chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Vaccination site pain, Vaccination site swelling
Clinical narrative: Hot feet; Swelling under axilla, vaccination side, hurts when touched; Swelling under axilla, vaccination side, hurts when touched; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Hot feet), HEADACHE (Headache), VACCINATION SITE SWELLING (Swelling under axilla, vaccination side, hurts when touched) and VACCINATION SITE PAIN (Swelling under axilla, vaccination side, hurts when touched) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced HEADACHE (Headache). On 05-May-2021, the patient experienced FEELING HOT (Hot feet), VACCINATION SITE SWELLING (Swelling under axilla, vaccination side, hurts when touched) and VACCINATION SITE PAIN (Swelling under axilla, vaccination side, hurts when touched). The patient was treated with IBUPROFEN for Swelling, at an unspecified dose and frequency. On 04-May-2021, HEADACHE (Headache) had resolved. At the time of the report, FEELING HOT (Hot feet) had resolved, VACCINATION SITE SWELLING (Swelling under axilla, vaccination side, hurts when touched) had not resolved and VACCINATION SITE PAIN (Swelling under axilla, vaccination side, hurts when touched) outcome was unknown.        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 reported by investigator   This case was linked to US-MODERNATX, INC.-MOD-2021-114544 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114544:Wife case
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included FAMOTIDINE, MULTIVITAMIN [ASCORBIC ACID;CALCIUM PANTOTHENATE;COLECALCIFEROL;CYANOCOBALAMIN;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE] and CALCIUM for an unknown indication.    On 07-May-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 IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.       Treatment medication was not provided.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Myalgia
Clinical narrative: after 1st Moderna dose he felt uncomfortable but that was bearable; Soreness and Pain all over; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (after 1st Moderna dose he felt uncomfortable but that was bearable) and MYALGIA (Soreness and Pain all over) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     Concurrent medical conditions included Polymyalgia since 2012 and Blood pressure (Patient is taking blood pressure medication). Concomitant products included PREDNISONE for Polymyalgia.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DISCOMFORT (after 1st Moderna dose he felt uncomfortable but that was bearable) and MYALGIA (Soreness and Pain all over). At the time of the report, DISCOMFORT (after 1st Moderna dose he felt uncomfortable but that was bearable) and MYALGIA (Soreness and Pain all over) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information was reported.   This case was linked to MOD-2021-114818 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Event term was added. Event outcome was updated. On 22-Jul-2021: Medical history start date, Concomitant medication dosage details and dose 2 information updated
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Hypoaesthesia, Movement disorder, Pain in extremity, Paraesthesia
Clinical narrative: Severe pain at injection site left arm; Cannot move left arm; fingers tingling left arm; fingers involuntary movement left arm; fingers were numb; pain extends from injection site and surrounding area Left arm; immediate pain in left arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Severe pain at injection site left arm), MOVEMENT DISORDER (Cannot move left arm), PARAESTHESIA (fingers tingling left arm), DYSKINESIA (fingers involuntary movement left arm) and HYPOAESTHESIA (fingers were numb) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Severe pain at injection site left arm), MOVEMENT DISORDER (Cannot move left arm), PARAESTHESIA (fingers tingling left arm), DYSKINESIA (fingers involuntary movement left arm), HYPOAESTHESIA (fingers were numb), VACCINATION SITE PAIN (pain extends from injection site and surrounding area Left arm) and PAIN IN EXTREMITY (immediate pain in left arm). At the time of the report, VACCINATION SITE PAIN (Severe pain at injection site left arm), MOVEMENT DISORDER (Cannot move left arm), PARAESTHESIA (fingers tingling left arm), DYSKINESIA (fingers involuntary movement left arm), HYPOAESTHESIA (fingers were numb), VACCINATION SITE PAIN (pain extends from injection site and surrounding area Left arm) and PAIN IN EXTREMITY (immediate pain in left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Severe pain at injection site left arm; Cannot move left arm; fingers tingling left arm; fingers involuntary movement left arm; fingers were numb; pain extends from injection site and surrounding area Left arm; immediate pain in left arm; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Severe pain at injection site left arm), MOVEMENT DISORDER (Cannot move left arm), PARAESTHESIA (fingers tingling left arm), DYSKINESIA (fingers involuntary movement left arm) and HYPOAESTHESIA (fingers were numb) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Severe pain at injection site left arm), MOVEMENT DISORDER (Cannot move left arm), PARAESTHESIA (fingers tingling left arm), DYSKINESIA (fingers involuntary movement left arm), HYPOAESTHESIA (fingers were numb), VACCINATION SITE PAIN (pain extends from injection site and surrounding area Left arm) and PAIN IN EXTREMITY (immediate pain in left arm). At the time of the report, VACCINATION SITE PAIN (Severe pain at injection site left arm), MOVEMENT DISORDER (Cannot move left arm), PARAESTHESIA (fingers tingling left arm), DYSKINESIA (fingers involuntary movement left arm), HYPOAESTHESIA (fingers were numb), VACCINATION SITE PAIN (pain extends from injection site and surrounding area Left arm) and PAIN IN EXTREMITY (immediate pain in left arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Epistaxis, Feeling abnormal, Loss of personal independence in daily activities, Product dose omission issue
Clinical narrative: felt real real weak; not be able to do house and yard work; she is not going to receive the second dose; felt like a different person; felt real real weak; nose hemorrhage around 1:45 AM and lost at least half a pint of blood, bleeding really hard; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (nose hemorrhage around 1:45 AM and lost at least half a pint of blood, bleeding really hard), the first episode of ASTHENIA (felt real real weak), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not be able to do house and yard work), PRODUCT DOSE OMISSION ISSUE (she is not going to receive the second dose) and FEELING ABNORMAL (felt like a different person) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE for Hypertension, THYROID for Thyroid disorder.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, the patient experienced EPISTAXIS (nose hemorrhage around 1:45 AM and lost at least half a pint of blood, bleeding really hard). On an unknown date, the patient experienced the first episode of ASTHENIA (felt real real weak), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not be able to do house and yard work), PRODUCT DOSE OMISSION ISSUE (she is not going to receive the second dose), FEELING ABNORMAL (felt like a different person) and the second episode of ASTHENIA (felt real real weak). On 07-May-2021, LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (not be able to do house and yard work), FEELING ABNORMAL (felt like a different person) and the last episode of ASTHENIA (felt real real weak) had resolved, PRODUCT DOSE OMISSION ISSUE (she is not going to receive the second dose) outcome was unknown. At the time of the report, EPISTAXIS (nose hemorrhage around 1:45 AM and lost at least half a pint of blood, bleeding really hard) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. No treatment drugs were reported. No consent to follow up
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Nasopharyngitis, Pyrexia
Clinical narrative: Felt cold; Fever of 104.0; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Felt cold) and PYREXIA (Fever of 104.0) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced PYREXIA (Fever of 104.0). On an unknown date, the patient experienced NASOPHARYNGITIS (Felt cold). At the time of the report, NASOPHARYNGITIS (Felt cold) and PYREXIA (Fever of 104.0) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-May-2021, Body temperature: 104.0 (High) Fever of 104.0.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache
Clinical narrative: he had a severe case of diarrhea that lasted 6 weeks; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and DIARRHOEA (he had a severe case of diarrhea that lasted 6 weeks) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced HEADACHE (headache) and DIARRHOEA (he had a severe case of diarrhea that lasted 6 weeks). At the time of the report, HEADACHE (headache) and DIARRHOEA (he had a severe case of diarrhea that lasted 6 weeks) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided. Patient  consulted with his primary care provider who prescribed him some medications. No specific medications reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-114763 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114763:
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Pain in extremity
Clinical narrative: Arm soreness; By mistake we gave an expired Moderna vaccine to a patient today; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) and EXPIRED PRODUCT ADMINISTERED (By mistake we gave an expired Moderna vaccine to a patient today) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (By mistake we gave an expired Moderna vaccine to a patient today). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm soreness). On 09-May-2021, EXPIRED PRODUCT ADMINISTERED (By mistake we gave an expired Moderna vaccine to a patient today) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm soreness) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided. ?It was reported that the patient took his second dose of Moderna COID-19 vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: New event, arm soreness was added and I narrative was updated.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: red, puffy, painful itchiness at injection site; red, puffy, painful itchiness at injection site; red, puffy, painful itchiness at injection site; red, puffy, painful itchiness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (red, puffy, painful itchiness at injection site), VACCINATION SITE ERYTHEMA (red, puffy, painful itchiness at injection site), VACCINATION SITE PRURITUS (red, puffy, painful itchiness at injection site) and VACCINATION SITE SWELLING (red, puffy, painful itchiness at injection site) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, the patient experienced VACCINATION SITE PAIN (red, puffy, painful itchiness at injection site), VACCINATION SITE ERYTHEMA (red, puffy, painful itchiness at injection site) and VACCINATION SITE PRURITUS (red, puffy, painful itchiness at injection site). On an unknown date, the patient experienced VACCINATION SITE SWELLING (red, puffy, painful itchiness at injection site). At the time of the report, VACCINATION SITE PAIN (red, puffy, painful itchiness at injection site), VACCINATION SITE ERYTHEMA (red, puffy, painful itchiness at injection site), VACCINATION SITE PRURITUS (red, puffy, painful itchiness at injection site) and VACCINATION SITE SWELLING (red, puffy, painful itchiness at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications include birth control
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair loss/hair falling out; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Hair loss/hair falling out) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced ALOPECIA (Hair loss/hair falling out). At the time of the report, ALOPECIA (Hair loss/hair falling out) outcome was unknown. Not Provided          No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up received contains non-significant information including patient's withdrawal of consent for follow up and updated event verbatim
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient given an expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given an expired vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient given an expired vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-114626, MOD21-088359, US-MODERNATX, INC.-MOD-2021-114420, US-MODERNATX, INC.-MOD-2021-114456 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114626: MOD21-088359: US-MODERNATX, INC.-MOD-2021-114420: US-MODERNATX, INC.-MOD-2021-114456:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Illness, Malaise
Clinical narrative: sick; stomach upset; not feeling well; lightheaded; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), ABDOMINAL DISCOMFORT (stomach upset), MALAISE (not feeling well), DIZZINESS (lightheaded) and DIZZINESS (dizziness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, the patient experienced ILLNESS (sick), ABDOMINAL DISCOMFORT (stomach upset), MALAISE (not feeling well), DIZZINESS (lightheaded) and DIZZINESS (dizziness). At the time of the report, ILLNESS (sick), ABDOMINAL DISCOMFORT (stomach upset), MALAISE (not feeling well), DIZZINESS (lightheaded) and DIZZINESS (dizziness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Relevant concomitant medications was reported.  Treatment information was not provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Decreased gait velocity, Heart rate, Heart rate increased
Clinical narrative: felt weaker; difficulty breathing while sleeping; could not walk at my normal pace; pulse was 102; Pulse irregular; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (pulse was 102), ASTHENIA (felt weaker), NOCTURNAL DYSPNOEA (difficulty breathing while sleeping), DECREASED GAIT VELOCITY (could not walk at my normal pace) and HEART RATE IRREGULAR (Pulse irregular) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Mitral valve replacement in 2013. Concurrent medical conditions included AFib in 1980. Concomitant products included METOPROLOL SUCCINATE for Atrial fibrillation, FUROSEMIDE from 15-Feb-2021 to an unknown date for an unknown indication.    On 18-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced HEART RATE IRREGULAR (Pulse irregular). On 31-Jan-2021, the patient experienced HEART RATE INCREASED (pulse was 102). On an unknown date, the patient experienced ASTHENIA (felt weaker), NOCTURNAL DYSPNOEA (difficulty breathing while sleeping) and DECREASED GAIT VELOCITY (could not walk at my normal pace). On 23-Jan-2021, HEART RATE IRREGULAR (Pulse irregular) had resolved. At the time of the report, HEART RATE INCREASED (pulse was 102) and ASTHENIA (felt weaker) had not resolved and NOCTURNAL DYSPNOEA (difficulty breathing while sleeping) and DECREASED GAIT VELOCITY (could not walk at my normal pace) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Blood pressure measurement: 500 (High) I made over 500 blood pressure.. On 07-Jan-2021, Heart rate: 67 (Low) Low. On 31-Jan-2021, Blood pressure measurement: 144/93 (High) High. On 31-Jan-2021, Heart rate: 102 (High) High.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient reported his normal resting pulse rate was in the 60s. The patient took pulse readings on 23JAN2021 which were 93, 70, 63, 77, 72, and 50. Treatment information was not provided by the reporter.   This case was linked to MOD-2021-114911 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: follow up information received Contains significant information, Added  patient's demographic information, batch/lot no., concomitant drug information updated.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate irregular, Nocturnal dyspnoea
Clinical narrative: felt weaker; difficulty breathing while sleeping; could not walk at my normal pace; pulse was 102; Pulse irregular; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (pulse was 102), ASTHENIA (felt weaker), NOCTURNAL DYSPNOEA (difficulty breathing while sleeping), DECREASED GAIT VELOCITY (could not walk at my normal pace) and HEART RATE IRREGULAR (Pulse irregular) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Mitral valve replacement in 2013. Concurrent medical conditions included AFib in 1980. Concomitant products included METOPROLOL SUCCINATE for Atrial fibrillation, FUROSEMIDE from 15-Feb-2021 to an unknown date for an unknown indication.    On 18-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced HEART RATE IRREGULAR (Pulse irregular). On 31-Jan-2021, the patient experienced HEART RATE INCREASED (pulse was 102). On an unknown date, the patient experienced ASTHENIA (felt weaker), NOCTURNAL DYSPNOEA (difficulty breathing while sleeping) and DECREASED GAIT VELOCITY (could not walk at my normal pace). On 23-Jan-2021, HEART RATE IRREGULAR (Pulse irregular) had resolved. At the time of the report, HEART RATE INCREASED (pulse was 102) and ASTHENIA (felt weaker) had not resolved and NOCTURNAL DYSPNOEA (difficulty breathing while sleeping) and DECREASED GAIT VELOCITY (could not walk at my normal pace) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, Blood pressure measurement: 500 (High) I made over 500 blood pressure.. On 07-Jan-2021, Heart rate: 67 (Low) Low. On 31-Jan-2021, Blood pressure measurement: 144/93 (High) High. On 31-Jan-2021, Heart rate: 102 (High) High.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient reported his normal resting pulse rate was in the 60s. The patient took pulse readings on 23JAN2021 which were 93, 70, 63, 77, 72, and 50. Treatment information was not provided by the reporter.   This case was linked to MOD-2021-114911 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: follow up information received Contains significant information, Added  patient's demographic information, batch/lot no., concomitant drug information updated.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: RITUXAN in January 2021, TETANUS VACCINE and FLU VACCINE VII. Concurrent medical conditions included Penicillin allergy, Allergy to antibiotic (Levaquin, Bacitracin, Z pack), Drug allergy (Codeine) and Waldenstrom's macroglobulinemia (improvement in symptoms in blood. The patient had an information of Rituxan in Jan, 21'. she was advised to wait about 90 days before she had the first vaccine to the effectiveness of it.) since 17-Jul-2019. Concomitant products included CLINDAMYCIN from 01-Jan-2015 to 01-May-2021 for Acne, LORATADINE (CLARITINE) from 01-Jan-2015 to an unknown date for Allergy, ROSUVASTATIN from 01-Oct-2020 to an unknown date for High cholesterol.    On 17-Mar-2021 at 4:45 AM, 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 IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient experienced soreness in arm for few days after 1st dose of vaccination.   This case was linked to MOD-2021-076633 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itchy; Rash all over body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy) and RASH (Rash all over body) in a 58-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 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced PRURITUS (itchy) and RASH (Rash all over body). At the time of the report, PRURITUS (itchy) and RASH (Rash all over body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medications were provided.  No Treatment medications were provided   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Non Significant- TCR attached.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: took first dose of Moderna vaccine after 2 shots of Pfizer; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (took first dose of Moderna vaccine after 2 shots of Pfizer) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced EXTRA DOSE ADMINISTERED (took first dose of Moderna vaccine after 2 shots of Pfizer). On 08-Apr-2021, EXTRA DOSE ADMINISTERED (took first dose of Moderna vaccine after 2 shots of Pfizer) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-114898 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow-up information  received on  09 Jun 2021 contains non-significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114898:dose 2
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: did not go back to get the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not go back to get the 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not go back to get the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (did not go back to get the 2nd dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported by the reporter No treatment medications was  provided by the reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Papule, Rash
Clinical narrative: Little white pin drops all over; Rash; Breaking out on arms, waist, chest, legs, hands, face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAPULE (Little white pin drops all over), RASH (Rash) and RASH (Breaking out on arms, waist, chest, legs, hands, face) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 039K20A) for COVID-19 vaccination.     The patient's past medical history included Cancer (on both arms).   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAPULE (Little white pin drops all over), RASH (Rash) and RASH (Breaking out on arms, waist, chest, legs, hands, face). At the time of the report, PAPULE (Little white pin drops all over) and RASH (Rash) had not resolved and RASH (Breaking out on arms, waist, chest, legs, hands, face) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Inconclusive.         Patient advises that since the rash started she's been to the emergency room twice, to her dermatologist and to her primary care doctor 6 or 7 times.  Patient advises her primary care doctor has been trying to figure out what her rash was and how to get it taken care of. She had blood work done at her primary care doctor. In the middle of all of this dealing with her rash, she's seeing the dermatologist for skin cancer. The dermatologist did send scrapings of the rash off. Advises she doesn't have those results.  No treatment medications were reported.  No concomitant medications were reported.   This case was linked to MOD-2021-109718 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: event added On 22-Jun-2021: Possible NNI please confirm
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Malaise, Product dose omission issue, Tremor
Clinical narrative: 48 days post first vaccine and no second shot; Felt Very Sick; Very Weak like having a Flu; Shaky Legs /  could not hold her up; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MALAISE (Felt Very Sick), ASTHENIA (Very Weak like having a Flu), TREMOR (Shaky Legs /  could not hold her up) and PRODUCT DOSE OMISSION ISSUE (48 days post first vaccine and no second shot) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced MALAISE (Felt Very Sick), ASTHENIA (Very Weak like having a Flu) and TREMOR (Shaky Legs /  could not hold her up). On 07-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (48 days post first vaccine and no second shot). On 26-Mar-2021, ASTHENIA (Very Weak like having a Flu) had resolved. On 20-Apr-2021, MALAISE (Felt Very Sick) and TREMOR (Shaky Legs /  could not hold her up) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (48 days post first vaccine and no second shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Injection site reaction, Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: feels like i had chills; reddened ring around injection site; felt feverish; slightly itchy; 2" round reddened spot; This spontaneous case was reported by a nurse and describes the occurrence of RASH ERYTHEMATOUS (2" round reddened spot), CHILLS (feels like i had chills), INJECTION SITE REACTION (reddened ring around injection site), PYREXIA (felt feverish) and RASH PRURITIC (slightly itchy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced RASH ERYTHEMATOUS (2" round reddened spot) and RASH PRURITIC (slightly itchy). On 17-Mar-2021, the patient experienced CHILLS (feels like i had chills), INJECTION SITE REACTION (reddened ring around injection site) and PYREXIA (felt feverish). On 18-Mar-2021, PYREXIA (felt feverish) had resolved. On 19-Mar-2021, INJECTION SITE REACTION (reddened ring around injection site) had resolved. At the time of the report, RASH ERYTHEMATOUS (2" round reddened spot), CHILLS (feels like i had chills) and RASH PRURITIC (slightly itchy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.    patient received Shingrix vaccine couple of years ago
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: took Second shot of Moderna vaccine after 2 shots of Pfizer; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (took Second shot of Moderna vaccine after 2 shots of Pfizer) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Lot# 030B21A and 024C21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported ).   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 06-May-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (took Second shot of Moderna vaccine after 2 shots of Pfizer). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (took Second shot of Moderna vaccine after 2 shots of Pfizer) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-114880 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114880:dose 1
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This spontaneous case was reported by an other (subsequently medically confirmed) and describes the occurrence of HYPERSENSITIVITY (Allergic reaction) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction). At the time of the report, HYPERSENSITIVITY (Allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: vaccionation adverse reaction; vaccination complication; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION COMPLICATION (vaccionation adverse reaction) and VACCINATION COMPLICATION (vaccination complication) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Non-Hodgkin's lymphoma. Concomitant products included IBRUTINIB (IMBRUVICA) from 23-Dec-2020 to an unknown date.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (vaccionation adverse reaction) and VACCINATION COMPLICATION (vaccination complication). At the time of the report, VACCINATION COMPLICATION (vaccionation adverse reaction) and VACCINATION COMPLICATION (vaccination complication) was resolving.        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.
Sex: F
Vaccine: COVID19
Symptoms: Euphoric mood
Clinical narrative: feeling high; This spontaneous case was reported by a consumer and describes the occurrence of EUPHORIC MOOD (feeling high) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EUPHORIC MOOD (feeling high). At the time of the report, EUPHORIC MOOD (feeling high) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   ?No treatment information was provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: a little sore and right arm was sore; a little sore and right arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (a little sore and right arm was sore) and MYALGIA (a little sore and right arm was sore) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (a little sore and right arm was sore) and MYALGIA (a little sore and right arm was sore). At the time of the report, VACCINATION SITE PAIN (a little sore and right arm was sore) and MYALGIA (a little sore and right arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-114954 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Adverse event; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Adverse event). Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant and treatment details were provided.   This case was linked to MOD-2021-114930 (Patient Link).
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain in extremity
Clinical narrative: Pain every where, from shoulders, arms, legs down to my feet; the pain in my knee kept me from bending it; Pain every where, from shoulders, arms, legs down to my feet; severe pain in all my muscles; severe joint pain; arm was extremely sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was extremely sore), PAIN IN EXTREMITY (Pain every where, from shoulders, arms, legs down to my feet), MYALGIA (severe pain in all my muscles), ARTHRALGIA (severe joint pain) and ARTHRALGIA (the pain in my knee kept me from bending it) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was extremely sore), MYALGIA (severe pain in all my muscles) and ARTHRALGIA (severe joint pain). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain every where, from shoulders, arms, legs down to my feet), ARTHRALGIA (the pain in my knee kept me from bending it) and ARTHRALGIA (Pain every where, from shoulders, arms, legs down to my feet). At the time of the report, PAIN IN EXTREMITY (arm was extremely sore), PAIN IN EXTREMITY (Pain every where, from shoulders, arms, legs down to my feet), MYALGIA (severe pain in all my muscles), ARTHRALGIA (severe joint pain), ARTHRALGIA (the pain in my knee kept me from bending it) and ARTHRALGIA (Pain every where, from shoulders, arms, legs down to my feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-115057 (Patient Link).
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Arthralgia, Fatigue, Gait inability, Illness
Clinical narrative: Adverse event; night sweats; he couldn't even walk 100 meters; very very ill; fatigue/absolute sapping fatigue; joint pian; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Adverse event), NIGHT SWEATS (night sweats), GAIT INABILITY (he couldn't even walk 100 meters), ILLNESS (very very ill) and FATIGUE (fatigue/absolute sapping fatigue) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Adverse event), NIGHT SWEATS (night sweats), GAIT INABILITY (he couldn't even walk 100 meters), ILLNESS (very very ill), FATIGUE (fatigue/absolute sapping fatigue) and ARTHRALGIA (joint pian). At the time of the report, ADVERSE EVENT (Adverse event) outcome was unknown and NIGHT SWEATS (night sweats), GAIT INABILITY (he couldn't even walk 100 meters), ILLNESS (very very ill), FATIGUE (fatigue/absolute sapping fatigue) and ARTHRALGIA (joint pian) had resolved. Not Provided          No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-114923 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Added E-mail address. Added Event information- Night sweats, gait inability, illness, fatigue, arthralgia.