chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Cough, Dyspnoea, Eyelid ptosis, Headache
Clinical narrative: Became out of breath; Speech was impaired due to numbness on Sunday; Intensification of numbness on left side of face; New numbness right side of face including drooping right eye lid.; Pain shot to my left foot; Sore throat feeling like had a virus; Cough; Fever went to 101.2; Pain at shot area; Excrutiating headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain shot to my left foot), OROPHARYNGEAL PAIN (Sore throat feeling like had a virus), HYPOAESTHESIA (Intensification of numbness on left side of face), EYELID PTOSIS (New numbness right side of face including drooping right eye lid.) and DYSPNOEA (Became out of breath) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (covid survivor and was long haul before these vaccines.). Concurrent medical conditions included Asthma (severe asthmatic.). Concomitant products included IBUPROFEN for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Pain shot to my left foot), OROPHARYNGEAL PAIN (Sore throat feeling like had a virus), EYELID PTOSIS (New numbness right side of face including drooping right eye lid.), COUGH (Cough), PYREXIA (Fever went to 101.2), VACCINATION SITE PAIN (Pain at shot area) and HEADACHE (Excrutiating headache). On 06-Oct-2021, the patient experienced HYPOAESTHESIA (Intensification of numbness on left side of face). On 10-Oct-2021, the patient experienced SPEECH DISORDER (Speech was impaired due to numbness on Sunday). On 11-Oct-2021, the patient experienced DYSPNOEA (Became out of breath). At the time of the report, PAIN IN EXTREMITY (Pain shot to my left foot), OROPHARYNGEAL PAIN (Sore throat feeling like had a virus), HYPOAESTHESIA (Intensification of numbness on left side of face), EYELID PTOSIS (New numbness right side of face including drooping right eye lid.), DYSPNOEA (Became out of breath), SPEECH DISORDER (Speech was impaired due to numbness on Sunday), COUGH (Cough), PYREXIA (Fever went to 101.2), VACCINATION SITE PAIN (Pain at shot area) and HEADACHE (Excrutiating headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.2 (High) fever went to 101.2.         Patient took 2 ibuprofen over 9 hours prior to the 2nd shot and taken no otcs including ibuprofen or vitamins after.  No treatment information was provided.   This case was linked to MOD-2021-323555 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Oropharyngeal pain, Pain in extremity, Pyrexia, Speech disorder
Clinical narrative: Became out of breath; Speech was impaired due to numbness on Sunday; Intensification of numbness on left side of face; New numbness right side of face including drooping right eye lid.; Pain shot to my left foot; Sore throat feeling like had a virus; Cough; Fever went to 101.2; Pain at shot area; Excrutiating headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain shot to my left foot), OROPHARYNGEAL PAIN (Sore throat feeling like had a virus), HYPOAESTHESIA (Intensification of numbness on left side of face), EYELID PTOSIS (New numbness right side of face including drooping right eye lid.) and DYSPNOEA (Became out of breath) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (covid survivor and was long haul before these vaccines.). Concurrent medical conditions included Asthma (severe asthmatic.). Concomitant products included IBUPROFEN for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Pain shot to my left foot), OROPHARYNGEAL PAIN (Sore throat feeling like had a virus), EYELID PTOSIS (New numbness right side of face including drooping right eye lid.), COUGH (Cough), PYREXIA (Fever went to 101.2), VACCINATION SITE PAIN (Pain at shot area) and HEADACHE (Excrutiating headache). On 06-Oct-2021, the patient experienced HYPOAESTHESIA (Intensification of numbness on left side of face). On 10-Oct-2021, the patient experienced SPEECH DISORDER (Speech was impaired due to numbness on Sunday). On 11-Oct-2021, the patient experienced DYSPNOEA (Became out of breath). At the time of the report, PAIN IN EXTREMITY (Pain shot to my left foot), OROPHARYNGEAL PAIN (Sore throat feeling like had a virus), HYPOAESTHESIA (Intensification of numbness on left side of face), EYELID PTOSIS (New numbness right side of face including drooping right eye lid.), DYSPNOEA (Became out of breath), SPEECH DISORDER (Speech was impaired due to numbness on Sunday), COUGH (Cough), PYREXIA (Fever went to 101.2), VACCINATION SITE PAIN (Pain at shot area) and HEADACHE (Excrutiating headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.2 (High) fever went to 101.2.         Patient took 2 ibuprofen over 9 hours prior to the 2nd shot and taken no otcs including ibuprofen or vitamins after.  No treatment information was provided.   This case was linked to MOD-2021-323555 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Became out of breath; Speech was impaired due to numbness on Sunday; Intensification of numbness on left side of face; New numbness right side of face including drooping right eye lid.; Pain shot to my left foot; Sore throat feeling like had a virus; Cough; Fever went to 101.2; Pain at shot area; Excrutiating headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain shot to my left foot), OROPHARYNGEAL PAIN (Sore throat feeling like had a virus), HYPOAESTHESIA (Intensification of numbness on left side of face), EYELID PTOSIS (New numbness right side of face including drooping right eye lid.) and DYSPNOEA (Became out of breath) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (covid survivor and was long haul before these vaccines.). Concurrent medical conditions included Asthma (severe asthmatic.). Concomitant products included IBUPROFEN for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Pain shot to my left foot), OROPHARYNGEAL PAIN (Sore throat feeling like had a virus), EYELID PTOSIS (New numbness right side of face including drooping right eye lid.), COUGH (Cough), PYREXIA (Fever went to 101.2), VACCINATION SITE PAIN (Pain at shot area) and HEADACHE (Excrutiating headache). On 06-Oct-2021, the patient experienced HYPOAESTHESIA (Intensification of numbness on left side of face). On 10-Oct-2021, the patient experienced SPEECH DISORDER (Speech was impaired due to numbness on Sunday). On 11-Oct-2021, the patient experienced DYSPNOEA (Became out of breath). At the time of the report, PAIN IN EXTREMITY (Pain shot to my left foot), OROPHARYNGEAL PAIN (Sore throat feeling like had a virus), HYPOAESTHESIA (Intensification of numbness on left side of face), EYELID PTOSIS (New numbness right side of face including drooping right eye lid.), DYSPNOEA (Became out of breath), SPEECH DISORDER (Speech was impaired due to numbness on Sunday), COUGH (Cough), PYREXIA (Fever went to 101.2), VACCINATION SITE PAIN (Pain at shot area) and HEADACHE (Excrutiating headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.2 (High) fever went to 101.2.         Patient took 2 ibuprofen over 9 hours prior to the 2nd shot and taken no otcs including ibuprofen or vitamins after.  No treatment information was provided.   This case was linked to MOD-2021-323555 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: diagnosed with Afib; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (diagnosed with Afib) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ATRIAL FIBRILLATION (diagnosed with Afib) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (diagnosed with Afib) outcome was unknown.            Patient diagnostic data included echocardiogram, ultrasound with unknown results. No relevant concomitant medications were reported. Treatment information included blood thinners & meds to slow his heart down.  Company comment: This case concerns a male patient of unknown age with no medical history reported, who experienced the unexpected event of atrial fibrillation. The event occurred on an unknown date, while the second dose of the Moderna Covid-19 vaccine was received in March 2021. The rechallenge is not applicable since no information was provided of the other dose. The benefit-risk relationship of the vaccine is not affected by this report   This case was linked to MOD-2021-028042 (Patient Link).; Sender's Comments: This case concerns a male patient of unknown age with no medical history reported, who experienced the unexpected event of atrial fibrillation. The event occurred on an unknown date, while the second dose of the Moderna Covid-19 vaccine was received in March 2021. The rechallenge is not applicable since no information was provided of the other dose. The benefit-risk relationship of the vaccine is not affected by this report
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: made me sick two times; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Oct-2021 and was forwarded to Moderna on 12-Oct-2021.    This spontaneous case was reported by a nurse and describes the occurrence of ILLNESS (made me sick two times) 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 ILLNESS (made me sick two times). At the time of the report, ILLNESS (made me sick two times) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were not reported. No treatment medications were not provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Caller reports that normally she can't see at night when she drives but since she got the second shot she can see clearly at night better without her glasses; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Caller reports that normally she can't see at night when she drives but since she got the second shot she can see clearly at night better without her glasses) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0R8E211A and 088D211A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient mentioned having a positive Covid19 diagnosis 24November2020-14Janurary2021.) from 24-Nov-2020 to 14-Jan-2021.   On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, 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 experienced THERAPEUTIC RESPONSE UNEXPECTED (Caller reports that normally she can't see at night when she drives but since she got the second shot she can see clearly at night better without her glasses). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Caller reports that normally she can't see at night when she drives but since she got the second shot she can see clearly at night better without her glasses) outcome was unknown.            Concomitant medications include blood pressure medication. Treatment medications include Tylenol extra strength and used a heating pad for her arm. Caller reports that normally she can't see at night when she drives but since she got the second shot she can see clearly at night, better without her glasses beginning at the end of August/beginning of September.   This case was linked to MOD-2021-350653 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: more than 35 days for 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 35 days for 2nd dose) 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 04-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 35 days for 2nd dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 35 days for 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: pain in the arm of injection after the first dose; rash on the same arm of injection after the first dose; 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 VACCINATION SITE PAIN (pain in the arm of injection after the first dose) and VACCINATION SITE RASH (rash on the same arm of injection after the first 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 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 VACCINATION SITE PAIN (pain in the arm of injection after the first dose) and VACCINATION SITE RASH (rash on the same arm of injection after the first dose). At the time of the report, VACCINATION SITE PAIN (pain in the arm of injection after the first dose) and VACCINATION SITE RASH (rash on the same arm of injection after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter Treatment information was not provided   Reporter did not allow further contact
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness postural, Dysphonia, Fatigue, Headache
Clinical narrative: Sick for three days; Chest pain; Night sweeting; Not being able to sleep; Dizziness while standing or resting; Voice changes; Muscle weakness and fatigue; muscle cramps; Felling tired all the time /felling "beaten down"; Terrific headaches and chest pain; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for three days), CHEST PAIN (Chest pain), NIGHT SWEATS (Night sweeting), INSOMNIA (Not being able to sleep) and DIZZINESS POSTURAL (Dizziness while standing or resting) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Pulmonary hypertension.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, 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 experienced ILLNESS (Sick for three days), CHEST PAIN (Chest pain), NIGHT SWEATS (Night sweeting), INSOMNIA (Not being able to sleep), DIZZINESS POSTURAL (Dizziness while standing or resting), DYSPHONIA (Voice changes), MUSCULAR WEAKNESS (Muscle weakness and fatigue), MUSCLE SPASMS (muscle cramps), FATIGUE (Felling tired all the time /felling "beaten down") and HEADACHE (Terrific headaches and chest pain). At the time of the report, ILLNESS (Sick for three days), CHEST PAIN (Chest pain), NIGHT SWEATS (Night sweeting), INSOMNIA (Not being able to sleep), DIZZINESS POSTURAL (Dizziness while standing or resting), DYSPHONIA (Voice changes), MUSCULAR WEAKNESS (Muscle weakness and fatigue), MUSCLE SPASMS (muscle cramps), FATIGUE (Felling tired all the time /felling "beaten down") and HEADACHE (Terrific headaches and chest pain) outcome was unknown.            No concomitant medications reported.  Treatment included a medication prescribed by the Cardiologist
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Insomnia, Muscle spasms, Muscular weakness, Night sweats
Clinical narrative: Sick for three days; Chest pain; Night sweeting; Not being able to sleep; Dizziness while standing or resting; Voice changes; Muscle weakness and fatigue; muscle cramps; Felling tired all the time /felling "beaten down"; Terrific headaches and chest pain; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for three days), CHEST PAIN (Chest pain), NIGHT SWEATS (Night sweeting), INSOMNIA (Not being able to sleep) and DIZZINESS POSTURAL (Dizziness while standing or resting) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Pulmonary hypertension.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, 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 experienced ILLNESS (Sick for three days), CHEST PAIN (Chest pain), NIGHT SWEATS (Night sweeting), INSOMNIA (Not being able to sleep), DIZZINESS POSTURAL (Dizziness while standing or resting), DYSPHONIA (Voice changes), MUSCULAR WEAKNESS (Muscle weakness and fatigue), MUSCLE SPASMS (muscle cramps), FATIGUE (Felling tired all the time /felling "beaten down") and HEADACHE (Terrific headaches and chest pain). At the time of the report, ILLNESS (Sick for three days), CHEST PAIN (Chest pain), NIGHT SWEATS (Night sweeting), INSOMNIA (Not being able to sleep), DIZZINESS POSTURAL (Dizziness while standing or resting), DYSPHONIA (Voice changes), MUSCULAR WEAKNESS (Muscle weakness and fatigue), MUSCLE SPASMS (muscle cramps), FATIGUE (Felling tired all the time /felling "beaten down") and HEADACHE (Terrific headaches and chest pain) outcome was unknown.            No concomitant medications reported.  Treatment included a medication prescribed by the Cardiologist
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 4 patients were administered expired doses; 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 EXPIRED PRODUCT ADMINISTERED (4 patients were administered expired doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 patients were administered expired doses). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (4 patients were administered expired doses) 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.  The vials were initially stored in refrigerator on 12-Oct-2021. Expiry date of vaccine is 09-Oct-2021.   No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm after each dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm after each dose) 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 Cancer and RA.    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, the patient experienced PAIN IN EXTREMITY (Sore arm after each dose). At the time of the report, PAIN IN EXTREMITY (Sore arm after each dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. treatment medications were not reported.   This case was linked to MOD-2021-350754, MOD-2021-350729.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Magnetic resonance imaging
Clinical narrative: leg problem more extensive after the 3rd dose; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (leg problem more extensive after the 3rd dose) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 013M20A and 039K209) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LIMB DISCOMFORT (leg problem more extensive after the 3rd dose) (seriousness criterion hospitalization). The patient was hospitalized on sometime in October 2021 due to LIMB DISCOMFORT. At the time of the report, LIMB DISCOMFORT (leg problem more extensive after the 3rd dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Magnetic resonance imaging: normal (normal) MRI normal.         No concomitant medications reported. No treatment information was provided.  Patient again experienced the same leg problem this time more extensive than the 1st one.  The patient was admitted in the hospital for the night.  Company's comment: This case concerns a 77 year old, male patient, with no medical history reported who experienced serious unexpected event of limb discomfort after third dose of mRNA-1273. The event occurred 24 days after third dose of mRNA-1273. The re-challenge for the third dose is not applicable as further dose is not expected. The benefit-risk relationship of Spikevax in not affected by this report.   This case was linked to MOD-2021-350735 (Patient Link).; Sender's Comments: This case concerns a 77 year old, male patient, with no medical history reported who experienced serious unexpected event of limb discomfort after third dose of mRNA-1273. The event occurred 24 days after third dose of mRNA-1273. The re-challenge for the third dose is not applicable as further dose is not expected. The benefit-risk relationship of Spikevax in not affected by this report.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received dose from an expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from an expired vial) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from an expired vial). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received dose from an expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter  Treatment information was not provided   This case was linked to MOD-2021-350883 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Tremor
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Internal tremors), DIZZINESS (Lightheaded) and HEADACHE (Headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Dental care (had a dental work during the same period of time).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, 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 experienced TREMOR (Internal tremors), DIZZINESS (Lightheaded) and HEADACHE (Headaches). At the time of the report, TREMOR (Internal tremors), DIZZINESS (Lightheaded) and HEADACHE (Headaches) outcome was unknown.            No concomitant medication were reported. No treatment information was provided by the reporter.  Patient reported of still having some of the symptoms sometimes.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nasopharyngitis
Clinical narrative: Cold; Small headache; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold) and HEADACHE (Small headache) 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 NASOPHARYNGITIS (Cold) and HEADACHE (Small headache). At the time of the report, NASOPHARYNGITIS (Cold) and HEADACHE (Small headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: not feeling good; 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 MALAISE (not feeling good) 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 MALAISE (not feeling good). At the time of the report, MALAISE (not feeling good) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment information was not reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (14 patients administered expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (14 patients administered expired vaccine). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (14 patients administered expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 2 patients received the Moderna Covid-19 vaccine 12 hours past it's beyond use date.; 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 EXPIRED PRODUCT ADMINISTERED (2 patients received the Moderna Covid-19 vaccine 12 hours past it's beyond use date.) 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. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 patients received the Moderna Covid-19 vaccine 12 hours past it's beyond use date.). In October 2021, EXPIRED PRODUCT ADMINISTERED (2 patients received the Moderna Covid-19 vaccine 12 hours past it's beyond use date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No Treatment informations were reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received dose from expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information were provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received dose from expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-350866, MOD-2021-350960, MOD-2021-350771 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia
Clinical narrative: slept for a long time after their first dose of COVID19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (slept for a long time after their first dose of COVID19 vaccine) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSOMNIA (slept for a long time after their first dose of COVID19 vaccine). At the time of the report, HYPERSOMNIA (slept for a long time after their first dose of COVID19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitants products were reported no treatment drugs were reported; Sender's Comments: This case concerns female patient of unknown age with no medical history reported, who experienced the unexpected non-serious adverse event of special interest of hypersomnia. The event occurred on unknown date after the first dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was unknown since the event occurred after the first dose and there is no information about the second dose. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 10 doses administered past the 30 day use by date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 doses administered past the 30 day use by date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047821A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 doses administered past the 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (10 doses administered past the 30 day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient given vaccine after the 30-day refrigeration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient given vaccine after the 30-day refrigeration date) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient given vaccine after the 30-day refrigeration date). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient given vaccine after the 30-day refrigeration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2021: Significant follow up received on 13 Oct 2021,Lot number added
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. treatment medications were not reported.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second given at day 22) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.  On 13-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second given at day 22). On 13-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second given at day 22) had resolved.      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 provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a dose of and expired vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of and expired vaccine) 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) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of and expired vaccine). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received a dose of and expired vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned.  No treatment medication was mentioned.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered past the published expiry date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided. The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter Treatment information was not provided
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: minor little symptoms - fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (minor little symptoms - fever) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (minor little symptoms - fever). At the time of the report, PYREXIA (minor little symptoms - fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment medication was not provided by the reporter.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: doses administered past the published expiry date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment information was provided by the reporter.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Developed a red rash in left arm at injection site that moved down his arm; Developed a itchy rash in left arm at injection site that moved down his arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Developed a red rash in left arm at injection site that moved down his arm) and VACCINATION SITE PRURITUS (Developed a itchy rash in left arm at injection site that moved down his arm) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Developed a red rash in left arm at injection site that moved down his arm) and VACCINATION SITE PRURITUS (Developed a itchy rash in left arm at injection site that moved down his arm). At the time of the report, VACCINATION SITE ERYTHEMA (Developed a red rash in left arm at injection site that moved down his arm) and VACCINATION SITE PRURITUS (Developed a itchy rash in left arm at injection site that moved down his arm) outcome was unknown.            Concomitant medications were not provided. Treatment information include steroid cream  twice a day   This case was linked to MOD-2021-350964 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received dose from expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from expired vial) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from expired vial). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received dose from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. The vial was removed from the freezer on the day of administration and the product did not undergo any temperature excursion issue.   This case was linked to MOD-2021-350883 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: Minor little symptoms; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Minor little symptoms) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 COMPLICATION (Minor little symptoms) and PYREXIA (Fever). At the time of the report, VACCINATION COMPLICATION (Minor little symptoms) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medication was reported.