon returning home, patient confirmed that she had wet her pants.  Patient was monitored during the evening for similar adverse events ; none noted.  Patient ate lunch approximately 1 hour before receiving shot and was given crackers while at clinic. Patient is a well-hydrated individual, and also drank water while on-site. No fever either before or after shot. A slightly elevated BP the next day (135/83). However, patient complained of headache, fatigue, and pain at injection location; elevated BP may be related to headache and/or ordeal from day of the shot.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: NO SYMPTOMS BUT MONITORING FOR 14 DAYS PER MD
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Eczema, Herpes zoster
Clinical narrative: April 7 I got the worst case of eczema ever. Only get it occasionally, say every couple of years. This was face, neck, arms, stomach, thigh and butt. Then  May 15v got Shingles. Still dealing with severe pain.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Injection site pain, Injection site reaction
Clinical narrative: sore arm around injection area, swelling in arm and armpit, red blotchy rash around injection area, headache, flu-like body aches, tiredness
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Oedema peripheral, Rash erythematous, Rash macular
Clinical narrative: sore arm around injection area, swelling in arm and armpit, red blotchy rash around injection area, headache, flu-like body aches, tiredness
Age: 73.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Culture stool, Diarrhoea, Interchange of vaccine products
Clinical narrative: Patient reports coming in for second dose of Moderna vaccine on 3/10/2021 and was given a J&J vaccine in error.  Patients report 4-5 episodes of diarrhea daily every day since 3/12/2021. Patient states she just recently went to see family doctor and a stool sample was sent off but has not yet resulted. Patient denies any other problems.   Spoke to nurse who administered vaccine. She stated that online immunization registery was down and pateint was asked prior to getting vaccine if she had ever received vaccine in the past and responded "no." Once immunization registry was back up it was discovered the patient had had first dose of Moderna on 2/10/2021. Medical Director was consulted and patient was informed of error while still in observation period. Observation period was extended.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase, Echocardiogram abnormal, Ejection fraction decreased, Electrocardiogram abnormal, Myocarditis
Clinical narrative: Patient hospitalized for overdose. Patient found to have potential myocarditis. Patient overdosed on antihistamines loratadine and doxylamine. Found to have rhabdomyolysis. CK levels have been trending downward. Patient found to have elevated troponin and ECHO showed decreased EF raising concern for myocarditis. Also with EKG changes.  Patient is asymptomatic without chest pain or palpitations.  Cannot differentiate cause of myocarditis, can be due to over dose and related to rhabdomyolysis or other causes.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Rhabdomyolysis, Troponin increased
Clinical narrative: Patient hospitalized for overdose. Patient found to have potential myocarditis. Patient overdosed on antihistamines loratadine and doxylamine. Found to have rhabdomyolysis. CK levels have been trending downward. Patient found to have elevated troponin and ECHO showed decreased EF raising concern for myocarditis. Also with EKG changes.  Patient is asymptomatic without chest pain or palpitations.  Cannot differentiate cause of myocarditis, can be due to over dose and related to rhabdomyolysis or other causes.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Gout, Groin pain
Clinical narrative: she had fatigue and was not feeling well the day of taking the Vax.  Pt had pain that started in the lower back, moved to the groin, down to thighs and then switched and moved down to the right ankle.  She then developed a swollen right foot.  On 3/22/21 she went to her doctors office and saw an alternate physician at Medical Group.  She was prescribed a 10mg pain killer along w/Tylenol.  On 3/25/21 she went to Emergency Center.  She had x-rays.  She was diagnosed w/ chronic right sided lumbar radiculopathy, poly articular arthritis and spondylolisthesis of the lumbar region.  She was told to FU w/ a pain specialist and PCP.  She saw Dr. on 4/9/2021 and was told it maybe gout so ordered lab test and prescribed steroids.   Around 4/12/21 she saw another Dr. at a Spine and Pain specialist.   She was just told to come back if she had another flare up.  On 5/13/2021 she had lower back pain flare up so went back to PCP Dr. .  She upped her gabapentin medication to 300 mg and referred her back to Pain Specialist.  On 5/26/2021 she went back and was given steroid injections.  She will FU Dr. on 6/14/21.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test abnormal, Lumbar radiculopathy, Malaise, Pain in extremity, Peripheral swelling
Clinical narrative: she had fatigue and was not feeling well the day of taking the Vax.  Pt had pain that started in the lower back, moved to the groin, down to thighs and then switched and moved down to the right ankle.  She then developed a swollen right foot.  On 3/22/21 she went to her doctors office and saw an alternate physician at Medical Group.  She was prescribed a 10mg pain killer along w/Tylenol.  On 3/25/21 she went to Emergency Center.  She had x-rays.  She was diagnosed w/ chronic right sided lumbar radiculopathy, poly articular arthritis and spondylolisthesis of the lumbar region.  She was told to FU w/ a pain specialist and PCP.  She saw Dr. on 4/9/2021 and was told it maybe gout so ordered lab test and prescribed steroids.   Around 4/12/21 she saw another Dr. at a Spine and Pain specialist.   She was just told to come back if she had another flare up.  On 5/13/2021 she had lower back pain flare up so went back to PCP Dr. .  She upped her gabapentin medication to 300 mg and referred her back to Pain Specialist.  On 5/26/2021 she went back and was given steroid injections.  She will FU Dr. on 6/14/21.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Polyarthritis, Spondylolisthesis, X-ray abnormal
Clinical narrative: she had fatigue and was not feeling well the day of taking the Vax.  Pt had pain that started in the lower back, moved to the groin, down to thighs and then switched and moved down to the right ankle.  She then developed a swollen right foot.  On 3/22/21 she went to her doctors office and saw an alternate physician at Medical Group.  She was prescribed a 10mg pain killer along w/Tylenol.  On 3/25/21 she went to Emergency Center.  She had x-rays.  She was diagnosed w/ chronic right sided lumbar radiculopathy, poly articular arthritis and spondylolisthesis of the lumbar region.  She was told to FU w/ a pain specialist and PCP.  She saw Dr. on 4/9/2021 and was told it maybe gout so ordered lab test and prescribed steroids.   Around 4/12/21 she saw another Dr. at a Spine and Pain specialist.   She was just told to come back if she had another flare up.  On 5/13/2021 she had lower back pain flare up so went back to PCP Dr. .  She upped her gabapentin medication to 300 mg and referred her back to Pain Specialist.  On 5/26/2021 she went back and was given steroid injections.  She will FU Dr. on 6/14/21.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness
Clinical narrative: Lightheadedness.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: Lightheadedness.
Age: 19.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Oropharyngeal pain, SARS-CoV-2 test positive, Tonsillar hypertrophy
Clinical narrative: Sore throat, swollen glands, swollen tonsils
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Neuropathy peripheral, Pain in extremity
Clinical narrative: PATEINT RECEIVED THE VACCINATION ON 5/21/2021 AT 1330 HOURS. BY 5/22/2021 HE HAS REPORTED THAT HE HAS DEVELOPED PERIPHERAL NEUROPATHY IN BOTH OF HIS HANDS THAT HAS PROGRESSIVELY GOTTEN WORSE OVER THE LAST 6 DAYS. TODAY HIS HANDS HURT SO BAD THAT HE CAN HARDLE ZIP UP HIS PANTS AND CANNOT LIFT MOST OPTIONS. ANYTHING THAT PUTS ANY PRESSURE ON HIS FINGERS OR HANDS CAUSES PAIN.  AT THIS TIME, I AM GOING TO CONTACT HIS PHYSICIAN TO SEE IF INCREASING HIS GABAPENTIN WILL BE OF ANY BENEFIT AND IN THE MEANTIME WE ARE STARTING SCHEDULED APAP 1000 MG QID AND NAPROXEN 440 PO BID-TID UNTIL A PHYSICIAN CONSULT CAN BE MADE. CONDITION  DOES NOT APPEAR TO BE LIFE THREATENING AT THIS TIME, HOWEVER THE PATIENT IS EXTREMELY DISABLED AT THIS POIN AS USE OF EITHER HAND FOR COMPLETION OF DAILY ACTIVITES IS EXTEREMLY LIMITED.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Pt. was sent from training to Dialysis to receive 2nd dose of COVID vaccine. Pt. did not have vaccination card on hand, did not remember what brand vaccine he received nor did RN ask prior to departure. Pt. arrived at Dialysis and was administered Moderna vaccine. Pt. received initial Pfizer vaccine on 4/20/2021 at County Department of Public Health. Pt. aware of circumstances and states he told RN at Dialysis "I had Pfizer, my first dose was Pfizer". RN monitoring pt. is asymptomatic.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Ear discomfort, Fatigue, Pruritus
Clinical narrative: About 15 mins after injection my legs started itching, and I felt slightly disoriented, dizzy. I did feel like it wouldn't be smart to drive so my husband drove me home. I had a slight fever that night and next day, I felt super tired. I scheduled an ultrasound for 1 week following the shot, My ears kind of freaked out after the ultrasound and was itching and burning, I also got a rash around my neck after ultrasound. The rash felt like fire. Allegra helped with the itching. Faint rash traveled down my arms. The Dr. put me on prednisone the rash spread to my back and upper legs. Benadryl was not helpful. It lasted approximately 2 weeks.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash
Clinical narrative: About 15 mins after injection my legs started itching, and I felt slightly disoriented, dizzy. I did feel like it wouldn't be smart to drive so my husband drove me home. I had a slight fever that night and next day, I felt super tired. I scheduled an ultrasound for 1 week following the shot, My ears kind of freaked out after the ultrasound and was itching and burning, I also got a rash around my neck after ultrasound. The rash felt like fire. Allegra helped with the itching. Faint rash traveled down my arms. The Dr. put me on prednisone the rash spread to my back and upper legs. Benadryl was not helpful. It lasted approximately 2 weeks.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site cellulitis, Injection site mass, Peripheral swelling, Rash erythematous
Clinical narrative: I had flu like symptoms for 24 hours afterwards. My arm swelled up from shoulder to elbow. I had a bright red rash that started to go away and then came back and got worse over two weeks. I have a half dollar size lump at the injection site that showed up 24 hours after the vaccine - hard like bone. Not hard like a muscle knot or something. Hot to touch  - the whole rash area and itching. I went to  Urgent care  on the 21st -after it didn't go away in two weeks. They prescribed Cephalexin to take 1000 mg twice  a day for a week. The rash is mostly gone and heat is gone but lump is still there.  And followed up on Sunday 29th. The doctor said that the hard lump might be permanent. Doctor said the rash part looked like Cellulitis. Rash and fever are gone but lump is still there.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: I had flu like symptoms for 24 hours afterwards. My arm swelled up from shoulder to elbow. I had a bright red rash that started to go away and then came back and got worse over two weeks. I have a half dollar size lump at the injection site that showed up 24 hours after the vaccine - hard like bone. Not hard like a muscle knot or something. Hot to touch  - the whole rash area and itching. I went to  Urgent care  on the 21st -after it didn't go away in two weeks. They prescribed Cephalexin to take 1000 mg twice  a day for a week. The rash is mostly gone and heat is gone but lump is still there.  And followed up on Sunday 29th. The doctor said that the hard lump might be permanent. Doctor said the rash part looked like Cellulitis. Rash and fever are gone but lump is still there.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Lightheadedness.
Age: 90.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Injection site pain
Clinical narrative: Second dose given 21 days after 1st dose. Patient reports on 5/21/21 that she feels great and she has had no signs and symptoms to report other than a slight sore arm at the injection site lasting only for a few hours the first night.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Dyspnoea, Pain in extremity, Peripheral swelling, Pulmonary embolism
Clinical narrative: Patient reported signs and symptoms of SOB/right leg pain 1 week after receiving the Moderna vaccine. He stated that he was "breathing fire" and woke up with an extremely painful and swollen leg. Upon coming to the ED, it was found to be bilateral PE and right leg DVT.
Age: 67.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Death, Endocarditis bacterial
Clinical narrative: MIGHT NOT BE LINKED TO VACCINE but, please, watch for Bacterial Endocarditis following Covid vaccinations. On-set following vaccination seems suspicious but might be coincidental. He died of Bacterial Endocarditis on May 6, 2020. First weird symptoms began March 10, very slight chills after going out for a walk. He had had pretty strong flu-like symptoms began 4 1/2 days after first vaccine  dose and lasted 5  1/2 to 6 days (we reported to CDC and Moderna). Then he felt great for 3 days, then weird little symptoms began. Please,  just put in data base to look for trends. He most likely had a very very mild case of Covid in early to mid February 2020. Lasted 3 days with fatigue and diarrhea only.   Thank you very much
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest discomfort, Dizziness, Electrocardiogram normal, Fatigue
Clinical narrative: 4-5 days after vaccination- started with chest pressure and tightness. Elevated heart rates, heart palpitations, dizziness, fatigue. Symptoms lasted 2+ weeks. Chest tightness has lessened.. Elevated heart rates remain- occasional dizziness.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Palpitations
Clinical narrative: 4-5 days after vaccination- started with chest pressure and tightness. Elevated heart rates, heart palpitations, dizziness, fatigue. Symptoms lasted 2+ weeks. Chest tightness has lessened.. Elevated heart rates remain- occasional dizziness.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Immunoglobulin therapy, Petechiae, Platelet count decreased, Platelet transfusion
Clinical narrative: 5/2/21: Petechiae on arms, legs and inside mouth. Platelets at 1,000. Hospitalized through 5/27/21. 1st line of treatment was platelet infusion. 2nd line of treatment was IVIG. 3rd line of treatment was rixutan infusions weekly for 3 weeks. 4th line of treatment was Doptelet in increased doses for 10 days.  Discharged with platelets at 20,000 and return for blood work on June 1st; follow-up with surgeon in 2 weeks to check spleen.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Patient was given the second COVID 19 vaccine.  Patient reported no problems/concerns with the first vaccine, as well as no allergies to any medications.  Patient was given a 15 minute wait time after the injection.  Patient was talking with staff about an upcoming flight  and had some questions about COVID testing. At around the 26 minute mark patient reported some dizziness to the nurse.  Vital signs were assessed and BP was 122/82, HR-64, 02- 97% RA.  Patient was asked to wait a few addition minutes to reassess her vitals.  Around 4 minutes later patient stood up and BP was assessed once again standing 132/84.  Patient then stated she felt better and left.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-cyclic citrullinated peptide antibody negative, Antinuclear antibody negative, Arthralgia, Blood creatine phosphokinase normal, Blood thyroid stimulating hormone normal
Clinical narrative: polymyalgia rheumatica a 71 year old female who presents for an ACUTE VISIT to review rheum consult. Had onset of both upper arms and legs. Has rotator cuff tear on L and getting MRI soon. The prednisone + tylenol bid relieves her symptoms. Pain now 1.5/10. In the am 3/10 prior to prednisone. Prior to prednisone 8/10. Pain is in muscles, gets stiff on muscles behind knees and front and back thighs and tops of calves. NOT in the joints. +stiff in the am for 2 hours. Has been holding Lipitor since 5/5/2021= 3 weeks and no change in symptoms. She is taking metamucil and walking instead to help cholesterol. No unintentional weight loss, night sweats, or unexplained fevers.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood uric acid normal, C-reactive protein increased, Full blood count, Immunology test, Metabolic function test
Clinical narrative: polymyalgia rheumatica a 71 year old female who presents for an ACUTE VISIT to review rheum consult. Had onset of both upper arms and legs. Has rotator cuff tear on L and getting MRI soon. The prednisone + tylenol bid relieves her symptoms. Pain now 1.5/10. In the am 3/10 prior to prednisone. Prior to prednisone 8/10. Pain is in muscles, gets stiff on muscles behind knees and front and back thighs and tops of calves. NOT in the joints. +stiff in the am for 2 hours. Has been holding Lipitor since 5/5/2021= 3 weeks and no change in symptoms. She is taking metamucil and walking instead to help cholesterol. No unintentional weight loss, night sweats, or unexplained fevers.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Night sweats, Pain in extremity, Polymyalgia rheumatica
Clinical narrative: polymyalgia rheumatica a 71 year old female who presents for an ACUTE VISIT to review rheum consult. Had onset of both upper arms and legs. Has rotator cuff tear on L and getting MRI soon. The prednisone + tylenol bid relieves her symptoms. Pain now 1.5/10. In the am 3/10 prior to prednisone. Prior to prednisone 8/10. Pain is in muscles, gets stiff on muscles behind knees and front and back thighs and tops of calves. NOT in the joints. +stiff in the am for 2 hours. Has been holding Lipitor since 5/5/2021= 3 weeks and no change in symptoms. She is taking metamucil and walking instead to help cholesterol. No unintentional weight loss, night sweats, or unexplained fevers.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Red blood cell sedimentation rate increased, Rheumatoid factor positive, Rotator cuff syndrome, Weight decreased
Clinical narrative: polymyalgia rheumatica a 71 year old female who presents for an ACUTE VISIT to review rheum consult. Had onset of both upper arms and legs. Has rotator cuff tear on L and getting MRI soon. The prednisone + tylenol bid relieves her symptoms. Pain now 1.5/10. In the am 3/10 prior to prednisone. Prior to prednisone 8/10. Pain is in muscles, gets stiff on muscles behind knees and front and back thighs and tops of calves. NOT in the joints. +stiff in the am for 2 hours. Has been holding Lipitor since 5/5/2021= 3 weeks and no change in symptoms. She is taking metamucil and walking instead to help cholesterol. No unintentional weight loss, night sweats, or unexplained fevers.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: I got severe chills (tremors) first that lasted a good 10-15 minutes first.  Later that day I got a fever and chills continued off and on throughout the day. I also had body aches and a headache.  My left arm was also very sore. All symptoms went away on the third day except for the soreness in my arm. That lasted about four days from the time I got the shot.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: I got severe chills (tremors) first that lasted a good 10-15 minutes first.  Later that day I got a fever and chills continued off and on throughout the day. I also had body aches and a headache.  My left arm was also very sore. All symptoms went away on the third day except for the soreness in my arm. That lasted about four days from the time I got the shot.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Body temperature increased, Cough, Dyspnoea, Influenza A virus test negative
Clinical narrative: Routine screening. for Covid-19. Asymptomatic.   Date 2 developed shortness of breath with exertion, dry cough and afebrile.  Day 5 same symptoms, plus temperature of 100 to 101.1 F