chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 12 year old patient received a 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old patient received a 1st dose) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old patient received a 1st dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old patient received a 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This case received via the regulatory authority (reference number: 21-128824) on Aug 10, 2021, and forwarded to Moderna, reported by a consumer, describes the occurrence of product administered to patient of inappropriate age (16 years old when he received the first dose of the Moderna vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced product administered to patient of inappropriate age (16 years old when he received the first dose of the Moderna vaccine). At the time of the report, product administered to patient of inappropriate age (16 years old when he received the first dose of the Moderna vaccine): resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) 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 04-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 COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.    This case was linked to MOD-2021-283115 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of product dose omission issue (considering the second shot/has it been too long to get it/first shot March 11) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Mar 11, 2021, patient received the 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 (considering the second shot/has it been too long to get it/first shot March 11). At the time of the report, product dose omission issue (considering the second shot/has it been too long to get it/first shot March 11): resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: inadvertently gave expired Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently gave expired Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently gave expired Moderna vaccine). On 10-Aug-2021, EXPIRED PRODUCT ADMINISTERED (inadvertently gave expired Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Pharmacist called to report that she inadvertently gave expired moderna vaccine to three patients.  She found out that the punctured vial had been left out all day on 09-Aug-2021 - over 12 hours in room temperature.  Pharmacist also confirmed that the expired vial was discarded and put into waste disposal.    No concomitant medications were reported. No treatment medication were reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Feeding disorder, Pyrexia, Sneezing
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# unknown) for COVID-19 immunization. The patient's past medical history included kidney transplant on Mar 24, 2021. On Mar 18, 2021, patient received first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. Patient treated with Tylenol (paracetamol) ongoing since an unknown date, at an unspecified dose and frequency. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# unknown) for COVID-19 immunization. The patient's past medical history included kidney transplant on Mar 24, 2021. On Mar 18, 2021, patient received first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. Patient treated with Tylenol (paracetamol) ongoing since an unknown date, at an unspecified dose and frequency. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medications reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: If someone had the Moderna vaccine first dose Feb 2020 but didn't get the 2nd do they need to restart the series; 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 PRODUCT DOSE OMISSION ISSUE (If someone had the Moderna vaccine first dose Feb 2020 but didn't get the 2nd do they need to restart the series) 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 DOSE OMISSION ISSUE (If someone had the Moderna vaccine first dose Feb 2020 but didn't get the 2nd do they need to restart the series). At the time of the report, PRODUCT DOSE OMISSION ISSUE (If someone had the Moderna vaccine first dose Feb 2020 but didn't get the 2nd do they need to restart the series) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity
Clinical narrative: Arm hurts so bad; Just don't feel well; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts so bad) and MALAISE (Just don't feel well) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurts so bad) and MALAISE (Just don't feel well). At the time of the report, PAIN IN EXTREMITY (Arm hurts so bad) and MALAISE (Just don't feel well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cold sweat, Fatigue, Impaired work ability
Clinical narrative: Heart racing; Cold sweats; Chills; Sleeping through the day; Had to leave work on Tuesday; Very sore in the left shoulder; Tired and drained; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart racing), COLD SWEAT (cold sweats), SOMNOLENCE (sleeping through the day), IMPAIRED WORK ABILITY (Had to leave work on Tuesday) and ARTHRALGIA (very sore in the left shoulder) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced ARTHRALGIA (very sore in the left shoulder) and FATIGUE (tired and drained). On 10-Aug-2021, the patient experienced SOMNOLENCE (sleeping through the day) and IMPAIRED WORK ABILITY (Had to leave work on Tuesday). On 10-Aug-2021 at 2:00 AM, the patient experienced PALPITATIONS (heart racing), COLD SWEAT (cold sweats) and CHILLS (chills). At the time of the report, PALPITATIONS (heart racing), COLD SWEAT (cold sweats), SOMNOLENCE (sleeping through the day), IMPAIRED WORK ABILITY (Had to leave work on Tuesday), ARTHRALGIA (very sore in the left shoulder), FATIGUE (tired and drained) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications are provided by reporter. No treatment medications are provided by reporter.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Somnolence
Clinical narrative: Heart racing; Cold sweats; Chills; Sleeping through the day; Had to leave work on Tuesday; Very sore in the left shoulder; Tired and drained; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart racing), COLD SWEAT (cold sweats), SOMNOLENCE (sleeping through the day), IMPAIRED WORK ABILITY (Had to leave work on Tuesday) and ARTHRALGIA (very sore in the left shoulder) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced ARTHRALGIA (very sore in the left shoulder) and FATIGUE (tired and drained). On 10-Aug-2021, the patient experienced SOMNOLENCE (sleeping through the day) and IMPAIRED WORK ABILITY (Had to leave work on Tuesday). On 10-Aug-2021 at 2:00 AM, the patient experienced PALPITATIONS (heart racing), COLD SWEAT (cold sweats) and CHILLS (chills). At the time of the report, PALPITATIONS (heart racing), COLD SWEAT (cold sweats), SOMNOLENCE (sleeping through the day), IMPAIRED WORK ABILITY (Had to leave work on Tuesday), ARTHRALGIA (very sore in the left shoulder), FATIGUE (tired and drained) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications are provided by reporter. No treatment medications are provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 6 weeks from first dose of vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (6 weeks from first dose of vaccine) 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 PRODUCT DOSE OMISSION ISSUE (6 weeks from first dose of vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (6 weeks from first dose of vaccine) had resolved.        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 were provided  Treatment medication were not provided
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Product dose omission issue
Clinical narrative: soreness; has missed her  second  dose.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (has missed her  second  dose.) and MYALGIA (soreness) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (has missed her  second  dose.). On an unknown date, the patient experienced MYALGIA (soreness). On 06-Jan-2021, PRODUCT DOSE OMISSION ISSUE (has missed her  second  dose.) had resolved. At the time of the report, MYALGIA (soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medicine  were not provided. Treatment medicine were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: patients who stated they received the first dose 6 weeks ago or longer; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patients who stated they received the first dose 6 weeks ago or longer) 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 24-Jun-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 (patients who stated they received the first dose 6 weeks ago or longer). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patients who stated they received the first dose 6 weeks ago or longer) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination site pain (pain in the injection site) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination site pain (pain in the injection site). At the time of the report, vaccination site pain (pain in the injection site) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: feel like I have been run over by a truck; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feel like I have been run over by a truck) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (feel like I have been run over by a truck). At the time of the report, FEELING ABNORMAL (feel like I have been run over by a truck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was unknown by the reporter. Treatment information was not provided
Age: 12.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patients aged 12 received their first dose of Moderna by mistake; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patients aged 12 received their first dose of Moderna by mistake) in a 12-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 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patients aged 12 received their first dose of Moderna by mistake). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patients aged 12 received their first dose of Moderna by mistake) had resolved.        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 product use was unknown by the reporter. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the 2nd dose of the Moderna COVID19 vaccine >36 days after the first 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 (received the 2nd dose of the Moderna COVID19 vaccine >36 days after the 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 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the 2nd dose of the Moderna COVID19 vaccine >36 days after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the 2nd dose of the Moderna COVID19 vaccine >36 days after the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant product included 'unknown'  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 1st dose given Jan/Feb2021; wanting to complete the series; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (1st dose given Jan/Feb2021; wanting to complete the series) 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 PRODUCT DOSE OMISSION ISSUE (1st dose given Jan/Feb2021; wanting to complete the series). At the time of the report, PRODUCT DOSE OMISSION ISSUE (1st dose given Jan/Feb2021; wanting to complete the series) had resolved.        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.   It was reported that employees received their first dose of the Moderna Covid-19 vaccine in Jan/Feb2021 and initially refused to get the second dose but now were wanting to complete the series.  There were four or five patients with no patient identifiers and vaccination details were not available to the reporter
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects after my second shot if i got it them the first time(first dose); 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 (side effects after my second shot if i got it them the first time(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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects after my second shot if i got it them the first time(first dose)). At the time of the report, VACCINATION COMPLICATION (side effects after my second shot if i got it them the first time(first dose)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Consent for follow up declined.  No concomitant medication was provided by reporter. No treatment information was provided by reporter.   Reporter did not allow further contact
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Muscular weakness, Pain in extremity
Clinical narrative: aAms and legs are feeling weak; Feeling light fatigue; Slight headache along his eyebrows; Very mild sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very mild sore arm), MUSCULAR WEAKNESS (aAms and legs are feeling weak), FATIGUE (Feeling light fatigue) and HEADACHE (Slight headache along his eyebrows) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, the patient experienced PAIN IN EXTREMITY (Very mild sore arm). On 10-Aug-2021, the patient experienced HEADACHE (Slight headache along his eyebrows). On 11-Aug-2021, the patient experienced MUSCULAR WEAKNESS (aAms and legs are feeling weak) and FATIGUE (Feeling light fatigue). At the time of the report, PAIN IN EXTREMITY (Very mild sore arm) and HEADACHE (Slight headache along his eyebrows) outcome was unknown and MUSCULAR WEAKNESS (aAms and legs are feeling weak) and FATIGUE (Feeling light fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant or treatment medications were provided. No treatment information was reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (received dose of Moderna vaccine after excursion) and EXPIRED PRODUCT ADMINISTERED (administered dose of an affected vial of the Moderna COVID-19 vaccine) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. No medical history was provided by reporter. On 09-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (received dose of Moderna vaccine after excursion) and EXPIRED PRODUCT ADMINISTERED (administered dose of an affected vial of the Moderna COVID-19 vaccine). On 09-Aug-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (received dose of Moderna vaccine after excursion) and EXPIRED PRODUCT ADMINISTERED (administered dose of an affected vial of the Moderna COVID-19 vaccine) 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. No Concomitant medications were provided. No treatment medications were provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Lip swelling, Swelling
Clinical narrative: Severe swelling to lips; Two large ,areas of swelling to both jowls, slight swelling to NLF; Two pinpoint bruises to NLF, one bruise to left top lip, 2 bruises to left lower lip and 1 large bruise to right lower lip 3 hrs post injection.; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Severe swelling to lips), SWELLING (Two large ,areas of swelling to both jowls, slight swelling to NLF) and CONTUSION (Two pinpoint bruises to NLF, one bruise to left top lip, 2 bruises to left lower lip and 1 large bruise to right lower lip 3 hrs post injection.) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU VACCINE VII in September 2020. Concurrent medical conditions included Hypertension, Thyroid disorder, Penicillin allergy and Sulfonamide allergy. Concomitant products included LISINOPRIL and AMLODIPINE for Hypertension, HYDROCHLOROTHIAZIDE and LEVOTHYROXINE for Thyroid disorder.    In January 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 LIP SWELLING (Severe swelling to lips), SWELLING (Two large ,areas of swelling to both jowls, slight swelling to NLF) and CONTUSION (Two pinpoint bruises to NLF, one bruise to left top lip, 2 bruises to left lower lip and 1 large bruise to right lower lip 3 hrs post injection.). The patient was treated with METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) on 08-Jul-2021 for Swelling, at an unspecified dose and frequency. At the time of the report, LIP SWELLING (Severe swelling to lips), SWELLING (Two large ,areas of swelling to both jowls, slight swelling to NLF) and CONTUSION (Two pinpoint bruises to NLF, one bruise to left top lip, 2 bruises to left lower lip and 1 large bruise to right lower lip 3 hrs post injection.) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Restylane Defyne into marionette lines and Restylane Kysse into the lips (Lot numbers and exp. Unknown) on 8/6/2021 and developed severe swelling to lips, two large areas of swelling to both jowls, slight swelling to NLF.Two pinpoint bruises to NLF, one bruise to left top lip, 2 bruises to left lower lip and 1 large bruise to right lower lip 3 hrs post injection. She reported that she had taken ibuprofen prior to injections. She reported no illnesses in month prior to treatment and no dental procedures in last 6-12 months.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Rash
Clinical narrative: dermatologist said it was an allergic reaction to something; developed a rash on several parts of body; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (dermatologist said it was an allergic reaction to something) and RASH (developed a rash on several parts of body) 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 HYPERSENSITIVITY (dermatologist said it was an allergic reaction to something) and RASH (developed a rash on several parts of body). At the time of the report, HYPERSENSITIVITY (dermatologist said it was an allergic reaction to something) and RASH (developed a rash on several parts of body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nasal congestion, Pyrexia, Sinusitis
Clinical narrative: Nose congestion for 10 days; Feeling sick for 10 days; sinusitis; Low grade fever for 10days; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (Nose congestion for 10 days), MALAISE (Feeling sick for 10 days), SINUSITIS (sinusitis) and PYREXIA (Low grade fever for 10days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (Nose congestion for 10 days), MALAISE (Feeling sick for 10 days), SINUSITIS (sinusitis) and PYREXIA (Low grade fever for 10days). At the time of the report, NASAL CONGESTION (Nose congestion for 10 days), MALAISE (Feeling sick for 10 days), SINUSITIS (sinusitis) and PYREXIA (Low grade fever for 10days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history was provided by the reporter. No treatment information was provided by the reporter. No Concomitant medicines were reported.   Reporter did not allow further contact
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Inappropriate schedule of product administration
Clinical narrative: Herat rate increased/Elevated heart rate, 137-154 bpm during standing and walking; second dose of Moderna Covid-19 Vaccine last 11Aug2021; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Aug-2021 and was forwarded to Moderna on 12-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Herat rate increased/Elevated heart rate, 137-154 bpm during standing and walking) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of Moderna Covid-19 Vaccine last 11Aug2021) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of Moderna Covid-19 Vaccine last 11Aug2021). On 11-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEART RATE INCREASED (Herat rate increased/Elevated heart rate, 137-154 bpm during standing and walking). On 11-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of Moderna Covid-19 Vaccine last 11Aug2021) had resolved. At the time of the report, HEART RATE INCREASED (Herat rate increased/Elevated heart rate, 137-154 bpm during standing and walking) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2021, Heart rate: 137-154 (High) elevated heart rate,137-154 bpm during standing and walking..         Concomitant product information was not provided. Treatment information was not provided   This case was linked to MOD-2021-284948 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Additional information received and patient demographics were updated.Dose 2 details were added. Event Inappropriate schedule of vaccine administration event was added.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Head discomfort, Pyrexia
Clinical narrative: Brain feels like it is about to explode; developed a fever of 102 for 10 days since the first dose and won't go away; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Brain feels like it is about to explode) and PYREXIA (developed a fever of 102 for 10 days since the first dose and won't go away) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEAD DISCOMFORT (Brain feels like it is about to explode) and PYREXIA (developed a fever of 102 for 10 days since the first dose and won't go away). At the time of the report, HEAD DISCOMFORT (Brain feels like it is about to explode) and PYREXIA (developed a fever of 102 for 10 days since the first dose and won't go away) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, Body temperature: 102 (High) Fever of 102 for 10 days.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported. No treatment medications were provided. This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Brain feels like it is about to explode) and PYREXIA (developed a fever of 102 for 10 days since the first dose and won't go away) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEAD DISCOMFORT (Brain feels like it is about to explode) and PYREXIA (developed a fever of 102 for 10 days since the first dose and won't go away). At the time of the report, HEAD DISCOMFORT (Brain feels like it is about to explode) and PYREXIA (developed a fever of 102 for 10 days since the first dose and won't go away) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, Body temperature: 102 (High) Fever of 102 for 10 days.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported. No treatment medications were provided.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of COVID-19 in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient got COVID-19. At the time of the report, COVID-19 outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported. This case linked to MOD21-129646, MOD21-129646 and MOD21-129728 (patient link). Most recent follow-up information incorporated: On Aug 12, 2021: Follow-up received. On Dec 7, 2021: Follow-up contained insignificant information. Reporter's phone number updated from previous document.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Pain, Pain in extremity
Clinical narrative: Achy; Arm was tender; Second shot hurt more; Little tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), PAIN IN EXTREMITY (Arm was tender), INJECTION SITE PAIN (Second shot hurt more) and FATIGUE (Little tired) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 006C21A) for COVID-19 vaccination.     no medical history has been provided.  Concomitant products included MESALAZINE (DELZICOL), IBUPROFEN, PREDNISONE, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (FLUTICASONE + SALMETEROL), SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]), LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN D 12 HOUR) and COLECALCIFEROL (VITAMIN D3) for an unknown indication.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-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 (Achy), PAIN IN EXTREMITY (Arm was tender), INJECTION SITE PAIN (Second shot hurt more) and FATIGUE (Little tired). At the time of the report, PAIN (Achy), PAIN IN EXTREMITY (Arm was tender), INJECTION SITE PAIN (Second shot hurt more) and FATIGUE (Little tired) outcome was unknown.            Prednisone was taken by the patient after the first dose for Lupus flare up. Ibuprofen was taken by the patient after the second dose to help alleviate the adverse events.   This case was linked to MOD-2021-285055 (Patient Link).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Vaccination site induration, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: the area right below where she got the injection hot to the touch; the area right below where she got the injection itches; hard right below where she got the injection; left arm was sore & hard right below where she got the injection; huge rash on her left arm right below where she got the injection; sore under her left armpit where the lymph nodes are; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (the area right below where she got the injection hot to the touch), VACCINATION SITE PRURITUS (the area right below where she got the injection itches), VACCINATION SITE INDURATION (hard right below where she got the injection), VACCINATION SITE PAIN (left arm was sore & hard right below where she got the injection) and VACCINATION SITE RASH (huge rash on her left arm right below where she got the injection) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2021, the patient experienced AXILLARY PAIN (sore under her left armpit where the lymph nodes are). On 10-Aug-2021, the patient experienced VACCINATION SITE INDURATION (hard right below where she got the injection), VACCINATION SITE PAIN (left arm was sore & hard right below where she got the injection) and VACCINATION SITE RASH (huge rash on her left arm right below where she got the injection). On an unknown date, the patient experienced VACCINATION SITE WARMTH (the area right below where she got the injection hot to the touch) and VACCINATION SITE PRURITUS (the area right below where she got the injection itches). At the time of the report, VACCINATION SITE WARMTH (the area right below where she got the injection hot to the touch), VACCINATION SITE PRURITUS (the area right below where she got the injection itches), VACCINATION SITE INDURATION (hard right below where she got the injection), VACCINATION SITE PAIN (left arm was sore & hard right below where she got the injection), VACCINATION SITE RASH (huge rash on her left arm right below where she got the injection) and AXILLARY PAIN (sore under her left armpit where the lymph nodes are) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.  The patient had been using cold compresses for the hotness.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: the area right below where she got the injection hot to the touch; the area right below where she got the injection itches; hard right below where she got the injection; left arm was sore & hard right below where she got the injection; huge rash on her left arm right below where she got the injection; sore under her left armpit where the lymph nodes are; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (the area right below where she got the injection hot to the touch), VACCINATION SITE PRURITUS (the area right below where she got the injection itches), VACCINATION SITE INDURATION (hard right below where she got the injection), VACCINATION SITE PAIN (left arm was sore & hard right below where she got the injection) and VACCINATION SITE RASH (huge rash on her left arm right below where she got the injection) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2021, the patient experienced AXILLARY PAIN (sore under her left armpit where the lymph nodes are). On 10-Aug-2021, the patient experienced VACCINATION SITE INDURATION (hard right below where she got the injection), VACCINATION SITE PAIN (left arm was sore & hard right below where she got the injection) and VACCINATION SITE RASH (huge rash on her left arm right below where she got the injection). On an unknown date, the patient experienced VACCINATION SITE WARMTH (the area right below where she got the injection hot to the touch) and VACCINATION SITE PRURITUS (the area right below where she got the injection itches). At the time of the report, VACCINATION SITE WARMTH (the area right below where she got the injection hot to the touch), VACCINATION SITE PRURITUS (the area right below where she got the injection itches), VACCINATION SITE INDURATION (hard right below where she got the injection), VACCINATION SITE PAIN (left arm was sore & hard right below where she got the injection), VACCINATION SITE RASH (huge rash on her left arm right below where she got the injection) and AXILLARY PAIN (sore under her left armpit where the lymph nodes are) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.  The patient had been using cold compresses for the hotness.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Diarrhea; feel off, strange / feeling not myself; Nausea; sore  arm,; fatigue; mild headache / dull headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), MALAISE (feel off, strange / feeling not myself), MYALGIA (sore  arm,), FATIGUE (fatigue) and HEADACHE (mild headache / dull headache) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included Multivitamin.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced MYALGIA (sore  arm,), FATIGUE (fatigue) and HEADACHE (mild headache / dull headache). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), MALAISE (feel off, strange / feeling not myself) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 03-Aug-2021, MYALGIA (sore  arm,) and FATIGUE (fatigue) had resolved. At the time of the report, DIARRHOEA (Diarrhea), MALAISE (feel off, strange / feeling not myself) and NAUSEA (Nausea) outcome was unknown and HEADACHE (mild headache / dull headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that he  went  to his  doctor and  they advised him to take Ibuprofen and drink fluid. Patient took Tylenol but  it did not help that much, and  patient is  only  Multivitamin as  his regular medication.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.