chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: cellulitis; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (cellulitis) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced CELLULITIS (cellulitis) (seriousness criterion medically significant). At the time of the report, CELLULITIS (cellulitis) outcome was unknown.            The patient developed two lumps on arm and on the face. Dermatologist thought they were cellulitis, but medication did not work. No Concomitant medication information was provided. Treatment medication information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. Very limited information regarding this event has been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding this event has been provided at this time. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Tooth injury
Clinical narrative: Passed out; Broke a tooth; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant) and TOOTH INJURY (Broke a tooth). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out) and TOOTH INJURY (Broke a tooth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was mentioned   no treatment medication information was mentioned   Additional information mentioned that the patient had a reaction to the vaccine where she passed out and broke a tooth.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Fainted and fell on the floor; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Fainted and fell on the floor) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced SYNCOPE (Fainted and fell on the floor) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 2 days due to SYNCOPE. At the time of the report, SYNCOPE (Fainted and fell on the floor) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medicines were reported. Treatment information included heart monitoring and head scan.  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: COVID19
Symptoms: Death, Thrombosis
Clinical narrative: This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of DEATH (She passed away) and THROMBOSIS (Clots in her leg) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEATH (She passed away) (seriousness criteria death, hospitalization and medically significant) and THROMBOSIS (Clots in her leg) (seriousness criteria hospitalization and medically significant). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, THROMBOSIS (Clots in her leg) outcome was unknown.            No concomitant medications reported.  Description: The patient had clots in her leg and was hospitalized. There was talk of amputation, but she passed away before that occurred.  No treatment information provided.  Company Comment:  Very limited information regarding these events have been provided at this time.  Further information cannot be requested.; Sender's Comments: Very limited information regarding these events have been provided at this time.  Further information cannot be requested.; Reported Cause(s) of Death: Unknown cause of death
Age: 64.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Keratitis, Seizure
Clinical narrative: Seizure; Keratitis; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) and KERATITIS (Keratitis) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 031A21A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    The patient's past medical history included Coronary artery bypass in 2017, Leg amputation in December 2018, Leg operation (SURGERY IN LEG BLOOD VESSEL) in 2020, Gallbladder operation NOS and Carpal tunnel release. Concurrent medical conditions included Abstains from alcohol, Non-tobacco user, Sulfonamide allergy (All sulfur medicines manifest nausea), Blood pressure high, Plaque psoriasis, Neuropathy, High cholesterol and Diabetes. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) for Anticoagulant therapy, LOSARTAN for Blood pressure high, INSULIN for Diabetes, ACETYLSALICYLIC ACID (BABY ASPIRIN) for Heart disorder, ATORVASTATIN CALCIUM (LIPITOR) for High cholesterol, GABAPENTIN for Neuropathy.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg every two weeks. In May 2021, the patient experienced KERATITIS (Keratitis) (seriousness criterion hospitalization). On 17-May-2021, the patient experienced SEIZURE (Seizure) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 17-May-2021 due to SEIZURE. On 17-May-2021, SEIZURE (Seizure) had resolved. At the time of the report, KERATITIS (Keratitis) was resolving.            Patient's concomitant medications also included taking unspecified vitamins. As per the patient's wife, he still had keratitis two weeks ago (as of 28-MAY-2021).  Unknown lab tests were done as well as unknown medications prescribed.  The patient was still taking unspecified antibiotics for the keratitis.  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. Also, the co-suspect drug humira should be considered as a confounding factor to the events.; 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. Also, the co-suspect drug humira should be considered as a confounding factor to the events.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction to vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction to vaccine) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 016C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Antihistamine therapy, MULTIVITAMINS [VITAMINS NOS] for Vitamin supplementation.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction to vaccine) (seriousness criterion medically significant). The patient was treated with ALBUTEROL [SALBUTAMOL] on 02-Jun-2021 for Anaphylaxis, at an unspecified dose and frequency. On 02-Jun-2021, ANAPHYLACTIC REACTION (Anaphylactic reaction to vaccine) had resolved.            On 02 Jun 2021, after the vaccination patient began to experience shortness of breath at 12:30 pm and patient's airways started to constrict at around 9:00 pm. Therefore patient went to the hospital.  Action taken with mRNA-1273 in response to the events was not applicable. 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. 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 the event, a causal relationship cannot be excluded. Further information has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Seizure
Clinical narrative: seizures within half an hour of each other; left arm was sore; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of SEIZURE (seizures within half an hour of each other) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: MMR Vaccine (Patient got the vaccine when she was 2 years old). Concomitant products included SERTRALINE for an unknown indication.    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, the patient experienced PAIN IN EXTREMITY (left arm was sore). On 30-May-2021, the patient experienced SEIZURE (seizures within half an hour of each other) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 30-May-2021 to 30-May-2021 due to SEIZURE. At the time of the report, SEIZURE (seizures within half an hour of each other) had resolved and PAIN IN EXTREMITY (left arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was reported to have no history of seizure episodes.  On 30-MAY-2021, she was reported to have 2 episodes of seizure within half an hour of each other.  Patient was reported to be treated with iv medicine at the hospital, shot of anti-seizure medicine and anti-nausea medicine.  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. Of note, the patient's medical history of sertraline intake may be a confounding factor that may play a possible contributory role to the event of seizure. 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 the events, a causal relationship cannot be excluded. Of note, the patient's medical history of sertraline intake may be a confounding factor that may play a possible contributory role to the event of seizure. Further information has been requested.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Feeling abnormal, Renal failure, Renal impairment
Clinical narrative: Stage 5 renal failure; Abnormal renal function; Feeling weird; This spontaneous case was reported by a consumer and describes the occurrence of RENAL FAILURE (Stage 5 renal failure) and RENAL IMPAIRMENT (Abnormal renal function) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced RENAL FAILURE (Stage 5 renal failure) (seriousness criteria hospitalization, medically significant and life threatening) and RENAL IMPAIRMENT (Abnormal renal function) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced FEELING ABNORMAL (Feeling weird). The patient was hospitalized from 28-May-2021 to 31-May-2021 due to RENAL FAILURE and RENAL IMPAIRMENT. At the time of the report, RENAL FAILURE (Stage 5 renal failure), RENAL IMPAIRMENT (Abnormal renal function) and FEELING ABNORMAL (Feeling weird) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal renal function (abnormal) Abnormal renal function.         No concomitant medication and no treatment information was reported.  It was reported that there were some pending tests at the time of report.  On 2021, patient felt weird.  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: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Atrioventricular block complete, Dyspnoea, Fatigue, Gait disturbance
Clinical narrative: Complete heart block; He feel out of breath; Feeling tired; Weakness in legs; Could not walk 20 steps/Can not climb staircase; This spontaneous case was reported by a consumer and describes the occurrence of ATRIOVENTRICULAR BLOCK COMPLETE (Complete heart block) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M21A and 038K20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bone marrow disorder and Pacemaker insertion (cardiac) since 03-Mar-2021. Concomitant products included MYCOPHENOLATE MOFETIL (MYCOPHENOLATE) for Bone marrow disorder.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced ASTHENIA (Weakness in legs) and FATIGUE (Feeling tired). 01-Mar-2021, the patient experienced GAIT DISTURBANCE (Could not walk 20 steps/Can not climb staircase). On 02-Mar-2021, the patient experienced ATRIOVENTRICULAR BLOCK COMPLETE (Complete heart block) (seriousness criteria hospitalization, medically significant and intervention required) and DYSPNOEA (He feel out of breath). The patient was hospitalized on 02-Mar-2021 due to ATRIOVENTRICULAR BLOCK COMPLETE. At the time of the report, ATRIOVENTRICULAR BLOCK COMPLETE (Complete heart block), ASTHENIA (Weakness in legs), GAIT DISTURBANCE (Could not walk 20 steps/Can not climb staircase), DYSPNOEA (He feel out of breath) and FATIGUE (Feeling tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Heart rate: 23-27 (abnormal) heart rate was irregular and went down to 23-27 beats per minute'..         patient of Bone marrow disease and taking Mycophenolate for last 4 years.  Treatment medication information was not provided.  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. 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 the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate
Clinical narrative: Complete heart block; He feel out of breath; Feeling tired; Weakness in legs; Could not walk 20 steps/Can not climb staircase; This spontaneous case was reported by a consumer and describes the occurrence of ATRIOVENTRICULAR BLOCK COMPLETE (Complete heart block) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M21A and 038K20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bone marrow disorder and Pacemaker insertion (cardiac) since 03-Mar-2021. Concomitant products included MYCOPHENOLATE MOFETIL (MYCOPHENOLATE) for Bone marrow disorder.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced ASTHENIA (Weakness in legs) and FATIGUE (Feeling tired). 01-Mar-2021, the patient experienced GAIT DISTURBANCE (Could not walk 20 steps/Can not climb staircase). On 02-Mar-2021, the patient experienced ATRIOVENTRICULAR BLOCK COMPLETE (Complete heart block) (seriousness criteria hospitalization, medically significant and intervention required) and DYSPNOEA (He feel out of breath). The patient was hospitalized on 02-Mar-2021 due to ATRIOVENTRICULAR BLOCK COMPLETE. At the time of the report, ATRIOVENTRICULAR BLOCK COMPLETE (Complete heart block), ASTHENIA (Weakness in legs), GAIT DISTURBANCE (Could not walk 20 steps/Can not climb staircase), DYSPNOEA (He feel out of breath) and FATIGUE (Feeling tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Heart rate: 23-27 (abnormal) heart rate was irregular and went down to 23-27 beats per minute'..         patient of Bone marrow disease and taking Mycophenolate for last 4 years.  Treatment medication information was not provided.  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. 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 the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure, Condition aggravated, Deep vein thrombosis, Thrombosis
Clinical narrative: Heart Failure; Bilateral DVT; Blood Clot; Exacerbation of pre existing medical conditions; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CARDIAC FAILURE (Heart Failure), DEEP VEIN THROMBOSIS (Bilateral DVT) and THROMBOSIS (Blood Clot) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Deep vein thrombosis ('had an episode of DVT 30 years ago').    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced CARDIAC FAILURE (Heart Failure) (seriousness criterion medically significant), DEEP VEIN THROMBOSIS (Bilateral DVT) (seriousness criterion medically significant), THROMBOSIS (Blood Clot) (seriousness criterion medically significant) and CONDITION AGGRAVATED (Exacerbation of pre existing medical conditions). At the time of the report, CARDIAC FAILURE (Heart Failure), DEEP VEIN THROMBOSIS (Bilateral DVT), THROMBOSIS (Blood Clot) and CONDITION AGGRAVATED (Exacerbation of pre existing medical conditions) 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.   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. Further information has been requested. Of note, the patient's age and pre-existing medical conditions are confounding factors that may play possible contributory roles.; 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. Further information has been requested. Of note, the patient's age and pre-existing medical conditions are confounding factors that may play possible contributory roles.
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Blood clot in her lungs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Blood clot in her lungs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (Blood clot in her lungs) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (Blood clot in her lungs) outcome was unknown.            The concomitant medications were not reported. The treatment information was not provided.  The action taken with mRNA 1273 with the events was considered as not applicable.  Company comment: Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Magnetic resonance imaging, Transient ischaemic attack
Clinical narrative: Ministrokes; odd symptoms; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Ministrokes) in a 94-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient was confirmed covid free earlier in January (exact date unknown).  Concomitant products included ACETYLCYSTEINE, CALCIUM LEVOMEFOLATE, MECOBALAMIN (CEREFOLIN NAC [ACETYLCYSTEINE;CALCIUM LEVOMEFOLATE;MECOBALAMIN]), AMOXICILLIN and COLECALCIFEROL (VITAMIN D3) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Ministrokes) (seriousness criterion medically significant) and ADVERSE EVENT (odd symptoms). The patient was treated with ESLICARBAZEPINE ACETATE (APTIOM) ongoing since an unknown date at a dose of 200 milligram and ASPIRIN [ACETYLSALICYLIC ACID] at a dose of 325. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Ministrokes) and ADVERSE EVENT (odd symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2021, Magnetic resonance imaging: confirmed ministroke (Positive) confirmed ministroke.         It was reported that the odd symptoms were attributed to amoxicillin and the patient stopped taking it. Company comment: Very limited information regarding these events have been provided at this time. Patient's advance age can be a confounding factor to the event Transient ischemic attack while antibiotic use (amoxicillin) have been said to contribute to the Adverse event NOS.  No further information is expected.   This case was linked to US-irms-MOD21-106616 (Patient Link).; Sender's Comments: Very limited information regarding these events have been provided at this time. Patient's advance age can be a confounding factor to the event Transient ischemic attack while antibiotic use (amoxicillin) have been said to contribute to the Adverse event NOS.  No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Patient tested positive for COVID after receiving first Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Patient tested positive for COVID after receiving first Moderna COVID-19 vaccine) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient tested positive for COVID after receiving first Moderna COVID-19 vaccine) (seriousness criterion hospitalization). The patient was treated with AMOXICILLIN on 07-May-2021 at an unspecified dose and frequency and AZITHROMYCIN on 19-May-2021 at an unspecified dose and frequency. At the time of the report, COVID-19 (Patient tested positive for COVID after receiving first Moderna COVID-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive.     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 medication information reported. The reporter did not have any information on when or how long the patient was hospitalized.; 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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: 9 blood clots; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (9 blood clots) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced THROMBOSIS (9 blood clots) (seriousness criteria hospitalization and medically significant). At the time of the report, THROMBOSIS (9 blood clots) was resolving.            No concomitant medications were provided. The patient was in the ICU (intensive care unit) for 3 days. No additional treatment information was provided. The reporter stated that the patient thought that her Moderna COVID-19 vaccinations caused the blood clots.; 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. No further information is expected at this time.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Thrombosis
Clinical narrative: blood clots from the knee to top of her leg.; feeling uncomfortable; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clots from the knee to top of her leg.) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypercholesterolemia. Concurrent medical conditions included Diabetes and Hypertension.   On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced THROMBOSIS (blood clots from the knee to top of her leg.) (seriousness criterion medically significant) and MALAISE (feeling uncomfortable). At the time of the report, THROMBOSIS (blood clots from the knee to top of her leg.) and MALAISE (feeling uncomfortable) outcome was unknown.            Very limited information regarding this event/s has been provided at this time.  Further information is not expected.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information is not expected.
Sex: M
Vaccine: COVID19
Symptoms: Ventricular tachycardia
Clinical narrative: Ventricular tachycardia; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VENTRICULAR TACHYCARDIA (Ventricular tachycardia) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VENTRICULAR TACHYCARDIA (Ventricular tachycardia) (seriousness criterion medically significant). At the time of the report, VENTRICULAR TACHYCARDIA (Ventricular tachycardia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication and treatment information were not provided.  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: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizure immediately after the dose was given; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure immediately after the dose was given) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced SEIZURE (Seizure immediately after the dose was given) (seriousness criterion medically significant). On 04-Jun-2021, SEIZURE (Seizure immediately after the dose was given) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No treatment information was reported.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (COVID) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID) (seriousness criterion hospitalization). At the time of the report, COVID-19 (COVID) outcome was unknown.            The patient's concomitant medications included blood pressure and diabetes medicines.  It was reported that, patient had Covid after the first dose, and patient was admitted in hospital for 2 days because of Covid.  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, this event is assessed as unlikely related to mRNA-1273.  No corrective treatment was provided.; Sender's Comments: 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, this event is assessed as unlikely related to mRNA-1273.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Swelling face
Clinical narrative: Face started swelling ,her whole face swelled up; Excruciating headache; Lymph nodes in her neck were swollen, could not turn her neck; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (Face started swelling ,her whole face swelled up), HEADACHE (Excruciating headache) and LYMPHADENOPATHY (Lymph nodes in her neck were swollen, could not turn her neck) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included SECUKINUMAB (COSENTYX) for Rheumatoid arthritis, DULOXETINE HYDROCHLORIDE (CYMBALTA), PIROXICAM (PAXIL [PIROXICAM]), HYDROXYCHLOROQUINE, BUSPIRONE, AMLODIPINE, LEFLUNOMIDE, GABAPENTIN, HYDROCODONE, CALCIUM, VITAMIN D NOS and CURCUMA LONGA RHIZOME, PIPER NIGRUM FRUIT (TURMERIC +) for an unknown indication.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-May-2021, the patient experienced HEADACHE (Excruciating headache) (seriousness criterion hospitalization) and LYMPHADENOPATHY (Lymph nodes in her neck were swollen, could not turn her neck) (seriousness criterion hospitalization). On 30-May-2021, the patient experienced SWELLING FACE (Face started swelling ,her whole face swelled up) (seriousness criterion hospitalization). The patient was hospitalized on 03-Jun-2021 due to HEADACHE, LYMPHADENOPATHY and SWELLING FACE. The patient was treated with PREDNISONE ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, SWELLING FACE (Face started swelling ,her whole face swelled up), HEADACHE (Excruciating headache) and LYMPHADENOPATHY (Lymph nodes in her neck were swollen, could not turn her neck) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's treatment medication information also included  were antibiotics.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Contusion, Fall, Fatigue
Clinical narrative: Foggy feeling in head; syncopal episode; brain fog; fell down on the side walk hitting her hand; right hand bruising; fatigue/tiredness; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (syncopal episode) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (fatigue/tiredness). On 11-Apr-2021, the patient experienced SYNCOPE (syncopal episode) (seriousness criterion medically significant) and CONTUSION (right hand bruising). 11-Apr-2021, the patient experienced ASTHENIA (brain fog) and FALL (fell down on the side walk hitting her hand). On an unknown date, the patient experienced FEELING ABNORMAL (Foggy feeling in head). At the time of the report, SYNCOPE (syncopal episode), ASTHENIA (brain fog), FALL (fell down on the side walk hitting her hand), CONTUSION (right hand bruising), FEELING ABNORMAL (Foggy feeling in head) and FATIGUE (fatigue/tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 153/91 (High) 153/91.         The action taken with mRNA-1273 with the events was considered as not applicable. Treatment information was not provided.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Syncope
Clinical narrative: Foggy feeling in head; syncopal episode; brain fog; fell down on the side walk hitting her hand; right hand bruising; fatigue/tiredness; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (syncopal episode) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LISINOPRIL and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (fatigue/tiredness). On 11-Apr-2021, the patient experienced SYNCOPE (syncopal episode) (seriousness criterion medically significant) and CONTUSION (right hand bruising). 11-Apr-2021, the patient experienced ASTHENIA (brain fog) and FALL (fell down on the side walk hitting her hand). On an unknown date, the patient experienced FEELING ABNORMAL (Foggy feeling in head). At the time of the report, SYNCOPE (syncopal episode), ASTHENIA (brain fog), FALL (fell down on the side walk hitting her hand), CONTUSION (right hand bruising), FEELING ABNORMAL (Foggy feeling in head) and FATIGUE (fatigue/tiredness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 153/91 (High) 153/91.         The action taken with mRNA-1273 with the events was considered as not applicable. Treatment information was not provided.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Dyspnoea, Fatigue, Myalgia
Clinical narrative: Joint pain; Tiredness; muscle pain; swelling of face; swelling of throat; difficulty breathing; Diarrhea; This is a spontaneous report from a contactable consumer.    A 61-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 16Mar2021 at 10:30 (Batch/Lot number was not reported) as unknown, single dose for covid-19 immunization. Medical history included sjogren's syndrome, arthritis, fibromyalgia and systemic lupus erythematosus. Concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and Since the vaccination, patient has not been tested for COVID-19. On 16Mar2021 at 18:30, the patient experienced Joint pain, tiredness, muscle pain, swelling of face, swelling of throat, difficulty breathing and diarrhea. The events were not treated. The patient was recovering from the events.   Amendment: This follow-up report is being submitted to amend previously reported information: Relevant Med History 2, the verbatim was updated from Arthritis NOS to Arthritis and Relevant Med History 4, the verbatim was updated from Lupus syndrome to Lupus and Narrative regenerated per original source document.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Swelling face
Clinical narrative: Joint pain; Tiredness; muscle pain; swelling of face; swelling of throat; difficulty breathing; Diarrhea; This is a spontaneous report from a contactable consumer.    A 61-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 16Mar2021 at 10:30 (Batch/Lot number was not reported) as unknown, single dose for covid-19 immunization. Medical history included sjogren's syndrome, arthritis, fibromyalgia and systemic lupus erythematosus. Concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and Since the vaccination, patient has not been tested for COVID-19. On 16Mar2021 at 18:30, the patient experienced Joint pain, tiredness, muscle pain, swelling of face, swelling of throat, difficulty breathing and diarrhea. The events were not treated. The patient was recovering from the events.   Amendment: This follow-up report is being submitted to amend previously reported information: Relevant Med History 2, the verbatim was updated from Arthritis NOS to Arthritis and Relevant Med History 4, the verbatim was updated from Lupus syndrome to Lupus and Narrative regenerated per original source document.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea
Clinical narrative: Headache; Queasy; chills; This is a spontaneous report received from a non-contactable consumer (patient). A 87-year-old non-pregnant-female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6205) via an unspecified route of administration in her left arm on 16Mar2021 at 2:45 PM as single dose for COVID-19 immunisation. The patient's medical history was reported as none. The patient had no allergies to medications, food or other products. The patient received other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not tested for COVID-19. The patient received other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unknown date as single dose for COVID-19 immunisation. On 17Mar2021 at 6:00 AM the patient experienced headache, queasy and chills. The patient did not receive any treatment in response to the events. At the time reporting, the patient was recovering from the events headache, queasy and chills.  No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Patient details (Patient's first/middle/last names initial captured in corresponding field, Patient's country captured as US), Historical vaccine added, Concomitant Therapy captured as Yes, Events details (treatment received) and Narrative lead sentence updated.