chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: reported that the eczema keeps getting worse; This spontaneous case was reported by a patient and describes the occurrence of ECZEMA (Patient received the second dose of the Moderna vaccine on 30March2021/ reported that the eczema keeps getting worse) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ECZEMA (Patient received the second dose of the Moderna vaccine on 30March2021/ reported that the eczema keeps getting worse). At the time of the report, ECZEMA (Patient received the second dose of the Moderna vaccine on 30March2021/ reported that the eczema keeps getting worse) had not resolved.            The patient stated that about  3 months ago , her dermatologist that she had been seeing her prescribing a steroid cream. Concomitant drug information does not provided.   This case was linked to MOD-2021-318836 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Depression, Disturbance in attention, Dizziness, Fatigue
Clinical narrative: Vestibular migraine; Dizziness; Lack of concentration; Irritability; Anxiety; Depression; Tearfulness; Nausea; Fatigue; Headache; Started to feel ill; Blurred vision in both eyes; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Started to feel ill), VISION BLURRED (Blurred vision in both eyes), VESTIBULAR MIGRAINE (Vestibular migraine), DIZZINESS (Dizziness) and DISTURBANCE IN ATTENTION (Lack of concentration) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028C20A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LORAZEPAM, SERTRALINE and PARACETAMOL, TRAMADOL HYDROCHLORIDE (TRACEDOL).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced ILLNESS (Started to feel ill), VISION BLURRED (Blurred vision in both eyes) and HEADACHE (Headache). On an unknown date, the patient experienced VESTIBULAR MIGRAINE (Vestibular migraine), DIZZINESS (Dizziness), DISTURBANCE IN ATTENTION (Lack of concentration), IRRITABILITY (Irritability), ANXIETY (Anxiety), DEPRESSION (Depression), TEARFULNESS (Tearfulness), NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, ILLNESS (Started to feel ill), VISION BLURRED (Blurred vision in both eyes), VESTIBULAR MIGRAINE (Vestibular migraine), DIZZINESS (Dizziness), DISTURBANCE IN ATTENTION (Lack of concentration), IRRITABILITY (Irritability), ANXIETY (Anxiety), DEPRESSION (Depression), TEARFULNESS (Tearfulness), NAUSEA (Nausea), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: ms spine MRI ruled out MS.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Irritability, Magnetic resonance imaging, Nausea
Clinical narrative: Vestibular migraine; Dizziness; Lack of concentration; Irritability; Anxiety; Depression; Tearfulness; Nausea; Fatigue; Headache; Started to feel ill; Blurred vision in both eyes; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Started to feel ill), VISION BLURRED (Blurred vision in both eyes), VESTIBULAR MIGRAINE (Vestibular migraine), DIZZINESS (Dizziness) and DISTURBANCE IN ATTENTION (Lack of concentration) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028C20A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LORAZEPAM, SERTRALINE and PARACETAMOL, TRAMADOL HYDROCHLORIDE (TRACEDOL).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced ILLNESS (Started to feel ill), VISION BLURRED (Blurred vision in both eyes) and HEADACHE (Headache). On an unknown date, the patient experienced VESTIBULAR MIGRAINE (Vestibular migraine), DIZZINESS (Dizziness), DISTURBANCE IN ATTENTION (Lack of concentration), IRRITABILITY (Irritability), ANXIETY (Anxiety), DEPRESSION (Depression), TEARFULNESS (Tearfulness), NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, ILLNESS (Started to feel ill), VISION BLURRED (Blurred vision in both eyes), VESTIBULAR MIGRAINE (Vestibular migraine), DIZZINESS (Dizziness), DISTURBANCE IN ATTENTION (Lack of concentration), IRRITABILITY (Irritability), ANXIETY (Anxiety), DEPRESSION (Depression), TEARFULNESS (Tearfulness), NAUSEA (Nausea), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: ms spine MRI ruled out MS.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Tearfulness, Vestibular migraine, Vision blurred
Clinical narrative: Vestibular migraine; Dizziness; Lack of concentration; Irritability; Anxiety; Depression; Tearfulness; Nausea; Fatigue; Headache; Started to feel ill; Blurred vision in both eyes; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Started to feel ill), VISION BLURRED (Blurred vision in both eyes), VESTIBULAR MIGRAINE (Vestibular migraine), DIZZINESS (Dizziness) and DISTURBANCE IN ATTENTION (Lack of concentration) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028C20A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LORAZEPAM, SERTRALINE and PARACETAMOL, TRAMADOL HYDROCHLORIDE (TRACEDOL).   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced ILLNESS (Started to feel ill), VISION BLURRED (Blurred vision in both eyes) and HEADACHE (Headache). On an unknown date, the patient experienced VESTIBULAR MIGRAINE (Vestibular migraine), DIZZINESS (Dizziness), DISTURBANCE IN ATTENTION (Lack of concentration), IRRITABILITY (Irritability), ANXIETY (Anxiety), DEPRESSION (Depression), TEARFULNESS (Tearfulness), NAUSEA (Nausea) and FATIGUE (Fatigue). At the time of the report, ILLNESS (Started to feel ill), VISION BLURRED (Blurred vision in both eyes), VESTIBULAR MIGRAINE (Vestibular migraine), DIZZINESS (Dizziness), DISTURBANCE IN ATTENTION (Lack of concentration), IRRITABILITY (Irritability), ANXIETY (Anxiety), DEPRESSION (Depression), TEARFULNESS (Tearfulness), NAUSEA (Nausea), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: ms spine MRI ruled out MS.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: did have mycarditis og the heart; 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 MYOCARDITIS (did have mycarditis og the heart) 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 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced MYOCARDITIS (did have mycarditis og the heart) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (did have mycarditis og the heart) outcome was unknown.            No concomitant medication details was provided. No treatment medication details was provided.  Action taken was not applicable.  This case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced serious expected event of myocarditis. The events occurred approximately 4 days after the second dose of Spikevax with first symptom reported as dyspnoea. Rechallenge was not applicable. The benefit-risk relationship of drug is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced serious expected event of myocarditis. The events occurred approximately 4 days after the second dose of Spikevax with first symptom reported as dyspnoea. Rechallenge was not applicable. The benefit-risk relationship of drug is not affected by this report
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Pyrexia
Clinical narrative: Watery stools every day since april and continues; Stomach was upset; Fever; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Watery stools every day since april and continues), ABDOMINAL DISCOMFORT (Stomach was upset) and PYREXIA (Fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 027B21A) for COVID-19 vaccination.     The patient's past medical history included Stools watery (20 years ago).   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 29-Apr-2021, the patient experienced DIARRHOEA (Watery stools every day since april and continues), ABDOMINAL DISCOMFORT (Stomach was upset) and PYREXIA (Fever). On 29-Apr-2021, PYREXIA (Fever) had resolved. On 01-May-2021, ABDOMINAL DISCOMFORT (Stomach was upset) had resolved. At the time of the report, DIARRHOEA (Watery stools every day since april and continues) had not resolved.            Concomitant medications were not reported by the reporter Treatment drugs were not reported by the reporter   This case was linked to MOD-2021-319094 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore right injection site arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LIOTHYRONINE SODIUM (T3) from an unknown date to 01-Mar-2021 for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore right injection site arm) (seriousness criterion medically significant). At the time of the report, VACCINATION SITE PAIN (sore right injection site arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had a sore right injection site arm which felt better in a few days.  No treatment medication was reported.  Company comment: This case concerns a 61-year-old mal subject who experienced the expected event of  VACCINATION SITE PAIN. The event occurred the same date after the first dose of Spikevax and it had resolved. The event is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of spikevax is not affected by this report.   This case was linked to MOD-2021-319204 (Patient Link).; Sender's Comments: This case concerns a 61-year-old mal subject who experienced the expected event of  VACCINATION SITE PAIN. The event occurred the same date after the first dose of Spikevax and it had resolved. The event is consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of spikevax is not affected by this report.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Feeling abnormal, Sinusitis
Clinical narrative: Weird side effects; feels like she has a bad sinus infection; Now she is losing taste and smell.; Now she is losing taste and smell.; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Weird side effects), SINUSITIS (feels like she has a bad sinus infection), AGEUSIA (Now she is losing taste and smell.) and ANOSMIA (Now she is losing taste and smell.) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Weird side effects), SINUSITIS (feels like she has a bad sinus infection), AGEUSIA (Now she is losing taste and smell.) and ANOSMIA (Now she is losing taste and smell.). At the time of the report, FEELING ABNORMAL (Weird side effects), SINUSITIS (feels like she has a bad sinus infection), AGEUSIA (Now she is losing taste and smell.) and ANOSMIA (Now she is losing taste and smell.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No Treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Significant follow up received and additional event added.
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Muscle spasms
Clinical narrative: I been getting really bad cramps but I don't get my period; I don't get my period this has never happen; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (I been getting really bad cramps but I don't get my period) and AMENORRHOEA (I don't get my period this has never happen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (I been getting really bad cramps but I don't get my period) and AMENORRHOEA (I don't get my period this has never happen). At the time of the report, MUSCLE SPASMS (I been getting really bad cramps but I don't get my period) and AMENORRHOEA (I don't get my period this has never happen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pollakiuria, Urine output increased, Vaccination site induration
Clinical narrative: full bladder feeling/ feeling a need to urinate; having excessive urination; injection sites felt hard; This spontaneous case was reported by a consumer and describes the occurrence of POLLAKIURIA (full bladder feeling/ feeling a need to urinate), URINE OUTPUT INCREASED (having excessive urination) and VACCINATION SITE INDURATION (injection sites felt hard) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced POLLAKIURIA (full bladder feeling/ feeling a need to urinate), URINE OUTPUT INCREASED (having excessive urination) and VACCINATION SITE INDURATION (injection sites felt hard). At the time of the report, POLLAKIURIA (full bladder feeling/ feeling a need to urinate), URINE OUTPUT INCREASED (having excessive urination) and VACCINATION SITE INDURATION (injection sites felt hard) outcome was unknown.            Patient was sensitive to sodium and suspects the sodium in vaccine. No concomitant medications were reported. No treatment medications were reported   This case was linked to MOD-2021-319620, MOD-2021-319619 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Chills, Peripheral swelling, Pyrexia
Clinical narrative: Swollen arm; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), PYREXIA (Fever) and CHILLS (Chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: IMMUNOTHERAPY until 05-Apr-2021.    On 02-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), PYREXIA (Fever) and CHILLS (Chills). On 03-Sep-2021, PERIPHERAL SWELLING (Swollen arm), PYREXIA (Fever) and CHILLS (Chills) had resolved.            No concomitant treatment was provided. No treatment medication was provided.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: itching at the injections site; redness at the injections site; injections site swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at the injections site), VACCINATION SITE ERYTHEMA (redness at the injections site) and VACCINATION SITE SWELLING (injections site swelling) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-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 PRURITUS (itching at the injections site), VACCINATION SITE ERYTHEMA (redness at the injections site) and VACCINATION SITE SWELLING (injections site swelling). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (itching at the injections site) and VACCINATION SITE SWELLING (injections site swelling) had resolved and VACCINATION SITE ERYTHEMA (redness at the injections site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  7-8 days later after the vaccination, the patient had a delayed reaction, with redness at the injections site, on their left arm, and also swelling and itching that lasted 3 days approximately. Patient wonders if this was normal and whether they should get the second dose.
Sex: U
Vaccine: COVID19
Symptoms: Bone pain, Pain in extremity, Vaccination site pain
Clinical narrative: Pain in arm; Bone pain/bone pain in arm; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), BONE PAIN (Bone pain/bone pain in arm) and VACCINATION SITE PAIN (Injection site pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm), BONE PAIN (Bone pain/bone pain in arm) and VACCINATION SITE PAIN (Injection site pain). At the time of the report, PAIN IN EXTREMITY (Pain in arm), BONE PAIN (Bone pain/bone pain in arm) and VACCINATION SITE PAIN (Injection site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication information was reported. No treatment medications were provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Myalgia, Oropharyngeal discomfort, Pain in extremity
Clinical narrative: Sore arm; Symptoms kept on getting worse; Throat started closing up 15 to 20 minutes after the shot; Developed chills; Body aches/Body was aching really bad; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Symptoms kept on getting worse), OROPHARYNGEAL DISCOMFORT (Throat started closing up 15 to 20 minutes after the shot), PAIN IN EXTREMITY (Sore arm), CHILLS (Developed chills) and MYALGIA (Body aches/Body was aching really bad) in a 58-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.     Concurrent medical conditions included Diabetes.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (Throat started closing up 15 to 20 minutes after the shot), CHILLS (Developed chills) and PYREXIA (Fever). 10-Sep-2021, the patient experienced MYALGIA (Body aches/Body was aching really bad). On 11-Sep-2021, the patient experienced CONDITION AGGRAVATED (Symptoms kept on getting worse). On 12-Sep-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 12-Sep-2021, PYREXIA (Fever) had resolved. At the time of the report, CONDITION AGGRAVATED (Symptoms kept on getting worse), OROPHARYNGEAL DISCOMFORT (Throat started closing up 15 to 20 minutes after the shot) and CHILLS (Developed chills) outcome was unknown and PAIN IN EXTREMITY (Sore arm) and MYALGIA (Body aches/Body was aching really bad) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product information was provided. No treatment information was provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Sore arm; Symptoms kept on getting worse; Throat started closing up 15 to 20 minutes after the shot; Developed chills; Body aches/Body was aching really bad; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Symptoms kept on getting worse), OROPHARYNGEAL DISCOMFORT (Throat started closing up 15 to 20 minutes after the shot), PAIN IN EXTREMITY (Sore arm), CHILLS (Developed chills) and MYALGIA (Body aches/Body was aching really bad) in a 58-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.     Concurrent medical conditions included Diabetes.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (Throat started closing up 15 to 20 minutes after the shot), CHILLS (Developed chills) and PYREXIA (Fever). 10-Sep-2021, the patient experienced MYALGIA (Body aches/Body was aching really bad). On 11-Sep-2021, the patient experienced CONDITION AGGRAVATED (Symptoms kept on getting worse). On 12-Sep-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 12-Sep-2021, PYREXIA (Fever) had resolved. At the time of the report, CONDITION AGGRAVATED (Symptoms kept on getting worse), OROPHARYNGEAL DISCOMFORT (Throat started closing up 15 to 20 minutes after the shot) and CHILLS (Developed chills) outcome was unknown and PAIN IN EXTREMITY (Sore arm) and MYALGIA (Body aches/Body was aching really bad) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product information was provided. No treatment information was provided.
Sex: U
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  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported.  No treatment medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Greater than 35 days without 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Greater than 35 days without 2nd dose) 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 03-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Greater than 35 days without 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Greater than 35 days without 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment medications were not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side affects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side affects) 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 (Side affects). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Side affects) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: not clear if interval between doses is correct and not clear if eligible for third dose booster; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (not clear if interval between doses is correct and not clear if eligible for third dose booster) 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.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (not clear if interval between doses is correct and not clear if eligible for third dose booster). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (not clear if interval between doses is correct and not clear if eligible for third dose booster) had resolved.            No concomitant medication reported. No treatment information was provided
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Got COVID; 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 COVID-19 (Got COVID) 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 COVID-19 (Got COVID). At the time of the report, COVID-19 (Got COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     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 medication information was provided. No treatment medication were provided.
Age: 99.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: something in her heart; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (something in her heart) in a 99-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (something in her heart). At the time of the report, CARDIAC DISORDER (something in her heart) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Sep-2021: Follow up document attached on 13-Sep-2021 includes NNI
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever of 101F after 2nd dose; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever of 101F after 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.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PYREXIA (Fever of 101F after 2nd dose). In 2021, PYREXIA (Fever of 101F after 2nd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 101 (High) 101 Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.  It was reported that  fever went away by itself in a day or two   This case was linked to MOD-2021-319548, MOD-2021-319555.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever of 102F after 3rd dose; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever of 102F after 3rd 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 09-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced PYREXIA (Fever of 102F after 3rd dose). On 09-Sep-2021, PYREXIA (Fever of 102F after 3rd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Sep-2021, Body temperature: 102 (High) High.     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 medications were provided by the reporter.   This case was linked to MOD-2021-319554, MOD-2021-319548 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got really sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got really sick) 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 ILLNESS (got really sick). At the time of the report, ILLNESS (got really sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient received booster shot on Friday, September 10. The patient got really sick, much worse than with the previous two shots, and on the second day, woke with really swollen lymph nodes in neck.  No concomitant medications were reported. No treatment medications were provided.   This case was linked to MOD-2021-319590, MOD-2021-319591 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Got sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got sick). At the time of the report, ILLNESS (Got sick) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.    This case was linked to MOD-2021-319587, MOD-2021-319591 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Illness, Lymphadenopathy
Clinical narrative: Really swollen lymph nodes in my neck; Got really sick much worse than with the previous two shots; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got really sick much worse than with the previous two shots) and LYMPHADENOPATHY (Really swollen lymph nodes in my neck) 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 10-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced LYMPHADENOPATHY (Really swollen lymph nodes in my neck). In September 2021, the patient experienced ILLNESS (Got really sick much worse than with the previous two shots). At the time of the report, ILLNESS (Got really sick much worse than with the previous two shots) and LYMPHADENOPATHY (Really swollen lymph nodes in my neck) outcome was unknown.            No concomitant products were reported. No treatment information was reported by the reporter.   This case was linked to MOD-2021-319590, MOD-2021-319587 (Patient Link).
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Died) in a 44-year-old male 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) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            The concomitant medications were not reported. The treatment information was not provided.  Company Comment :This case concerns a 44-year-old, male patient with no relevant medical history, who experienced the unexpected event of death (unknown cause). The event occurred unknown duration after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-143352 (E2B Linked Report).; Sender's Comments: This case concerns a 44-year-old, male patient with no relevant medical history, who experienced the unexpected event of death (unknown cause). The event occurred unknown duration after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter's assessment. The benefit-risk relationship of Spikevax is not affected by this report. MOD-2021-143352:; Reported Cause(s) of Death: unknown cause of death
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pollakiuria, Urine output increased, Vaccination site induration
Clinical narrative: full bladder feeling/ feeling a need to urinate; having excessive urination; injection sites felt hard; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (injection sites felt hard), POLLAKIURIA (full bladder feeling/ feeling a need to urinate) and URINE OUTPUT INCREASED (having excessive urination) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug hypersensitivity (sensitive to sodium.) and Immunocompromised.    On 25-Mar-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 INDURATION (injection sites felt hard), POLLAKIURIA (full bladder feeling/ feeling a need to urinate) and URINE OUTPUT INCREASED (having excessive urination). At the time of the report, VACCINATION SITE INDURATION (injection sites felt hard), POLLAKIURIA (full bladder feeling/ feeling a need to urinate) and URINE OUTPUT INCREASED (having excessive urination) outcome was unknown.            No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2021-319270 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Sore arm/Still slightly sore; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm/Still slightly sore) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart disease, unspecified.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced MYALGIA (Sore arm/Still slightly sore). At the time of the report, MYALGIA (Sore arm/Still slightly sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No Treatment information was reported.   Reporter did not allow further contact
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Got diarrhea/Constant issues with diarrhea, about 4 times per week/When actually have diarrhea, it's multiple times a day/Couldn't make it to the bathroom immediately, pooped my pants/Have to use the bathroom immediately/(When actually have diarrhea; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Got diarrhea/Constant issues with diarrhea, about 4 times per week/When actually have diarrhea, it's multiple times a day/Couldn't make it to the bathroom immediately, pooped my pants/Have to use the bathroom immediately/(When actually have diarrhea)) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced DIARRHOEA (Got diarrhea/Constant issues with diarrhea, about 4 times per week/When actually have diarrhea, it's multiple times a day/Couldn't make it to the bathroom immediately, pooped my pants/Have to use the bathroom immediately/(When actually have diarrhea)). At the time of the report, DIARRHOEA (Got diarrhea/Constant issues with diarrhea, about 4 times per week/When actually have diarrhea, it's multiple times a day/Couldn't make it to the bathroom immediately, pooped my pants/Have to use the bathroom immediately/(When actually have diarrhea)) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment information was provided.  Patient wanted to mention he had no signs and symptoms of COVID or never tested positive for COVID. HCP has scheduled a colonoscopy.   This case was linked to MOD-2021-319295 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Headache, Illness, Malaise
Clinical narrative: sick for 2 days; felt yucky; didn't feel well; sore arm; fever/ highest was 101.2 F; really tired; headachy; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for 2 days), DISCOMFORT (felt yucky), MALAISE (didn't feel well), MYALGIA (sore arm) and PYREXIA (fever/ highest was 101.2 F) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by reporter.  Concurrent medical conditions included Cancer. Concomitant products included IMATINIB MESILATE (GLEEVEC) for Chemotherapy.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick for 2 days), DISCOMFORT (felt yucky), MALAISE (didn't feel well), MYALGIA (sore arm), PYREXIA (fever/ highest was 101.2 F), FATIGUE (really tired) and HEADACHE (headachy). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, ILLNESS (sick for 2 days), DISCOMFORT (felt yucky), MALAISE (didn't feel well), MYALGIA (sore arm), PYREXIA (fever/ highest was 101.2 F), FATIGUE (really tired) and HEADACHE (headachy) outcome was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: sick for 2 days; felt yucky; didn't feel well; sore arm; fever/ highest was 101.2 F; really tired; headachy; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for 2 days), DISCOMFORT (felt yucky), MALAISE (didn't feel well), MYALGIA (sore arm) and PYREXIA (fever/ highest was 101.2 F) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported by reporter.  Concurrent medical conditions included Cancer. Concomitant products included IMATINIB MESILATE (GLEEVEC) for Chemotherapy.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick for 2 days), DISCOMFORT (felt yucky), MALAISE (didn't feel well), MYALGIA (sore arm), PYREXIA (fever/ highest was 101.2 F), FATIGUE (really tired) and HEADACHE (headachy). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, ILLNESS (sick for 2 days), DISCOMFORT (felt yucky), MALAISE (didn't feel well), MYALGIA (sore arm), PYREXIA (fever/ highest was 101.2 F), FATIGUE (really tired) and HEADACHE (headachy) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever; my body hurt; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and MYALGIA (my body hurt) 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 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Sep-2021, the patient experienced PYREXIA (Fever) and MYALGIA (my body hurt). At the time of the report, PYREXIA (Fever) and MYALGIA (my body hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment medications provided.