chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count, Pyrexia, Red blood cell analysis, White blood cell count
Clinical narrative: Resurge in aplastic anemia; Swollen arm; Been cold; Chills; Running Fever; This spontaneous case was reported by a consumer and describes the occurrence of APLASTIC ANAEMIA (Resurge in aplastic anemia) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Aplastic anemia. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), METOPROLOL TARTRATE and FEBUXOSTAT for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), FEELING COLD (Been cold), CHILLS (Chills) and PYREXIA (Running Fever). On 23-Feb-2021, the patient experienced APLASTIC ANAEMIA (Resurge in aplastic anemia) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 08-Feb-2021, PERIPHERAL SWELLING (Swollen arm), FEELING COLD (Been cold), CHILLS (Chills) and PYREXIA (Running Fever) had resolved. At the time of the report, APLASTIC ANAEMIA (Resurge in aplastic anemia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Dec-2020, Platelet count: 60 (Inconclusive) Inconclusive. On 18-Dec-2020, Red blood cell analysis: 14 (Inconclusive) hemoglobin. On 23-Feb-2021, Haemoglobin: 10.8 (Low) dropped. On 23-Feb-2021, Platelet count: 21 (Low) dropped. On 14-May-2021, Haemoglobin: 8.8 (Low) dropped. On 14-May-2021, Platelet count: 13 (Low) dropped. On 14-May-2021, White blood cell count: 2.2 (Low) dropped.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated her aplastic anemia gotten worse after taking vaccine. The patient also stated that she had been under a lot of stress because her husband was sick, and she was not sure if that also a contributing factor.  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.    Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Additional information received captured patient demographics.; 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: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Thrombosis
Clinical narrative: Developed blood clot; Sever pain in his stomach; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Developed blood clot) and ABDOMINAL PAIN UPPER (Sever pain in his stomach) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 016L20A) for COVID-19 vaccination.     Concomitant products included RIVAROXABAN (XARELTO), AMLODIPINE, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) and AZILSARTAN MEDOXOMIL, CHLORTALIDONE (EDARBYCLOR) for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Sever pain in his stomach) (seriousness criterion hospitalization). On an unknown date, the patient experienced THROMBOSIS (Developed blood clot) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 28-Apr-2021 to 04-May-2021 due to ABDOMINAL PAIN UPPER and THROMBOSIS. The patient was treated with Surgery (leading to two and half feet of his small intestine removed) for Thrombosis. At the time of the report, THROMBOSIS (Developed blood clot) and ABDOMINAL PAIN UPPER (Sever pain in his stomach) outcome was unknown.            Patient started having severe pain in his stomach on 27-Apr-2021. He was taken to the hospital on 28-Apr-2021, patient's doctor said that he had a clot in his intestine and that caused the pain, was operated removed to two and half feet of his small intestine. Patient was discharged from the hospital on 04-May-2021.  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 this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abnormal loss of weight, Aggression, Asthenia
Clinical narrative: Weakness; Weight decreased; Violent; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of ASTHENIA (Weakness), ABNORMAL LOSS OF WEIGHT (Weight decreased) and AGGRESSION (Violent) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 8CDPBC and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced ASTHENIA (Weakness) (seriousness criterion hospitalization), ABNORMAL LOSS OF WEIGHT (Weight decreased) (seriousness criterion hospitalization) and AGGRESSION (Violent) (seriousness criterion hospitalization). At the time of the report, ASTHENIA (Weakness), ABNORMAL LOSS OF WEIGHT (Weight decreased) and AGGRESSION (Violent) outcome was unknown.            No treatment information was provided. Action taken with the mRNA-1273 in response to the event is not applicable. Patient was currently admitted in the hospital and the doctors could not figure out the root cause of her illness.  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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Peripheral swelling, Thrombosis, Ultrasound scan, Vaccination site pain
Clinical narrative: Clots in left arm after taking 2 shots; Swollen arm after 2 vaccine shots; pain in left arm; 50 days gap between 2 vaccine doses; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Clots in left arm after taking 2 shots) in a 50-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.     Concurrent medical conditions included Idiopathic thrombocytopenic purpura, Spina bifida and Psoriasis.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-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 THROMBOSIS (Clots in left arm after taking 2 shots) (seriousness criterion medically significant), PERIPHERAL SWELLING (Swollen arm after 2 vaccine shots), VACCINATION SITE PAIN (pain in left arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (50 days gap between 2 vaccine doses). The patient was treated with APIXABAN (ELIQUIS) at a dose of 25 mg twice a day and APIXABAN (ELIQUIS) at a dose of 5 mg twice a day. At the time of the report, THROMBOSIS (Clots in left arm after taking 2 shots), PERIPHERAL SWELLING (Swollen arm after 2 vaccine shots) and VACCINATION SITE PAIN (pain in left arm) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (50 days gap between 2 vaccine doses) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: abnormal (abnormal) clot in the left arm.         Patient went to emergency after 3 weeks of taking Moderna COVID-19 second Vaccine.  No relevant concomitant medications were reported Reportedly, the treatment with Apixaban (Eliquis) needed to continue for 6 months.  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.; 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: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells palsy in face; This spontaneous case was reported by a patient and describes the occurrence of BELL'S PALSY (Bells palsy in face) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-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 BELL'S PALSY (Bells palsy in face) (seriousness criterion medically significant). The patient was treated with METHYLPREDNISOLONE at an unspecified dose and frequency and VALACYCLOVIR [VALACICLOVIR] at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (Bells palsy in face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided. Company comment; 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: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Hypokinesia, Intentional dose omission, Loss of consciousness, Pain in extremity
Clinical narrative: Did not go for 2nd shot; Passed out; Extreme arm pain; Could not lift up arms; Trouble with bowels; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 74-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.     No Medical History information was reported.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), PAIN IN EXTREMITY (Extreme arm pain), HYPOKINESIA (Could not lift up arms) and ABDOMINAL DISCOMFORT (Trouble with bowels). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (Did not go for 2nd shot). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), PAIN IN EXTREMITY (Extreme arm pain), HYPOKINESIA (Could not lift up arms) and ABDOMINAL DISCOMFORT (Trouble with bowels) outcome was unknown and INTENTIONAL DOSE OMISSION (Did not go for 2nd shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.  Company Comment : Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Encephalitis
Clinical narrative: Encephalitis; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ENCEPHALITIS (Encephalitis) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014c219) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 16-May-2021, the patient experienced ENCEPHALITIS (Encephalitis) (seriousness criterion medically significant). At the time of the report, ENCEPHALITIS (Encephalitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported. The patient's mother reported that on 06-May-2021, patient developed a headache on both sides of her head and lost coherence and mobility. On 15-May-2021, she had the same episode and  lasted seven hours and they went to the hospital and on 16-May-2021 she was diagnosed with encephalitis, and still waiting for autoimmune test result.  No treatment information provided.  Company Comment: Very limited information regarding the event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the event has been provided at this time.  Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Induration
Clinical narrative: wanted to rule out cellulitis; left arm is now the side of the softball; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (wanted to rule out cellulitis) in a 63-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 reported.     On 11-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CELLULITIS (wanted to rule out cellulitis) (seriousness criterion medically significant) and INDURATION (left arm is now the side of the softball). At the time of the report, CELLULITIS (wanted to rule out cellulitis) and INDURATION (left arm is now the side of the softball) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications listed.  No treatment listed.  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.; 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: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Decreased appetite, Electrocardiogram, Pain in extremity
Clinical narrative: lost weight; lack appetite; Patient is taken to the hospital with chest pain, it like a knife going in chest; arm pain; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Patient is taken to the hospital with chest pain, it like a knife going in chest), WEIGHT DECREASED (lost weight) and DECREASED APPETITE (lack appetite) in a 74-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 reported.     On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, the patient experienced CHEST PAIN (Patient is taken to the hospital with chest pain, it like a knife going in chest) (seriousness criterion hospitalization). On an unknown date, the patient experienced WEIGHT DECREASED (lost weight) (seriousness criterion hospitalization), DECREASED APPETITE (lack appetite) (seriousness criterion hospitalization), PAIN IN EXTREMITY (arm pain) and CHILLS (Chills). The patient was hospitalized on 09-May-2021 due to CHEST PAIN, DECREASED APPETITE and WEIGHT DECREASED. The patient was treated with BISMUTH SUBSALICYLATE, CALCIUM CARBONATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) ongoing since an unknown date at a dose of UNK dosage form and CALCIUM CARBONATE (MYLANTA [CALCIUM CARBONATE]) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, CHEST PAIN (Patient is taken to the hospital with chest pain, it like a knife going in chest), WEIGHT DECREASED (lost weight), DECREASED APPETITE (lack appetite), PAIN IN EXTREMITY (arm pain) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2021, Electrocardiogram: normal (normal) arteries are clean and blood pressure is ok.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: lost weight; lack appetite; Patient is taken to the hospital with chest pain, it like a knife going in chest; arm pain; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Patient is taken to the hospital with chest pain, it like a knife going in chest), WEIGHT DECREASED (lost weight) and DECREASED APPETITE (lack appetite) in a 74-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 reported.     On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, the patient experienced CHEST PAIN (Patient is taken to the hospital with chest pain, it like a knife going in chest) (seriousness criterion hospitalization). On an unknown date, the patient experienced WEIGHT DECREASED (lost weight) (seriousness criterion hospitalization), DECREASED APPETITE (lack appetite) (seriousness criterion hospitalization), PAIN IN EXTREMITY (arm pain) and CHILLS (Chills). The patient was hospitalized on 09-May-2021 due to CHEST PAIN, DECREASED APPETITE and WEIGHT DECREASED. The patient was treated with BISMUTH SUBSALICYLATE, CALCIUM CARBONATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]) ongoing since an unknown date at a dose of UNK dosage form and CALCIUM CARBONATE (MYLANTA [CALCIUM CARBONATE]) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, CHEST PAIN (Patient is taken to the hospital with chest pain, it like a knife going in chest), WEIGHT DECREASED (lost weight), DECREASED APPETITE (lack appetite), PAIN IN EXTREMITY (arm pain) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2021, Electrocardiogram: normal (normal) arteries are clean and blood pressure is ok.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Paralysis
Clinical narrative: Strength less than half in his right hand; Paralyses started 72 hours after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (Paralyses started 72 hours after vaccine) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, the patient experienced ASTHENIA (Strength less than half in his right hand). In May 2021, the patient experienced PARALYSIS (Paralyses started 72 hours after vaccine) (seriousness criterion medically significant). At the time of the report, PARALYSIS (Paralyses started 72 hours after vaccine) and ASTHENIA (Strength less than half in his right hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. Patient received covid vaccine on 15 May 2021. Per father son paralyses started 72 hours after strength less than half in his right hand. No treatment information was provided  Company Comment : Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Influenza like illness, Myalgia, Thrombosis
Clinical narrative: blood clot from ankle the groin; flu like symptoms; difficulty walking; soreness in Left arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clot from ankle the groin) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-May-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) (unknown route) 1 dosage form. On 10-May-2021, the patient experienced THROMBOSIS (blood clot from ankle the groin) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (flu like symptoms), GAIT DISTURBANCE (difficulty walking) and MYALGIA (soreness in Left arm). The patient was treated with RIVAROXABAN (XARELTO) ongoing since an unknown date for Clot blood, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (blood clot from ankle the groin), INFLUENZA LIKE ILLNESS (flu like symptoms), GAIT DISTURBANCE (difficulty walking) and MYALGIA (soreness in Left arm) outcome was unknown.            No concomitant medications were provided.  The patient went to the ER after experiencing the blood clot (from her ankle to the groin area) and was provided treatment with Xarelto.  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.; 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: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy 10 days after getting 1st dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Bell's palsy 10 days after getting 1st dose) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (Bell's palsy 10 days after getting 1st dose) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bell's palsy 10 days after getting 1st dose) 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.   Concomitant product used was not provided by the reporter.  This patient returned to take the second dose of vaccination and mentioned that 10 days after 1st dose of vaccination he noticed Bell's Palsy while taking shower. He did not see a HCP (Health Care Professional) nor given any medication. Pharmacist advised patient to see HCP and discuss about getting 2nd dose.  Company comment: Very limited information regarding the event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the event has been provided at this time.  Further information has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Hepatic cancer
Clinical narrative: Liver cancer (It was in his ducts & everything)/ had the cancer, but this vaccine accelerated it; This spontaneous case was reported by a consumer and describes the occurrence of HEPATIC CANCER (Liver cancer (It was in his ducts & everything)/ had the cancer, but this vaccine accelerated it) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEPATIC CANCER (Liver cancer (It was in his ducts & everything)/ had the cancer, but this vaccine accelerated it) (seriousness criteria death and medically significant). The patient died on 17-May-2021. The reported cause of death was liver cancer. It is unknown if an autopsy was performed.            No concomitant medications was reported.  No treatment medications was provided.  03-Mar-2021: Husband was diagnosed with liver cancer. It was in his ducts and everything. He had cancer at the time we took both vaccines. He died 10 weeks after being diagnosed with liver cancer. Caller felt the vaccine escalated the process.  Company comment: Very limited information regarding the event has been provided at this time.  Further information has been requested.   This case was linked to MODERNATX, INC.-MOD-2021-019697 (E2B Linked Report).; Sender's Comments: Very limited information regarding the event has been provided at this time.  Further information has been requested. MODERNATX, INC.-MOD-2021-019697:Wife's case; Reported Cause(s) of Death: Liver cancer
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Postmenopausal haemorrhage, Tinnitus
Clinical narrative: experiencing a cycle but has been menopausal; tinnitus in left ear; tingly feeling in arm, hands and back / feels like body parts are on pins and needles; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (experiencing a cycle but has been menopausal) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history for the patient was reported.  Concomitant products included SPIRONOLACTONE and ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (experiencing a cycle but has been menopausal) (seriousness criterion medically significant), TINNITUS (tinnitus in left ear) and PARAESTHESIA (tingly feeling in arm, hands and back / feels like body parts are on pins and needles). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (experiencing a cycle but has been menopausal), TINNITUS (tinnitus in left ear) and PARAESTHESIA (tingly feeling in arm, hands and back / feels like body parts are on pins and needles) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history was provided by the reporter.   Treatment information was not provided.  Company comment: Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Heart attack; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization, disability, medically significant and life threatening). The patient was hospitalized on 14-Apr-2021 due to MYOCARDIAL INFARCTION. At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.  No treatment information provided.  It was reported that three days after vaccination the patient had a heart attack. He was admitted to the ICU for three days, starting on 14-Apr-2021. He had seen his primary care doctor and his cardiologist multiple times since that incident and he was unsure of whether he should get the second vaccine dose or not..  Company comment: Very limited information regarding the event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the event has been provided at this time.  Further information has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Facial paralysis; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Facial paralysis) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 021C21A) for COVID-19 vaccination.     The patient's past medical history included Stroke (one year ago).   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-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 FACIAL PARALYSIS (Facial paralysis) (seriousness criterion medically significant). The patient was treated with PREDNISONE ongoing since an unknown date for Facial paralysis, at a dose of UNK dosage form. At the time of the report, FACIAL PARALYSIS (Facial paralysis) had not resolved.            No relevant concomitant medications were reported.  The reporter stated that patient had no side effects with first dose, 2 or 3 days after receiving second vaccine, patient had a facial paralysis and emergency room  (ER) told him it was due to the vaccine. Patient was treated with prednisone and antiviral medication.  Action taken with mRNA-1273 in response to events was not applicable.  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.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Intentional dose omission
Clinical narrative: Miscarriage; Electing not to receive second Moderna dose after learning she was pregnant; Pregnant when she received her first Moderna dose; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of ABORTION SPONTANEOUS (Miscarriage) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included Polycystic ovarian syndrome and Hypothyroidism. Concomitant products included LEVOTHYROXINE and METFORMIN for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 01-Jan-2021 and the estimated date of delivery was 08-Oct-2021. On 08-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant when she received her first Moderna dose). On 05-Feb-2021, the patient experienced INTENTIONAL DOSE OMISSION (Electing not to receive second Moderna dose after learning she was pregnant). On 27-Apr-2021, the patient experienced ABORTION SPONTANEOUS (Miscarriage) (seriousness criterion medically significant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  first week of the pregnancy.  On 08-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant when she received her first Moderna dose) had resolved. On 05-Feb-2021, INTENTIONAL DOSE OMISSION (Electing not to receive second Moderna dose after learning she was pregnant) had resolved. On 27-Apr-2021, ABORTION SPONTANEOUS (Miscarriage) had resolved.        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 information regarding treatment was provided.  Nurse reported she was unaware she was pregnant when she received her first Moderna dose on 08-Jan-2021. Nurse reported that she discovered she was pregnant a week 29-Jan-2021 prior to her scheduled second Moderna dose on 05-Feb-2021. Testing was performed on the fetus and physicians determined the baby was a normal healthy girl with no genetic abnormalities or findings. Reportedly, she stopped metformin during her pregnancy so glucose testing could be performed.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Fatigue, Pain in extremity, Palpitations, Somnolence
Clinical narrative: Heart fluttering; Palpitations; Ringing in ears; sleeping a lot; Pain in arm; feeling fatigued; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of CARDIAC FLUTTER (Heart fluttering) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced CARDIAC FLUTTER (Heart fluttering) (seriousness criterion medically significant), PALPITATIONS (Palpitations), TINNITUS (Ringing in ears), SOMNOLENCE (sleeping a lot), PAIN IN EXTREMITY (Pain in arm) and FATIGUE (feeling fatigued). On 14-Apr-2021, CARDIAC FLUTTER (Heart fluttering), PALPITATIONS (Palpitations), TINNITUS (Ringing in ears), SOMNOLENCE (sleeping a lot), PAIN IN EXTREMITY (Pain in arm) and FATIGUE (feeling fatigued) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment medication was 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.   This case was linked to MOD-2021-155061 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Heart fluttering; Palpitations; Ringing in ears; sleeping a lot; Pain in arm; feeling fatigued; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of CARDIAC FLUTTER (Heart fluttering) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced CARDIAC FLUTTER (Heart fluttering) (seriousness criterion medically significant), PALPITATIONS (Palpitations), TINNITUS (Ringing in ears), SOMNOLENCE (sleeping a lot), PAIN IN EXTREMITY (Pain in arm) and FATIGUE (feeling fatigued). On 14-Apr-2021, CARDIAC FLUTTER (Heart fluttering), PALPITATIONS (Palpitations), TINNITUS (Ringing in ears), SOMNOLENCE (sleeping a lot), PAIN IN EXTREMITY (Pain in arm) and FATIGUE (feeling fatigued) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment medication was 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.   This case was linked to MOD-2021-155061 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac monitoring, Cerebrovascular accident, Echocardiogram, Feeling abnormal, Gait disturbance
Clinical narrative: MRI of brain showed I had two strokes, one recent and one older; Difficulty walking/limp; Numbness; Stumbling; Weird feeling; Left leg was very weak; Arm weak feels heavy/left arm felt heavy; Episode of vertigo with difficulty walking; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (MRI of brain showed I had two strokes, one recent and one older) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke. Concurrent medical conditions included Penicillin allergy. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 26-Mar-2021, the patient experienced VERTIGO (Episode of vertigo with difficulty walking). On 18-Apr-2021, the patient experienced LIMB DISCOMFORT (Arm weak feels heavy/left arm felt heavy) and MUSCULAR WEAKNESS (Left leg was very weak). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (MRI of brain showed I had two strokes, one recent and one older) (seriousness criterion medically significant), GAIT INABILITY (Difficulty walking/limp), HYPOAESTHESIA (Numbness), GAIT DISTURBANCE (Stumbling) and FEELING ABNORMAL (Weird feeling). The patient was treated with Physical therapy (Prescribed balance exercise) for Vertigo. At the time of the report, CEREBROVASCULAR ACCIDENT (MRI of brain showed I had two strokes, one recent and one older), VERTIGO (Episode of vertigo with difficulty walking), GAIT INABILITY (Difficulty walking/limp), HYPOAESTHESIA (Numbness), LIMB DISCOMFORT (Arm weak feels heavy/left arm felt heavy), GAIT DISTURBANCE (Stumbling), FEELING ABNORMAL (Weird feeling) and MUSCULAR WEAKNESS (Left leg was very weak) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Cardiac monitoring: normal (normal) normal- no AF. On 22-Apr-2021, Echocardiogram: normal (normal) normal. On 22-Apr-2021, Magnetic resonance imaging head: abnormal (abnormal) Showed two strokes. On 22-Apr-2021, Ultrasound Doppler: abnormal (abnormal) Showed two strokes.         Treatment information were not provided. Action taken with mRNA-1273 in response to the event was not applicable.  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.; 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: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Hypoaesthesia, Limb discomfort, Magnetic resonance imaging head, Muscular weakness
Clinical narrative: MRI of brain showed I had two strokes, one recent and one older; Difficulty walking/limp; Numbness; Stumbling; Weird feeling; Left leg was very weak; Arm weak feels heavy/left arm felt heavy; Episode of vertigo with difficulty walking; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (MRI of brain showed I had two strokes, one recent and one older) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke. Concurrent medical conditions included Penicillin allergy. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 26-Mar-2021, the patient experienced VERTIGO (Episode of vertigo with difficulty walking). On 18-Apr-2021, the patient experienced LIMB DISCOMFORT (Arm weak feels heavy/left arm felt heavy) and MUSCULAR WEAKNESS (Left leg was very weak). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (MRI of brain showed I had two strokes, one recent and one older) (seriousness criterion medically significant), GAIT INABILITY (Difficulty walking/limp), HYPOAESTHESIA (Numbness), GAIT DISTURBANCE (Stumbling) and FEELING ABNORMAL (Weird feeling). The patient was treated with Physical therapy (Prescribed balance exercise) for Vertigo. At the time of the report, CEREBROVASCULAR ACCIDENT (MRI of brain showed I had two strokes, one recent and one older), VERTIGO (Episode of vertigo with difficulty walking), GAIT INABILITY (Difficulty walking/limp), HYPOAESTHESIA (Numbness), LIMB DISCOMFORT (Arm weak feels heavy/left arm felt heavy), GAIT DISTURBANCE (Stumbling), FEELING ABNORMAL (Weird feeling) and MUSCULAR WEAKNESS (Left leg was very weak) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Cardiac monitoring: normal (normal) normal- no AF. On 22-Apr-2021, Echocardiogram: normal (normal) normal. On 22-Apr-2021, Magnetic resonance imaging head: abnormal (abnormal) Showed two strokes. On 22-Apr-2021, Ultrasound Doppler: abnormal (abnormal) Showed two strokes.         Treatment information were not provided. Action taken with mRNA-1273 in response to the event was not applicable.  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.; 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: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound Doppler, Vertigo
Clinical narrative: MRI of brain showed I had two strokes, one recent and one older; Difficulty walking/limp; Numbness; Stumbling; Weird feeling; Left leg was very weak; Arm weak feels heavy/left arm felt heavy; Episode of vertigo with difficulty walking; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (MRI of brain showed I had two strokes, one recent and one older) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stroke. Concurrent medical conditions included Penicillin allergy. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 26-Mar-2021, the patient experienced VERTIGO (Episode of vertigo with difficulty walking). On 18-Apr-2021, the patient experienced LIMB DISCOMFORT (Arm weak feels heavy/left arm felt heavy) and MUSCULAR WEAKNESS (Left leg was very weak). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (MRI of brain showed I had two strokes, one recent and one older) (seriousness criterion medically significant), GAIT INABILITY (Difficulty walking/limp), HYPOAESTHESIA (Numbness), GAIT DISTURBANCE (Stumbling) and FEELING ABNORMAL (Weird feeling). The patient was treated with Physical therapy (Prescribed balance exercise) for Vertigo. At the time of the report, CEREBROVASCULAR ACCIDENT (MRI of brain showed I had two strokes, one recent and one older), VERTIGO (Episode of vertigo with difficulty walking), GAIT INABILITY (Difficulty walking/limp), HYPOAESTHESIA (Numbness), LIMB DISCOMFORT (Arm weak feels heavy/left arm felt heavy), GAIT DISTURBANCE (Stumbling), FEELING ABNORMAL (Weird feeling) and MUSCULAR WEAKNESS (Left leg was very weak) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Cardiac monitoring: normal (normal) normal- no AF. On 22-Apr-2021, Echocardiogram: normal (normal) normal. On 22-Apr-2021, Magnetic resonance imaging head: abnormal (abnormal) Showed two strokes. On 22-Apr-2021, Ultrasound Doppler: abnormal (abnormal) Showed two strokes.         Treatment information were not provided. Action taken with mRNA-1273 in response to the event was not applicable.  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.; 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.