chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: real sleepy; tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (real sleepy) and FATIGUE (tired) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IMATINIB MESILATE (GLEEVEC) for Leukaemia, CHLORPROMAZINE HYDROCHLORIDE (THORAZINE [CHLORPROMAZINE HYDROCHLORIDE]) for Muscle relaxant, HYDROCODONE, GABAPENTIN, DULOXETINE HYDROCHLORIDE (CYMBALTA) and ORLISTAT (XENICAL) for an unknown indication.    On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jun-2021, the patient experienced SOMNOLENCE (real sleepy) and FATIGUE (tired). At the time of the report, SOMNOLENCE (real sleepy) and FATIGUE (tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-261818 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: it's breaking out into blisters/lower part of my arm has tiny little blisters; hurts/ exacerbates the pain; wrapping her arm to ease the discomfort; burns; where I got the shot, there's a little knot in there; my arm is red where she got the shot; itching at the injection site/itching became worse; swelling at the injection site; this rash has not gone away; my arm was swollen; it constantly itches; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (it's breaking out into blisters/lower part of my arm has tiny little blisters), PRURITUS (it constantly itches), PAIN (hurts/ exacerbates the pain), LIMB DISCOMFORT (wrapping her arm to ease the discomfort) and PERIPHERAL SWELLING (my arm was swollen) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009D21A and 011D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included IMATINIB MESILATE (GLEEVEC) for Leukemia, CHLORPROMAZINE (THORAZINE [CHLORPROMAZINE]) for Muscle relaxant, HYDROCODONE, GABAPENTIN, DULOXETINE HYDROCHLORIDE (CYMBALTA) and ORLISTAT (XENICAL) for an unknown indication.   On 06-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jul-2021, the patient experienced PRURITUS (it constantly itches). 04-Jul-2021, the patient experienced PERIPHERAL SWELLING (my arm was swollen). On 10-Jul-2021, the patient experienced BLISTER (it's breaking out into blisters/lower part of my arm has tiny little blisters), PAIN (hurts/ exacerbates the pain), LIMB DISCOMFORT (wrapping her arm to ease the discomfort), BURNING SENSATION (burns), VACCINATION SITE MASS (where I got the shot, there's a little knot in there), VACCINATION SITE ERYTHEMA (my arm is red where she got the shot), VACCINATION SITE PRURITUS (itching at the injection site/itching became worse), VACCINATION SITE SWELLING (swelling at the injection site) and RASH (this rash has not gone away). At the time of the report, BLISTER (it's breaking out into blisters/lower part of my arm has tiny little blisters), PRURITUS (it constantly itches), PAIN (hurts/ exacerbates the pain), LIMB DISCOMFORT (wrapping her arm to ease the discomfort), PERIPHERAL SWELLING (my arm was swollen), BURNING SENSATION (burns), VACCINATION SITE MASS (where I got the shot, there's a little knot in there), VACCINATION SITE ERYTHEMA (my arm is red where she got the shot), VACCINATION SITE PRURITUS (itching at the injection site/itching became worse), VACCINATION SITE SWELLING (swelling at the injection site) and RASH (this rash has not gone away) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The treatment information was not provided.   This case was linked to MOD-2021-261816 (Patient Link).
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old Vaccinated with Moderna COVID-19 Vaccine on 08JUL2021; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old Vaccinated with Moderna COVID-19 Vaccine on 08JUL2021) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old Vaccinated with Moderna COVID-19 Vaccine on 08JUL2021). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old Vaccinated with Moderna COVID-19 Vaccine on 08JUL2021) 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 medication information was provided. No treatment medication information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow-up received contains No new Information
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Fatigue, Oropharyngeal pain
Clinical narrative: Sore throat; LOSS OF TASTE; Loss of smell; Was very tired; Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19), OROPHARYNGEAL PAIN (Sore throat), AGEUSIA (LOSS OF TASTE), ANOSMIA (Loss of smell) and FATIGUE (Was very tired) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 054C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jul-2021, the patient experienced COVID-19 (Tested positive for COVID-19). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), AGEUSIA (LOSS OF TASTE), ANOSMIA (Loss of smell) and FATIGUE (Was very tired). The patient was treated with AMOXICILLIN (oral) for Sore throat, at a dose of 875 mg once a day and PREDNISOLONE (oral) for Sore throat, at a dose of 15 ml once a day. At the time of the report, COVID-19 (Tested positive for COVID-19), OROPHARYNGEAL PAIN (Sore throat) and FATIGUE (Was very tired) outcome was unknown and AGEUSIA (LOSS OF TASTE) and ANOSMIA (Loss of smell) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jul-2021, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19.         This case was linked to MOD-2021-261635 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Ethnic group and facility type were updated. New events loss of smell and loss of taste were added. Treatment medications were added.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Sore throat; LOSS OF TASTE; Loss of smell; Was very tired; Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19), OROPHARYNGEAL PAIN (Sore throat), AGEUSIA (LOSS OF TASTE), ANOSMIA (Loss of smell) and FATIGUE (Was very tired) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 054C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jul-2021, the patient experienced COVID-19 (Tested positive for COVID-19). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), AGEUSIA (LOSS OF TASTE), ANOSMIA (Loss of smell) and FATIGUE (Was very tired). The patient was treated with AMOXICILLIN (oral) for Sore throat, at a dose of 875 mg once a day and PREDNISOLONE (oral) for Sore throat, at a dose of 15 ml once a day. At the time of the report, COVID-19 (Tested positive for COVID-19), OROPHARYNGEAL PAIN (Sore throat) and FATIGUE (Was very tired) outcome was unknown and AGEUSIA (LOSS OF TASTE) and ANOSMIA (Loss of smell) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jul-2021, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19.         This case was linked to MOD-2021-261635 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Ethnic group and facility type were updated. New events loss of smell and loss of taste were added. Treatment medications were added.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: She had received her first shot on 7July2021 in another country, the second shot on the 7July2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (She had received her first shot on 7July2021 in another country, the second shot on the 7July2021) 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 07-Jul-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 INCORRECT DOSE ADMINISTERED (She had received her first shot on 7July2021 in another country,the second shot on the 7July2021). At the time of the report, INCORRECT DOSE ADMINISTERED (She had received her first shot on 7July2021 in another country,the second shot on the 7July2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided Concomitant medications were not reported
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: HCP reported patient received first dose on 29Jan2021 and did not get second dose yet.; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (HCP reported patient received first dose on 29Jan2021 and did not get second dose yet.) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (HCP reported patient received first dose on 29Jan2021 and did not get second dose yet.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (HCP reported patient received first dose on 29Jan2021 and did not get second dose yet.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Illness, Nasal congestion, Swelling face
Clinical narrative: Cough; Can't breath; Super congested; Swollen face; Feel sick; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), DYSPNOEA (Can't breath), NASAL CONGESTION (Super congested), SWELLING FACE (Swollen face) and ILLNESS (Feel sick) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Codeine Allergy). Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX) for an unknown indication.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient experienced COUGH (Cough), DYSPNOEA (Can't breath), NASAL CONGESTION (Super congested), SWELLING FACE (Swollen face) and ILLNESS (Feel sick). At the time of the report, COUGH (Cough), DYSPNOEA (Can't breath), NASAL CONGESTION (Super congested), SWELLING FACE (Swollen face) and ILLNESS (Feel sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information were reported.
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Product dose omission issue
Clinical narrative: bronchitis; Now it's been 3 months (since first dose)Should I still get the second dose?; This spontaneous case was reported by a patient and describes the occurrence of BRONCHITIS (bronchitis) and PRODUCT DOSE OMISSION ISSUE (Now it's been 3 months (since first dose)Should I still get 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.    In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BRONCHITIS (bronchitis) and PRODUCT DOSE OMISSION ISSUE (Now it's been 3 months (since first dose)Should I still get the second dose?). At the time of the report, BRONCHITIS (bronchitis) and PRODUCT DOSE OMISSION ISSUE (Now it's been 3 months (since first dose)Should I still get the second dose?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Product dose omission issue, Pyrexia
Clinical narrative: (2nd dose not received yet) outside of recommended time frame; chills; headache; fever; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE ((2nd dose not received yet) outside of recommended time frame), CHILLS (chills), HEADACHE (headache) and PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE ((2nd dose not received yet) outside of recommended time frame), CHILLS (chills), HEADACHE (headache) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, PRODUCT DOSE OMISSION ISSUE ((2nd dose not received yet) outside of recommended time frame), CHILLS (chills), HEADACHE (headache) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was reported. No treatment medications was reported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pruritus, Pyrexia, Rash
Clinical narrative: It was itchy; rash around my wrist, changes in size & location, comes & goes; headache; fever; tired; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (It was itchy), RASH (rash around my wrist, changes in size & location, comes & goes), HEADACHE (headache), PYREXIA (fever) and FATIGUE (tired) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 032B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced HEADACHE (headache), PYREXIA (fever) and FATIGUE (tired). On 15-May-2021, the patient experienced PRURITUS (It was itchy) and RASH (rash around my wrist, changes in size & location, comes & goes). The patient was treated with PREDNISONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (It was itchy), RASH (rash around my wrist, changes in size & location, comes & goes), HEADACHE (headache), PYREXIA (fever) and FATIGUE (tired) outcome was unknown.            No concomitant drug details were reported.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Nasal congestion, Productive cough, Swelling, Throat clearing
Clinical narrative: Coughing up phlegm; constantly trying to clear throat; congested nose; difficulty breathing; Neck is a little swollen; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCTIVE COUGH (Coughing up phlegm), THROAT CLEARING (constantly trying to clear throat), NASAL CONGESTION (congested nose), DYSPNOEA (difficulty breathing) and SWELLING (Neck is a little swollen) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX) for an unknown indication.    On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jul-2021, the patient experienced PRODUCTIVE COUGH (Coughing up phlegm), THROAT CLEARING (constantly trying to clear throat), NASAL CONGESTION (congested nose), DYSPNOEA (difficulty breathing) and SWELLING (Neck is a little swollen). At the time of the report, PRODUCTIVE COUGH (Coughing up phlegm), THROAT CLEARING (constantly trying to clear throat), NASAL CONGESTION (congested nose), DYSPNOEA (difficulty breathing) and SWELLING (Neck is a little swollen) 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 treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: family member under the age of 18 received the vaccine by accident; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (family member under the age of 18 received the vaccine by accident) 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (family member under the age of 18 received the vaccine by accident). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (family member under the age of 18 received the vaccine by accident) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided by the reporter.   Reporter did not allow further contact
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Headache, Oropharyngeal pain
Clinical narrative: sore throat; Stomach Ache; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), ABDOMINAL PAIN UPPER (Stomach Ache), CHILLS (chills) and HEADACHE (headache) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included CALCIUM, Vitamin D, OMEPRAZOLE and MACROGOL 3350 (MIRALAX) for an unknown indication.    On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), ABDOMINAL PAIN UPPER (Stomach Ache), CHILLS (chills) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (sore throat), ABDOMINAL PAIN UPPER (Stomach Ache), CHILLS (chills) and HEADACHE (headache) 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.   Concomitant medications includes Hair/Nail/Skin Vitamin, Multi-Vitamins and Thyroid Medicine.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient got his 1st dose of Moderna Vaccine on14thApril2021; He´s still waiting for the 2nd dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient got his 1st dose of Moderna Vaccine on14thApril2021; He´s still waiting for the 2nd dose) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-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 PRODUCT DOSE OMISSION ISSUE (Patient got his 1st dose of Moderna Vaccine on14thApril2021; He´s still waiting for the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient got his 1st dose of Moderna Vaccine on14thApril2021; He´s still waiting for the 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.  Upon internal review on 04-AUG-2021, the age was corrected to 19 years.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed 2nd dose for unknown reason(s); This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Jul-2021 and was forwarded to Moderna on 20-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose for unknown reason(s)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L201) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, 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 (Missed 2nd dose for unknown reason(s)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed 2nd dose for unknown reason(s)) 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 concomitants were reported. No treatment was reported.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Pain in extremity, SARS-CoV-1 test
Clinical narrative: sore arm; sick as a dog; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (sore arm) and ILLNESS (sick as a dog) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0391120A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and ILLNESS (sick as a dog). At the time of the report, PAIN IN EXTREMITY (sore arm) and ILLNESS (sick as a dog) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jul-2021, SARS-CoV-1 test: positive (Positive) Positive.     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 medication was reported. No treatment done for side effects of initial vaccine. After the dose patient has tested positive for COVID on 19uly2021.   This case was linked to MOD-2021-262234 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: received my first dose of the moderna shot on March 31st/It's been 4 months since I received my first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received my first dose of the moderna shot on March 31st/It's been 4 months since I received my first dose) 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 31-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 PRODUCT DOSE OMISSION ISSUE (received my first dose of the moderna shot on March 31st/It's been 4 months since I received my first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received my first dose of the moderna shot on March 31st/It's been 4 months since I received my first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were not reported. No treatment medications were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: large blotchy rash on my neck and chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (large blotchy rash on my neck and chest) 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 RASH MACULAR (large blotchy rash on my neck and chest). At the time of the report, RASH MACULAR (large blotchy rash on my neck and chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided. No concomitant medications were reported.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, SARS-CoV-2 test
Clinical narrative: sore arm; fatigue; This spontaneous case was reported by a nurse and describes the occurrence of MYALGIA (sore arm) and FATIGUE (fatigue) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009M2014 and 0391120A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-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 MYALGIA (sore arm) and FATIGUE (fatigue). At the time of the report, MYALGIA (sore arm) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.   This case was linked to MOD-2021-262203 (Patient Link).
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: It was First Punctured at 10AM on 20JUL2021 and kept at 69 Fahrenheit; kept at room temp for 26 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (It was First Punctured at 10AM on 20JUL2021 and kept at 69 Fahrenheit) and PRODUCT TEMPERATURE EXCURSION ISSUE (kept at room temp for 26 hours) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021 at 11:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (It was First Punctured at 10AM on 20JUL2021 and kept at 69 Fahrenheit) and PRODUCT TEMPERATURE EXCURSION ISSUE (kept at room temp for 26 hours). On 21-Jul-2021 at 11:30 AM, EXPIRED PRODUCT ADMINISTERED (It was First Punctured at 10AM on 20JUL2021 and kept at 69 Fahrenheit) and PRODUCT TEMPERATURE EXCURSION ISSUE (kept at room temp for 26 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter reported that patient has received vaccine from an expired vial. She stated that one punctured vial of Moderna COVID-19 vaccine was kept at room temp for 26 hours. The vial was moved from refrigerator to the room temperature on 20-JUL-2021 around 7:30AM and was first punctured at 10AM on 20-JUL-2021 and kept at 69 Fahrenheit. The vial was never exposed to temperature excursion in the past.  No relevant concomitant medications were reported. No treatment information was provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Chills; Fever; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body ache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN and FEXOFENADINE HYDROCHLORIDE for an unknown indication.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body ache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) for Adverse event, at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), PYREXIA (Fever) and MYALGIA (Body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-262305 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Bronchitis, Product dose omission issue
Clinical narrative: bronchitis; can't smell good; can't taste anything; more than 35 days passed for second dose; This spontaneous case was reported by a patient and describes the occurrence of BRONCHITIS (bronchitis), ANOSMIA (can't smell good), AGEUSIA (can't taste anything) and PRODUCT DOSE OMISSION ISSUE (more than 35 days passed for second dose) in a 67-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 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BRONCHITIS (bronchitis), ANOSMIA (can't smell good), AGEUSIA (can't taste anything) and PRODUCT DOSE OMISSION ISSUE (more than 35 days passed for second dose). At the time of the report, BRONCHITIS (bronchitis), ANOSMIA (can't smell good), AGEUSIA (can't taste anything) and PRODUCT DOSE OMISSION ISSUE (more than 35 days passed for second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant and  treatment medications were provided.   Reporter did not allow further contact
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability, Pyrexia
Clinical narrative: Hasn't been able to work; Fever; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED WORK ABILITY (Hasn't been able to work) and PYREXIA (Fever) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced IMPAIRED WORK ABILITY (Hasn't been able to work) and PYREXIA (Fever). At the time of the report, IMPAIRED WORK ABILITY (Hasn't been able to work) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lethargy, Pain in extremity
Clinical narrative: second Moderna shot 42 days later; felt reallylethargic; Very very sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second Moderna shot 42 days later), LETHARGY (felt reallylethargic) and PAIN IN EXTREMITY (Very very sore arm) in a 66-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second Moderna shot 42 days later), LETHARGY (felt reallylethargic) and PAIN IN EXTREMITY (Very very sore arm). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second Moderna shot 42 days later), LETHARGY (felt reallylethargic) and PAIN IN EXTREMITY (Very very sore arm) outcome was unknown.            On unknown date, Covid test was performed on patient with Positive results  No concomitant medications were provided.  No treatment medications were provided.     This case was linked to MOD-2021-037367 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Gingival pain, Lymphadenopathy, Mouth ulceration, Myalgia
Clinical narrative: Sore throat; Ulcers on the side of the mouth; blister on the side of the tongue; Inflammation of the gum; Swollen glands; Sores in the mouth, Pain in the left side of the mouth, Thrombin pain in the mouth; Gum is swollen; Body ache; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), MYALGIA (Body ache), OROPHARYNGEAL PAIN (Sore throat) and MOUTH ULCERATION (Ulcers on the side of the mouth) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 037A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN and FEXOFENADINE HYDROCHLORIDE for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), PYREXIA (Fever), MYALGIA (Body ache), OROPHARYNGEAL PAIN (Sore throat), MOUTH ULCERATION (Ulcers on the side of the mouth), TONGUE BLISTERING (blister on the side of the tongue), NONINFECTIVE GINGIVITIS (Inflammation of the gum), LYMPHADENOPATHY (Swollen glands), ORAL PAIN (Sores in the mouth, Pain in the left side of the mouth, Thrombin pain in the mouth) and GINGIVAL PAIN (Gum is swollen). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), PYREXIA (Fever), MYALGIA (Body ache), OROPHARYNGEAL PAIN (Sore throat), MOUTH ULCERATION (Ulcers on the side of the mouth), TONGUE BLISTERING (blister on the side of the tongue), NONINFECTIVE GINGIVITIS (Inflammation of the gum), LYMPHADENOPATHY (Swollen glands), ORAL PAIN (Sores in the mouth, Pain in the left side of the mouth, Thrombin pain in the mouth) and GINGIVAL PAIN (Gum is swollen) outcome was unknown.            This case was linked to MOD-2021-262267 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Noninfective gingivitis, Oral pain, Oropharyngeal pain, Pyrexia, Tongue blistering
Clinical narrative: Sore throat; Ulcers on the side of the mouth; blister on the side of the tongue; Inflammation of the gum; Swollen glands; Sores in the mouth, Pain in the left side of the mouth, Thrombin pain in the mouth; Gum is swollen; Body ache; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), MYALGIA (Body ache), OROPHARYNGEAL PAIN (Sore throat) and MOUTH ULCERATION (Ulcers on the side of the mouth) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 037A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN and FEXOFENADINE HYDROCHLORIDE for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), PYREXIA (Fever), MYALGIA (Body ache), OROPHARYNGEAL PAIN (Sore throat), MOUTH ULCERATION (Ulcers on the side of the mouth), TONGUE BLISTERING (blister on the side of the tongue), NONINFECTIVE GINGIVITIS (Inflammation of the gum), LYMPHADENOPATHY (Swollen glands), ORAL PAIN (Sores in the mouth, Pain in the left side of the mouth, Thrombin pain in the mouth) and GINGIVAL PAIN (Gum is swollen). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), PYREXIA (Fever), MYALGIA (Body ache), OROPHARYNGEAL PAIN (Sore throat), MOUTH ULCERATION (Ulcers on the side of the mouth), TONGUE BLISTERING (blister on the side of the tongue), NONINFECTIVE GINGIVITIS (Inflammation of the gum), LYMPHADENOPATHY (Swollen glands), ORAL PAIN (Sores in the mouth, Pain in the left side of the mouth, Thrombin pain in the mouth) and GINGIVAL PAIN (Gum is swollen) outcome was unknown.            This case was linked to MOD-2021-262267 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: infected with COVID and fully vaccinated; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (infected with COVID and fully vaccinated) 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jul-2021, the patient experienced COVID-19 (infected with COVID and fully vaccinated). At the time of the report, COVID-19 (infected with COVID and fully vaccinated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) Positive.         No Concomitant and  treatment medications were provided.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspepsia
Clinical narrative: Chest pain; heart burn; indigestion; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), DYSPEPSIA (heart burn) and DYSPEPSIA (indigestion) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 030B21A) for COVID-19 vaccination.     The patient's past medical history included Stent insertion NOS.   On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-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 CHEST PAIN (Chest pain), DYSPEPSIA (heart burn) and DYSPEPSIA (indigestion). At the time of the report, CHEST PAIN (Chest pain), DYSPEPSIA (heart burn) and DYSPEPSIA (indigestion) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications included Pain medication and Tegutall. Treatment medication is not provided.   This case was linked to MOD-2021-262418 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Pain, Pain in extremity, Pyrexia
Clinical narrative: had side effects a little bit longer than she did; arm pain; redness and pain for longer than she experienced; pain for longer than she; something weird; ran a fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had side effects a little bit longer than she did), PAIN IN EXTREMITY (arm pain), ERYTHEMA (redness and pain for longer than she experienced), PAIN (pain for longer than she) and FEELING ABNORMAL (something weird) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had side effects a little bit longer than she did), PAIN IN EXTREMITY (arm pain), ERYTHEMA (redness and pain for longer than she experienced), PAIN (pain for longer than she), FEELING ABNORMAL (something weird) and PYREXIA (ran a fever). At the time of the report, VACCINATION COMPLICATION (had side effects a little bit longer than she did), PAIN IN EXTREMITY (arm pain), ERYTHEMA (redness and pain for longer than she experienced), PAIN (pain for longer than she), FEELING ABNORMAL (something weird) and PYREXIA (ran a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: had side effects a little bit longer than she did; arm pain; redness and pain for longer than she experienced; pain for longer than she; something weird; ran a fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had side effects a little bit longer than she did), PAIN IN EXTREMITY (arm pain), ERYTHEMA (redness and pain for longer than she experienced), PAIN (pain for longer than she) and FEELING ABNORMAL (something weird) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had side effects a little bit longer than she did), PAIN IN EXTREMITY (arm pain), ERYTHEMA (redness and pain for longer than she experienced), PAIN (pain for longer than she), FEELING ABNORMAL (something weird) and PYREXIA (ran a fever). At the time of the report, VACCINATION COMPLICATION (had side effects a little bit longer than she did), PAIN IN EXTREMITY (arm pain), ERYTHEMA (redness and pain for longer than she experienced), PAIN (pain for longer than she), FEELING ABNORMAL (something weird) and PYREXIA (ran a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered the vaccine after the 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered the vaccine after the 30-day use by date) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered the vaccine after the 30-day use by date). On 21-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered the vaccine after the 30-day use by date) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Patient was administered the vaccine after the 30-day use by date) to be possibly related.    On 18-Jun-2021, product was moved to refrigeration, it should be used by 18-Jul-2021 and date of administration was 21-Jul-2021.   No concomitant medication reported.  No treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received contain Non significant information. On 21-Jul-2021: Follow up received and  Added patient demographics. Added vaccine start date and Route of administration. Added Event start date and stop date. On 29-Jul-2021: Follow up received and added patient Demographics like ethnic group and race, reporter added. Event term updated.