chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Aug-2021 at 10:50 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient). On 01-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided No treatment medication was provided  1 Vial of Moderna COVID-19 vaccine was taken out of the refrigerator, punctured and kept at room temperature (67.2F) beyond 12 hours. The vial was first punctured at 1:01PM on 31-Jul-2021 and that is when it was first moved to the room temperature. Punctured Vial kept in room temperature beyond 12 hours.Total amount of time the punctured vial was exposed to room temperature range: 9 hours and 49 minutes at 67.2 Fahrenheit steady temperature   This case was linked to MOD-2021-273049 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Influenza like illness, Limb discomfort
Clinical narrative: Little light headed; Left leg felt light; Felt like I was going to get the flu; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Little light headed), LIMB DISCOMFORT (Left leg felt light) and INFLUENZA LIKE ILLNESS (Felt like I was going to get the flu) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Little light headed), LIMB DISCOMFORT (Left leg felt light) and INFLUENZA LIKE ILLNESS (Felt like I was going to get the flu). At the time of the report, DIZZINESS (Little light headed), LIMB DISCOMFORT (Left leg felt light) and INFLUENZA LIKE ILLNESS (Felt like I was going to get the flu) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No Treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: patient missed  the recommended window for her second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient missed  the recommended window for her second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient missed  the recommended window for her second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient missed  the recommended window for her second 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.   Concomitant product use was not provided. Treatment information was not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Fatigue, Muscle discomfort, Paraesthesia oral, Pedantic speech
Clinical narrative: splotchy rash on torso, arms, legs, and back; super super tired; fuzzy tongue which comes and goes; sides of her tongue feels weird; she has to be more deliberate when she speaks; could not get muscle testing to work; typing mistakes, reverses numbers and letters; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (splotchy rash on torso, arms, legs, and back), TRICHOGLOSSIA (fuzzy tongue which comes and goes), PARAESTHESIA ORAL (sides of her tongue feels weird), PEDANTIC SPEECH (she has to be more deliberate when she speaks) and MUSCLE DISCOMFORT (could not get muscle testing to work) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included Stroke.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced FATIGUE (super super tired). On 15-Apr-2021, the patient experienced RASH MACULAR (splotchy rash on torso, arms, legs, and back). In 2021, the patient experienced TRICHOGLOSSIA (fuzzy tongue which comes and goes), PARAESTHESIA ORAL (sides of her tongue feels weird), PEDANTIC SPEECH (she has to be more deliberate when she speaks), MUSCLE DISCOMFORT (could not get muscle testing to work) and CONFUSIONAL STATE (typing mistakes, reverses numbers and letters). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Rash, at a dose of 1 dosage form. At the time of the report, RASH MACULAR (splotchy rash on torso, arms, legs, and back) had not resolved, TRICHOGLOSSIA (fuzzy tongue which comes and goes), PARAESTHESIA ORAL (sides of her tongue feels weird), PEDANTIC SPEECH (she has to be more deliberate when she speaks), MUSCLE DISCOMFORT (could not get muscle testing to work) and CONFUSIONAL STATE (typing mistakes, reverses numbers and letters) outcome was unknown and FATIGUE (super super tired) had resolved.            No concomitant medications were reported.  The treatment information was play music to help with the typing.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Trichoglossia
Clinical narrative: splotchy rash on torso, arms, legs, and back; super super tired; fuzzy tongue which comes and goes; sides of her tongue feels weird; she has to be more deliberate when she speaks; could not get muscle testing to work; typing mistakes, reverses numbers and letters; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (splotchy rash on torso, arms, legs, and back), TRICHOGLOSSIA (fuzzy tongue which comes and goes), PARAESTHESIA ORAL (sides of her tongue feels weird), PEDANTIC SPEECH (she has to be more deliberate when she speaks) and MUSCLE DISCOMFORT (could not get muscle testing to work) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Family history included Stroke.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced FATIGUE (super super tired). On 15-Apr-2021, the patient experienced RASH MACULAR (splotchy rash on torso, arms, legs, and back). In 2021, the patient experienced TRICHOGLOSSIA (fuzzy tongue which comes and goes), PARAESTHESIA ORAL (sides of her tongue feels weird), PEDANTIC SPEECH (she has to be more deliberate when she speaks), MUSCLE DISCOMFORT (could not get muscle testing to work) and CONFUSIONAL STATE (typing mistakes, reverses numbers and letters). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Rash, at a dose of 1 dosage form. At the time of the report, RASH MACULAR (splotchy rash on torso, arms, legs, and back) had not resolved, TRICHOGLOSSIA (fuzzy tongue which comes and goes), PARAESTHESIA ORAL (sides of her tongue feels weird), PEDANTIC SPEECH (she has to be more deliberate when she speaks), MUSCLE DISCOMFORT (could not get muscle testing to work) and CONFUSIONAL STATE (typing mistakes, reverses numbers and letters) outcome was unknown and FATIGUE (super super tired) had resolved.            No concomitant medications were reported.  The treatment information was play music to help with the typing.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Impaired work ability
Clinical narrative: lightheadedness/ dizziness; brain fog; patient can barely function; prolonged fatigue / unrelenting fatigue; This spontaneous case was reported by a physician and describes the occurrence of DIZZINESS (lightheadedness/ dizziness), FEELING ABNORMAL (brain fog), IMPAIRED WORK ABILITY (patient can barely function) and FATIGUE (prolonged fatigue / unrelenting fatigue) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic anemia.    In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (lightheadedness/ dizziness), FEELING ABNORMAL (brain fog), IMPAIRED WORK ABILITY (patient can barely function) and FATIGUE (prolonged fatigue / unrelenting fatigue). At the time of the report, DIZZINESS (lightheadedness/ dizziness), FEELING ABNORMAL (brain fog), IMPAIRED WORK ABILITY (patient can barely function) and FATIGUE (prolonged fatigue / unrelenting fatigue) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  No treatment medications were provided.  The physician believed that it was not related to patient's chronic anemia but he believed probably due to patient's age.   The physician believed second dose was on 24-Apr-2021.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccine after vial being punctured 16 hours ago; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after vial being punctured 16 hours ago) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after vial being punctured 16 hours ago). On 02-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after vial being punctured 16 hours ago) 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.   The reporter stated that the facility administered a vaccine from a punctured vial that was left over night in the counter. They left a punctured vial at 10 pm over the counter and administered it at 1 pm the next day to a patient. The punctured vial was sitting at room temperature for 16 hours.  No concomitant medication information was provided. No treatment medication were provided.
Sex: F
Vaccine: COVID19
Symptoms: Product availability issue, Product dose omission issue
Clinical narrative: received the 1st dose of the Moderna vaccine on 07Jun2021, and by the time she needed the 2nd dose there were no vaccines; received the 1st dose of the Moderna vaccine on 07Jun2021, and by the time she needed the 2nd dose there were no vaccines; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received the 1st dose of the Moderna vaccine on 07Jun2021, and by the time she needed the 2nd dose there were no vaccines) and PRODUCT AVAILABILITY ISSUE (received the 1st dose of the Moderna vaccine on 07Jun2021, and by the time she needed the 2nd dose there were no vaccines) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    On 07-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 (received the 1st dose of the Moderna vaccine on 07Jun2021, and by the time she needed the 2nd dose there were no vaccines) and PRODUCT AVAILABILITY ISSUE (received the 1st dose of the Moderna vaccine on 07Jun2021, and by the time she needed the 2nd dose there were no vaccines). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received the 1st dose of the Moderna vaccine on 07Jun2021, and by the time she needed the 2nd dose there were no vaccines) and PRODUCT AVAILABILITY ISSUE (received the 1st dose of the Moderna vaccine on 07Jun2021, and by the time she needed the 2nd dose there were no vaccines) 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.
Sex: M
Vaccine: COVID19
Symptoms: Gastric disorder, Thyroid disorder
Clinical narrative: gastric issues; Thyroid problem after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of THYROID DISORDER (Thyroid problem after vaccination) and GASTRIC DISORDER (gastric issues) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced THYROID DISORDER (Thyroid problem after vaccination). On an unknown date, the patient experienced GASTRIC DISORDER (gastric issues). At the time of the report, THYROID DISORDER (Thyroid problem after vaccination) and GASTRIC DISORDER (gastric issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was on antibiotics for prosthesis for about 5 days now for 14 days treatment.  No treatment information was provided by the reporter.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Throat tightness
Clinical narrative: numbness on her right wrist and hands; tingling on her right wrist and hands; tightness of throat; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness on her right wrist and hands), PARAESTHESIA (tingling on her right wrist and hands) and THROAT TIGHTNESS (tightness of throat) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Prochlorperazine Allergy). Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced HYPOAESTHESIA (numbness on her right wrist and hands), PARAESTHESIA (tingling on her right wrist and hands) and THROAT TIGHTNESS (tightness of throat). At the time of the report, HYPOAESTHESIA (numbness on her right wrist and hands), PARAESTHESIA (tingling on her right wrist and hands) and THROAT TIGHTNESS (tightness of throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided by the reporter.
Age: 26.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient given vaccine from punctured vial that was on the counter since 16Jul21 and administered on 30Jul2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given vaccine from punctured vial that was on the counter since 16Jul21 and administered on 30Jul2021) in a 26-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given vaccine from punctured vial that was on the counter since 16Jul21 and administered on 30Jul2021). On 30-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient given vaccine from punctured vial that was on the counter since 16Jul21 and administered on 30Jul2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal
Clinical narrative: Not feeling good; pain in her upper shoulder; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Not feeling good) and ARTHRALGIA (pain in her upper shoulder) 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 01-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 (Not feeling good) and ARTHRALGIA (pain in her upper shoulder). At the time of the report, FEELING ABNORMAL (Not feeling good) and ARTHRALGIA (pain in her upper shoulder) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Events start date was given on Aug 2021. No concomitant medication information was provided. No treatment medication were provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Periorbital swelling, Pyrexia, Vision blurred
Clinical narrative: not feeling right; Puffy vision; difficulties to focus; low grade fever; headache; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (not feeling right), PERIORBITAL SWELLING (Puffy vision), VISION BLURRED (difficulties to focus), HEADACHE (headache) and PYREXIA (low grade fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027c21a) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included VIT D [VITAMIN D NOS], CYANOCOBALAMIN (VIT B12), ATORVASTATIN CALCIUM (LIPITOR) and SALBUTAMOL (PROVENTIL [SALBUTAMOL]) for an unknown indication.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (headache). On 31-Jul-2021, the patient experienced PYREXIA (low grade fever). On 02-Aug-2021, the patient experienced FEELING ABNORMAL (not feeling right), PERIORBITAL SWELLING (Puffy vision) and VISION BLURRED (difficulties to focus). On 01-Aug-2021, HEADACHE (headache) had resolved. At the time of the report, FEELING ABNORMAL (not feeling right), PERIORBITAL SWELLING (Puffy vision), VISION BLURRED (difficulties to focus) and PYREXIA (low grade fever) had not 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.   The patient had a severe reaction (unspecified) to a flu shot in the past (date unknown).  Treatment information was not provided by the reporter.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Inappropriate schedule of product administration
Clinical narrative: missed his second dose appointment due to being in the hospital for a "heart problem"; Second dose not received in allowed time window; This spontaneous case was reported by a pharmacist and describes the occurrence of CARDIAC DISORDER (missed his second dose appointment due to being in the hospital for a "heart problem") and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose not received in allowed time window) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-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 CARDIAC DISORDER (missed his second dose appointment due to being in the hospital for a "heart problem") and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose not received in allowed time window). At the time of the report, CARDIAC DISORDER (missed his second dose appointment due to being in the hospital for a "heart problem") and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose not received in allowed time window) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.                                                                                              No treatment medications were provided by the reporter.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient given vaccine from punctured vial that was on the counter since 16Jul2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given vaccine from punctured vial that was on the counter since 16Jul2021) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given vaccine from punctured vial that was on the counter since 16Jul2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient given vaccine from punctured vial that was on the counter since 16Jul2021) 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 information on concomitant medication were reported. No information on treatment medication were reported.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Under 18 years of age vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under 18 years of age vaccine administered) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under 18 years of age vaccine administered). On 14-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under 18 years of age vaccine administered) 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 by the reporter.   After the vaccination no adverse events were reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up received No new information added.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: under 18 years of age; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years of age) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years of age). On 14-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years of age) 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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Initial additional document contains no new information.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Vaccination site pain
Clinical narrative: a soar arm at the injection point; under 18 years of age; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (a soar arm at the injection point) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years of age) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years of age). On an unknown date, the patient experienced VACCINATION SITE PAIN (a soar arm at the injection point). On 14-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years of age) had resolved. At the time of the report, VACCINATION SITE PAIN (a soar arm at the injection point) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up received and contains no new information. On 06-Aug-2021: Follow Up received and patient pregnancy status updated unknown to no ,patient vaccine route of administration and anatomical location were added, new event sore arm were added.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Myalgia
Clinical narrative: Shingles; Sore arm /Sever heel pain; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) and MYALGIA (Sore arm /Sever heel pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced HERPES ZOSTER (Shingles) and MYALGIA (Sore arm /Sever heel pain). The patient was treated with ACYCLOVIR [ACICLOVIR] for Shingles, at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles) and MYALGIA (Sore arm /Sever heel pain) outcome was unknown.            No concomitant medications were reported   This case was linked to MOD-2021-273317 (Patient Link).
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Pain, Swelling
Clinical narrative: immediate numbing; swelling; really hurting; slight headache; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPOAESTHESIA (immediate numbing), SWELLING (swelling), PAIN (really hurting) and HEADACHE (slight headache) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced HYPOAESTHESIA (immediate numbing), SWELLING (swelling), PAIN (really hurting) and HEADACHE (slight headache). At the time of the report, HYPOAESTHESIA (immediate numbing), SWELLING (swelling), PAIN (really hurting) and HEADACHE (slight 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 product use was not provided by the reporter.  Treatment information included ice pack.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Aug-2021 at 12:16 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient). On 01-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient) 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.   Additional information provided for vaccine that was punctured on 31-JUL-2021 and was kept at room temperature of 67.2 Fahrenheit for 11 hours and 15 minutes beyond the punctured vial 12 hour expiration before administration to the patient.  Concomitant product use was not provided. Treatment information was not provided.   This case was linked to MOD-2021-273049, MOD-2021-273129, MOD-2021-273149, MOD-2021-273448, MOD-2021-273721 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient missed 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient missed 2nd dose) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient missed 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient missed 2nd 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.   Concomitant product use was not reported. Treatment information was not provided.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: Mother got COVID-19 after the first shot; It has been six months and her mom still has not received the second shot.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Mother got COVID-19 after the first shot) and PRODUCT DOSE OMISSION ISSUE (It has been six months and her mom still has not received the second shot.) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-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 (Mother got COVID-19 after the first shot) and PRODUCT DOSE OMISSION ISSUE (It has been six months and her mom still has not received the second shot.). At the time of the report, COVID-19 (Mother got COVID-19 after the first shot) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (It has been six months and her mom still has not received the second shot.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug information was not provided.  Treatment information was not provided. Patient weight 175 units not provided.
Sex: U
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Had the same problem as her after taking the Moderna Covid19 Vaccine; 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 UNEVALUABLE EVENT (Had the same problem as her after taking the Moderna Covid19 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 UNEVALUABLE EVENT (Had the same problem as her after taking the Moderna Covid19 Vaccine). At the time of the report, UNEVALUABLE EVENT (Had the same problem as her after taking the Moderna Covid19 Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD21-125467 (Linked Report).; Sender's Comments:  MOD21-125467:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Herpes zoster, Pain in extremity
Clinical narrative: Shingles in the eye; Severe heal pain; Vomit; fatigue; chills; diarrhea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (diarrhea), HERPES ZOSTER (Shingles in the eye), PAIN IN EXTREMITY (Severe heal pain), VOMITING (Vomit) and FATIGUE (fatigue) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced DIARRHOEA (diarrhea), VOMITING (Vomit), FATIGUE (fatigue) and CHILLS (chills). On an unknown date, the patient experienced HERPES ZOSTER (Shingles in the eye) and PAIN IN EXTREMITY (Severe heal pain). The patient was treated with ACYCLOVIR [ACICLOVIR] for Shingles, at a dose of 1 dosage form. On 25-Feb-2021, DIARRHOEA (diarrhea), VOMITING (Vomit), FATIGUE (fatigue) and CHILLS (chills) had resolved. At the time of the report, HERPES ZOSTER (Shingles in the eye) and PAIN IN EXTREMITY (Severe heal pain) outcome was unknown.            No concomitant medication was reported.   This case was linked to MOD-2021-273282 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Shingles in the eye; Severe heal pain; Vomit; fatigue; chills; diarrhea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIARRHOEA (diarrhea), HERPES ZOSTER (Shingles in the eye), PAIN IN EXTREMITY (Severe heal pain), VOMITING (Vomit) and FATIGUE (fatigue) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced DIARRHOEA (diarrhea), VOMITING (Vomit), FATIGUE (fatigue) and CHILLS (chills). On an unknown date, the patient experienced HERPES ZOSTER (Shingles in the eye) and PAIN IN EXTREMITY (Severe heal pain). The patient was treated with ACYCLOVIR [ACICLOVIR] for Shingles, at a dose of 1 dosage form. On 25-Feb-2021, DIARRHOEA (diarrhea), VOMITING (Vomit), FATIGUE (fatigue) and CHILLS (chills) had resolved. At the time of the report, HERPES ZOSTER (Shingles in the eye) and PAIN IN EXTREMITY (Severe heal pain) outcome was unknown.            No concomitant medication was reported.   This case was linked to MOD-2021-273282 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Influenza like illness, Somnolence
Clinical narrative: flu-like symptoms; sleepy/eyelids are so heavy she wants to close them and sleep/hasn't slept like this since she was a newborn baby; exhausted; her joints are hurting; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), SOMNOLENCE (sleepy/eyelids are so heavy she wants to close them and sleep/hasn't slept like this since she was a newborn baby), CHILLS (chills), FATIGUE (exhausted) and ARTHRALGIA (her joints are hurting) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     The patient's past medical history included Arteriovenous malformation (spinal cord) in 1990. Concurrent medical conditions included Nerve damage, Allergy, Wheelchair user in 2001 and Smoker. Concomitant products included LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Allergy, GABAPENTIN, BACLOFEN, OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]), TIZANIDINE, CLONAZEPAM, AMITRIPTYLINE and ROPINIROLE for Nerve damage.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced CHILLS (chills). On 31-Jul-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), SOMNOLENCE (sleepy/eyelids are so heavy she wants to close them and sleep/hasn't slept like this since she was a newborn baby), FATIGUE (exhausted) and ARTHRALGIA (her joints are hurting). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), SOMNOLENCE (sleepy/eyelids are so heavy she wants to close them and sleep/hasn't slept like this since she was a newborn baby), CHILLS (chills), FATIGUE (exhausted) and ARTHRALGIA (her joints are hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's medical history included abnormal veins wrapped around her spinal cord, one of them ruptured and bled. From then on, her waist down went totally numb and she lost her ability to walk. Patient also stated that without the concomitant medications she take, her legs would be shaking and spasmatic No treatment was received by the patient
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Urticaria, Vaccination site erythema
Clinical narrative: sore arm that hurts to the touch; On both upper legs, itchy red welts; little red spot the size of a quarter at the location of the dose; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm that hurts to the touch), URTICARIA (On both upper legs, itchy red welts), RASH (Rash) and VACCINATION SITE ERYTHEMA (little red spot the size of a quarter at the location of the dose) in a 49-year-old male 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 ESCITALOPRAM OXALATE (LEXAPRO), CLONAZEPAM and BUPRENORPHINE for an unknown indication.    On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, the patient experienced RASH (Rash). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm that hurts to the touch), URTICARIA (On both upper legs, itchy red welts) and VACCINATION SITE ERYTHEMA (little red spot the size of a quarter at the location of the dose). At the time of the report, PAIN IN EXTREMITY (sore arm that hurts to the touch), URTICARIA (On both upper legs, itchy red welts), RASH (Rash) and VACCINATION SITE ERYTHEMA (little red spot the size of a quarter at the location of the dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   It was reported that the patient experienced very itchy red welts that looked like poison ivy on both upper legs either the same day as the vaccination or the next day.  Treatment included over the counter medication (soothing spray) for itchiness and an unknown ointment.  Patient consented for safety team to follow up via email.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Glandular swelling under left arm pit; Glandular swelling under left arm pit and on left thigh; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Glandular swelling under left arm pit) and LYMPHADENOPATHY (Glandular swelling under left arm pit and on left thigh) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0321321A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, the patient experienced LYMPHADENOPATHY (Glandular swelling under left arm pit) and LYMPHADENOPATHY (Glandular swelling under left arm pit and on left thigh). At the time of the report, LYMPHADENOPATHY (Glandular swelling under left arm pit) and LYMPHADENOPATHY (Glandular swelling under left arm pit and on left thigh) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  The patient reported that she had a procedure done in June 2021 and therefore did not receive the second dose.  No treatment information was provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site mass, Vaccination site warmth
Clinical narrative: lump in the injection site; warm to the touch/ heat; it's itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump in the injection site), VACCINATION SITE WARMTH (warm to the touch/ heat) and PRURITUS (it's itchy) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced VACCINATION SITE MASS (lump in the injection site), VACCINATION SITE WARMTH (warm to the touch/ heat) and PRURITUS (it's itchy). At the time of the report, VACCINATION SITE MASS (lump in the injection site), VACCINATION SITE WARMTH (warm to the touch/ heat) and PRURITUS (it's itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided by reporter.  No treatment information was provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: It has been more than 36 from 1st dose, patient hasn't received 2nd dose; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been more than 36 from 1st dose, patient hasn't received 2nd dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 10-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been more than 36 from 1st dose, patient hasn't received 2nd dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been more than 36 from 1st dose, patient hasn't received 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: follow up information included No new information.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: high fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-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 PYREXIA (high fever). At the time of the report, PYREXIA (high fever) had resolved.            Concomitant product use was not provided. No treatment was reported. Action taken in response to mRNA-1273 was not applicable