chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 27 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 30-JUN-2021) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210604979.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: HEADACHES; This spontaneous report received from a patient concerned a 29 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 29-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021, the subject experienced headaches. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from headaches. This report was non-serious.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Poor quality product administered
Clinical narrative: EXPIRED VACCINE USE; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a pharmacist concerned a 45 year old male.  The patient's pre-existing medical conditions included no known allergies.  The patient received covid-19 vaccine (suspension for injection, intramuscular, batch number: 042A21A,expiry: 06-JUN-2021) dose was not reported, administered on 02-JUN-2021 15:41 for prophylactic vaccination. No concomitant medications were reported. On 02-JUN-2021, the subject experienced expired vaccine use. On 02-JUN-2021, the subject experienced out of specification product use. The action taken with covid-19 vaccine was not applicable. The outcome of the expired vaccine use and out of specification product use was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 27-MAY-2021, the subject experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Product packaging quantity issue, Underdose
Clinical narrative: PRODUCT QUANTITY PACKAGING ISSUE; UNDERDOSE; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced product quantity packaging issue, and underdose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the product quantity packaging issue and underdose was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry date: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch numbers. No concomitant medications were reported. On APR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210607727 and 20210607948.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cough, Diarrhoea, Extra dose administered
Clinical narrative: CONTINUOUS DIARRHEA INITIALLY/DIARRHEA OFF AND ON; COUGH; SLIGHT HEADACHE; NAUSEA; FEVER UP TO 100.3; VACCINE DRAW UP THE SYRINGE WITH 1.5 ML OR MORE/GIVEN AN OVERDOSE OF VACCINE; CHILLS (FELT LIKE COMING DOWN WITH A COLD); ACHES AND PAINS; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the subject experienced aches and pains. On 12-MAY-2021, the subject experienced vaccine draw up the syringe with 1.5 ml or more/given an overdose of vaccine. On 12-MAY-2021, the subject experienced chills (felt like coming down with a cold). On 13-MAY-2021, the subject experienced continuous diarrhea initially/diarrhea off and on. On 13-MAY-2021, the subject experienced cough. On 13-MAY-2021, the subject experienced slight headache. On 13-MAY-2021, the subject experienced nausea. On 13-MAY-2021, the subject experienced fever up to 100.3. Laboratory data included: Body temperature (NR: not provided) UP TO 100.3. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches and pains, and chills (felt like coming down with a cold) on 17-MAY-2021, and slight headache, nausea, and fever up to 100.3 on 16-MAY-2021, had not recovered from continuous diarrhea initially/diarrhea off and on, and cough, and the outcome of vaccine draw up the syringe with 1.5 ml or more/given an overdose of vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: CONTINUOUS DIARRHEA INITIALLY/DIARRHEA OFF AND ON; COUGH; SLIGHT HEADACHE; NAUSEA; FEVER UP TO 100.3; VACCINE DRAW UP THE SYRINGE WITH 1.5 ML OR MORE/GIVEN AN OVERDOSE OF VACCINE; CHILLS (FELT LIKE COMING DOWN WITH A COLD); ACHES AND PAINS; This spontaneous report received from a patient concerned a 67 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the subject experienced aches and pains. On 12-MAY-2021, the subject experienced vaccine draw up the syringe with 1.5 ml or more/given an overdose of vaccine. On 12-MAY-2021, the subject experienced chills (felt like coming down with a cold). On 13-MAY-2021, the subject experienced continuous diarrhea initially/diarrhea off and on. On 13-MAY-2021, the subject experienced cough. On 13-MAY-2021, the subject experienced slight headache. On 13-MAY-2021, the subject experienced nausea. On 13-MAY-2021, the subject experienced fever up to 100.3. Laboratory data included: Body temperature (NR: not provided) UP TO 100.3. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches and pains, and chills (felt like coming down with a cold) on 17-MAY-2021, and slight headache, nausea, and fever up to 100.3 on 16-MAY-2021, had not recovered from continuous diarrhea initially/diarrhea off and on, and cough, and the outcome of vaccine draw up the syringe with 1.5 ml or more/given an overdose of vaccine was not reported. This report was non-serious.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Pain
Clinical narrative: TIRED; BRAIN FOG; ACHES; CHILLS; This spontaneous report received from a pharmacist concerned a 38 year old male. The patient's weight was 130 pounds, and height was 62 inches. The patient's concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. the patient had no premedical history. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 02-JUN-2021, the subject experienced brain fog. On 02-JUN-2021, the subject experienced aches. On 02-JUN-2021, the subject experienced chills. On 03-JUN-2021, the subject experienced tired. The action taken with covid-19 vaccine  was not applicable. The patient was recovering from brain fog, chills, aches, and tired. This report was non-serious. This case, from the same reporter is linked to 20210456372.
Sex: U
Vaccine: COVID19
Symptoms: Liver disorder, Pancreatic disorder
Clinical narrative: This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced liver issue, and pancreas issue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the liver issue and pancreas issue was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Respiratory symptom
Clinical narrative: RESPIRATORY SYMPTOMS; This spontaneous report received from a physician concerned a 69 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown expiry: UNKNOWN) dose was not reported, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 2021, the subject experienced respiratory symptoms.  The action taken with covid-19 vaccine was not applicable. The patient recovered from respiratory symptoms on 2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Chills, Loss of personal independence in daily activities
Clinical narrative: Blood pressure 194/100; Losing 3 days of work; Arm all swollen at injection site; Fever; Chills; This spontaneous case was reported by a patient and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure 194/100) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure 194/100) (seriousness criterion medically significant), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Losing 3 days of work), PYREXIA (Fever) and CHILLS (Chills). 27-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Arm all swollen at injection site). On 29-Apr-2021, BLOOD PRESSURE INCREASED (Blood pressure 194/100), PYREXIA (Fever) and CHILLS (Chills) had resolved, VACCINATION SITE SWELLING (Arm all swollen at injection site) outcome was unknown. On 30-Apr-2021, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Losing 3 days of work) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Blood pressure measurement: 194/100 (abnormal) 194/100. On 27-Apr-2021, Body temperature: >102 (abnormal) abnormal.         Concomitant medications was not reported/ unknown.  Treatment was not reported/ unknown.  Action taken with mRNA-1273 in response to the event was not provided/unknown.   This case was linked to MOD-2021-062775 (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 event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site swelling
Clinical narrative: Blood pressure 194/100; Losing 3 days of work; Arm all swollen at injection site; Fever; Chills; This spontaneous case was reported by a patient and describes the occurrence of BLOOD PRESSURE INCREASED (Blood pressure 194/100) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure 194/100) (seriousness criterion medically significant), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Losing 3 days of work), PYREXIA (Fever) and CHILLS (Chills). 27-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Arm all swollen at injection site). On 29-Apr-2021, BLOOD PRESSURE INCREASED (Blood pressure 194/100), PYREXIA (Fever) and CHILLS (Chills) had resolved, VACCINATION SITE SWELLING (Arm all swollen at injection site) outcome was unknown. On 30-Apr-2021, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Losing 3 days of work) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Blood pressure measurement: 194/100 (abnormal) 194/100. On 27-Apr-2021, Body temperature: >102 (abnormal) abnormal.         Concomitant medications was not reported/ unknown.  Treatment was not reported/ unknown.  Action taken with mRNA-1273 in response to the event was not provided/unknown.   This case was linked to MOD-2021-062775 (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 event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; 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 BELL'S PALSY (Bell's palsy) 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 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, the patient experienced BELL'S PALSY (Bell's palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bell's palsy) outcome was unknown. Not Provided          No concomitant and treatment medications were reported.  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.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information contains non-significant information.; 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: U
Vaccine: COVID19
Symptoms: Heart rate, Paraesthesia oral
Clinical narrative: Lips tingled; 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 PARAESTHESIA ORAL (Lips tingled) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (recovered from Covid).    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced PARAESTHESIA ORAL (Lips tingled) (seriousness criterion medically significant). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA ORAL (Lips tingled) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Heart rate: increased (High) Elevated heart rate.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant product use was not provided by the reporter.  Patient had lips tingled and an elevated heart rate. She /he was told by the facility where she/ he got the first shot not to get the second since had a reaction.  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: Chronic myelomonocytic leukaemia
Clinical narrative: CMML cases that have undergone clinical progression; 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 CHRONIC MYELOMONOCYTIC LEUKAEMIA (CMML cases that have undergone clinical progression) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic myelomonocytic leukemia.    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 CHRONIC MYELOMONOCYTIC LEUKAEMIA (CMML cases that have undergone clinical progression) (seriousness criterion medically significant). At the time of the report, CHRONIC MYELOMONOCYTIC LEUKAEMIA (CMML cases that have undergone clinical progression) 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.   This is an invalid case due to no identifiable patient. Also, very limited information regarding the event has been provided at this time.; Sender's Comments: This is an invalid case due to no identifiable patient. Also, very limited information regarding the event has been provided at this time.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal behaviour, Hydrocephalus
Clinical narrative: ended up with fluid in the brain; he was not acting right; This spontaneous case was reported by a consumer and describes the occurrence of HYDROCEPHALUS (ended up with fluid in the brain) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYDROCEPHALUS (ended up with fluid in the brain) (seriousness criterion medically significant) and ABNORMAL BEHAVIOUR (he was not acting right). At the time of the report, HYDROCEPHALUS (ended up with fluid in the brain) and ABNORMAL BEHAVIOUR (he was not acting right) outcome was unknown.            The fluid was drained on Wednesday 19-May-2021. At the time of the report, the patient was waiting to see if a shunt would need to be placed in his head.  No relevant concomitant medications were reported. No additional treatment information was provided.  Company Comment: Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chronic obstructive pulmonary disease, Headache, Malaise, Neoplasm malignant
Clinical narrative: Cancer; Feeling sick; Chronic obstructive pulmonary disease; Asthma; Headache; This spontaneous case was reported by a physician and describes the occurrence of NEOPLASM MALIGNANT (Cancer) in a 73-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) for Rheumatoid arthritis.    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 and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced NEOPLASM MALIGNANT (Cancer) (seriousness criterion medically significant), MALAISE (Feeling sick), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Chronic obstructive pulmonary disease), ASTHMA (Asthma) and HEADACHE (Headache). At the time of the report, NEOPLASM MALIGNANT (Cancer), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (Chronic obstructive pulmonary disease) and ASTHMA (Asthma) had not resolved and MALAISE (Feeling sick) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was unknown.  Company Comment: Very limited information regarding this events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Bladder discomfort, Product dose omission issue
Clinical narrative: "Bladder trouble"; "First dose back in March"; This spontaneous case was reported by a consumer and describes the occurrence of BLADDER DISCOMFORT ("Bladder trouble") in a 66-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 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLADDER DISCOMFORT ("Bladder trouble") (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE ("First dose back in March"). At the time of the report, BLADDER DISCOMFORT ("Bladder trouble") and PRODUCT DOSE OMISSION ISSUE ("First dose back in March") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product details was not provided. No treatment information was provided.  Company comment This report refers to a case of product dose omission issue for mRNA-1273 (lot # unknown) with AE of Bladder discomfort reported. Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: This report refers to a case of product dose omission issue for mRNA-1273 (lot # unknown) with AE of Bladder discomfort reported. Very limited information regarding this event has been provided at this time. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Deafness, Erythema, Heart rate increased, Migraine
Clinical narrative: red face; migraine; red veins in eye white predominant; hearing loss; Tinnitus; high heart rate; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (hearing loss) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016m2DA and 013lDA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Tinnitus. Concomitant products included VITAMIN D3 for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced HEART RATE INCREASED (high heart rate). On 03-Mar-2021, the patient experienced TINNITUS (Tinnitus). On an unknown date, the patient experienced DEAFNESS (hearing loss) (seriousness criterion medically significant), ERYTHEMA (red face), MIGRAINE (migraine) and OCULAR HYPERAEMIA (red veins in eye white predominant). The patient was treated with MAGNESIUM at a dose of 1 dosage form; ACETYLCYSTEINE (NAC [ACETYLCYSTEINE]) at a dose of 1 dosage form; ZINC at a dose of 1 dosage form and ASCORBIC ACID (VITAMIN C ASC ACID) at a dose of 1 dosage form. On 18-Feb-2021, HEART RATE INCREASED (high heart rate) had resolved. At the time of the report, DEAFNESS (hearing loss) and TINNITUS (Tinnitus) had not resolved, ERYTHEMA (red face) had resolved with sequelae and MIGRAINE (migraine) and OCULAR HYPERAEMIA (red veins in eye white predominant) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, COVID-19: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Chronic or long- standing health condition includes DOTS.  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.  However, patient's medical history of tinnitus remains a confounder.   This case was linked to. 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.  However, patient's medical history of tinnitus remains a confounder.
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia, Tinnitus
Clinical narrative: red face; migraine; red veins in eye white predominant; hearing loss; Tinnitus; high heart rate; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (hearing loss) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016m2DA and 013lDA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Tinnitus. Concomitant products included VITAMIN D3 for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced HEART RATE INCREASED (high heart rate). On 03-Mar-2021, the patient experienced TINNITUS (Tinnitus). On an unknown date, the patient experienced DEAFNESS (hearing loss) (seriousness criterion medically significant), ERYTHEMA (red face), MIGRAINE (migraine) and OCULAR HYPERAEMIA (red veins in eye white predominant). The patient was treated with MAGNESIUM at a dose of 1 dosage form; ACETYLCYSTEINE (NAC [ACETYLCYSTEINE]) at a dose of 1 dosage form; ZINC at a dose of 1 dosage form and ASCORBIC ACID (VITAMIN C ASC ACID) at a dose of 1 dosage form. On 18-Feb-2021, HEART RATE INCREASED (high heart rate) had resolved. At the time of the report, DEAFNESS (hearing loss) and TINNITUS (Tinnitus) had not resolved, ERYTHEMA (red face) had resolved with sequelae and MIGRAINE (migraine) and OCULAR HYPERAEMIA (red veins in eye white predominant) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, COVID-19: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Chronic or long- standing health condition includes DOTS.  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.  However, patient's medical history of tinnitus remains a confounder.   This case was linked to. 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.  However, patient's medical history of tinnitus remains a confounder.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Tunnel vision
Clinical narrative: tunnel vision; dizziness; 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 TUNNEL VISION (tunnel vision) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced TUNNEL VISION (tunnel vision) (seriousness criterion medically significant) and DIZZINESS (dizziness). At the time of the report, TUNNEL VISION (tunnel vision) and DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Very limited information regarding these events have been provided. Further information has been requested.; Sender's Comments: Very limited information regarding these events have been provided. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: uncontroable convulsions for 4 hours; 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 SEIZURE (uncontroable convulsions for 4 hours) 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 27-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced SEIZURE (uncontroable convulsions for 4 hours) (seriousness criterion medically significant). At the time of the report, SEIZURE (uncontroable convulsions for 4 hours) outcome was unknown.            No concomitant medication information was provided. Treatment information was not provided, but the patient would've gone to emergency room  if he could've made it. Action taken with mRNA-1273 in response to the drug was not applicable.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Reporter did not allow further contact; 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: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Thrombosis
Clinical narrative: Blood clots; Severe allergic reactions; 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 THROMBOSIS (Blood clots) and HYPERSENSITIVITY (Severe allergic reactions) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clots) (seriousness criterion medically significant) and HYPERSENSITIVITY (Severe allergic reactions) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clots) and HYPERSENSITIVITY (Severe allergic reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication and treatment information were not reported. 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.   Reporter did not allow further contact; 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: Bell's palsy
Clinical narrative: Bells Palsy; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bells Palsy) 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 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, the patient experienced BELL'S PALSY (Bells Palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bells Palsy) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Influenza, Movement disorder, Product dose omission issue
Clinical narrative: couldn't move; sweating like crazy; she felt like she had the flu for days; Patient was due for her second dose today, 18April2021, however wants to reschedule; This spontaneous case was reported by a consumer and describes the occurrence of MOVEMENT DISORDER (couldn't move) and HYPERHIDROSIS (sweating like crazy) 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 reported by the reporter.  Concomitant products included VITAMIN B6, HYDROXOCOBALAMIN (VITAMIN B12 [HYDROXOCOBALAMIN]), POTASSIUM, POMALIDOMIDE (POMALYST), APIXABAN (ELIQUIS), PLANTAGO OVATA (LAXISOFT) and ATORVASTATIN for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced MOVEMENT DISORDER (couldn't move) (seriousness criterion hospitalization) and HYPERHIDROSIS (sweating like crazy) (seriousness criterion hospitalization). On an unknown date, the patient experienced INFLUENZA (she felt like she had the flu for days) and PRODUCT DOSE OMISSION ISSUE (Patient was due for her second dose today, 18April2021, however wants to reschedule). At the time of the report, MOVEMENT DISORDER (couldn't move), HYPERHIDROSIS (sweating like crazy), INFLUENZA (she felt like she had the flu for days) and PRODUCT DOSE OMISSION ISSUE (Patient was due for her second dose today, 18April2021, however wants to reschedule) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cold sweat, Hyperhidrosis, Myalgia
Clinical narrative: mild seizure; sweaty; peaked and pale looked; felt clammy; fever of 100 degrees Fahrenheit; chills; achiness; not felt good at all; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (mild seizure) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 006B21A) 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 BUPROPION HYDROCHLORIDE (WELLBUTRIN) and VITAMIN D3 for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 17-Apr-2021, the patient experienced VACCINATION COMPLICATION (not felt good at all), PYREXIA (fever of 100 degrees Fahrenheit), CHILLS (chills) and MYALGIA (achiness). On 18-Apr-2021, the patient experienced SEIZURE (mild seizure) (seriousness criterion medically significant), HYPERHIDROSIS (sweaty), PALLOR (peaked and pale looked) and COLD SWEAT (felt clammy). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, SEIZURE (mild seizure), HYPERHIDROSIS (sweaty), PALLOR (peaked and pale looked), VACCINATION COMPLICATION (not felt good at all), COLD SWEAT (felt clammy), PYREXIA (fever of 100 degrees Fahrenheit), CHILLS (chills) and MYALGIA (achiness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Body temperature: 100 degrees fahrenheit (Inconclusive) 100 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment included as Tylenol. She also had orange juice and water during these episode.  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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Pyrexia, Seizure, Vaccination complication
Clinical narrative: mild seizure; sweaty; peaked and pale looked; felt clammy; fever of 100 degrees Fahrenheit; chills; achiness; not felt good at all; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (mild seizure) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 006B21A) 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 BUPROPION HYDROCHLORIDE (WELLBUTRIN) and VITAMIN D3 for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 17-Apr-2021, the patient experienced VACCINATION COMPLICATION (not felt good at all), PYREXIA (fever of 100 degrees Fahrenheit), CHILLS (chills) and MYALGIA (achiness). On 18-Apr-2021, the patient experienced SEIZURE (mild seizure) (seriousness criterion medically significant), HYPERHIDROSIS (sweaty), PALLOR (peaked and pale looked) and COLD SWEAT (felt clammy). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, SEIZURE (mild seizure), HYPERHIDROSIS (sweaty), PALLOR (peaked and pale looked), VACCINATION COMPLICATION (not felt good at all), COLD SWEAT (felt clammy), PYREXIA (fever of 100 degrees Fahrenheit), CHILLS (chills) and MYALGIA (achiness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Body temperature: 100 degrees fahrenheit (Inconclusive) 100 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment included as Tylenol. She also had orange juice and water during these episode.  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: M
Vaccine: COVID19
Symptoms: Femur fracture, Product dose omission issue
Clinical narrative: but is currently in the hospital for a femure fracture; supposed to get the 2nd dose/ likely miss the 2nd dose; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of FEMUR FRACTURE (but is currently in the hospital for a femure fracture) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (unknown route) at an unspecified dose. On 14-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (supposed to get the 2nd dose/ likely miss the 2nd dose). In April 2021, the patient experienced FEMUR FRACTURE (but is currently in the hospital for a femure fracture) (seriousness criteria hospitalization and medically significant). At the time of the report, FEMUR FRACTURE (but is currently in the hospital for a femure fracture) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (supposed to get the 2nd dose/ likely miss the 2nd dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter reported that her step father supposed to get the 2nd dose of Moderna Covid19 vaccine on Wednesday 14-APR-2021 but he will likely miss the second dose as he is currently in the hospital for a fracture femur. No treatment or concomitant medication were reported.  Based on current available information and the temporal association between product use and the start date of the event a causal relationship is unlikely.; Sender's Comments: Based o current available information and the temporal association between product use and the start date of the event a causal relationship is unlikely.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Loss of consciousness, Myalgia, Pyrexia
Clinical narrative: Passing out; Window of blurry vision before passing out for about 30 seconds; Upon regaining consciousness, patient immediately vomited; Fever; Feeling achy; Chills; Tired; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passing out) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 044B2V) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (LO LOESTRIN FE) for Birth control.   On 20-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 LOSS OF CONSCIOUSNESS (Passing out) (seriousness criterion medically significant), VISION BLURRED (Window of blurry vision before passing out for about 30 seconds), VOMITING (Upon regaining consciousness, patient immediately vomited), PYREXIA (Fever), MYALGIA (Feeling achy), CHILLS (Chills) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (Passing out), VISION BLURRED (Window of blurry vision before passing out for about 30 seconds), VOMITING (Upon regaining consciousness, patient immediately vomited), PYREXIA (Fever), MYALGIA (Feeling achy), CHILLS (Chills) and FATIGUE (Tired) outcome was unknown.            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.