chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza, Product dose omission issue, Vomiting
Clinical narrative: got really sick; thinks she might have had the flu as well.; she did not take her second dose; She threw up; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got really sick), INFLUENZA (thinks she might have had the flu as well), VOMITING (She threw up) and PRODUCT DOSE OMISSION ISSUE (she did not take her second dose) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PIROXICAM (PAXIL [PIROXICAM]), BUPROPION, GABAPENTIN, OXYBUTYNIN, BACLOFEN, TIZANIDINE and MIDODRINE for an unknown indication.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got really sick), INFLUENZA (thinks she might have had the flu as well), VOMITING (She threw up) and PRODUCT DOSE OMISSION ISSUE (she did not take her second dose). At the time of the report, ILLNESS (got really sick) and INFLUENZA (thinks she might have had the flu as well) outcome was unknown and VOMITING (She threw up) and PRODUCT DOSE OMISSION ISSUE (she did not take her second 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.   Patient got her first dose 3 or 4 months ago from the reporting date. No treatment information was provided. The patient weight provided as 111 without units.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore left arm after 3rd shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm after 3rd shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 27-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore left arm after 3rd shot). On 28-Sep-2021, PAIN IN EXTREMITY (Sore left arm after 3rd shot) had resolved.            No concomitant were medications reported. No treatment were medications reported.    This case was linked to MOD21-148294 (Patient Link).
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Headache, Insomnia, Joint stiffness, Malaise
Clinical narrative: he does not feel so great; eyes are aching; malaise; it was very difficult getting out of bed now; it was very difficult sleeping at night; headache after the third dose; fever (not high) after the third dose; aches after the third dose,pains after the third dose; joint stiffness after the third dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches after the third dose,pains after the third dose), JOINT STIFFNESS (joint stiffness after the third dose), MALAISE (he does not feel so great), EYE PAIN (eyes are aching) and MALAISE (malaise) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN and CITALOPRAM for an unknown indication.    On 27-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced PAIN (aches after the third dose,pains after the third dose), JOINT STIFFNESS (joint stiffness after the third dose), HEADACHE (headache after the third dose) and PYREXIA (fever (not high) after the third dose). On 28-Sep-2021, the patient experienced MALAISE (he does not feel so great), EYE PAIN (eyes are aching), MALAISE (malaise), MOBILITY DECREASED (it was very difficult getting out of bed now) and INSOMNIA (it was very difficult sleeping at night). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 500 milligram. At the time of the report, PAIN (aches after the third dose,pains after the third dose), JOINT STIFFNESS (joint stiffness after the third dose), MALAISE (he does not feel so great), EYE PAIN (eyes are aching), MALAISE (malaise), MOBILITY DECREASED (it was very difficult getting out of bed now), INSOMNIA (it was very difficult sleeping at night), HEADACHE (headache after the third dose) and PYREXIA (fever (not high) after the third dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had the third dose yesterday at 3pm and now 21 hours later, did not feel so great, eyes were aching, malaise, it was very difficult getting out of bed and sleeping at night. Unknown immunocompromised status of receiving third dose.   This case was linked to MOD-2021-335120, MOD-2021-335133 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up information: Unknown immunocompromised status receiving third dose.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Pain, Pyrexia
Clinical narrative: he does not feel so great; eyes are aching; malaise; it was very difficult getting out of bed now; it was very difficult sleeping at night; headache after the third dose; fever (not high) after the third dose; aches after the third dose,pains after the third dose; joint stiffness after the third dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches after the third dose,pains after the third dose), JOINT STIFFNESS (joint stiffness after the third dose), MALAISE (he does not feel so great), EYE PAIN (eyes are aching) and MALAISE (malaise) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN and CITALOPRAM for an unknown indication.    On 27-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced PAIN (aches after the third dose,pains after the third dose), JOINT STIFFNESS (joint stiffness after the third dose), HEADACHE (headache after the third dose) and PYREXIA (fever (not high) after the third dose). On 28-Sep-2021, the patient experienced MALAISE (he does not feel so great), EYE PAIN (eyes are aching), MALAISE (malaise), MOBILITY DECREASED (it was very difficult getting out of bed now) and INSOMNIA (it was very difficult sleeping at night). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 500 milligram. At the time of the report, PAIN (aches after the third dose,pains after the third dose), JOINT STIFFNESS (joint stiffness after the third dose), MALAISE (he does not feel so great), EYE PAIN (eyes are aching), MALAISE (malaise), MOBILITY DECREASED (it was very difficult getting out of bed now), INSOMNIA (it was very difficult sleeping at night), HEADACHE (headache after the third dose) and PYREXIA (fever (not high) after the third dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had the third dose yesterday at 3pm and now 21 hours later, did not feel so great, eyes were aching, malaise, it was very difficult getting out of bed and sleeping at night. Unknown immunocompromised status of receiving third dose.   This case was linked to MOD-2021-335120, MOD-2021-335133 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up information: Unknown immunocompromised status receiving third dose.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pyrexia, Vaccination complication
Clinical narrative: Really severe reaction; High fever; Fatigue; Achy all over; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Really severe reaction), PYREXIA (High fever), FATIGUE (Fatigue) and MYALGIA (Achy all over) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020 and Clot blood (Patient was hospitalized for 7 days (discharged on 02Nov2020) because of a blood clot in the lung.). Concurrent medical conditions included Neurological disorder NOS (neurological ones, as she said COVID affected her spine and has problems with coordination).    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, the patient experienced VACCINATION COMPLICATION (Really severe reaction), PYREXIA (High fever), FATIGUE (Fatigue) and MYALGIA (Achy all over). On 17-May-2021, VACCINATION COMPLICATION (Really severe reaction), PYREXIA (High fever), FATIGUE (Fatigue) and MYALGIA (Achy all over) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment information was provided.  Patient felt like having covid again.   This case was linked to MOD-2021-335178 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: She received and the third gave her energy.; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (She received and the third gave her energy.) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A, 013L20A and 016M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic, Blood pressure high and Thyroid disorder. Concomitant products included OLMESARTAN MEDOXOMIL for Blood pressure high, METFORMIN for Diabetes, LEVOTHYROXINE for Thyroid disorder.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (She received and the third gave her energy.). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (She received and the third gave her energy.) outcome was unknown.            No treatment medication was  reported.   This case was linked to MOD-2021-335075 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Pain in extremity
Clinical narrative: slight soreness in the left arm; tired; really strong chemical state in the mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (really strong chemical state in the mouth), PAIN IN EXTREMITY (slight soreness in the left arm) and FATIGUE (tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSGEUSIA (really strong chemical state in the mouth). On an unknown date, the patient experienced PAIN IN EXTREMITY (slight soreness in the left arm) and FATIGUE (tired). The patient was treated with MACROGOL 3350 (MIRALAX) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSGEUSIA (really strong chemical state in the mouth), PAIN IN EXTREMITY (slight soreness in the left arm) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was taking other unknown medication.  2 to 3 minutes after receiving the first dose, the patient had the reaction. MiraLax made her nauseous because of the polyethylene glycol.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Memory impairment, Myalgia, Pyrexia
Clinical narrative: No recollection of what had happened during the past 12 hours; 2nd dose 6 weeks after the first dose; Fever; Fatigue; Achy symptoms; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (No recollection of what had happened during the past 12 hours), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose 6 weeks after the first dose), PYREXIA (Fever), FATIGUE (Fatigue) and MYALGIA (Achy symptoms) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020, Clot blood (Patient was hospitalized for 7 days (discharged on 02Nov2021) because of a blood clot in the lung.) from October 2020 to November 2020 and Weight loss. Concurrent medical conditions included Neurological disorder NOS (neurological ones, as she said COVID affected her spine and has problems with coordination.).    On 25-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jun-2021, the patient experienced MEMORY IMPAIRMENT (No recollection of what had happened during the past 12 hours), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose 6 weeks after the first dose), PYREXIA (Fever), FATIGUE (Fatigue) and MYALGIA (Achy symptoms). On 25-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose 6 weeks after the first dose) had resolved. At the time of the report, MEMORY IMPAIRMENT (No recollection of what had happened during the past 12 hours) had resolved and PYREXIA (Fever), FATIGUE (Fatigue) and MYALGIA (Achy symptoms) outcome was unknown.            No concomitant medication was reported.  No treatment medication was reported.  The patient had no recollection of what had happened during the past 12 hours what day it was and had to call her daughter. It took a couple days to clear it all out.   This case was linked to MOD-2021-335144 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Chills, Diarrhoea, Gait disturbance
Clinical narrative: Upset stomach; Cannot lift her arms/cannot bend fingers; Difficulty walking; Severe sweating; Diarrhea; Greatest pain on right side; Excruciating pain in shoulder/excruciating pain in hands, through knees/pain in all joints, fingers; All joints in pain; Chills; This spontaneous case was reported by a physician and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), MOBILITY DECREASED (Cannot lift her arms/cannot bend fingers), GAIT DISTURBANCE (Difficulty walking), HYPERHIDROSIS (Severe sweating) and DIARRHOEA (Diarrhea) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0173NA, 040A21A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Colectomy. Concurrent medical conditions included Immunocompromised.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), MOBILITY DECREASED (Cannot lift her arms/cannot bend fingers), GAIT DISTURBANCE (Difficulty walking), HYPERHIDROSIS (Severe sweating), DIARRHOEA (Diarrhea), PAIN (Greatest pain on right side), MYALGIA (Excruciating pain in shoulder/excruciating pain in hands, through knees/pain in all joints, fingers), ARTHRALGIA (All joints in pain) and CHILLS (Chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and MAGNESIUM SALICYLATE at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach), MOBILITY DECREASED (Cannot lift her arms/cannot bend fingers), GAIT DISTURBANCE (Difficulty walking), HYPERHIDROSIS (Severe sweating), DIARRHOEA (Diarrhea), PAIN (Greatest pain on right side), MYALGIA (Excruciating pain in shoulder/excruciating pain in hands, through knees/pain in all joints, fingers), ARTHRALGIA (All joints in pain) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient is on no concomitant medications, but she takes a lot of vitamins.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Mobility decreased, Myalgia, Pain
Clinical narrative: Upset stomach; Cannot lift her arms/cannot bend fingers; Difficulty walking; Severe sweating; Diarrhea; Greatest pain on right side; Excruciating pain in shoulder/excruciating pain in hands, through knees/pain in all joints, fingers; All joints in pain; Chills; This spontaneous case was reported by a physician and describes the occurrence of ABDOMINAL DISCOMFORT (Upset stomach), MOBILITY DECREASED (Cannot lift her arms/cannot bend fingers), GAIT DISTURBANCE (Difficulty walking), HYPERHIDROSIS (Severe sweating) and DIARRHOEA (Diarrhea) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0173NA, 040A21A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Colectomy. Concurrent medical conditions included Immunocompromised.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Upset stomach), MOBILITY DECREASED (Cannot lift her arms/cannot bend fingers), GAIT DISTURBANCE (Difficulty walking), HYPERHIDROSIS (Severe sweating), DIARRHOEA (Diarrhea), PAIN (Greatest pain on right side), MYALGIA (Excruciating pain in shoulder/excruciating pain in hands, through knees/pain in all joints, fingers), ARTHRALGIA (All joints in pain) and CHILLS (Chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and MAGNESIUM SALICYLATE at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Upset stomach), MOBILITY DECREASED (Cannot lift her arms/cannot bend fingers), GAIT DISTURBANCE (Difficulty walking), HYPERHIDROSIS (Severe sweating), DIARRHOEA (Diarrhea), PAIN (Greatest pain on right side), MYALGIA (Excruciating pain in shoulder/excruciating pain in hands, through knees/pain in all joints, fingers), ARTHRALGIA (All joints in pain) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient is on no concomitant medications, but she takes a lot of vitamins.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Felt a little achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felt a little achy) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic to cats.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Felt a little achy). At the time of the report, PAIN (Felt a little achy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-335365.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium, Blood potassium decreased, Blood test, Disturbance in attention, Immunodeficiency
Clinical narrative: immunocompromised; remember things can't remember much of next 2 weeks; it affects ability to concentrate and remember things; Potassium low; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (immunocompromised), MEMORY IMPAIRMENT (remember things can't remember much of next 2 weeks), DISTURBANCE IN ATTENTION (it affects ability to concentrate and remember things) and BLOOD POTASSIUM DECREASED (Potassium low) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jul-2021, the patient experienced BLOOD POTASSIUM DECREASED (Potassium low). On an unknown date, the patient experienced IMMUNODEFICIENCY (immunocompromised), MEMORY IMPAIRMENT (remember things can't remember much of next 2 weeks) and DISTURBANCE IN ATTENTION (it affects ability to concentrate and remember things). At the time of the report, IMMUNODEFICIENCY (immunocompromised), MEMORY IMPAIRMENT (remember things can't remember much of next 2 weeks), DISTURBANCE IN ATTENTION (it affects ability to concentrate and remember things) and BLOOD POTASSIUM DECREASED (Potassium low) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood test: positive for anti-double strand dna antibodies (Positive) positive for anti-double strand DNA antibodies. On 27-Jul-2021, Blood potassium: low (Low) low. On an unknown date, Monoclonal immunoglobulin present: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications information was not reported. Treatment information was not provided. The patient did many blood tests, the first one after a month of getting second dose, it showed that patient had anti-nuclear antibodies. The second test was positive for anti-double strand DNA antibodies, while the third test was positive for M Spike. Patient went to the ER on 27Jul2021 for low potassium levels. Patient stated to be immunocompromised; Sender's Comments: This case concerns a 59 year-old female patient with no reported medical history, who experienced the unexpected non-serious event of Immunodeficiency. The event occurred an unknown number of days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Manual override done to remove seriousness criteria of Medically significant from event Immunodeficiency based on medical judgement and review of source document that did not include information supporting seriousness criteria.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Monoclonal immunoglobulin present
Clinical narrative: immunocompromised; remember things can't remember much of next 2 weeks; it affects ability to concentrate and remember things; Potassium low; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (immunocompromised), MEMORY IMPAIRMENT (remember things can't remember much of next 2 weeks), DISTURBANCE IN ATTENTION (it affects ability to concentrate and remember things) and BLOOD POTASSIUM DECREASED (Potassium low) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jul-2021, the patient experienced BLOOD POTASSIUM DECREASED (Potassium low). On an unknown date, the patient experienced IMMUNODEFICIENCY (immunocompromised), MEMORY IMPAIRMENT (remember things can't remember much of next 2 weeks) and DISTURBANCE IN ATTENTION (it affects ability to concentrate and remember things). At the time of the report, IMMUNODEFICIENCY (immunocompromised), MEMORY IMPAIRMENT (remember things can't remember much of next 2 weeks), DISTURBANCE IN ATTENTION (it affects ability to concentrate and remember things) and BLOOD POTASSIUM DECREASED (Potassium low) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood test: positive for anti-double strand dna antibodies (Positive) positive for anti-double strand DNA antibodies. On 27-Jul-2021, Blood potassium: low (Low) low. On an unknown date, Monoclonal immunoglobulin present: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications information was not reported. Treatment information was not provided. The patient did many blood tests, the first one after a month of getting second dose, it showed that patient had anti-nuclear antibodies. The second test was positive for anti-double strand DNA antibodies, while the third test was positive for M Spike. Patient went to the ER on 27Jul2021 for low potassium levels. Patient stated to be immunocompromised; Sender's Comments: This case concerns a 59 year-old female patient with no reported medical history, who experienced the unexpected non-serious event of Immunodeficiency. The event occurred an unknown number of days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Manual override done to remove seriousness criteria of Medically significant from event Immunodeficiency based on medical judgement and review of source document that did not include information supporting seriousness criteria.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: three doses were administered to three patients after manufacturer date of expiry; 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 (three doses were administered to three patients after manufacturer date of expiry) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (three doses were administered to three patients after manufacturer date of expiry). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (three doses were administered to three patients after manufacturer date of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drug was not reported. Treatment medication was not reported.  On 08-Sep-2021, The vial was initially stored in the refrigerator and the vial did not undergo any temperature excursions.  Three patients were administered expired Moderna covid-19 vaccine (Manufacturer Expiration Date: 18-Sep-2021)
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore right arm) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HCL), CETIRIZINE, FENOFIBRATE, ARIPIPRAZOLE (ABILIFY) and MONTELUKAST for an unknown indication.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore right arm). At the time of the report, VACCINATION SITE PAIN (sore right arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No treatment medication was provided.   This case was linked to MOD-2021-335251.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Patient is pregnant and got the first dose of the Moderna vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 12-Apr-2022. On 27-Sep-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY. On 27-Sep-2021, MATERNAL EXPOSURE DURING PREGNANCY had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   ? No treatment information was provided.; Sender's Comments: This report concerns a 36 year old female subject with no relevant medical history, who experienced the unexpected event of vaccine exposure during pregnancy. The patient received the first dose of vaccine at unknown weeks of gestation. The benefit-risk relationship of Spikevax is not affected by this report.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose). On 23-Sep-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 provided by the reporter. No Treatment information was reported.
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Cough, Vaccination site pain
Clinical narrative: cough; sore right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough) and VACCINATION SITE PAIN (sore right injection site arm) in a 20-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history of patient was reported by the reporter.  Concomitant products included HYDROXYZINE HYDROCHLORIDE (HYDROXYZINE HCL), CETIRIZINE, FENOFIBRATE, ARIPIPRAZOLE (ABILIFY) and MONTELUKAST for an unknown indication.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 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 COUGH (cough) and VACCINATION SITE PAIN (sore right injection site arm). At the time of the report, COUGH (cough) and VACCINATION SITE PAIN (sore right injection site arm) outcome was unknown.            No treatment drugs were reported .   This case was linked to MOD-2021-335227 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Computerised tomogram, Diverticulitis
Clinical narrative: Diverticulitis; A-Fib/ heart rhythm problem; This spontaneous case was reported by a nurse and describes the occurrence of DIVERTICULITIS (Diverticulitis) and ATRIAL FIBRILLATION (A-Fib/ heart rhythm problem) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (not severely).   On 25-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced DIVERTICULITIS (Diverticulitis) (seriousness criteria hospitalization and medically significant) and ATRIAL FIBRILLATION (A-Fib/ heart rhythm problem) (seriousness criteria hospitalization and medically significant). The patient was treated with DILTIAZEM (CARDIZEM [DILTIAZEM]) for Atrial fibrillation, at an unspecified dose and frequency; APIXABAN (ELIQUIS) for Atrial fibrillation, at an unspecified dose and frequency; METRONIDAZOLE (FLAGYL [METRONIDAZOLE]) (intravenous) for Diverticulitis, at an unspecified dose and frequency; CEFTRIAXONE SODIUM (ROCEPHIN) (intravenous) for Diverticulitis, at an unspecified dose and frequency and AMOXICILLIN SODIUM, CLAVULANIC ACID (AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANIC ACID]) (intravenous) for Diverticulitis, at an unspecified dose and frequency. At the time of the report, DIVERTICULITIS (Diverticulitis) and ATRIAL FIBRILLATION (A-Fib/ heart rhythm problem) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Computerised tomogram: abnormal (abnormal) saw A-Fib.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. Patient had some more tests done at hospital and the results were not provided.  Company Comment: This case concerns a 64-year-old male patient with medical history of immunocompromise, who experienced the unexpected and serious events of diverticulitis and atrial fibrillation. Time to onset from vaccination was not reported. The rechallenge was unknown, as the patient reports that he might get a third dose. The medical history of immunocompromise remains as a confounder.  The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 64-year-old male patient with medical history of immunocompromise, who experienced the unexpected and serious events of diverticulitis and atrial fibrillation. Time to onset from vaccination was not reported. The rechallenge was unknown, as the patient reports that he might get a third dose. The medical history of immunocompromise remains as a confounder.  The benefit-risk relationship of Spikevax is not affected by this report.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Chapped lips, Lip swelling
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of lip swelling (swollen lips) and chapped lips (thought it was just chapped lips but it keeps getting worse and worse) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Sep 3, 2021, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. In September 2021, patient experienced lip swelling (swollen  lips) and chapped lips (thought it was just chapped lips but it keeps getting worse and worse). At the time of the report, lip swelling (swollen lips) and chapped lips (thought  it was just chapped lips but it keeps getting worse and worse): not resolved. Concomitant medications not provided by reporter. Patient received an antibiotic, which was not helping yet.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Urticaria
Clinical narrative: chronic hives/full of hives; some aches; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (chronic hives/full of hives) and MYALGIA (some aches) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     Concurrent medical conditions included Egg allergy (because he ate a lot of eggs).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced MYALGIA (some aches). On an unknown date, the patient experienced URTICARIA (chronic hives/full of hives). At the time of the report, URTICARIA (chronic hives/full of hives) and MYALGIA (some aches) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-335299 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Did not get good response to 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Did not get good response to 2 doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Did not get good response to 2 doses). At the time of the report, VACCINATION COMPLICATION (Did not get good response to 2 doses) 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.   This case was linked to MOD-2021-335300 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizzy / light dizziness / light headed; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy / light dizziness / light headed) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A1) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for Blood pressure high.    On 25-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Sep-2021, the patient experienced DIZZINESS (dizzy / light dizziness / light headed). At the time of the report, DIZZINESS (dizzy / light dizziness / light headed) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Urticaria
Clinical narrative: chronic hives/ he is still full of hives; some aches (second dose); little loopy for 12 hours; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (chronic hives/ he is still full of hives), MYALGIA (some aches (second dose)) and FATIGUE (little loopy for 12 hours) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 026B21A) for COVID-19 vaccination.     Concurrent medical conditions included Egg allergy and Hives.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-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 URTICARIA (chronic hives/ he is still full of hives), MYALGIA (some aches (second dose)) and FATIGUE (little loopy for 12 hours). At the time of the report, URTICARIA (chronic hives/ he is still full of hives), MYALGIA (some aches (second dose)) and FATIGUE (little loopy for 12 hours) outcome was unknown.            No Concomitant medications were provided. No treatment medications were provided. It was reported that consumer called to report a chronic hives situation. Consumer works in the forest, so he was subjected to nettles. He thought the hives had to do with nettles, because he runs every day in the forest, and it looked like mosquito bites. Now, he said the nettle season was over, and he was still full of hives. He also thought he might have an egg allergy because he eats a lot of eggs.   This case was linked to MOD-2021-335282 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Did not get good response to 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Did not get good response to 2 doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised and Rheumatoid arthritis.   On 20-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 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 VACCINATION COMPLICATION (Did not get good response to 2 doses). At the time of the report, VACCINATION COMPLICATION (Did not get good response to 2 doses) outcome was unknown.            Patient was on a medication for rheumatoid arthritis.  No treatment information was provided.   This case was linked to MOD-2021-335290 (Patient Link).
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 3rd dose MODERNA, 1st and 2nd dose PFIZER; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3rd dose MODERNA, 1st and 2nd dose PFIZER) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Immunocompromised.   On 24-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) Dose 1 and dose 2. On 24-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3rd dose MODERNA, 1st and 2nd dose PFIZER). On 24-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (3rd dose MODERNA, 1st and 2nd dose PFIZER) 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.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy on the right side of his face; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's Palsy on the right side of his face) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058E21A and 091D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Sep-2021, the patient experienced BELL'S PALSY (Bell's Palsy on the right side of his face) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bell's Palsy on the right side of his face) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.  Wife is calling to report that her 58-year-old husband received the first dose of Moderna COVID-19 vaccine on 01AUG2021 in the Right arm  (Lot# 091D21A & Exp. Date: Unknown).  He had the second  Moderna COVID-19 vaccine on 29AUG2021, in the left arm  (Lot# 058E21A & Exp. Date: Unknown ).  Wife states that on 26SEP2021, He developed Bell's Palsy on the right side of his face (Not confirmed by HCP).    Wife states that they have not informed his doctor yet and have not called VAERS.  Company comment: This case concerns a 58 year old male with no relevant medical history who experienced Serious expected event of Bell''s palsy approximately a less than a month after receiving the second dose of Moderna Covid 19 vaccine. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.; Sender's Comments: This case concerns a 58 year old male with no relevant medical history who experienced Serious expected event of Bell''s palsy approximately a less than a month after receiving the second dose of Moderna Covid 19 vaccine. Rechallenge was not applicable. The benefit-risk relationship is not affected by this report.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Dose) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Dose). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided Concomitant medication were not provided.