chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: White blood cell count
Clinical narrative: auto immune disorder; both wrist started swelling\Swollen Knee/swollen ankle; Swollen hands\swollen feet; muscle pain every night\Pain became persistent and wont go away.; Joint (and muscle ) pain; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (auto immune disorder) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included QUINAPRIL for an unknown indication.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-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 AUTOIMMUNE DISORDER (auto immune disorder) (seriousness criterion medically significant), JOINT SWELLING (both wrist started swelling\Swollen Knee/swollen ankle) and MYALGIA (muscle pain every night\Pain became persistent and wont go away.). an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen hands\swollen feet) and ARTHRALGIA (Joint (and muscle ) pain). At the time of the report, AUTOIMMUNE DISORDER (auto immune disorder), JOINT SWELLING (both wrist started swelling\Swollen Knee/swollen ankle), PERIPHERAL SWELLING (Swollen hands\swollen feet) and ARTHRALGIA (Joint (and muscle ) pain) outcome was unknown and MYALGIA (muscle pain every night\Pain became persistent and wont go away.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, White blood cell count: high (High) extremely high but no visible sign of infection..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment for the events included steroids.  It was reported that, side effects from both doses were alike and started on the night of vaccination. Two weeks after 2nd dose of vaccine, both wrists started swelling followed by the joint and muscle pain every night. Pain became persistent and won't go away. Pain only subsided 5-6 hours after taking steroids. It's been 6-8 weeks of extended inflammation. The laboratory exams performed to further understand the event included number of drug test and results pointed to an auto immune disorder.  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.
Sex: U
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Diagnosed with Pneumonia after receiving both the doses of Moderna vaccine 3 months ago; 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 PNEUMONIA (Diagnosed with Pneumonia after receiving both the doses of Moderna vaccine 3 months ago) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pneumonia (7 months after receiving Moderna vaccine).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced PNEUMONIA (Diagnosed with Pneumonia after receiving both the doses of Moderna vaccine 3 months ago) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Diagnosed with Pneumonia after receiving both the doses of Moderna vaccine 3 months ago) outcome was unknown.            No concomitant products were reported. No treatment information was provided.  Very limited information regarding the events has been provided at this time. Case without patient identifiers and contact information.; Sender's Comments: Very limited information regarding the events has been provided at this time. Case without patient identifiers and contact information.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Leukoencephalopathy
Clinical narrative: Diagnosed with Posterior Leukoencephalopathy.; This spontaneous case was reported by a consumer and describes the occurrence of LEUKOENCEPHALOPATHY (Diagnosed with Posterior Leukoencephalopathy.) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LEUKOENCEPHALOPATHY (Diagnosed with Posterior Leukoencephalopathy.) (seriousness criteria hospitalization and medically significant). At the time of the report, LEUKOENCEPHALOPATHY (Diagnosed with Posterior Leukoencephalopathy.) outcome was unknown.            Concomitant products include Cholesterol medication. Treatment information was not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Reporter described the event as Brain inflammation and delirium.  Company Comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information has been requested.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate abnormal, Hypoaesthesia, Palpitations, Swelling
Clinical narrative: Palpitation; Heart was acting erratically; Numbness on the left side; Puffiness on the left side; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021 and was forwarded to Moderna on 04-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitation), HEART RATE ABNORMAL (Heart was acting erratically), HYPOAESTHESIA (Numbness on the left side) and SWELLING (Puffiness on the left side) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     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 29-May-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-May-2021, the patient experienced PALPITATIONS (Palpitation) (seriousness criterion hospitalization), HEART RATE ABNORMAL (Heart was acting erratically) (seriousness criterion hospitalization), HYPOAESTHESIA (Numbness on the left side) (seriousness criterion hospitalization) and SWELLING (Puffiness on the left side) (seriousness criterion hospitalization). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 1once a day; IBUPROFEN (ADVIL 12 HOUR) on 29-May-2021 at a dose of 1 UNK and PARACETAMOL (TYLENOL) from 29-May-2021 to 30-May-2021 at a dose of 1 UNK. At the time of the report, PALPITATIONS (Palpitation), HEART RATE ABNORMAL (Heart was acting erratically), HYPOAESTHESIA (Numbness on the left side) and SWELLING (Puffiness on the left side) had not resolved.            No relevant concomitant medications were  provided. The reporter was in contact with physician and also went to emergency room (ER) but they were not able to resolve the problem. The reporter confirmed that these side effects were still going on. 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.
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Ophthalmic migraine
Clinical narrative: Heartache pain; Ocular migraine; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (Heartache pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANGINA PECTORIS (Heartache pain) (seriousness criterion medically significant) and OPHTHALMIC MIGRAINE (Ocular migraine). At the time of the report, ANGINA PECTORIS (Heartache pain) and OPHTHALMIC MIGRAINE (Ocular migraine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product details not provided.  Patient developed heart ache pain for 2 weeks and ocular migraine which the patient never had before in her life.  Treatment details not provided.  Company comment: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia
Clinical narrative: COVID; COVID Pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) and COVID-19 PNEUMONIA (COVID Pneumonia) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     The patient's past medical history included Ex-smoker. Concurrent medical conditions included Lung disease (patient states that he has an underlying condition on his lungs which he sleeps with masks and takes medication ). Concomitant products included BISACODYL (ELITON [BISACODYL]) and SALMETEROL XINAFOATE (PULMOTEROL) 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 an unknown date, the patient experienced COVID-19 (COVID) (seriousness criterion hospitalization) and COVID-19 PNEUMONIA (COVID Pneumonia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 30-Apr-2021 to 15-May-2021 due to COVID-19 and COVID-19 PNEUMONIA. At the time of the report, COVID-19 (COVID) and COVID-19 PNEUMONIA (COVID Pneumonia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient refers that he didn't receive any treatment after discharge and does not recall the treatment he received while hospitalized.  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.; 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cold sweat, Dizziness, Incorrect route of product administration, Oxygen saturation
Clinical narrative: incorrect route of product administration; shaky; lightheaded; fever; sore arm; cold sweats; no strength,very weak; slept all day; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweats), ASTHENIA (no strength,very weak), SOMNOLENCE (slept all day), TREMOR (shaky), DIZZINESS (lightheaded) and PYREXIA (fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060A21A  or 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Confined in the hospital for 3 weeks) on 23-Oct-2020.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced COLD SWEAT (cold sweats) (seriousness criterion medically significant), ASTHENIA (no strength,very weak) (seriousness criterion medically significant), SOMNOLENCE (slept all day) (seriousness criterion medically significant), PYREXIA (fever) (seriousness criterion medically significant) and PAIN IN EXTREMITY (sore arm). On 24-May-2021, the patient experienced TREMOR (shaky) (seriousness criterion medically significant) and DIZZINESS (lightheaded) (seriousness criterion medically significant). On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (incorrect route of product administration). On 21-May-2021, PAIN IN EXTREMITY (sore arm) had resolved. On 24-May-2021, COLD SWEAT (cold sweats), ASTHENIA (no strength,very weak), SOMNOLENCE (slept all day) and PYREXIA (fever) had resolved. On 27-May-2021, TREMOR (shaky) and DIZZINESS (lightheaded) had resolved. At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (incorrect route of product administration) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2021, Oxygen saturation: 82% percent (Low) decreased 82%.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided Treatment included oxygen inhalation to 8l pm Patient stated that she discharged on NOV 2020 with oxygen inhalation of 5lpm during night time and 2.5-3 lpm as needed during day time.  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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Somnolence, Tremor
Clinical narrative: incorrect route of product administration; shaky; lightheaded; fever; sore arm; cold sweats; no strength,very weak; slept all day; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweats), ASTHENIA (no strength,very weak), SOMNOLENCE (slept all day), TREMOR (shaky), DIZZINESS (lightheaded) and PYREXIA (fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060A21A  or 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Confined in the hospital for 3 weeks) on 23-Oct-2020.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced COLD SWEAT (cold sweats) (seriousness criterion medically significant), ASTHENIA (no strength,very weak) (seriousness criterion medically significant), SOMNOLENCE (slept all day) (seriousness criterion medically significant), PYREXIA (fever) (seriousness criterion medically significant) and PAIN IN EXTREMITY (sore arm). On 24-May-2021, the patient experienced TREMOR (shaky) (seriousness criterion medically significant) and DIZZINESS (lightheaded) (seriousness criterion medically significant). On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (incorrect route of product administration). On 21-May-2021, PAIN IN EXTREMITY (sore arm) had resolved. On 24-May-2021, COLD SWEAT (cold sweats), ASTHENIA (no strength,very weak), SOMNOLENCE (slept all day) and PYREXIA (fever) had resolved. On 27-May-2021, TREMOR (shaky) and DIZZINESS (lightheaded) had resolved. At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (incorrect route of product administration) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2021, Oxygen saturation: 82% percent (Low) decreased 82%.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided Treatment included oxygen inhalation to 8l pm Patient stated that she discharged on NOV 2020 with oxygen inhalation of 5lpm during night time and 2.5-3 lpm as needed during day time.  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: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Inappropriate schedule of product administration, Myalgia
Clinical narrative: Can't hear out of one of his ears after 2nd dose; Intense body aches after vaccine/ Intense body pains after vaccine; 2nd dose given sooner than 25 days after 1st dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of DEAFNESS UNILATERAL (Can't hear out of one of his ears after 2nd dose) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Leg amputation. Concurrent medical conditions included Diabetes, Blindness (nearly blind and has no legs), Cholesterol high and Physical disability (Patient has no Legs.).   On 28-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 28-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given sooner than 25 days after 1st dose). On an unknown date, the patient experienced DEAFNESS UNILATERAL (Can't hear out of one of his ears after 2nd dose) (seriousness criterion medically significant) and MYALGIA (Intense body aches after vaccine/ Intense body pains after vaccine). On 28-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given sooner than 25 days after 1st dose) had resolved. At the time of the report, DEAFNESS UNILATERAL (Can't hear out of one of his ears after 2nd dose) and MYALGIA (Intense body aches after vaccine/ Intense body pains after vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications included, antihistamines were reported.   It was reported, the patient has no cough and his head is not stuffed up.   Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Got COVID-19 4 days later; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got COVID-19 4 days later) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got COVID-19 4 days later) (seriousness criterion hospitalization). At the time of the report, COVID-19 (Got COVID-19 4 days later) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment information was not provided. The patient stated that she got COVID-19 4 days later and was hospitalized for 11 days.    Company comment: Based on reporter's causality and mechanism of action mRna -1273 vaccine, does not cause the Covid -19 disease. The event is assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on reporter's causality and mechanism of action mRna -1273 vaccine, does not cause the Covid -19 disease. The event is assessed as unlikely related to mRNA-1273.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: had a miscarriage; had vaccine during the first 10 weeks and had a miscarriage; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of ABORTION SPONTANEOUS (had a miscarriage) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced ABORTION SPONTANEOUS (had a miscarriage) (seriousness criterion medically significant) and EXPOSURE DURING PREGNANCY (had vaccine during the first 10 weeks and had a miscarriage). The delivery occurred on an unknown date, which was reported as Spontaneous Abortion. For foetus 1, The outcome was reported as Spontaneous Abortion NOS. At the time of the report, ABORTION SPONTANEOUS (had a miscarriage) and EXPOSURE DURING PREGNANCY (had vaccine during the first 10 weeks and had a miscarriage) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication and treatment drug was reported.  It was reported that the baby died  Company comment: This is a case of product exposure during pregnancy which resulted in Spontaneous Abortion, for this female with undocumented age. Very limited information has been provided at this time.; Sender's Comments: This is a case of product exposure during pregnancy which resulted in Spontaneous Abortion, for this female with undocumented age. Very limited information has been provided at this time.
Age: 89.0
Sex: U
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: got pneumonia after receiving first vaccine shot,the vaccine caused her pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (got pneumonia after receiving first vaccine shot,the vaccine caused her pneumonia) in an 89-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (got pneumonia after receiving first vaccine shot,the vaccine caused her pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (got pneumonia after receiving first vaccine shot,the vaccine caused her pneumonia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient refuses to go for second shot as she is convinced that the vaccine caused her pneumonia.  Company comment Very limited information regarding this event has been provided at this time. No further information is expected at this time.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time. No further information is expected at this time.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure diastolic, Blood pressure diastolic increased, Swollen tongue
Clinical narrative: diastolic blood pressure shot up around 150 mmHG; a swollen tongue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLOOD PRESSURE DIASTOLIC INCREASED (diastolic blood pressure shot up around 150 mmHG) and SWOLLEN TONGUE (a swollen tongue) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced BLOOD PRESSURE DIASTOLIC INCREASED (diastolic blood pressure shot up around 150 mmHG) (seriousness criterion medically significant) and SWOLLEN TONGUE (a swollen tongue) (seriousness criterion medically significant). On 18-Mar-2021, BLOOD PRESSURE DIASTOLIC INCREASED (diastolic blood pressure shot up around 150 mmHG) and SWOLLEN TONGUE (a swollen tongue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Blood pressure diastolic: 150 mmHg (High) Elevated.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment medications reported  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: palsy after 1 week of taking moderna covid -19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (palsy after 1 week of taking moderna covid -19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARALYSIS (palsy after 1 week of taking moderna covid -19 vaccine) (seriousness criterion medically significant). At the time of the report, PARALYSIS (palsy after 1 week of taking moderna covid -19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     The patient experienced palsy a week after taking Moderna Covid-19 vaccine.  No treatment  or concomitant  medications were reported by the reporter.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Paraesthesia, Syncope
Clinical narrative: moderate to severe fainting spell; tingling in legs and hands; profuse sweating; chills; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (moderate to severe fainting spell) in a 62-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 03-Jun-2021 at 2:10 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced PARAESTHESIA (tingling in legs and hands), HYPERHIDROSIS (profuse sweating) and CHILLS (chills). On 04-Jun-2021 at 12:15 PM, the patient experienced SYNCOPE (moderate to severe fainting spell) (seriousness criterion medically significant). On 04-Jun-2021, SYNCOPE (moderate to severe fainting spell), HYPERHIDROSIS (profuse sweating) and CHILLS (chills) had resolved. At the time of the report, PARAESTHESIA (tingling in legs and hands) outcome was unknown.            It was reported the patient did not go to ER but did consider calling an ambulance if the initial part of the spell did not pass within another 30 minutes.  No treatment and concomitant medication information reported.  Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizure; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Seizure) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SEIZURE (Seizure) (seriousness criteria hospitalization, medically significant and life threatening). At the time of the report, SEIZURE (Seizure) had not resolved.            No concomitant medications were reported. Treatment medications were not provided.  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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Computerised tomogram, Dyspnoea at rest, Headache, Loss of personal independence in daily activities
Clinical narrative: shortness of breath at Rest (Comes and goes)  After Second Dose; Chest Pain at Rest and when Deep Breathing (After Second Vaccine); Became dependent on others after second dose; Headache; Nausea; This spontaneous case was reported by a health care professional and describes the occurrence of DYSPNOEA AT REST (shortness of breath at Rest (Comes and goes)  After Second Dose) and CHEST PAIN (Chest Pain at Rest and when Deep Breathing (After Second Vaccine)) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Became dependent on others after second dose), HEADACHE (Headache) and NAUSEA (Nausea). On 20-Mar-2021, the patient experienced DYSPNOEA AT REST (shortness of breath at Rest (Comes and goes)  After Second Dose) (seriousness criteria hospitalization and medically significant) and CHEST PAIN (Chest Pain at Rest and when Deep Breathing (After Second Vaccine)) (seriousness criterion hospitalization). On 24-Mar-2021, HEADACHE (Headache) and NAUSEA (Nausea) had resolved. At the time of the report, DYSPNOEA AT REST (shortness of breath at Rest (Comes and goes)  After Second Dose), CHEST PAIN (Chest Pain at Rest and when Deep Breathing (After Second Vaccine)) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Became dependent on others after second dose) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) scan of lungs and Cardiac scan showed clear, all tests were normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter. No treatment medications were reporter by the reporter.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of 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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: shortness of breath at Rest (Comes and goes)  After Second Dose; Chest Pain at Rest and when Deep Breathing (After Second Vaccine); Became dependent on others after second dose; Headache; Nausea; This spontaneous case was reported by a health care professional and describes the occurrence of DYSPNOEA AT REST (shortness of breath at Rest (Comes and goes)  After Second Dose) and CHEST PAIN (Chest Pain at Rest and when Deep Breathing (After Second Vaccine)) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Became dependent on others after second dose), HEADACHE (Headache) and NAUSEA (Nausea). On 20-Mar-2021, the patient experienced DYSPNOEA AT REST (shortness of breath at Rest (Comes and goes)  After Second Dose) (seriousness criteria hospitalization and medically significant) and CHEST PAIN (Chest Pain at Rest and when Deep Breathing (After Second Vaccine)) (seriousness criterion hospitalization). On 24-Mar-2021, HEADACHE (Headache) and NAUSEA (Nausea) had resolved. At the time of the report, DYSPNOEA AT REST (shortness of breath at Rest (Comes and goes)  After Second Dose), CHEST PAIN (Chest Pain at Rest and when Deep Breathing (After Second Vaccine)) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Became dependent on others after second dose) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) scan of lungs and Cardiac scan showed clear, all tests were normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter. No treatment medications were reporter by the reporter.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of 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: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic shock, Eructation, Erythema, Peripheral swelling, Swelling face
Clinical narrative: choking; Burping after the first dose; Hands and face red; Hands and face swollen; Hands and face swollen; Anaphylactic shock; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   The patient's past medical history included Thyroid cancer (history of thyroid cancer). Concurrent medical conditions included HIV infection (HIV positive and on a regimen and undetectable for 20 years) and Renal pain (kidneys hurt once in a while and stated as not taking booster dose in October). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), LEVOTHYROXINE SODIUM (LEVOTIRON), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and COBICISTAT, ELVITEGRAVIR, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (GENVOYA) for an unknown indication.  On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criterion medically significant), CHOKING (choking), ERUCTATION (Burping after the first dose), ERYTHEMA (Hands and face red), SWELLING FACE (Hands and face swollen) and PERIPHERAL SWELLING (Hands and face swollen). At the time of the report, ANAPHYLACTIC SHOCK (Anaphylactic shock), CHOKING (choking), ERUCTATION (Burping after the first dose), ERYTHEMA (Hands and face red), SWELLING FACE (Hands and face swollen) and PERIPHERAL SWELLING (Hands and face swollen) had resolved.  The patient reported having anaphylactic shock after receiving vaccine on 12-Mar-2021. Patient reported burping, hands and face red after reaching home about 45mins after receiving the first dose and was rushed to Emergency room where the patient experienced choking and swollen hand and face.  No corrective treatment was provided.  The 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.   This case was linked to MOD-2021-209375 (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: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Deafness bilateral, Hypokinesia, Tinnitus
Clinical narrative: Sharp/stabbing pain in the right part of the abdomen; Difficulty moving or turning body; Ringing in ear predominantly in right ear; the patient has extensive hearing loss, with hearing loss being worse in the right ear; This spontaneous case was reported by a patient and describes the occurrence of DEAFNESS UNILATERAL (Hearing loss worsened a little each day, after a week I could hardly hear(right ear)) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced DEAFNESS UNILATERAL (Hearing loss worsened a little each day, after a week I could hardly hear(right ear)) (seriousness criterion medically significant), ABDOMINAL PAIN (Sharp/stabbing pain in the right part of the abdomen), HYPOKINESIA (Difficulty moving or turning body) and TINNITUS (Ringing in ear predominantly in right ear). On 05-May-2021, ABDOMINAL PAIN (Sharp/stabbing pain in the right part of the abdomen) and HYPOKINESIA (Difficulty moving or turning body) had resolved. At the time of the report, DEAFNESS UNILATERAL (Hearing loss worsened a little each day, after a week I could hardly hear(right ear)) and TINNITUS (Ringing in ear predominantly in right ear) 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.   No concomitant medication was reported. No treatment was reported. Patient reported that a  week after having received the vaccine the patient claims they could barely hear, and were reading lips to communicate. The patient has visited an Ear Nose and Throat specialist physician who has confirmed that the patient has extensive hearing loss. Patient is not planning on receiving the second dose of the Moderna COVID-19 vaccine.; 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: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic shock, Eructation, Erythema, Peripheral swelling, Swelling face
Clinical narrative: Anaphylactic shock; choking; Burping; Hands and face red; Hands and face swollen; Hands and face swollen; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021 and was forwarded to Moderna on 04-Jun-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid cancer (history of thyroid cancer). Concurrent medical conditions included HIV infection (HIV positive and on a regimen and undetectable for 20 years) and Renal pain (kidneys hurt once in a while and stated as not taking booster dose in October).   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criterion medically significant), CHOKING (choking), ERUCTATION (Burping), ERYTHEMA (Hands and face red), SWELLING FACE (Hands and face swollen) and PERIPHERAL SWELLING (Hands and face swollen). On 17-Apr-2021, ANAPHYLACTIC SHOCK (Anaphylactic shock), CHOKING (choking), ERUCTATION (Burping), ERYTHEMA (Hands and face red), SWELLING FACE (Hands and face swollen) and PERIPHERAL SWELLING (Hands and face swollen) had resolved.            No corrective treatment was provided.  It was reported that, after receiving 2nd dose, patient was having similar reaction in 5 minutes when under medical supervision and was revived." to "Patient reported as burping, hands and face red after reaching home about 45mins after receiving the first dose on 12th Mar 2021 and was rushed to Emergency room where caller mentioned as experienced choking and swollen hand and face. Caller received second dose on 17th Apr 2021 and mentioned as having similar reaction in 5 mins when under medical supervision and was revived.  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-2021-209326 (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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Joint swelling, Malaise, Pain, Pulmonary embolism
Clinical narrative: large blood clot in the right lung/smaller blood clot in the left lung; blood clot in the calf of the left leg; Baker's cyst behind the left knee; "I still didn't feel right or good"; "problems with my kidneys"; dull pain; "really bad chest pains"; "knee got swollen up"; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (large blood clot in the right lung/smaller blood clot in the left lung) and THROMBOSIS (blood clot in the calf of the left leg) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included LOSARTAN, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), OMEPRAZOLE, EZETIMIBE, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), VITAMIN D [VITAMIN D NOS], CALCIUM, MULTIVITAMINS [VITAMINS NOS] and APIXABAN (ELIQUIS) for an unknown indication.    On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced JOINT SWELLING ("knee got swollen up"). On 26-Apr-2021, the patient experienced PULMONARY EMBOLISM (large blood clot in the right lung/smaller blood clot in the left lung) (seriousness criteria hospitalization and medically significant) and CHEST PAIN ("really bad chest pains"). On an unknown date, the patient experienced THROMBOSIS (blood clot in the calf of the left leg) (seriousness criterion medically significant), SYNOVIAL CYST (Baker's cyst behind the left knee), MALAISE ("I still didn't feel right or good"), RENAL PAIN ("problems with my kidneys") and PAIN (dull pain). At the time of the report, PULMONARY EMBOLISM (large blood clot in the right lung/smaller blood clot in the left lung), THROMBOSIS (blood clot in the calf of the left leg), JOINT SWELLING ("knee got swollen up"), SYNOVIAL CYST (Baker's cyst behind the left knee), MALAISE ("I still didn't feel right or good"), CHEST PAIN ("really bad chest pains"), RENAL PAIN ("problems with my kidneys") and PAIN (dull pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Company comment: Very limited information regarding this events has been provided at this time. 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: Very limited information regarding this events has been provided at this time. 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.