chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Weight increased
Clinical narrative: Pulmonary coccidioides; Rheumatoid arthritis flare up; condition aggravated; Patient was on the continuous positive airway pressure machine; arm was sore; weight gain; urinary tract infection; stomach upset; abdominal pain; chills; vomiting; This spontaneous case was reported by a physician and describes the occurrence of COCCIDIOIDOMYCOSIS (Pulmonary coccidioides) and RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) 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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COCCIDIOIDOMYCOSIS (Pulmonary coccidioides) (seriousness criterion medically significant), RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) (seriousness criterion medically significant), CONDITION AGGRAVATED (condition aggravated), CONTINUOUS POSITIVE AIRWAY PRESSURE (Patient was on the continuous positive airway pressure machine), PAIN IN EXTREMITY (arm was sore), WEIGHT INCREASED (weight gain), URINARY TRACT INFECTION (urinary tract infection), ABDOMINAL DISCOMFORT (stomach upset), ABDOMINAL PAIN (abdominal pain), CHILLS (chills) and VOMITING (vomiting). At the time of the report, COCCIDIOIDOMYCOSIS (Pulmonary coccidioides), RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), CONDITION AGGRAVATED (condition aggravated), CONTINUOUS POSITIVE AIRWAY PRESSURE (Patient was on the continuous positive airway pressure machine), PAIN IN EXTREMITY (arm was sore), WEIGHT INCREASED (weight gain), ABDOMINAL DISCOMFORT (stomach upset), ABDOMINAL PAIN (abdominal pain), CHILLS (chills) and VOMITING (vomiting) 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.   Treatment medications was not provided.  Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Dizziness, Dysstasia, Headache
Clinical narrative: Temperature was 99 degrees Fahrenheit; Almost passed out; Whole right side of my body went numb; Left leg tingly/Whole right side of my body tingly; Dizzy; Hard to stand; Chest pain; Arm pain at the injection site; Nausea; Slight Headache; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Almost passed out) in a 33-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 Anxiety. Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) and LAMOTRIGINE for Anxiety.   On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced LOSS OF CONSCIOUSNESS (Almost passed out) (seriousness criterion medically significant), HYPOAESTHESIA (Whole right side of my body went numb), PARAESTHESIA (Left leg tingly/Whole right side of my body tingly), DIZZINESS (Dizzy), DYSSTASIA (Hard to stand), CHEST PAIN (Chest pain), VACCINATION SITE PAIN (Arm pain at the injection site), NAUSEA (Nausea) and HEADACHE (Slight Headache). On 03-Jun-2021, the patient experienced PYREXIA (Temperature was 99 degrees Fahrenheit). At the time of the report, LOSS OF CONSCIOUSNESS (Almost passed out), HYPOAESTHESIA (Whole right side of my body went numb), PARAESTHESIA (Left leg tingly/Whole right side of my body tingly), DIZZINESS (Dizzy), DYSSTASIA (Hard to stand), CHEST PAIN (Chest pain), VACCINATION SITE PAIN (Arm pain at the injection site), NAUSEA (Nausea), HEADACHE (Slight Headache) and PYREXIA (Temperature was 99 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jun-2021, Body temperature: 99 (Borderline) Fever-99 degrees Fahrenheit.         Patient reported that she had not taken anything for her symptoms.  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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Loss of consciousness, Nausea, Paraesthesia, Pyrexia
Clinical narrative: Temperature was 99 degrees Fahrenheit; Almost passed out; Whole right side of my body went numb; Left leg tingly/Whole right side of my body tingly; Dizzy; Hard to stand; Chest pain; Arm pain at the injection site; Nausea; Slight Headache; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Almost passed out) in a 33-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 Anxiety. Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) and LAMOTRIGINE for Anxiety.   On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced LOSS OF CONSCIOUSNESS (Almost passed out) (seriousness criterion medically significant), HYPOAESTHESIA (Whole right side of my body went numb), PARAESTHESIA (Left leg tingly/Whole right side of my body tingly), DIZZINESS (Dizzy), DYSSTASIA (Hard to stand), CHEST PAIN (Chest pain), VACCINATION SITE PAIN (Arm pain at the injection site), NAUSEA (Nausea) and HEADACHE (Slight Headache). On 03-Jun-2021, the patient experienced PYREXIA (Temperature was 99 degrees Fahrenheit). At the time of the report, LOSS OF CONSCIOUSNESS (Almost passed out), HYPOAESTHESIA (Whole right side of my body went numb), PARAESTHESIA (Left leg tingly/Whole right side of my body tingly), DIZZINESS (Dizzy), DYSSTASIA (Hard to stand), CHEST PAIN (Chest pain), VACCINATION SITE PAIN (Arm pain at the injection site), NAUSEA (Nausea), HEADACHE (Slight Headache) and PYREXIA (Temperature was 99 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jun-2021, Body temperature: 99 (Borderline) Fever-99 degrees Fahrenheit.         Patient reported that she had not taken anything for her symptoms.  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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Temperature was 99 degrees Fahrenheit; Almost passed out; Whole right side of my body went numb; Left leg tingly/Whole right side of my body tingly; Dizzy; Hard to stand; Chest pain; Arm pain at the injection site; Nausea; Slight Headache; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Almost passed out) in a 33-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 Anxiety. Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) and LAMOTRIGINE for Anxiety.   On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced LOSS OF CONSCIOUSNESS (Almost passed out) (seriousness criterion medically significant), HYPOAESTHESIA (Whole right side of my body went numb), PARAESTHESIA (Left leg tingly/Whole right side of my body tingly), DIZZINESS (Dizzy), DYSSTASIA (Hard to stand), CHEST PAIN (Chest pain), VACCINATION SITE PAIN (Arm pain at the injection site), NAUSEA (Nausea) and HEADACHE (Slight Headache). On 03-Jun-2021, the patient experienced PYREXIA (Temperature was 99 degrees Fahrenheit). At the time of the report, LOSS OF CONSCIOUSNESS (Almost passed out), HYPOAESTHESIA (Whole right side of my body went numb), PARAESTHESIA (Left leg tingly/Whole right side of my body tingly), DIZZINESS (Dizzy), DYSSTASIA (Hard to stand), CHEST PAIN (Chest pain), VACCINATION SITE PAIN (Arm pain at the injection site), NAUSEA (Nausea), HEADACHE (Slight Headache) and PYREXIA (Temperature was 99 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jun-2021, Body temperature: 99 (Borderline) Fever-99 degrees Fahrenheit.         Patient reported that she had not taken anything for her symptoms.  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: Cold sweat, Syncope
Clinical narrative: Had to lie down possible faint; Cold sweat; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Had to lie down possible faint) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 03-Jun-2021, the patient experienced SYNCOPE (Had to lie down possible faint) (seriousness criterion medically significant) and COLD SWEAT (Cold sweat). At the time of the report, SYNCOPE (Had to lie down possible faint) and COLD SWEAT (Cold sweat) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.  Concomitant and treatment information were not provided.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: Cardiac problems  after receiving either Pfizer or Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of CARDIAC DISORDER (Cardiac problems  after receiving either Pfizer or Moderna vaccine) in an elderly 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (Cardiac problems  after receiving either Pfizer or Moderna vaccine) (seriousness criteria death and life threatening). The reported cause of death was cardiac disorder. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  It was reported that the reporter has seen that patients above 60 years of age who developed Cardiac problems after receiving either Pfizer or Moderna vaccine. Two patients even passed away post cardiac problems after vaccination.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the 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.; Reported Cause(s) of Death: Cardiac disorder
Age: 41.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Device use error, Epilepsy, Muscle twitching, Pain
Clinical narrative: Epilepsy; Device use error; Twitches; Generalized aching; This spontaneous case was reported by a physician and describes the occurrence of EPILEPSY (Epilepsy) in a 41-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.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis and Plaque psoriasis.    Concurrent medical conditions included Seizures, Hypothyroidism, Sleep apnoea, Seasonal allergy and Non-tobacco user. Concomitant products included MONTELUKAST SODIUM for Allergy, LEVOTHYROXINE for Hypothyroidism, LAMOTRIGINE for Seizure.   On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced PAIN (Generalized aching). On 20-May-2021, the patient experienced EPILEPSY (Epilepsy) (seriousness criterion medically significant), DEVICE USE ERROR (Device use error) and MUSCLE TWITCHING (Twitches). In April 2021, PAIN (Generalized aching) had resolved. At the time of the report, EPILEPSY (Epilepsy) and DEVICE USE ERROR (Device use error) outcome was unknown and MUSCLE TWITCHING (Twitches) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was an non alcoholic.  No treatment medications were reported.  Very limited information regarding these events has been provided at this time. No further information is expected. The patient's medical history of seizures is a confounding factor that may play a possible contributory role.; Sender's Comments: Very limited information regarding these events has been provided at this time. No further information is expected. The patient's medical history of seizures is a confounding factor that may play a possible contributory role.
Sex: U
Vaccine: COVID19
Symptoms: Autoimmune disorder
Clinical narrative: Several rather rare and odd autoimmune diseases; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of AUTOIMMUNE DISORDER (Several rather rare and odd autoimmune diseases) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (Several rather rare and odd autoimmune diseases) (seriousness criterion medically significant). At the time of the report, AUTOIMMUNE DISORDER (Several rather rare and odd autoimmune diseases) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  Company comment: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Hyperhidrosis, Incorrect route of product administration, Insomnia, Sepsis
Clinical narrative: Vaccine has been calcified; Might develop sepsis; Night sweat; Cannot sleep; Cannot raise his arm pass his shoulder.; Injected the first dose about 2 inches high and they inject it in his shoulder socket; Shoulder pain / His shoulder really hurts.; This spontaneous case was reported by a consumer and describes the occurrence of SEPSIS (Might develop sepsis) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shoulder operation and Knee operation.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE CALCIFICATION (Vaccine has been calcified), SEPSIS (Might develop sepsis) (seriousness criterion medically significant), HYPERHIDROSIS (Night sweat), INSOMNIA (Cannot sleep), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Cannot raise his arm pass his shoulder.), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Injected the first dose about 2 inches high and they inject it in his shoulder socket) and ARTHRALGIA (Shoulder pain / His shoulder really hurts.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE CALCIFICATION (Vaccine has been calcified), SEPSIS (Might develop sepsis), HYPERHIDROSIS (Night sweat), INSOMNIA (Cannot sleep), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Cannot raise his arm pass his shoulder.), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Injected the first dose about 2 inches high and they inject it in his shoulder socket) and ARTHRALGIA (Shoulder pain / His shoulder really hurts.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray limb: abnormal abnormal (abnormal) The X-ray showed that the vaccine has been calcified in his shoulder socket..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment 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.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site calcification, Vaccination site joint movement impairment, X-ray limb
Clinical narrative: Vaccine has been calcified; Might develop sepsis; Night sweat; Cannot sleep; Cannot raise his arm pass his shoulder.; Injected the first dose about 2 inches high and they inject it in his shoulder socket; Shoulder pain / His shoulder really hurts.; This spontaneous case was reported by a consumer and describes the occurrence of SEPSIS (Might develop sepsis) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shoulder operation and Knee operation.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE CALCIFICATION (Vaccine has been calcified), SEPSIS (Might develop sepsis) (seriousness criterion medically significant), HYPERHIDROSIS (Night sweat), INSOMNIA (Cannot sleep), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Cannot raise his arm pass his shoulder.), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Injected the first dose about 2 inches high and they inject it in his shoulder socket) and ARTHRALGIA (Shoulder pain / His shoulder really hurts.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE CALCIFICATION (Vaccine has been calcified), SEPSIS (Might develop sepsis), HYPERHIDROSIS (Night sweat), INSOMNIA (Cannot sleep), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Cannot raise his arm pass his shoulder.), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Injected the first dose about 2 inches high and they inject it in his shoulder socket) and ARTHRALGIA (Shoulder pain / His shoulder really hurts.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray limb: abnormal abnormal (abnormal) The X-ray showed that the vaccine has been calcified in his shoulder socket..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment 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.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: speaking problem; This spontaneous case was reported by an other caregiver and describes the occurrence of SPEECH DISORDER (speaking problem) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced SPEECH DISORDER (speaking problem) (seriousness criterion hospitalization). The patient was hospitalized for 1 day due to SPEECH DISORDER. At the time of the report, SPEECH DISORDER (speaking problem) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.  No treatment information was available. The reporter mentioned that the patient has visited 5 doctors, including a neurologist, has spent one night in the hospital, and after several diagnostic tests no cause was found to the speech disorder.   Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Pneumonia, SARS-CoV-2 antibody test, Vaccination site urticaria
Clinical narrative: Frozen lungs; arm hurt and was sore for at least 2 weeks; Large burning welt where ther injection was; My arm hurt and was sore; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Frozen lungs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Spasms (onabotulinumtoxinA injection into paraspinous muscles to stop spasms), Spinal cord neoplasm NOS, Bladder infection and Glucose low. Concurrent medical conditions included Blood pressure high, Dysautonomia, Paralysis (could not walk, eat, or go to the bathroom) and Headache.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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, the patient experienced PNEUMONIA (Frozen lungs) (seriousness criterion medically significant), PAIN IN EXTREMITY (arm hurt and was sore for at least 2 weeks), VACCINATION SITE URTICARIA (Large burning welt where ther injection was) and MYALGIA (My arm hurt and was sore). At the time of the report, PNEUMONIA (Frozen lungs), PAIN IN EXTREMITY (arm hurt and was sore for at least 2 weeks), VACCINATION SITE URTICARIA (Large burning welt where ther injection was) and MYALGIA (My arm hurt and was sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 antibody test: high (High) high.         Concomitant product use was not provided.  Patient mentioned she had phone visits with G.I., Pulmonologist, Dermatologist, P.C.P., Neurologist several times during this Botox, Toxicity. She stated that Moderna Vaccine and monthly IVIG infusions had helped a lot to get rid of the Botox after she had suffered extreme symptoms for 6.5 months. The patient told everyone she had "botox/Covid."  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 ht events a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Multiple sclerosis, Trigeminal neuralgia
Clinical narrative: Multiple Sclerosis; Trigeminal Neura; This spontaneous case was reported by a patient and describes the occurrence of MULTIPLE SCLEROSIS (Multiple Sclerosis) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.                                                                          On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MULTIPLE SCLEROSIS (Multiple Sclerosis) (seriousness criterion medically significant) and TRIGEMINAL NEURALGIA (Trigeminal Neura). At the time of the report, MULTIPLE SCLEROSIS (Multiple Sclerosis) and TRIGEMINAL NEURALGIA (Trigeminal Neura) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Thrombocytopenia
Clinical narrative: Severe brain bleed; Severe thrombocytopenia/; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of THROMBOCYTOPENIA (Severe thrombocytopenia/) and CEREBRAL HAEMORRHAGE (Severe brain bleed) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, the patient experienced THROMBOCYTOPENIA (Severe thrombocytopenia/) (seriousness criteria hospitalization, medically significant and life threatening). On 09-Jun-2021, the patient experienced CEREBRAL HAEMORRHAGE (Severe brain bleed) (seriousness criteria hospitalization, medically significant and life threatening). At the time of the report, THROMBOCYTOPENIA (Severe thrombocytopenia/) and CEREBRAL HAEMORRHAGE (Severe brain bleed) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment information for the events was not provided. Very limited information regarding these events has been provided at this time. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Additional event was added.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Peripheral swelling, Swelling, Swelling face
Clinical narrative: Feet  swelling; Ankle swelling; Face swollen; swell all over his body; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (Feet  swelling), JOINT SWELLING (Ankle swelling), SWELLING FACE (Face swollen) and SWELLING (swell all over his body) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 016B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL and OMEPRAZOLE for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced PERIPHERAL SWELLING (Feet  swelling) (seriousness criterion hospitalization), JOINT SWELLING (Ankle swelling) (seriousness criterion hospitalization), SWELLING FACE (Face swollen) (seriousness criterion hospitalization) and SWELLING (swell all over his body) (seriousness criterion hospitalization). At the time of the report, PERIPHERAL SWELLING (Feet  swelling), JOINT SWELLING (Ankle swelling), SWELLING FACE (Face swollen) and SWELLING (swell all over his body) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient stated that he works from home an noticed his feet and ankle swelling after receiving the vaccine. He reported taking a picture with his grand baby and noticed his face was swollen as well about a week after receiving the vaccine. Patient states his symptoms lasted on and off for a month. He received the second vaccine on 10-May-2021 in the left arm, (LOT 016B21A) and reported that he immediately began to swell all over his body and that the swelling was so bad he could not put a shirt on and he could not see his ankles. The patient was rushed to the Emergency room and hospitalized for treatment. He knows that he was given steroids and diuretics and states his symptoms are ongoing but that he did experience sporadic remission while hospitalized. He reported that his symptoms lasted on and off for a month.  Additional treatment included taking 80 mg of Prednisone for 10 weeks.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Inappropriate schedule of product administration, Pruritus, Swelling face
Clinical narrative: Provider on duty refused to give second dose due to previous allergic reaction from the 1st dose; Swelling in my face; Redness in my face; Itching in his face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (Swelling in my face), ERYTHEMA (Redness in my face) and PRURITUS (Itching in his face) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced SWELLING FACE (Swelling in my face) (seriousness criterion medically significant), ERYTHEMA (Redness in my face) (seriousness criterion medically significant) and PRURITUS (Itching in his face) (seriousness criterion medically significant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Provider on duty refused to give second dose due to previous allergic reaction from the 1st dose). The patient was treated with PREDNISONE at a dose of 1 dosage form. On 03-Apr-2021, SWELLING FACE (Swelling in my face), ERYTHEMA (Redness in my face) and PRURITUS (Itching in his face) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Provider on duty refused to give second dose due to previous allergic reaction from the 1st dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  Treatment information was prescribed antiallergic medicine and Prednisone but the patient took only prednisone.  The patient was supposed to get the 2nd dose on 01May2021 but the healthcare provider on duty refused to give the shot as he had previous allergic reaction to the 1st dose.  Action taken was no change.  Company Comment: This case concerns a 63-year-old male with serious unexpected events of swelling face, erythema and pruritus. Event latency within 5 minutes after first dose mRNA-1273. Based on 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: This case concerns a 63-year-old male with serious unexpected events of swelling face, erythema and pruritus. Event latency within 5 minutes after first dose mRNA-1273. Based on 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: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Nephrotic syndrome, Peripheral swelling, Swelling, Swelling face
Clinical narrative: Nephrotic syndrome; immediately began to swell all over body/swelling was so bad I could not put a shirt on; feet swelling; face swelling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NEPHROTIC SYNDROME (Nephrotic syndrome), SWELLING (immediately began to swell all over body/swelling was so bad I could not put a shirt on), PERIPHERAL SWELLING (feet swelling) and SWELLING FACE (face swelling) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 025A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL and OMEPRAZOLE for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced NEPHROTIC SYNDROME (Nephrotic syndrome) (seriousness criteria hospitalization and medically significant), SWELLING (immediately began to swell all over body/swelling was so bad I could not put a shirt on) (seriousness criterion hospitalization), PERIPHERAL SWELLING (feet swelling) (seriousness criterion hospitalization) and SWELLING FACE (face swelling) (seriousness criterion hospitalization). The patient was treated with PREDNISONE for Nephrotic syndrome, at a dose of 80 mg for 10 weeks. At the time of the report, NEPHROTIC SYNDROME (Nephrotic syndrome), SWELLING (immediately began to swell all over body/swelling was so bad I could not put a shirt on), PERIPHERAL SWELLING (feet swelling) and SWELLING FACE (face swelling) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 01-May-2021, the patient reported that he was rushed to the Emergency room and hospitalized for treatment due to the events.  At the time of the report the patient stated  his symptoms are ongoing but he did experience sporadic remission while he hospitalized. He was diagnosed with nephrotic syndrome.  He was currently taking 80 mg Prednisone for 10 weeks.  Treatment included steroids and diuretics.  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.   This case was linked to MOD-2021-211527 (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. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Product dose omission issue
Clinical narrative: Atrial Fibrillation (AFib); Missed second dose of vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of ATRIAL FIBRILLATION (Atrial Fibrillation (AFib)) in a male 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 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ATRIAL FIBRILLATION (Atrial Fibrillation (AFib)) (seriousness criterion medically significant) and PRODUCT DOSE OMISSION ISSUE (Missed second dose of vaccine). At the time of the report, ATRIAL FIBRILLATION (Atrial Fibrillation (AFib)) and PRODUCT DOSE OMISSION ISSUE (Missed second dose of vaccine) 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 were reported by the reporter. Treatment medication was not provided.  Based on current available information and the temporal association between product use and the start date of the event 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 event a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sleep deficit
Clinical narrative: Severe arm pain; bad pain where she cant move her arm nor sleep with the pain; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Severe arm 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 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced PAIN IN EXTREMITY (Severe arm pain) (seriousness criteria hospitalization and medically significant) and SLEEP DEFICIT (bad pain where she cant move her arm nor sleep with the pain). The patient was hospitalized on 07-Jun-2021 due to PAIN IN EXTREMITY. At the time of the report, PAIN IN EXTREMITY (Severe arm pain) and SLEEP DEFICIT (bad pain where she cant move her arm nor sleep with the pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported.  Toradol was given for the severe pain the patient experienced.  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: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Angioedema, Swollen tongue
Clinical narrative: Angioedema; Tongue started swelling; her tongue started swelling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANGIOEDEMA (Angioedema) and SWOLLEN TONGUE (Tongue started swelling) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Angioedema (Patient has a history of angioedema to ACE inhibitors). Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), GABAPENTIN, POTASSIUM, NIFEDIPINE, ISOSORBIDE, ESOMEPRAZOLE, PROPRANOLOL (PROPANOLOL [PROPRANOLOL]) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 11-Feb-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criteria hospitalization and medically significant) and SWOLLEN TONGUE (Tongue started swelling) (seriousness criterion hospitalization). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; METHYLPREDNISOLONE at an unspecified dose and frequency and FAMOTIDINE at a dose of Famotidine for 5 days. On 12-Feb-2021, ANGIOEDEMA (Angioedema) had resolved. At the time of the report, SWOLLEN TONGUE (Tongue started swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, Off label use, Pain in extremity, Product use issue
Clinical narrative: breastfeeding currently; breastfeeding currently; Only mild-mod sore arm; This is a spontaneous report from a contactable physician. A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 intramuscular, administered in Arm Left on 22Dec2020 13:00 (Batch/Lot Number: EH9899) as 1st dose, single dose for an unspecified indication. Medical history included Obese (BMI Approx 30), seasonal allergy. Concomitant medication included fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported. The patient's other medications in two weeks includes Prenatal Vitamins, Allegra, Probiotics. Patient don't have known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced breastfeeding currently on 22Dec2020 and only mild-mod sore arm on Dec2020.The patient underwent lab tests and procedures which included body mass index resulted in approx. 30 on unknown date. The outcome for events was unknown.  Follow-up (07May2021): Follow-up attempts completed. No further information expected.