chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Heart is hurting me,squeezing pain; She can't breathe, it is difficult to breathe, painful breathing sometimes; painful breathing sometimes; Whole left side is painful and hurting; Can't move the arm,can't put her hand up; Pain on the arm, constant pain, injection was painful, pain on the arm that is sharp; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (Heart is hurting me,squeezing pain) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANGINA PECTORIS (Heart is hurting me,squeezing pain) (seriousness criterion medically significant), DYSPNOEA (She can't breathe, it is difficult to breathe, painful breathing sometimes), PAINFUL RESPIRATION (painful breathing sometimes), PAIN (Whole left side is painful and hurting), VACCINATION SITE MOVEMENT IMPAIRMENT (Can't move the arm,can't put her hand up) and VACCINATION SITE PAIN (Pain on the arm, constant pain, injection was painful, pain on the arm that is sharp). At the time of the report, ANGINA PECTORIS (Heart is hurting me,squeezing pain), DYSPNOEA (She can't breathe, it is difficult to breathe, painful breathing sometimes), PAINFUL RESPIRATION (painful breathing sometimes), PAIN (Whole left side is painful and hurting), VACCINATION SITE MOVEMENT IMPAIRMENT (Can't move the arm,can't put her hand up) and VACCINATION SITE PAIN (Pain on the arm, constant pain, injection was painful, pain on the arm that is sharp) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not want to answer any more questions regarding cardiac related signs and symptoms specifically for the myocarditis and pericarditis. The patient stated that she started noticing it 4 days ago on 22Oct2021. No additional information was obtained.  Company Comment: This case concerns a 29 year-old female patient with no reported medical history, who experienced the unexpected serious event of Angina pectoris. The event occurred an unknown number of days after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 29 year-old female patient with no reported medical history, who experienced the unexpected serious event of Angina pectoris. The event occurred an unknown number of days after the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Insomnia, Lymphadenopathy
Clinical narrative: Swollen lymph nodes (throat) - most apparent on day 3 after vaccine. Fatigue, unable to fall asleep.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Thrombosis
Clinical narrative: My menstrual cycle was dark and clotted- not normal for me.  I?ve heard of this reaction before so I?m  documenting it here for your side effects.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Erythema, Headache, Oral pain, Rash
Clinical narrative: Weak  Pain in chest  Rashes and swollen admit  On going Headaches Pain in mouth and face Red skin
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Weak  Pain in chest  Rashes and swollen admit  On going Headaches Pain in mouth and face Red skin
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Computerised tomogram abdomen, Computerised tomogram head, Computerised tomogram normal, Computerised tomogram pelvis
Clinical narrative: vomiting, altered mental status, confusion, delirium, total body pain, fever, ER visit
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Confusional state, Delirium, Mental status changes, Pain, Pyrexia
Clinical narrative: vomiting, altered mental status, confusion, delirium, total body pain, fever, ER visit
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Urine analysis normal, Vomiting
Clinical narrative: vomiting, altered mental status, confusion, delirium, total body pain, fever, ER visit
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Discomfort, Fear, Feeling abnormal, Injection site pain
Clinical narrative: Late evening of second   day left arm slightly painful at point of injection. Few hours later woke to an odd feeling; an extremely large swelling under left arm about 10? round.  No pain of swelling but scary and uncomfortable.  Upon examining?.Felt FULL  with Gel Like substance. Next morning ?.6:53 a.m.  area  significantly reduced?..almost normal ?.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Late evening of second   day left arm slightly painful at point of injection. Few hours later woke to an odd feeling; an extremely large swelling under left arm about 10? round.  No pain of swelling but scary and uncomfortable.  Upon examining?.Felt FULL  with Gel Like substance. Next morning ?.6:53 a.m.  area  significantly reduced?..almost normal ?.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Lethargy
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder, Injection site pain, Myocardial infarction
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Error: Patient too young for vaccine administered.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site paraesthesia, Injection site pruritus
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Shoulder injury related to vaccine administration
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Inflammation, Rash, Tenderness
Clinical narrative: Tenderness  at the back of his left ear; Inflammation at the back of his left ear; Rash at the top of his head; Fatigue; Inappropriate schedule of vaccine administerd; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (left ear), INFLAMMATION, RASH (the top of his head), FATIGUE, and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced TENDERNESS, INFLAMMATION, RASH (Rash at the top of his head), FATIGUE (Fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION. On 22-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administerd) had resolved. At the time of the report, TENDERNESS, INFLAMMATION, RASH, and FATIGUE outcome was unknown.            No concomitant medication was mentioned. No treatment medication was mentioned.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Feeling abnormal, Headache, Myalgia
Clinical narrative: joint pain; muscle pain; was misserable; fever 102.5; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (was misserable), PYREXIA (fever 102.5), HEADACHE (headache), NAUSEA (nausea) and ARTHRALGIA (joint pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced FEELING ABNORMAL (was misserable), PYREXIA (fever 102.5), HEADACHE (headache) and NAUSEA (nausea). On an unknown date, the patient experienced ARTHRALGIA (joint pain) and MYALGIA (muscle pain). At the time of the report, FEELING ABNORMAL (was misserable), PYREXIA (fever 102.5), HEADACHE (headache), NAUSEA (nausea), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Pyrexia: high (High) 102.5.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information ibuprofen 600 mg was reported.  Concomitant medication use was unknown. Patient  was taking medications for other health conditions but did not want to provide that information. patient was hesitant to get the booster because does not want to get sick but is going to consult her doctor.     This case was linked to MOD-2021-363565 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: joint pain; muscle pain; was misserable; fever 102.5; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (was misserable), PYREXIA (fever 102.5), HEADACHE (headache), NAUSEA (nausea) and ARTHRALGIA (joint pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced FEELING ABNORMAL (was misserable), PYREXIA (fever 102.5), HEADACHE (headache) and NAUSEA (nausea). On an unknown date, the patient experienced ARTHRALGIA (joint pain) and MYALGIA (muscle pain). At the time of the report, FEELING ABNORMAL (was misserable), PYREXIA (fever 102.5), HEADACHE (headache), NAUSEA (nausea), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Pyrexia: high (High) 102.5.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information ibuprofen 600 mg was reported.  Concomitant medication use was unknown. Patient  was taking medications for other health conditions but did not want to provide that information. patient was hesitant to get the booster because does not want to get sick but is going to consult her doctor.     This case was linked to MOD-2021-363565 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Hypoaesthesia, Lip swelling, Swelling face
Clinical narrative: Dermatitis reaction; Lips were big; Face was numb; Face got swollen like she had a food allergy; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS (Dermatitis reaction), LIP SWELLING (Lips were big), HYPOAESTHESIA (Face was numb) and SWELLING FACE (Face got swollen like she had a food allergy) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. 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 26-Oct-2021, the patient experienced DERMATITIS (Dermatitis reaction) (seriousness criterion medically significant), LIP SWELLING (Lips were big) (seriousness criterion medically significant), HYPOAESTHESIA (Face was numb) (seriousness criterion medically significant) and SWELLING FACE (Face got swollen like she had a food allergy) (seriousness criterion medically significant). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, DERMATITIS (Dermatitis reaction), LIP SWELLING (Lips were big) and HYPOAESTHESIA (Face was numb) outcome was unknown and SWELLING FACE (Face got swollen like she had a food allergy) was resolving.            Concomitant drugs were not reported.  This case concerns a 40 year-old female patient with no reported medical history who experienced the unexpected serious events of dermatitis, lip swelling, hypoaesthesia and swelling of face. The events occurred approximately 2 days after the third dose of mRNA-1273. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 40 year-old female patient with no reported medical history who experienced the unexpected serious events of dermatitis, lip swelling, hypoaesthesia and swelling of face. The events occurred approximately 2 days after the third dose of mRNA-1273. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered dose past the 12-hour mark; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered dose past the 12-hour mark) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered dose past the 12-hour mark). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered dose past the 12-hour mark) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported No treatment medication was reported   This case was linked to MOD-2021-365212, MOD-2021-365214 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow-up received and contains updated reporter's email
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired doses to patients past the published expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired doses to patients past the published expiration date) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired doses to patients past the published expiration date). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired doses to patients past the published expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator was on 20-Oct-2021 and the expiration date of the vial was on 10-Oct-2021.  No concomitant medication was reported. No treatment information was reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired doses to patients past the published expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired doses to patients past the published expiration date) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired doses to patients past the published expiration date). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired doses to patients past the published expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.  Number of doses/vials 1 vial, 1 dose involved. The Lot 018B21A  vial was initially stored in the refrigerator on 13Oct2021. The vial did not undergone any temperature excursions.   This case was linked to MOD-2021-365264 (Patient Link).
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever; Chills; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Myalgia) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 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 PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Myalgia). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Myalgia) had resolved.            The  concomitant medications on use were not provided. No treatment information was provided.   This case was linked to MOD-2021-002894, MOD-2021-365426 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Mobility decreased
Clinical narrative: cannot get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (cannot get out of bed) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced MOBILITY DECREASED. At the time of the report, MOBILITY DECREASED (cannot get out of bed) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on an unknown date, Blood pressure measurement normal. On an unknown date, Body temperature normal.         Concomitant medications were not provided. Treatment information was not provided.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered a dose from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial) 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.   This case was linked to MOD-2021-366918, MOD-2021-365600, MOD-2021-365692, MOD-2021-365742, MOD-2021-365891, MOD-2021-366043, MOD-2021-366226, MOD-2021-366595, MOD-2021-366925 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; 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 (Expired dose administered) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   Reporter did not allow further contact
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Body aches after first shot; This spontaneous case was reported by a nurse and describes the occurrence of MYALGIA (Body aches after first shot) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced MYALGIA (Body aches after first shot). On 18-Sep-2021, MYALGIA (Body aches after first shot) 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 information was reported. No treatment medications were provided.   This case was linked to MOD-2021-366238 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: opposite arm (left) started to hurt in the upper area/ pain moved all the way the down to her wrist/ collar bone down now/felt like someone punched me; could not even activate the turn signal in their car/not lift their left arm/could not lift boxes at work; 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 PAIN IN EXTREMITY (opposite arm (left) started to hurt in the upper area/ pain moved all the way the down to her wrist/ collar bone down now/felt like someone punched me) and LIMB DISCOMFORT (could not even activate the turn signal in their car/not lift their left arm/could not lift boxes at work) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced PAIN IN EXTREMITY (opposite arm (left) started to hurt in the upper area/ pain moved all the way the down to her wrist/ collar bone down now/felt like someone punched me) and LIMB DISCOMFORT (could not even activate the turn signal in their car/not lift their left arm/could not lift boxes at work). At the time of the report, PAIN IN EXTREMITY (opposite arm (left) started to hurt in the upper area/ pain moved all the way the down to her wrist/ collar bone down now/felt like someone punched me) and LIMB DISCOMFORT (could not even activate the turn signal in their car/not lift their left arm/could not lift boxes at work) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment reported.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Chills, Headache, Myalgia, Ocular discomfort
Clinical narrative: Labelling Wrong (different strength vs. one on packaging / mispaired - primary); felt like someone punched him in the eyes; splitting headache; soreness all over; He was very sick; bad systemic reaction; Got a full 3rd dose and he is not immunocompromised; full body shivers all night long; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (He was very sick), OCULAR DISCOMFORT (felt like someone punched him in the eyes), VACCINATION COMPLICATION (bad systemic reaction), ACCIDENTAL OVERDOSE (Got a full 3rd dose and he is not immunocompromised) and PRODUCT LABEL ISSUE (Labelling Wrong (different strength vs. one on packaging / mispaired - primary)) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Oct-2021, the patient experienced VACCINATION COMPLICATION (He was very sick), VACCINATION COMPLICATION (bad systemic reaction), ACCIDENTAL OVERDOSE (Got a full 3rd dose and he is not immunocompromised) and CHILLS (full body shivers all night long). On 25-Oct-2021, the patient experienced OCULAR DISCOMFORT (felt like someone punched him in the eyes), HEADACHE (splitting headache) and MYALGIA (soreness all over). On an unknown date, the patient experienced PRODUCT LABEL ISSUE (Labelling Wrong (different strength vs. one on packaging / mispaired - primary)). On 25-Oct-2021, CHILLS (full body shivers all night long) outcome was unknown. On 26-Oct-2021, OCULAR DISCOMFORT (felt like someone punched him in the eyes), VACCINATION COMPLICATION (bad systemic reaction), HEADACHE (splitting headache) and MYALGIA (soreness all over) outcome was unknown. At the time of the report, VACCINATION COMPLICATION (He was very sick), ACCIDENTAL OVERDOSE (Got a full 3rd dose and he is not immunocompromised) and PRODUCT LABEL ISSUE (Labelling Wrong (different strength vs. one on packaging / mispaired - primary)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: followup received on 27-oct-2021 and  contains non significant information.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Product label issue, Vaccination complication
Clinical narrative: Labelling Wrong (different strength vs. one on packaging / mispaired - primary); felt like someone punched him in the eyes; splitting headache; soreness all over; He was very sick; bad systemic reaction; Got a full 3rd dose and he is not immunocompromised; full body shivers all night long; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (He was very sick), OCULAR DISCOMFORT (felt like someone punched him in the eyes), VACCINATION COMPLICATION (bad systemic reaction), ACCIDENTAL OVERDOSE (Got a full 3rd dose and he is not immunocompromised) and PRODUCT LABEL ISSUE (Labelling Wrong (different strength vs. one on packaging / mispaired - primary)) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Oct-2021, the patient experienced VACCINATION COMPLICATION (He was very sick), VACCINATION COMPLICATION (bad systemic reaction), ACCIDENTAL OVERDOSE (Got a full 3rd dose and he is not immunocompromised) and CHILLS (full body shivers all night long). On 25-Oct-2021, the patient experienced OCULAR DISCOMFORT (felt like someone punched him in the eyes), HEADACHE (splitting headache) and MYALGIA (soreness all over). On an unknown date, the patient experienced PRODUCT LABEL ISSUE (Labelling Wrong (different strength vs. one on packaging / mispaired - primary)). On 25-Oct-2021, CHILLS (full body shivers all night long) outcome was unknown. On 26-Oct-2021, OCULAR DISCOMFORT (felt like someone punched him in the eyes), VACCINATION COMPLICATION (bad systemic reaction), HEADACHE (splitting headache) and MYALGIA (soreness all over) outcome was unknown. At the time of the report, VACCINATION COMPLICATION (He was very sick), ACCIDENTAL OVERDOSE (Got a full 3rd dose and he is not immunocompromised) and PRODUCT LABEL ISSUE (Labelling Wrong (different strength vs. one on packaging / mispaired - primary)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Oct-2021: followup received on 27-oct-2021 and  contains non significant information.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received Moderna vaccine after the J&J vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received Moderna vaccine after the J&J vaccine) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: J&J Vaccine on 18-Nov-2020. Past adverse reactions to the above products included No adverse event with J&J Vaccine. Concurrent medical conditions included Type 1 diabetes mellitus.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received Moderna vaccine after the J&J vaccine). On 10-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received Moderna vaccine after the J&J vaccine) had resolved.            Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that patient received J&J vaccine as part of the study.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; 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 PYREXIA 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 PYREXIA. At the time of the report, PYREXIA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No relevant concomitant medication was reported. Treatment information were not provided.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered a dose from an expired vial.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial.) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial.). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered a 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 were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-366918 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose). On 23-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose) 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.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Accidentally administered expired doses to patients past the published expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Accidentally administered expired doses to patients past the published expiration date) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Accidentally administered expired doses to patients past the published expiration date). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Accidentally administered expired doses to patients past the published expiration date) 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 reported.  Number of doses/vials for lot 006C21A include 1 vial, 4 doses. The vial was initially stored in the refrigerator on 20 Oct 2021. The vial did not undergone any temperature excursions.   This case was linked to MOD-2021-365268, MOD-2021-365264 (Patient Link).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered a dose from an expired vial.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial.) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial.). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications are provided by the reporter. Patient reported that there was a transcription error when taking notes of the expiration dates of the lot  for the vials they have at their facility. They've mistakenly administered expired vials to 10 patients.   This case was linked to MOD-2021-366918, MOD-2021-366925 (Patient Link).
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient). On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.  The vial was punctured on 26-oct-2021 at 3 PM and returned to the refrigerator after administering to a couple of patients on 26 Oct 2021 and then on 27 Oct 2021 at 9:30 AM, the punctured vial was used to administer booster doses to 4 patients. No adverse reactions was reported so far.   This case was linked to MOD-2021-365967, MOD-2021-365848, MOD-2021-366345 (Patient Link).
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered a dose from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered a dose from an expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant and Treatment medication were reported.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered expired doses to patients past the published expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired doses to patients past the published expiration date) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired doses to patients past the published expiration date). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered expired doses to patients past the published expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: Feeling a little sore; whole body feeling sick; high fever in the night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Feeling a little sore), MALAISE (whole body feeling sick) and PYREXIA (high fever in the night) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, 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 (Feeling a little sore), MALAISE (whole body feeling sick) and PYREXIA (high fever in the night). At the time of the report, PAIN (Feeling a little sore) outcome was unknown and MALAISE (whole body feeling sick) and PYREXIA (high fever in the night) was resolving.            No concomitant medication was reported   No treatment medication was reported  The first day patient wasn't too bad, day 3 started to feel better   This case was linked to MOD-2021-341228 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2021: Follow up received with significant information , events updated
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine given to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 9:30 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 27-Oct-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-365967, MOD-2021-365701 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Received the same dosage as the first two doses; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Received the same dosage as the first two doses) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Received the same dosage as the first two doses). At the time of the report, ACCIDENTAL OVERDOSE (Received the same dosage as the first two doses) outcome was unknown.            No Concomitant medications were reported. No Treatment medications were reported.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Energy increased, Insomnia
Clinical narrative: Unable to sleep at all; Way too much energy/beyond wired; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Unable to sleep at all) and ENERGY INCREASED (Way too much energy/beyond wired) in a 44-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 26-Oct-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced INSOMNIA (Unable to sleep at all) and ENERGY INCREASED (Way too much energy/beyond wired). At the time of the report, INSOMNIA (Unable to sleep at all) and ENERGY INCREASED (Way too much energy/beyond wired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: sore injection site arm; itchy injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm) and VACCINATION SITE PRURITUS (itchy injection site arm) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore injection site arm) and VACCINATION SITE PRURITUS (itchy injection site arm). At the time of the report, VACCINATION SITE PAIN (sore injection site arm) and VACCINATION SITE PRURITUS (itchy injection site arm) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of myalgia (sore arm) and fatigue (fatigued/felt tired) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 045C21A and 013L20A) for COVID-19 immunization. No medical history reported. On Jan 21, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 23, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 25, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced myalgia (sore arm) and fatigue (fatigued/felt tired). At the time of the report, myalgia (sore arm) and fatigue (fatigued/felt tired) outcome: unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-365820, MOD-2021-365923 (patient link).