chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: I am having vaginal bleeding.; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (I am having vaginal bleeding.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hysterectomy (Patient had a hysterectomy over 20 years ago).   On 02-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced VAGINAL HAEMORRHAGE (I am having vaginal bleeding.). At the time of the report, VAGINAL HAEMORRHAGE (I am having vaginal bleeding.) outcome was unknown.            No concomitant medications were reported. No treatment medication was reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product dose omission issue
Clinical narrative: Soreness of the left arm; Missed second Dose ( Beyond day 42); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of the left arm) and PRODUCT DOSE OMISSION ISSUE (Missed second Dose ( Beyond day 42)) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL and QUETIAPINE FUMARATE (SEROQUEL) for an unknown indication.    On 08-Apr-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 (Soreness of the left arm) and PRODUCT DOSE OMISSION ISSUE (Missed second Dose ( Beyond day 42)). At the time of the report, PAIN IN EXTREMITY (Soreness of the left arm) and PRODUCT DOSE OMISSION ISSUE (Missed second Dose ( Beyond day 42)) 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.   Treatment medication was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Ear pain, Headache, Illness, Nasopharyngitis
Clinical narrative: I took my First Covid shot last Saturday and have been getting sick every since; dizziness; cold symptoms; ear aches; I'm getting severe headaches; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (I took my First Covid shot last Saturday and have been getting sick every since), DIZZINESS (dizziness), NASOPHARYNGITIS (cold symptoms), EAR PAIN (ear aches) and HEADACHE (I'm getting severe headaches) 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 (I took my First Covid shot last Saturday and have been getting sick every since), DIZZINESS (dizziness), NASOPHARYNGITIS (cold symptoms), EAR PAIN (ear aches) and HEADACHE (I'm getting severe headaches). At the time of the report, ILLNESS (I took my First Covid shot last Saturday and have been getting sick every since), DIZZINESS (dizziness), NASOPHARYNGITIS (cold symptoms), EAR PAIN (ear aches) and HEADACHE (I'm getting severe headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Irritability, Pruritus
Clinical narrative: itchiness throughout my body; its frustating; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness throughout my body) and IRRITABILITY (its frustating) 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 PRURITUS (itchiness throughout my body) and IRRITABILITY (its frustating). At the time of the report, PRURITUS (itchiness throughout my body) and IRRITABILITY (its frustating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medication was reported.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Lymphadenopathy, Product dose omission issue, Swelling, Vaccination site swelling
Clinical narrative: no second vaccination taken; swelling of left side of neck; swelling of left arm (injection arm); swelling of lymph nodes in left armpit/swelling of left side of neck; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (no second vaccination taken), SWELLING (swelling of left side of neck), VACCINATION SITE SWELLING (swelling of left arm (injection arm)) and LYMPHADENOPATHY (swelling of lymph nodes in left armpit/swelling of left side of neck) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (no second vaccination taken), SWELLING (swelling of left side of neck), VACCINATION SITE SWELLING (swelling of left arm (injection arm)) and LYMPHADENOPATHY (swelling of lymph nodes in left armpit/swelling of left side of neck). The patient was treated with AMOXICILLIN, CLAVULANIC ACID (AUGMENTINE [AMOXICILLIN;CLAVULANIC ACID]) at a dose of UNK dosage form and METHYLPREDNISOLONE SODIUM SUCCINATE (SOLU-MEDROL) at a dose of UNK dosage form. At the time of the report, PRODUCT DOSE OMISSION ISSUE (no second vaccination taken), SWELLING (swelling of left side of neck), VACCINATION SITE SWELLING (swelling of left arm (injection arm)) and LYMPHADENOPATHY (swelling of lymph nodes in left armpit/swelling of left side of neck) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: unknown (Inconclusive) upper body.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Reporter did not allow further contact
Age: 23.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: 1 dose of the vaccine was given to 1 patient after on the 32nd day of refrigideration; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021 and was forwarded to Moderna on 04-Jun-2021.    This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (1 dose of the vaccine was given to 1 patient after on the 32nd day of refrigideration) in a 23-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced PRODUCT STORAGE ERROR (1 dose of the vaccine was given to 1 patient after on the 32nd day of refrigideration). At the time of the report, PRODUCT STORAGE ERROR (1 dose of the vaccine was given to 1 patient after on the 32nd day of refrigideration) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported . No treatment medication was reported .
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick; 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 ILLNESS (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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick). At the time of the report, ILLNESS (sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: >42 days between the first and second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>42 days between the first and second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>42 days between the first and second dose). On 04-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>42 days between the first and second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Treatment medication was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Lethargy, Pain in extremity
Clinical narrative: Sluggish; It felt like a bully at school.; Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Sluggish), FEELING ABNORMAL (It felt like a bully at school.) and PAIN IN EXTREMITY (Soreness in arm) in a female 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 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced LETHARGY (Sluggish), FEELING ABNORMAL (It felt like a bully at school.) and PAIN IN EXTREMITY (Soreness in arm). At the time of the report, LETHARGY (Sluggish), FEELING ABNORMAL (It felt like a bully at school.) and PAIN IN EXTREMITY (Soreness in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product details was not provided by the reporter. Treatment information was not provided.    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up document contains No new information On 27-Jul-2021: TCR : Follow up document contains No New Information
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Got sick off the first dose of the vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (Got sick off the first dose of the vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Got sick off the first dose of the vaccine). At the time of the report, ILLNESS (Got sick off the first dose of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not provided.  Treatment medication was not given.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine, Vaginal haemorrhage
Clinical narrative: spotting; severe allergic reactions; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (spotting) and ALLERGY TO VACCINE (severe allergic reactions) 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 VAGINAL HAEMORRHAGE (spotting) and ALLERGY TO VACCINE (severe allergic reactions). At the time of the report, VAGINAL HAEMORRHAGE (spotting) and ALLERGY TO VACCINE (severe allergic reactions) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication was reported. Treatment medication was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Myalgia, Pain in extremity
Clinical narrative: pain in right arm/shot settled in her muscles and bones; shot settled in her muscles and bones; shot settled in her muscles and bones; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in right arm/shot settled in her muscles and bones), BONE PAIN (shot settled in her muscles and bones) and MYALGIA (shot settled in her muscles and bones) in a 67-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.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 13-May-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 PAIN IN EXTREMITY (pain in right arm/shot settled in her muscles and bones), BONE PAIN (shot settled in her muscles and bones) and MYALGIA (shot settled in her muscles and bones). At the time of the report, PAIN IN EXTREMITY (pain in right arm/shot settled in her muscles and bones), BONE PAIN (shot settled in her muscles and bones) and MYALGIA (shot settled in her muscles and bones) outcome was unknown.            No concomitant medication was reported. Treatment medication was not provided.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.   This case was linked to MOD-2021-193869 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Very itchy; Small rashes; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Very itchy) and RASH (Small rashes) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Very itchy) and RASH (Small rashes). At the time of the report, PRURITUS (Very itchy) and RASH (Small rashes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported  Treatment medication information were not reported
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Intentional product use issue
Clinical narrative: Second dose not scheduled >40 days; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Second dose not scheduled >40 days) and FATIGUE (fatigue) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0072C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN for an unknown indication.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2021, the patient experienced FATIGUE (fatigue). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Second dose not scheduled >40 days). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Second dose not scheduled >40 days) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was on an antibiotic as she had a dental procedure.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: 104 fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PYREXIA (104 fever) 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 PYREXIA (104 fever). At the time of the report, PYREXIA (104 fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) 104.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired dose of vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Diarrhoea, Hypoaesthesia, Influenza like illness
Clinical narrative: Flu like symptoms; Left arm was hurting and really sore top and underneath; Diarrhea; Numbness in tongue/ Numbness in nostrils; Loss of taste is getting better; Loss of smell is getting better; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Left arm was hurting and really sore top and underneath), DIARRHOEA (Diarrhea), HYPOAESTHESIA (Numbness in tongue/ Numbness in nostrils) and AGEUSIA (Loss of taste is getting better) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Left arm was hurting and really sore top and underneath), DIARRHOEA (Diarrhea), HYPOAESTHESIA (Numbness in tongue/ Numbness in nostrils), AGEUSIA (Loss of taste is getting better) and ANOSMIA (Loss of smell is getting better). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Left arm was hurting and really sore top and underneath), DIARRHOEA (Diarrhea), HYPOAESTHESIA (Numbness in tongue/ Numbness in nostrils), AGEUSIA (Loss of taste is getting better) and ANOSMIA (Loss of smell is getting better) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, SARS-CoV-2 test
Clinical narrative: Flu like symptoms; Left arm was hurting and really sore top and underneath; Diarrhea; Numbness in tongue/ Numbness in nostrils; Loss of taste is getting better; Loss of smell is getting better; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Left arm was hurting and really sore top and underneath), DIARRHOEA (Diarrhea), HYPOAESTHESIA (Numbness in tongue/ Numbness in nostrils) and AGEUSIA (Loss of taste is getting better) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Left arm was hurting and really sore top and underneath), DIARRHOEA (Diarrhea), HYPOAESTHESIA (Numbness in tongue/ Numbness in nostrils), AGEUSIA (Loss of taste is getting better) and ANOSMIA (Loss of smell is getting better). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Left arm was hurting and really sore top and underneath), DIARRHOEA (Diarrhea), HYPOAESTHESIA (Numbness in tongue/ Numbness in nostrils), AGEUSIA (Loss of taste is getting better) and ANOSMIA (Loss of smell is getting better) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications reported.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: arm is still in a lot of pain; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (arm is still in a lot of pain) 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 MYALGIA (arm is still in a lot of pain). At the time of the report, MYALGIA (arm is still in a lot of pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: I am 16 weeks pregnant today and I received my first dose of moderna in March.; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (I am 16 weeks pregnant today and I received my first dose of moderna in March.) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (I am 16 weeks pregnant today and I received my first dose of moderna in March.). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (I am 16 weeks pregnant today and I received my first dose of moderna in March.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.    Most recent FOLLOW-UP information incorporated above includes: On 05-Jun-2021: Internal review on 19-Jul-2021 resulted in updates to the pregnancy details.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired dose of vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Additional information includes COVID-19 vaccine were administered to patients after the vaccine's storage viability had been exceeded. The vaccine was received and placed in a refrigerated sate on 22Apr2021. The vaccines stayed in this condition until their usage dates. No relevant concomitant medications reported.  No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Light-headedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light-headedness) 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 DIZZINESS (Light-headedness). At the time of the report, DIZZINESS (Light-headedness) outcome was unknown.            No concomitant products were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: stomach hurts; 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 ABDOMINAL PAIN UPPER (stomach hurts) 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 ABDOMINAL PAIN UPPER (stomach hurts). At the time of the report, ABDOMINAL PAIN UPPER (stomach hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: experienced a side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experienced a side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (experienced a side effects). At the time of the report, VACCINATION COMPLICATION (experienced a side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported. No treatment drugs are not provided by reporter.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired dose of vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired dose of vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Is it normal to still have symptoms after 4 days?; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Is it normal to still have symptoms after 4 days?) 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 (Is it normal to still have symptoms after 4 days?). At the time of the report, VACCINATION COMPLICATION (Is it normal to still have symptoms after 4 days?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: fever; chills; headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On an unknown date, the patient experienced PYREXIA (fever), CHILLS (chills) and HEADACHE (headache). At the time of the report, PYREXIA (fever), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided. Treatment products were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness after the Second Dose; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness after the Second 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 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 DIZZINESS (Dizziness after the Second Dose). At the time of the report, DIZZINESS (Dizziness after the Second Dose) 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: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itchiness all over her body; Rash all over the body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness all over her body) and RASH (Rash all over the body) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced PRURITUS (itchiness all over her body) and RASH (Rash all over the body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (itchiness all over her body) and RASH (Rash all over the body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 37 days now/ can't get in until 11Jun2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION ( 37 days now/ can't get in until 11Jun2021) 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 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 04-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION ( 37 days now/ can't get in until 11Jun2021).   On 04-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION ( 37 days now/ can't get in until 11Jun2021) had resolved.      Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Disturbance in attention, Influenza like illness, Nausea
Clinical narrative: nausea second day after administration of second Moderna Covid-19 vaccine; chills and shivers second day after administration of second Moderna Covid-19 vaccine/shivers second day after administration of second Moderna Covid-19 vaccine; flu like symptoms second day after administration of second Moderna Covid-19 vaccine; lack of concentration second day after administration of second Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea second day after administration of second Moderna Covid-19 vaccine), CHILLS (chills and shivers second day after administration of second Moderna Covid-19 vaccine/shivers second day after administration of second Moderna Covid-19 vaccine), INFLUENZA LIKE ILLNESS (flu like symptoms second day after administration of second Moderna Covid-19 vaccine) and DISTURBANCE IN ATTENTION (lack of concentration second day after administration of second Moderna Covid-19 vaccine) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, LISINOPRIL and ATORVASTATIN for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced NAUSEA (nausea second day after administration of second Moderna Covid-19 vaccine), CHILLS (chills and shivers second day after administration of second Moderna Covid-19 vaccine/shivers second day after administration of second Moderna Covid-19 vaccine), INFLUENZA LIKE ILLNESS (flu like symptoms second day after administration of second Moderna Covid-19 vaccine) and DISTURBANCE IN ATTENTION (lack of concentration second day after administration of second Moderna Covid-19 vaccine). The patient was treated with ONDANSETRON at an unspecified dose and frequency. At the time of the report, NAUSEA (nausea second day after administration of second Moderna Covid-19 vaccine), CHILLS (chills and shivers second day after administration of second Moderna Covid-19 vaccine/shivers second day after administration of second Moderna Covid-19 vaccine), INFLUENZA LIKE ILLNESS (flu like symptoms second day after administration of second Moderna Covid-19 vaccine) and DISTURBANCE IN ATTENTION (lack of concentration second day after administration of second Moderna Covid-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site sore) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Injection site sore). At the time of the report, VACCINATION SITE PAIN (Injection site sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: arm pain; fever of 101; body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), PYREXIA (fever of 101) and MYALGIA (body aches) 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 04-Jun-2021, the patient experienced PAIN IN EXTREMITY (arm pain), PYREXIA (fever of 101) and MYALGIA (body aches). At the time of the report, PAIN IN EXTREMITY (arm pain), PYREXIA (fever of 101) and MYALGIA (body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jun-2021, Body temperature: 101 (High) 101.         No relevant concomitant medications reported.  No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: usual soreness at the site / area was sore again; Red outline around the injection site / getting bigger; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (usual soreness at the site / area was sore again) and VACCINATION SITE ERYTHEMA (Red outline around the injection site / getting bigger) 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 28-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 VACCINATION SITE PAIN (usual soreness at the site / area was sore again) and VACCINATION SITE ERYTHEMA (Red outline around the injection site / getting bigger). At the time of the report, VACCINATION SITE PAIN (usual soreness at the site / area was sore again) and VACCINATION SITE ERYTHEMA (Red outline around the injection site / getting bigger) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Intense body aches/body pains after 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of MYALGIA (Intense body aches/body pains 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.  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 MYALGIA (Intense body aches/body pains after 2nd dose).   At the time of the report, MYALGIA (Intense body aches/body pains after 2nd dose) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: a runny nose hours after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (a runny nose hours after receiving the vaccine) 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 05-Jun-2021, the patient experienced RHINORRHOEA (a runny nose hours after receiving the vaccine). At the time of the report, RHINORRHOEA (a runny nose hours after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: feel tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feel tired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 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 FATIGUE (feel tired). At the time of the report, FATIGUE (feel tired) 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.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: have a 101.1 fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (have a 101.1 fever) 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) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced PYREXIA (have a 101.1 fever). At the time of the report, PYREXIA (have a 101.1 fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.