chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Eye irritation, Lung disorder, Photophobia
Clinical narrative: double vision when reading/still seeing double; eyes sensitive to light/eyes still very sensitive to light; burning eyes; unknown spot on left lung, another spot on right lung; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021. The most recent information was received on 24-Jul-2021 and was forwarded to Moderna on 24-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIPLOPIA (double vision when reading/still seeing double), PHOTOPHOBIA (eyes sensitive to light/eyes still very sensitive to light), EYE IRRITATION (burning eyes) and LUNG DISORDER (unknown spot on left lung, another spot on right lung) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIPLOPIA (double vision when reading/still seeing double), PHOTOPHOBIA (eyes sensitive to light/eyes still very sensitive to light), EYE IRRITATION (burning eyes) and LUNG DISORDER (unknown spot on left lung, another spot on right lung). At the time of the report, DIPLOPIA (double vision when reading/still seeing double) and PHOTOPHOBIA (eyes sensitive to light/eyes still very sensitive to light) had not resolved and EYE IRRITATION (burning eyes) and LUNG DISORDER (unknown spot on left lung, another spot on right lung) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  No concomitants were reported. No treatment drugs were reported. On 12-JUL-2021, patient got results of CT scan . It is reported that on an unknown date, patient had high blood sugar lately.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Outcome of the events eyes sensitive to light,blood sugar has been high,double vision when reading were changed from Unknown to Not recovered.Events Burning eyes,Have an Unknown spot on the left lung,another spot on right lung were added.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Received 0.3ml; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Received 0.3ml) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (Received 0.3ml). At the time of the report, PRODUCT ADMINISTRATION ERROR (Received 0.3ml) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Inappropriate schedule of product administration, Pain
Clinical narrative: 1st shot on 22APR2021 and  got his 2nd shot on 1JUN2021, / Got 2nd shot after more than 35 days of interval; Pain; Sick for one day; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st shot on 22APR2021 and  got his 2nd shot on 1JUN2021, / Got 2nd shot after more than 35 days of interval), PAIN (Pain) and ILLNESS (Sick for one day) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st shot on 22APR2021 and  got his 2nd shot on 1JUN2021, / Got 2nd shot after more than 35 days of interval), PAIN (Pain) and ILLNESS (Sick for one day). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st shot on 22APR2021 and  got his 2nd shot on 1JUN2021, / Got 2nd shot after more than 35 days of interval), PAIN (Pain) and ILLNESS (Sick for one day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose was administered to patient 4Jun2021 at approximately 9 AM after vial was punctured 3Jun2021 at approximately 9 AM.; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was administered to patient 4Jun2021 at approximately 9 AM after vial was punctured 3Jun2021 at approximately 9 AM.) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was administered to patient 4Jun2021 at approximately 9 AM after vial was punctured 3Jun2021 at approximately 9 AM.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was administered to patient 4Jun2021 at approximately 9 AM after vial was punctured 3Jun2021 at approximately 9 AM.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: The vial was punctured and left out at room temperature over night./patient received an invalid dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (The vial was punctured and left out at room temperature over night./patient received an invalid dose) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (The vial was punctured and left out at room temperature over night./patient received an invalid dose). At the time of the report, PRODUCT ADMINISTRATION ERROR (The vial was punctured and left out at room temperature over night./patient received an invalid dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Patient was administered with a vaccine that had experienced a temperature excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Patient was administered with a vaccine that had experienced a temperature excursion) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Patient was administered with a vaccine that had experienced a temperature excursion). At the time of the report, PRODUCT ADMINISTRATION ERROR (Patient was administered with a vaccine that had experienced a temperature excursion) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Fatigue, Feeling abnormal, Overdose, Pain in extremity
Clinical narrative: Sore arm; did not realize he had received the vaccine; minimal tenderness in his arm; Fatigue; patient received three doses of the Moderna covid-19 vaccine; patient received booster dose; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Jun-2021. The most recent information was received on 26-Jul-2021 and was forwarded to Moderna on 26-Jul-2021.    This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (did not realize he had received the vaccine), TENDERNESS (minimal tenderness in his arm), FATIGUE (Fatigue) and EXTRA DOSE ADMINISTERED (patient received booster dose) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stent placement (had two stents in his heart.). Concurrent medical conditions included Polymyalgia rheumatica, Hypertension and Atrial fibrillation. Concomitant products included PREDNISONE for Polymyalgia rheumatica, APIXABAN (ELIQUIS), ATENOLOL, LISINOPRIL and FEBUXOSTAT (ULORIC) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jul-2021, the patient experienced EXTRA DOSE ADMINISTERED (patient received booster dose). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (did not realize he had received the vaccine), TENDERNESS (minimal tenderness in his arm), FATIGUE (Fatigue) and OVERDOSE (patient received three doses of the Moderna covid-19 vaccine). On 01-Jul-2021, EXTRA DOSE ADMINISTERED (patient received booster dose) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (did not realize he had received the vaccine), TENDERNESS (minimal tenderness in his arm), FATIGUE (Fatigue) and OVERDOSE (patient received three doses of the Moderna covid-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-209121 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up received contains significant information. Added patient historical conditions, concomitant medications, events.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Tenderness
Clinical narrative: Sore arm; did not realize he had received the vaccine; minimal tenderness in his arm; Fatigue; patient received three doses of the Moderna covid-19 vaccine; patient received booster dose; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Jun-2021. The most recent information was received on 26-Jul-2021 and was forwarded to Moderna on 26-Jul-2021.    This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (did not realize he had received the vaccine), TENDERNESS (minimal tenderness in his arm), FATIGUE (Fatigue) and EXTRA DOSE ADMINISTERED (patient received booster dose) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stent placement (had two stents in his heart.). Concurrent medical conditions included Polymyalgia rheumatica, Hypertension and Atrial fibrillation. Concomitant products included PREDNISONE for Polymyalgia rheumatica, APIXABAN (ELIQUIS), ATENOLOL, LISINOPRIL and FEBUXOSTAT (ULORIC) for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jul-2021, the patient experienced EXTRA DOSE ADMINISTERED (patient received booster dose). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (did not realize he had received the vaccine), TENDERNESS (minimal tenderness in his arm), FATIGUE (Fatigue) and OVERDOSE (patient received three doses of the Moderna covid-19 vaccine). On 01-Jul-2021, EXTRA DOSE ADMINISTERED (patient received booster dose) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), FEELING ABNORMAL (did not realize he had received the vaccine), TENDERNESS (minimal tenderness in his arm), FATIGUE (Fatigue) and OVERDOSE (patient received three doses of the Moderna covid-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-209121 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up received contains significant information. Added patient historical conditions, concomitant medications, events.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Facal numbness; 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 HYPOAESTHESIA (Facal numbness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (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 HYPOAESTHESIA (Facal numbness). At the time of the report, HYPOAESTHESIA (Facal numbness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pruritus
Clinical narrative: itching on the shoulder blade after first shot; Fatigue after first shot; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching on the shoulder blade after first shot) and FATIGUE (Fatigue after first shot) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PRURITUS (itching on the shoulder blade after first shot) and FATIGUE (Fatigue after first shot). On 27-Mar-2021, FATIGUE (Fatigue after first shot) had resolved. On 05-Apr-2021, PRURITUS (itching on the shoulder blade after first shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Decreased appetite, Vaccination site pain, Weight
Clinical narrative: lost sense of smell; lost sense of taste; lost her appetite, doesn't feel like eating anything; still has soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ANOSMIA (lost sense of smell), AGEUSIA (lost sense of taste), DECREASED APPETITE (lost her appetite, doesn't feel like eating anything) and VACCINATION SITE PAIN (still has soreness at the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 ANOSMIA (lost sense of smell), AGEUSIA (lost sense of taste), DECREASED APPETITE (lost her appetite, doesn't feel like eating anything) and VACCINATION SITE PAIN (still has soreness at the injection site). At the time of the report, ANOSMIA (lost sense of smell), AGEUSIA (lost sense of taste), DECREASED APPETITE (lost her appetite, doesn't feel like eating anything) and VACCINATION SITE PAIN (still has soreness at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: lost 10 lbs (Low) lost 10 lbs.         No relevant concomitant medications reported.  No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects; 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 COMPLICATION (Side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant products usage were not reported by the reporter.  Treatment details not included.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Left arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm soreness) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004B21A) for COVID-19 immunisation.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (Left arm soreness). On 26-Apr-2021, PAIN IN EXTREMITY (Left arm soreness) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-irms-MOD21-107287 (Linked Report). This case was linked to MOD-2021-209118 (Patient Link).; Sender's Comments:  US-irms-MOD21-107287: (1st dose)
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Muscle tightness
Clinical narrative: bad taste in my mouth; leg tightness; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (bad taste in my mouth) and MUSCLE TIGHTNESS (leg tightness) 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 AGEUSIA (bad taste in my mouth) and MUSCLE TIGHTNESS (leg tightness). At the time of the report, AGEUSIA (bad taste in my mouth) and MUSCLE TIGHTNESS (leg tightness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in ears) 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 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Ringing in ears). At the time of the report, TINNITUS (Ringing in ears) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Malaise, Myalgia, Osteitis
Clinical narrative: Left size  of my collarbone was big   (inflamed) (size of a grape); An awful feeling.; I felt really sick; My left arm was hurting a lot/Pain all over my body; I felt really tired; This spontaneous case was reported by a consumer and describes the occurrence of OSTEITIS (Left size  of my collarbone was big   (inflamed) (size of a grape)), FEELING ABNORMAL (An awful feeling.), MALAISE (I felt really sick), MYALGIA (My left arm was hurting a lot/Pain all over my body) and FATIGUE (I felt really tired) 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 22-May-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 OSTEITIS (Left size  of my collarbone was big   (inflamed) (size of a grape)), FEELING ABNORMAL (An awful feeling.), MALAISE (I felt really sick), MYALGIA (My left arm was hurting a lot/Pain all over my body) and FATIGUE (I felt really tired). At the time of the report, OSTEITIS (Left size  of my collarbone was big   (inflamed) (size of a grape)), FEELING ABNORMAL (An awful feeling.), MALAISE (I felt really sick), MYALGIA (My left arm was hurting a lot/Pain all over my body) and FATIGUE (I felt really tired) outcome was unknown.            No Concomitant medication were reported. Treatment medication was not provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Migraine, Ocular discomfort
Clinical narrative: migraines; pressure in her eye; stabbing pain in her eye; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraines), OCULAR DISCOMFORT (pressure in her eye) and EYE PAIN (stabbing pain in her eye) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (migraines), OCULAR DISCOMFORT (pressure in her eye) and EYE PAIN (stabbing pain in her eye). At the time of the report, MIGRAINE (migraines), OCULAR DISCOMFORT (pressure in her eye) and EYE PAIN (stabbing pain in her eye) outcome was unknown.            No concomitant medication information was provided.  No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Updated contact information - Reporter details with consent to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic taste; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (Metallic taste). At the time of the report, DYSGEUSIA (Metallic taste) had not resolved.            Concomitant product use was not provided by the reporter. Treatment information was not provided.    This case was linked to MOD-2021-081339 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: has his second shot scheduled for today but he has a cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (has his second shot scheduled for today but he has a cold) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (has his second shot scheduled for today but he has a cold). At the time of the report, NASOPHARYNGITIS (has his second shot scheduled for today but he has a cold) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and Treatment medications were not provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Severe side effects; 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 ADVERSE EVENT (Severe side effects) 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 ADVERSE EVENT (Severe side effects). At the time of the report, ADVERSE EVENT (Severe side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Sude effects; 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 COMPLICATION (Sude effects) 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 COMPLICATION (Sude effects). At the time of the report, VACCINATION COMPLICATION (Sude effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: patient vaccinated from vial with 1st punctured more than 12 hours prior; 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 PRODUCT ADMINISTRATION ERROR (patient vaccinated from vial with 1st punctured more than 12 hours prior) 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 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (patient vaccinated from vial with 1st punctured more than 12 hours prior). At the time of the report, PRODUCT ADMINISTRATION ERROR (patient vaccinated from vial with 1st punctured more than 12 hours prior) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: A patient experienced mild chills with first dose; A patient experienced sore arm with first dose; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (A patient experienced mild chills with first dose) and MYALGIA (A patient experienced sore arm with first dose) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced CHILLS (A patient experienced mild chills with first dose) and MYALGIA (A patient experienced sore arm with first dose). The patient was treated with PARACETAMOL (TYLENOL) for Pain and Chills, at an unspecified dose and frequency and MECLOZINE HYDROCHLORIDE (MECLIZINE [MECLOZINE HYDROCHLORIDE]) for Vertigo, at an unspecified dose and frequency. At the time of the report, CHILLS (A patient experienced mild chills with first dose) and MYALGIA (A patient experienced sore arm with first dose) 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.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Dizziness, Ear pain, Headache
Clinical narrative: woozines; ear pain; Headache/ear sensations; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (woozines), EAR PAIN (ear pain) and HEADACHE (Headache/ear sensations) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Fish allergy (Allergy to Mackeral), Thyroid cancer (2005) in 2005, GERD since 2018, Osteopenia since 2015 and Osteoporosis since 2015. Concomitant products included LORATADINE (CLARITINE) for Headache, RISEDRONATE SODIUM (ACTONEL) for Osteoporosis, PRUCALOPRIDE SUCCINATE (MOTEGRITY) and MAGNESIUM OXIDE for Overgrowth bacterial, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for Vitamin D low, LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced HEADACHE (Headache/ear sensations). On an unknown date, the patient experienced DIZZINESS (woozines) and EAR PAIN (ear pain). The patient was treated with MONTELUKAST SODIUM (SINGULAIR) for Headache, at an unspecified dose and frequency. At the time of the report, DIZZINESS (woozines) and HEADACHE (Headache/ear sensations) had not resolved and EAR PAIN (ear pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) NORMAL. On an unknown date, Body temperature: 101 (Inconclusive) INCONCLUSIVE. On an unknown date, Magnetic resonance imaging: normal (normal) NORMAL.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient experienced other symptoms like brain fog and wild dreams.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging
Clinical narrative: woozines; ear pain; Headache/ear sensations; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (woozines), EAR PAIN (ear pain) and HEADACHE (Headache/ear sensations) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Fish allergy (Allergy to Mackeral), Thyroid cancer (2005) in 2005, GERD since 2018, Osteopenia since 2015 and Osteoporosis since 2015. Concomitant products included LORATADINE (CLARITINE) for Headache, RISEDRONATE SODIUM (ACTONEL) for Osteoporosis, PRUCALOPRIDE SUCCINATE (MOTEGRITY) and MAGNESIUM OXIDE for Overgrowth bacterial, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for Vitamin D low, LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced HEADACHE (Headache/ear sensations). On an unknown date, the patient experienced DIZZINESS (woozines) and EAR PAIN (ear pain). The patient was treated with MONTELUKAST SODIUM (SINGULAIR) for Headache, at an unspecified dose and frequency. At the time of the report, DIZZINESS (woozines) and HEADACHE (Headache/ear sensations) had not resolved and EAR PAIN (ear pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) NORMAL. On an unknown date, Body temperature: 101 (Inconclusive) INCONCLUSIVE. On an unknown date, Magnetic resonance imaging: normal (normal) NORMAL.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient experienced other symptoms like brain fog and wild dreams.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chills, Computerised tomogram, Hypoaesthesia, Rash
Clinical narrative: A patient experienced vertigo with second dose; A patient experienced numbness in the head and face after taking second dose of vaccine; A patient experienced mild rash with second dose; A patient experienced chills with second dose; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (A patient experienced vertigo with second dose), HYPOAESTHESIA (A patient experienced numbness in the head and face after taking second dose of vaccine), RASH (A patient experienced mild rash with second dose) and CHILLS (A patient experienced chills with second dose) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 16C21A and 028A21A) for COVID-19 vaccination.     Medical History was not reported.  Concomitant products included VITAMIN D NOS for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced VERTIGO (A patient experienced vertigo with second dose), HYPOAESTHESIA (A patient experienced numbness in the head and face after taking second dose of vaccine), RASH (A patient experienced mild rash with second dose) and CHILLS (A patient experienced chills with second dose). The patient was treated with MECLIZINE [MECLOZINE] ongoing since an unknown date for Vertigo, at a dose of UNK dosage form. At the time of the report, VERTIGO (A patient experienced vertigo with second dose) had not resolved, HYPOAESTHESIA (A patient experienced numbness in the head and face after taking second dose of vaccine) outcome was unknown and RASH (A patient experienced mild rash with second dose) and CHILLS (A patient experienced chills with second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: normal (normal) Normal. In 2021, Computerised tomogram: normal (normal) Normal. In 2021, Urine analysis: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 4th day Patient  experienced numbness on head which spread to right side of her of the face which she suspected as bell's palsy was noted.   This case was linked to MOD-2021-209114 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received and it contains no new information.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Urine analysis, Vertigo
Clinical narrative: A patient experienced vertigo with second dose; A patient experienced numbness in the head and face after taking second dose of vaccine; A patient experienced mild rash with second dose; A patient experienced chills with second dose; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (A patient experienced vertigo with second dose), HYPOAESTHESIA (A patient experienced numbness in the head and face after taking second dose of vaccine), RASH (A patient experienced mild rash with second dose) and CHILLS (A patient experienced chills with second dose) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 16C21A and 028A21A) for COVID-19 vaccination.     Medical History was not reported.  Concomitant products included VITAMIN D NOS for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced VERTIGO (A patient experienced vertigo with second dose), HYPOAESTHESIA (A patient experienced numbness in the head and face after taking second dose of vaccine), RASH (A patient experienced mild rash with second dose) and CHILLS (A patient experienced chills with second dose). The patient was treated with MECLIZINE [MECLOZINE] ongoing since an unknown date for Vertigo, at a dose of UNK dosage form. At the time of the report, VERTIGO (A patient experienced vertigo with second dose) had not resolved, HYPOAESTHESIA (A patient experienced numbness in the head and face after taking second dose of vaccine) outcome was unknown and RASH (A patient experienced mild rash with second dose) and CHILLS (A patient experienced chills with second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood test: normal (normal) Normal. In 2021, Computerised tomogram: normal (normal) Normal. In 2021, Urine analysis: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 4th day Patient  experienced numbness on head which spread to right side of her of the face which she suspected as bell's palsy was noted.   This case was linked to MOD-2021-209114 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received and it contains no new information.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Taste disorder
Clinical narrative: Completely loss of sense of taste.; sweet and salty taste has become savory; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Completely loss of sense of taste.) and TASTE DISORDER (sweet and salty taste has become savory) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20H and 024M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DILTIAZEM, METFORMIN, DUTASTERIDE (AVODART), DOXAZOSIN MESILATE (CARDURA), DIAZEPAM (VALIUM), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and APIXABAN (ELIQUIS) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced AGEUSIA (Completely loss of sense of taste.) and TASTE DISORDER (sweet and salty taste has become savory). At the time of the report, AGEUSIA (Completely loss of sense of taste.) and TASTE DISORDER (sweet and salty taste has become savory) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Received Expired dose of vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Received Expired dose of vaccine) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO Medical history information was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Received Expired dose of vaccine). At the time of the report, PRODUCT ADMINISTRATION ERROR (Received Expired dose of vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant Concomitant medications were reported.   No Treatment information for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021 and was forwarded to Moderna on 04-Jun-2021.    This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Received Expired dose of vaccine) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO Medical history information was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Received Expired dose of vaccine). At the time of the report, PRODUCT ADMINISTRATION ERROR (Received Expired dose of vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant Concomitant medications were reported.   No Treatment information for the event was provided.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: headache; very exhausted; sore all over the body; Feels like his son was on fire/high fever but not measured; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HEADACHE (headache), FATIGUE (very exhausted), MYALGIA (sore all over the body) and PYREXIA (Feels like his son was on fire/high fever but not measured) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO medical History information was reported.    On 02-Jun-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 02-Jun-2021, the patient experienced HEADACHE (headache), FATIGUE (very exhausted), MYALGIA (sore all over the body) and PYREXIA (Feels like his son was on fire/high fever but not measured). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (headache), FATIGUE (very exhausted), MYALGIA (sore all over the body) and PYREXIA (Feels like his son was on fire/high fever but not measured) outcome was unknown.            No concomitant medication was reported.    This case was linked to MOD-2021-209017 (Patient Link). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021 and was forwarded to Moderna on 04-Jun-2021.    This spontaneous case was reported by a patient family member or friend and describes the occurrence of HEADACHE (headache), FATIGUE (very exhausted), MYALGIA (sore all over the body) and PYREXIA (Feels like his son was on fire/high fever but not measured) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO medical History information was reported.    On 02-Jun-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 02-Jun-2021, the patient experienced HEADACHE (headache), FATIGUE (very exhausted), MYALGIA (sore all over the body) and PYREXIA (Feels like his son was on fire/high fever but not measured). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (headache), FATIGUE (very exhausted), MYALGIA (sore all over the body) and PYREXIA (Feels like his son was on fire/high fever but not measured) outcome was unknown.            No concomitant medication was reported.    This case was linked to MOD-2021-209017 (Patient Link).