chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: received a vaccine which was more than 30 days in the refrigerator; all the patients who received a vaccine which was more than 30 days in the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (all the patients who received a vaccine which was more than 30 days in the refrigerator) in a 26-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (all the patients who received a vaccine which was more than 30 days in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator) and PRODUCT STORAGE ERROR (all the patients who received a vaccine which was more than 30 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   NO Concomitant drug reported. NO Treatment drug reported. HCP reported patients who received  vaccine which was more than 30 days in the refrigerator (30 days were on 03Jul2021). For this patient, the number of days that have passed were 12. Patient received second dose on 15th Jul 2021.
Age: 43.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a vaccine which was more than 30 days in the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator) in a 43-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.    On 21-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment information was reported.   This case was linked to MOD-2021-126929 (Patient Link).   Reporter did not allow further contact
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a vaccine which was more than 30 days in the refrigerator; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a vaccine which was more than 30 days in the refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Dyspnoea, Headache, Malaise
Clinical narrative: Difficulty breathing; Sore throat; Swelling of the right arm; Tingling in the right fingers; Some loss of movement in the right hand; Headaches; Injection site pain; Dizziness; Malaise; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (Dizziness), MALAISE (Malaise), DYSPNOEA (Difficulty breathing), OROPHARYNGEAL PAIN (Sore throat) and PERIPHERAL SWELLING (Swelling of the right arm) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) 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) for an unknown indication.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced DIZZINESS (Dizziness), MALAISE (Malaise), HEADACHE (Headaches) and VACCINATION SITE PAIN (Injection site pain). On 14-Aug-2021, the patient experienced DYSPNOEA (Difficulty breathing), OROPHARYNGEAL PAIN (Sore throat), PERIPHERAL SWELLING (Swelling of the right arm), PARAESTHESIA (Tingling in the right fingers) and MOBILITY DECREASED (Some loss of movement in the right hand). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form; PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, DIZZINESS (Dizziness), MALAISE (Malaise), DYSPNOEA (Difficulty breathing), OROPHARYNGEAL PAIN (Sore throat), PERIPHERAL SWELLING (Swelling of the right arm), PARAESTHESIA (Tingling in the right fingers), MOBILITY DECREASED (Some loss of movement in the right hand), HEADACHE (Headaches) and VACCINATION SITE PAIN (Injection site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Aug-2021, Blood pressure measurement: 87/60 (Low) 87/60.     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.   Patient discontinued Wellbutrin Treatment medication included a steroid injection.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Oropharyngeal pain, Paraesthesia, Peripheral swelling, Vaccination site pain
Clinical narrative: Difficulty breathing; Sore throat; Swelling of the right arm; Tingling in the right fingers; Some loss of movement in the right hand; Headaches; Injection site pain; Dizziness; Malaise; This spontaneous case was reported by an other health care professional and describes the occurrence of DIZZINESS (Dizziness), MALAISE (Malaise), DYSPNOEA (Difficulty breathing), OROPHARYNGEAL PAIN (Sore throat) and PERIPHERAL SWELLING (Swelling of the right arm) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) 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) for an unknown indication.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced DIZZINESS (Dizziness), MALAISE (Malaise), HEADACHE (Headaches) and VACCINATION SITE PAIN (Injection site pain). On 14-Aug-2021, the patient experienced DYSPNOEA (Difficulty breathing), OROPHARYNGEAL PAIN (Sore throat), PERIPHERAL SWELLING (Swelling of the right arm), PARAESTHESIA (Tingling in the right fingers) and MOBILITY DECREASED (Some loss of movement in the right hand). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form; PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, DIZZINESS (Dizziness), MALAISE (Malaise), DYSPNOEA (Difficulty breathing), OROPHARYNGEAL PAIN (Sore throat), PERIPHERAL SWELLING (Swelling of the right arm), PARAESTHESIA (Tingling in the right fingers), MOBILITY DECREASED (Some loss of movement in the right hand), HEADACHE (Headaches) and VACCINATION SITE PAIN (Injection site pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Aug-2021, Blood pressure measurement: 87/60 (Low) 87/60.     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.   Patient discontinued Wellbutrin Treatment medication included a steroid injection.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Thrombosis
Clinical narrative: Blood clot a few weeks after first dose; Unable to get second dose of the vaccine, outside recommended schedule; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot a few weeks after first dose) 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.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clot a few weeks after first dose) (seriousness criterion medically significant) and PRODUCT DOSE OMISSION ISSUE (Unable to get second dose of the vaccine, outside recommended schedule). At the time of the report, THROMBOSIS (Blood clot a few weeks after first dose) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Unable to get second dose of the vaccine, outside recommended schedule) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information was not provided.   The reporter stated that the patient had received first dose of the Moderna COVID-19 vaccine in March 2021 and couple of weeks later, the patient reportedly had a blood clot and was unable to get the second dose of the vaccine.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and High cholesterol. Concomitant products included LOSARTAN, ATORVASTATIN, VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the event disappeared within 48 hours.  No Treatment information was provided by the reporter.   This case was linked to MOD-2021-027592 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain in extremity
Clinical narrative: Pain in the arm muscles; cramping in muscle of hands that generated her great pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Pain in the arm muscles) and PAIN IN EXTREMITY (cramping in muscle of hands that generated her great pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Aug-2021, the patient experienced MUSCLE SPASMS (Pain in the arm muscles) and PAIN IN EXTREMITY (cramping in muscle of hands that generated her great pain). At the time of the report, MUSCLE SPASMS (Pain in the arm muscles) and PAIN IN EXTREMITY (cramping in muscle of hands that generated her great pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Photopsia, Retinal tear, Vaccination complication, Vaccination site pain, Vitreous floaters
Clinical narrative: Vitreous hemorrhage on the left eye; Strange reaction; Second shot really hurt/injection site was sore for several days; Flashes in left eye, like lightning; Bottom part of the left eye was filling up with a sick mucus like fluid; Retina was tearing; This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS HAEMORRHAGE (Vitreous hemorrhage on the left eye) and RETINAL TEAR (Retina was tearing) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced VITREOUS HAEMORRHAGE (Vitreous hemorrhage on the left eye) (seriousness criterion medically significant), VACCINATION COMPLICATION (Strange reaction) and VACCINATION SITE PAIN (Second shot really hurt/injection site was sore for several days). In April 2021, the patient experienced RETINAL TEAR (Retina was tearing) (seriousness criterion medically significant), PHOTOPSIA (Flashes in left eye, like lightning) and VITREOUS FLOATERS (Bottom part of the left eye was filling up with a sick mucus like fluid). The patient was treated with Surgery (Laser surgery) for Vitreous haemorrhage and Surgery (Laser surgery) for Retinal tear. At the time of the report, VITREOUS HAEMORRHAGE (Vitreous hemorrhage on the left eye), RETINAL TEAR (Retina was tearing), VACCINATION COMPLICATION (Strange reaction), PHOTOPSIA (Flashes in left eye, like lightning), VITREOUS FLOATERS (Bottom part of the left eye was filling up with a sick mucus like fluid) and VACCINATION SITE PAIN (Second shot really hurt/injection site was sore for several days) outcome was unknown.            No concomitant medication information was provided.  Treatment information included laser surgery.  Very limited information regarding this events has been provided at this time.  However, 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-2021-044452 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time.  However, 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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vitreous haemorrhage
Clinical narrative: Vitreous hemorrhage on the left eye; Strange reaction; Second shot really hurt/injection site was sore for several days; Flashes in left eye, like lightning; Bottom part of the left eye was filling up with a sick mucus like fluid; Retina was tearing; This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS HAEMORRHAGE (Vitreous hemorrhage on the left eye) and RETINAL TEAR (Retina was tearing) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced VITREOUS HAEMORRHAGE (Vitreous hemorrhage on the left eye) (seriousness criterion medically significant), VACCINATION COMPLICATION (Strange reaction) and VACCINATION SITE PAIN (Second shot really hurt/injection site was sore for several days). In April 2021, the patient experienced RETINAL TEAR (Retina was tearing) (seriousness criterion medically significant), PHOTOPSIA (Flashes in left eye, like lightning) and VITREOUS FLOATERS (Bottom part of the left eye was filling up with a sick mucus like fluid). The patient was treated with Surgery (Laser surgery) for Vitreous haemorrhage and Surgery (Laser surgery) for Retinal tear. At the time of the report, VITREOUS HAEMORRHAGE (Vitreous hemorrhage on the left eye), RETINAL TEAR (Retina was tearing), VACCINATION COMPLICATION (Strange reaction), PHOTOPSIA (Flashes in left eye, like lightning), VITREOUS FLOATERS (Bottom part of the left eye was filling up with a sick mucus like fluid) and VACCINATION SITE PAIN (Second shot really hurt/injection site was sore for several days) outcome was unknown.            No concomitant medication information was provided.  Treatment information included laser surgery.  Very limited information regarding this events has been provided at this time.  However, 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-2021-044452 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time.  However, 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: Heart rate, Heart rate increased
Clinical narrative: Rapid heart rate; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid heart rate) 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 HEART RATE INCREASED (Rapid heart rate). At the time of the report, HEART RATE INCREASED (Rapid heart rate) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) rapid heart rate.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site irritation, Vaccination site warmth
Clinical narrative: Injection site is irritated; injection site is becoming hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE IRRITATION (Injection site is irritated) and VACCINATION SITE WARMTH (injection site is becoming hot) 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 VACCINATION SITE IRRITATION (Injection site is irritated) and VACCINATION SITE WARMTH (injection site is becoming hot). At the time of the report, VACCINATION SITE IRRITATION (Injection site is irritated) and VACCINATION SITE WARMTH (injection site is becoming hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: she is not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (she is not feeling well) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (she is not feeling well). At the time of the report, MALAISE (she is not feeling well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: I got the first shot april 26th and neved got a second shot. Can I still get the second shot and it be effective; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I got the first shot april 26th and neved got a second shot. Can I still get the second shot and it be effective) 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 26-Apr-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 PRODUCT DOSE OMISSION ISSUE (I got the first shot april 26th and neved got a second shot. Can I still get the second shot and it be effective). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I got the first shot april 26th and neved got a second shot. Can I still get the second shot and it be effective) had resolved.            No concomitant medication information was reported. No treatment medications were provided.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Headache
Clinical narrative: few other things; headache; This spontaneous case was reported by an other health care professional and describes the occurrence of ADVERSE EVENT (few other things) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jun-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 ADVERSE EVENT (few other things) (seriousness criterion death) and HEADACHE (headache). On 30-Jul-2021, HEADACHE (headache) had resolved. The patient died on 30-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed.        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 relevant concomitant and treatment medications were reported  Very limited information regarding the events has been provided at this time.   This case was linked to MOD-2021-286501 (Patient Link).; Sender's Comments: Very limited information regarding the events has been provided at this time.; Reported Cause(s) of Death: unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I tested positive months after being fully vaccinated; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (I tested positive months after being fully vaccinated) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (I tested positive months after being fully vaccinated). At the time of the report, COVID-19 (I tested positive months after being fully vaccinated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: unknown (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication was not provided by the reporter. Treatment was not provided by the reporter.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine administered  after it was stored beyond 12 hours at room temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administered  after it was stored beyond 12 hours at room temperature) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administered  after it was stored beyond 12 hours at room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine administered  after it was stored beyond 12 hours at room temperature) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided by the reporter.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Fall, Headache, Insomnia
Clinical narrative: Patient is having trouble sleeping; Patient having panic attacks; Anxiety; Felt very weak and then nearly fell down; Patient felt extremely weak/ patient continued to feel weak on 10Apr2021; Nausea; Headache; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Patient felt extremely weak/ patient continued to feel weak on 10Apr2021) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting). On 08-Apr-2021, the patient experienced ASTHENIA (Patient felt extremely weak/ patient continued to feel weak on 10Apr2021) (seriousness criterion medically significant). On 15-Apr-2021, the patient experienced FALL (Felt very weak and then nearly fell down). On an unknown date, the patient experienced INSOMNIA (Patient is having trouble sleeping), PANIC ATTACK (Patient having panic attacks) and ANXIETY (Anxiety). On 05-Apr-2021, HEADACHE (Headache) had resolved. At the time of the report, ASTHENIA (Patient felt extremely weak/ patient continued to feel weak on 10Apr2021), INSOMNIA (Patient is having trouble sleeping), PANIC ATTACK (Patient having panic attacks), ANXIETY (Anxiety), FALL (Felt very weak and then nearly fell down), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient visited emergency room where Electrocardiogram, Blood work was done and results was not reported .  Patient was given IV fluids. Everything came back normal. Patient was discharged from Emergency room and was asked to follow up with the Physician. Patient went to see his Primary Care Physician on 16APR2021. The patient' Doctor advised that he take one week off from work which he did. The patient went to go see his Physician again  Treatment medications include medications for anxiety.  company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-286531 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Panic attack, Vomiting
Clinical narrative: Patient is having trouble sleeping; Patient having panic attacks; Anxiety; Felt very weak and then nearly fell down; Patient felt extremely weak/ patient continued to feel weak on 10Apr2021; Nausea; Headache; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Patient felt extremely weak/ patient continued to feel weak on 10Apr2021) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced NAUSEA (Nausea), HEADACHE (Headache) and VOMITING (Vomiting). On 08-Apr-2021, the patient experienced ASTHENIA (Patient felt extremely weak/ patient continued to feel weak on 10Apr2021) (seriousness criterion medically significant). On 15-Apr-2021, the patient experienced FALL (Felt very weak and then nearly fell down). On an unknown date, the patient experienced INSOMNIA (Patient is having trouble sleeping), PANIC ATTACK (Patient having panic attacks) and ANXIETY (Anxiety). On 05-Apr-2021, HEADACHE (Headache) had resolved. At the time of the report, ASTHENIA (Patient felt extremely weak/ patient continued to feel weak on 10Apr2021), INSOMNIA (Patient is having trouble sleeping), PANIC ATTACK (Patient having panic attacks), ANXIETY (Anxiety), FALL (Felt very weak and then nearly fell down), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient visited emergency room where Electrocardiogram, Blood work was done and results was not reported .  Patient was given IV fluids. Everything came back normal. Patient was discharged from Emergency room and was asked to follow up with the Physician. Patient went to see his Primary Care Physician on 16APR2021. The patient' Doctor advised that he take one week off from work which he did. The patient went to go see his Physician again  Treatment medications include medications for anxiety.  company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-286531 (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.
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain
Clinical narrative: Slight pain on left side under the ribs when I breath in deep; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (Slight pain on left side under the ribs when I breath in deep) 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 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL CHEST PAIN (Slight pain on left side under the ribs when I breath in deep). At the time of the report, MUSCULOSKELETAL CHEST PAIN (Slight pain on left side under the ribs when I breath in deep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No Treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chills, Fatigue, Myalgia
Clinical narrative: Overheated; Muscles hurt; Chills; Felt fatigued; Feverish; This spontaneous case was reported by a nurse and describes the occurrence of BODY TEMPERATURE INCREASED (Overheated), MYALGIA (Muscles hurt), CHILLS (Chills), FATIGUE (Felt fatigued) and PYREXIA (Feverish) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced MYALGIA (Muscles hurt), CHILLS (Chills), FATIGUE (Felt fatigued) and PYREXIA (Feverish). On an unknown date, the patient experienced BODY TEMPERATURE INCREASED (Overheated). At the time of the report, BODY TEMPERATURE INCREASED (Overheated), MYALGIA (Muscles hurt), CHILLS (Chills), FATIGUE (Felt fatigued) and PYREXIA (Feverish) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Body temperature: increased (High) patient temperature got high after working in 103 degrees Fahrenheit temperature in the woods and stated that he was fine.     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 medications were provided by the reporter.    This case was linked to MOD-2021-286538 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Overheated; Muscles hurt; Chills; Felt fatigued; Feverish; This spontaneous case was reported by a nurse and describes the occurrence of BODY TEMPERATURE INCREASED (Overheated), MYALGIA (Muscles hurt), CHILLS (Chills), FATIGUE (Felt fatigued) and PYREXIA (Feverish) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced MYALGIA (Muscles hurt), CHILLS (Chills), FATIGUE (Felt fatigued) and PYREXIA (Feverish). On an unknown date, the patient experienced BODY TEMPERATURE INCREASED (Overheated). At the time of the report, BODY TEMPERATURE INCREASED (Overheated), MYALGIA (Muscles hurt), CHILLS (Chills), FATIGUE (Felt fatigued) and PYREXIA (Feverish) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Body temperature: increased (High) patient temperature got high after working in 103 degrees Fahrenheit temperature in the woods and stated that he was fine.     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 medications were provided by the reporter.    This case was linked to MOD-2021-286538 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Syncope, Urinary incontinence
Clinical narrative: The c/o of syncope and urinary incontinence; The c/o of syncope and urinary incontinence.; 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 SYNCOPE (The c/o of syncope and urinary incontinence) and URINARY INCONTINENCE (The c/o of syncope and urinary incontinence.) 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 13-Aug-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 SYNCOPE (The c/o of syncope and urinary incontinence) (seriousness criterion medically significant) and URINARY INCONTINENCE (The c/o of syncope and urinary incontinence.) (seriousness criterion medically significant). At the time of the report, SYNCOPE (The c/o of syncope and urinary incontinence) and URINARY INCONTINENCE (The c/o of syncope and urinary incontinence.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment information was not provided by reporter.  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: F
Vaccine: COVID19
Symptoms: Cellulitis, Erythema, Hypersensitivity, Mass, Pain
Clinical narrative: Cellulitis; Red patches; one lump but not bright red looks like pinkish color / three more lumps appeared; hot to the touch; painful; allergic reaction; hard at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (Cellulitis) 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 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant), ERYTHEMA (Red patches), MASS (one lump but not bright red looks like pinkish color / three more lumps appeared), SKIN WARM (hot to the touch), PAIN (painful), HYPERSENSITIVITY (allergic reaction) and VACCINATION SITE INDURATION (hard at the injection site). At the time of the report, CELLULITIS (Cellulitis), ERYTHEMA (Red patches), MASS (one lump but not bright red looks like pinkish color / three more lumps appeared), SKIN WARM (hot to the touch), PAIN (painful), HYPERSENSITIVITY (allergic reaction) and VACCINATION SITE INDURATION (hard at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment medication included antibiotics.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Skin warm, Vaccination site induration
Clinical narrative: Cellulitis; Red patches; one lump but not bright red looks like pinkish color / three more lumps appeared; hot to the touch; painful; allergic reaction; hard at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS (Cellulitis) 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 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CELLULITIS (Cellulitis) (seriousness criterion medically significant), ERYTHEMA (Red patches), MASS (one lump but not bright red looks like pinkish color / three more lumps appeared), SKIN WARM (hot to the touch), PAIN (painful), HYPERSENSITIVITY (allergic reaction) and VACCINATION SITE INDURATION (hard at the injection site). At the time of the report, CELLULITIS (Cellulitis), ERYTHEMA (Red patches), MASS (one lump but not bright red looks like pinkish color / three more lumps appeared), SKIN WARM (hot to the touch), PAIN (painful), HYPERSENSITIVITY (allergic reaction) and VACCINATION SITE INDURATION (hard at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment medication included antibiotics.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Ophthalmic migraine
Clinical narrative: One day shy of two weeks post had an ocular migraine; This spontaneous case was reported by a consumer and describes the occurrence of OPHTHALMIC MIGRAINE (One day shy of two weeks post had an ocular migraine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 OPHTHALMIC MIGRAINE (One day shy of two weeks post had an ocular migraine). At the time of the report, OPHTHALMIC MIGRAINE (One day shy of two weeks post had an ocular migraine) outcome was unknown.            No relevant concomitant medications were reported. Patient had the migraine weekly since its occurrence. No treatment information was provided.  Company comment: Very limited information regarding this event has been provided at this time. The event may probably be related to the patient's comorbidity, additional information required.; Sender's Comments: Very limited information regarding this event has been provided at this time. The event may probably be related to the patient's comorbidity, additional information required.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Mass, Pruritus, Vaccination site mass
Clinical narrative: lumps in the arm where he had the injection; Lumps throughout the body and arm; Lumps burn, are itchy, hard and bright red; Lumps burn, are itchy, hard and bright red; Lumps burn, are itchy, hard and bright red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lumps in the arm where he had the injection), MASS (Lumps throughout the body and arm), BURNING SENSATION (Lumps burn, are itchy, hard and bright red), ERYTHEMA (Lumps burn, are itchy, hard and bright red) and PRURITUS (Lumps burn, are itchy, hard and bright red) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Arm operation (Right Arm Surgery).    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MASS (lumps in the arm where he had the injection), MASS (Lumps throughout the body and arm), BURNING SENSATION (Lumps burn, are itchy, hard and bright red), ERYTHEMA (Lumps burn, are itchy, hard and bright red) and PRURITUS (Lumps burn, are itchy, hard and bright red). At the time of the report, VACCINATION SITE MASS (lumps in the arm where he had the injection), MASS (Lumps throughout the body and arm), BURNING SENSATION (Lumps burn, are itchy, hard and bright red), ERYTHEMA (Lumps burn, are itchy, hard and bright red) and PRURITUS (Lumps burn, are itchy, hard and bright red) 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. The patient had symptoms that started within a couple of hours after receiving the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Follow-up received on 13-Aug-2021. Included updated Reporter Last name, State, City, Postal code, Patient Initial, Date of Birth, Gender, Relevant History, Concomitant medications-none,Route of Administration, Anatomical location and Additional events.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed the second dose) 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 06-Apr-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 PRODUCT DOSE OMISSION ISSUE (missed the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed the second dose) had 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 medications were reported.  Treatment information was not provided by the reporter.