chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pyrexia
Clinical narrative: Low grade temp; Achy; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade temp) and MYALGIA (Achy) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy and Allergy to antibiotic (clindamycin).   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced PYREXIA (Low grade temp) and MYALGIA (Achy). On 26-Mar-2021, PYREXIA (Low grade temp) and MYALGIA (Achy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Body temperature: low (Low) Low grade fever.         No concomitant medication was reported  No treatment medication was reported
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypertension, Vaccination complication
Clinical narrative: Lightheaded; Possible neurological issue; High Blood Pressure; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheaded), VACCINATION COMPLICATION (Possible neurological issue) and HYPERTENSION (High Blood Pressure) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-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 DIZZINESS (Lightheaded), VACCINATION COMPLICATION (Possible neurological issue) and HYPERTENSION (High Blood Pressure). On 20-Mar-2021, DIZZINESS (Lightheaded), VACCINATION COMPLICATION (Possible neurological issue) and HYPERTENSION (High Blood Pressure) had resolved.        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.  It was reported that the patients all the issues were resolved themselves within approximately one week after the second shot.      Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Non significant follow up. Narrative description was updated.
Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No medical history was provided by the reporter.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (unknown route) UNK dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) 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.   Reporter did not allow further contact
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Headache, Hypersomnia, Nausea
Clinical narrative: Too weak to walk/felt very very weak; Slept alot; Couldn't eat; Headache; nausea; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (Too weak to walk/felt very very weak), HYPERSOMNIA (Slept alot), DECREASED APPETITE (Couldn't eat), HEADACHE (Headache) and NAUSEA (nausea) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced ASTHENIA (Too weak to walk/felt very very weak), HYPERSOMNIA (Slept alot), DECREASED APPETITE (Couldn't eat), HEADACHE (Headache) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 23-Apr-2021, ASTHENIA (Too weak to walk/felt very very weak), HYPERSOMNIA (Slept alot), DECREASED APPETITE (Couldn't eat), HEADACHE (Headache) and NAUSEA (nausea) had resolved.            No concomitant medications reported.  Treatment of the events were not reported.   This case was linked to MOD-2021-065962 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Fatigue, Nausea, Somnolence
Clinical narrative: no energy for about two days; did not feel like eating much; nausea; tired; Did not want to do anything but sleep that day; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (no energy for about two days), SOMNOLENCE (Did not want to do anything but sleep that day), DECREASED APPETITE (did not feel like eating much), NAUSEA (nausea) and FATIGUE (tired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced SOMNOLENCE (Did not want to do anything but sleep that day), NAUSEA (nausea) and FATIGUE (tired). On an unknown date, the patient experienced ASTHENIA (no energy for about two days) and DECREASED APPETITE (did not feel like eating much). At the time of the report, ASTHENIA (no energy for about two days), SOMNOLENCE (Did not want to do anything but sleep that day), DECREASED APPETITE (did not feel like eating much), NAUSEA (nausea) and FATIGUE (tired) had resolved.            No concomitant and treatment drugs were reported.   This case was linked to MOD-2021-047191 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Slight fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Slight 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 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 PYREXIA (Slight fever). At the time of the report, PYREXIA (Slight fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not reported. No concomitant medications reported.  Reporter (64 years old) stated patient is about 3 years older.  Full details were not obtained due to abrupt disconnection from call.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: further down the left arm, she had a red spot like a bug-bite; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (further down the left arm, she had a red spot like a bug-bite) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No history reported by the reporter.  Concomitant products included ALPRAZOLAM (XANAX), METHIMAZOLE, HCTZ and METOPROLOL for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced RASH MACULAR (further down the left arm, she had a red spot like a bug-bite). At the time of the report, RASH MACULAR (further down the left arm, she had a red spot like a bug-bite) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient's Concomitant medications also include, statin and allergy.  Treatment information provided as, Antibiotics.   This case was linked to MOD-2021-056080 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: Consumer doesn't have email or fax number
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: wiped out completely the next day after the vaccine both times; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION COMPLICATION (wiped out completely the next day after the vaccine both times) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, 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 VACCINATION COMPLICATION (wiped out completely the next day after the vaccine both times). At the time of the report, VACCINATION COMPLICATION (wiped out completely the next day after the vaccine both times) outcome was unknown.            Concomitant product use and treatment information not provided.   Reporter did not allow further contact
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: sore arm; arm redness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and ERYTHEMA (arm redness) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and ERYTHEMA (arm redness). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved and ERYTHEMA (arm redness) had not resolved.            No concomitant medication was reported.  Treatment drug information was not given.   This case was linked to MOD-2021-062907 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Updated the outcome of the event erythema from unknown to not recovered.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: DULL HEADACHE; Nauseated/felt sick at stomach; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (DULL HEADACHE) and NAUSEA (Nauseated/felt sick at stomach) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (DULL HEADACHE) and NAUSEA (Nauseated/felt sick at stomach). At the time of the report, HEADACHE (DULL HEADACHE) and NAUSEA (Nauseated/felt sick at stomach) had resolved.            No concomitant and treatment medication information was reported.   This case was linked to MOD-2021-057766 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: pain at the site of injection; This spontaneous case was reported by a nurse and describes the occurrence of INJECTION SITE PAIN (pain at the site of injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (pain at the site of injection). At the time of the report, INJECTION SITE PAIN (pain at the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Oropharyngeal pain, Pyrexia, Rash
Clinical narrative: sore throat; rash on side of arm; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), RASH (rash on side of arm), HEADACHE (Headache) and PYREXIA (Fever) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), RASH (rash on side of arm), HEADACHE (Headache) and PYREXIA (Fever). The patient was treated with IBUPROFEN for Headache, Sore throat, Fever and Rash, at an unspecified dose and frequency. On 15-Apr-2021, OROPHARYNGEAL PAIN (sore throat), RASH (rash on side of arm), HEADACHE (Headache) and PYREXIA (Fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Body temperature: Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-117894 (Patient Link).
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Impaired work ability, Myalgia
Clinical narrative: chills; Headache; Body Aches; Joint pain; Had to miss work; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED WORK ABILITY (Had to miss work), CHILLS (chills), HEADACHE (Headache), MYALGIA (Body Aches) and ARTHRALGIA (Joint pain) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced CHILLS (chills), HEADACHE (Headache), MYALGIA (Body Aches) and ARTHRALGIA (Joint pain). In May 2021, the patient experienced IMPAIRED WORK ABILITY (Had to miss work). In May 2021, IMPAIRED WORK ABILITY (Had to miss work), CHILLS (chills), HEADACHE (Headache), MYALGIA (Body Aches) and ARTHRALGIA (Joint pain) had resolved.            Relevant concomitant product usage were not reported by the reporter. No treatment details were added. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Rash, Urticaria
Clinical narrative: Hives on face, various areas on body.  Moved around to other areas each day; Rash on face , various areas on body.  Moved around to other areas each day.; Redness around vaccine site; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on face, various areas on body.  Moved around to other areas each day), INJECTION SITE ERYTHEMA (Redness around vaccine site) and RASH (Rash on face , various areas on body.  Moved around to other areas each day.) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 020B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INJECTION SITE ERYTHEMA (Redness around vaccine site). On 03-May-2021, the patient experienced URTICARIA (Hives on face, various areas on body.  Moved around to other areas each day) and RASH (Rash on face , various areas on body.  Moved around to other areas each day.). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEK) on 05-Apr-2021 at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 05-Apr-2021 at a dose of 1 dosage form. On 11-May-2021, URTICARIA (Hives on face, various areas on body.  Moved around to other areas each day) and RASH (Rash on face , various areas on body.  Moved around to other areas each day.) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (Redness around vaccine site) outcome was unknown.            This case was linked to MOD-2021-073736 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Spasms) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040321A) for COVID-19 vaccination. The patient's past medical history included Stroke.On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced MUSCLE SPASMS (Spasms). At the time of the report, MUSCLE SPASMS (Spasms) outcome was unknown.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. Treatment drug information was not given.  This case was linked to US-MODERNATX, INC.-MOD-2021-076263 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-076263:First dose case
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Pyrexia
Clinical narrative: Feeling sick; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick), PYREXIA (Fever) and CHILLS (Chills) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Apr-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 26-Apr-2021, the patient experienced MALAISE (Feeling sick), PYREXIA (Fever) and CHILLS (Chills). On 28-Apr-2021, MALAISE (Feeling sick), PYREXIA (Fever) and CHILLS (Chills) was resolving.            Concomitant medications were not provided.  Treatment medications were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-066061 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-066061:First dose
Age: 73.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Myalgia
Clinical narrative: MUSCLES IN BONES WAS SORE FROM WAIST DOWN; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (MUSCLES IN BONES WAS SORE FROM WAIST DOWN) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    No Medical History information was reported.   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 started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In April 2021, the patient experienced MYALGIA (MUSCLES IN BONES WAS SORE FROM WAIST DOWN). At the time of the report, MYALGIA (MUSCLES IN BONES WAS SORE FROM WAIST DOWN) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No medical history was provided by the reporter.  No concomitant medications were provided by the reporter.
Age: 66.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Polypectomy
Clinical narrative: Polyps were removed; This spontaneous case was reported by a physician and describes the occurrence of POLYPECTOMY (Polyps were removed) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    The patient has no known allergies.  The patient's past medical history included Injection site pain (Stings/hurt/burning sensation after Humira injection; resolved when switched to citrate-free) from 2015 to 2017 and Colonoscopy (Sometimes performed every three years; a fewpolyps were discovered) in February 2021. Concurrent medical conditions included Crohn's disease (moderate to severe) and Polyps (discovered during annual checkup via colonoscopy). Concomitant products included COLESEVELAM HYDROCHLORIDE (WELCHOL) for an unknown indication.   In 2016, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced POLYPECTOMY (Polyps were removed). On 16-Mar-2021, POLYPECTOMY (Polyps were removed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The reporter states that the polyps were removed on 16MAR2021 and "everything was ok."  No additional treatment was reported.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Neck pain
Clinical narrative: Neck pain; Upper back pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck pain), BACK PAIN (Upper back pain) and HEADACHE (Headache) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Thalassemia minor (thalassemia minor(beta)) and Anemia (anemia(iron deficiency)). Concomitant products included IRON, FOLIC ACID and CALCIUM for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced NECK PAIN (Neck pain), BACK PAIN (Upper back pain) and HEADACHE (Headache). At the time of the report, NECK PAIN (Neck pain), BACK PAIN (Upper back pain) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitants included multivitamin.  No treatment information was provided.    Reporter did not allow further contact
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: joint pain flare up; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain flare up) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included BENZOIN for Allergy.    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 ARTHRALGIA (joint pain flare up). At the time of the report, ARTHRALGIA (joint pain flare up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise
Clinical narrative: FELT SICK; REAL TIRED; This spontaneous case was reported by a physician and describes the occurrence of MALAISE (FELT SICK) and FATIGUE (REAL TIRED) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriasis and Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced MALAISE (FELT SICK) and FATIGUE (REAL TIRED). At the time of the report, MALAISE (FELT SICK) and FATIGUE (REAL TIRED) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Indication to use for Humira (citrate free) Moderate to severe chronic plaque psoriasis and Moderate to severe Rheumatoid  Arthritis   No Concomitant medications were reported by the reporter.  Treatment medication for these events were not reported by the reporter. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) had resolved.            No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-065536 (E2B Linked Report).; 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. US-MODERNATX, INC.-MOD-2021-065536:First dose case
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blister
Clinical narrative: Blisters on hands; Achy joints; This spontaneous case was reported by a physician and describes the occurrence of BLISTER (Blisters on hands) and ARTHRALGIA (Achy joints) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    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 BLISTER (Blisters on hands) and ARTHRALGIA (Achy joints). At the time of the report, BLISTER (Blisters on hands) and ARTHRALGIA (Achy joints) 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: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: This spontaneous case reported by a physician, describes the occurrence of nausea and pyrexia (fever) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Co-suspect product included Humira (adalimumab) for rheumatoid arthritis. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form; and Humira (adalimumab), subcutaneous; 1 dosage form. On an unknown date, patient experienced nausea and pyrexia (fever). At the time of the report, nausea and pyrexia (fever) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant medications or treatment information.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Electric shock sensation, Gait disturbance, Headache, Muscle spasms
Clinical narrative: Pain throughout the body; Muscle aches; Headache/ inability to touch her head due to sensitivity/head cramps; Temperature began to rise; Cramps to her earlobes; Pain at left arm; Felt electric shock pain in bilateral ears; Had to walk in a stooped position; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramps to her earlobes), PAIN IN EXTREMITY (Pain at left arm), ELECTRIC SHOCK SENSATION (Felt electric shock pain in bilateral ears), GAIT DISTURBANCE (Had to walk in a stooped position) and PAIN (Pain throughout the body) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     It was reported that the patient did not have any acute or chronic long standing health conditions at the time of vaccination.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for Nutritional supplement.   On 23-Mar-2021 at 4:05 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced MUSCLE SPASMS (Cramps to her earlobes), PAIN IN EXTREMITY (Pain at left arm), ELECTRIC SHOCK SENSATION (Felt electric shock pain in bilateral ears) and GAIT DISTURBANCE (Had to walk in a stooped position). 21-Apr-2021, the patient experienced HEADACHE (Headache/ inability to touch her head due to sensitivity/head cramps). 21-Apr-2021, the patient experienced PYREXIA (Temperature began to rise). On 24-Apr-2021, the patient experienced MYALGIA (Muscle aches). On 24-Apr-2021 at 8:00 AM, the patient experienced PAIN (Pain throughout the body). On 25-Apr-2021, PAIN (Pain throughout the body), MYALGIA (Muscle aches) and HEADACHE (Headache/ inability to touch her head due to sensitivity/head cramps) had resolved. At the time of the report, MUSCLE SPASMS (Cramps to her earlobes), PAIN IN EXTREMITY (Pain at left arm), ELECTRIC SHOCK SENSATION (Felt electric shock pain in bilateral ears), GAIT DISTURBANCE (Had to walk in a stooped position) and PYREXIA (Temperature began to rise) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 - 103 (High) High.         . No treatment information was provided.    This case was linked to MOD-2021-059509 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain in extremity, Pyrexia
Clinical narrative: Pain throughout the body; Muscle aches; Headache/ inability to touch her head due to sensitivity/head cramps; Temperature began to rise; Cramps to her earlobes; Pain at left arm; Felt electric shock pain in bilateral ears; Had to walk in a stooped position; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramps to her earlobes), PAIN IN EXTREMITY (Pain at left arm), ELECTRIC SHOCK SENSATION (Felt electric shock pain in bilateral ears), GAIT DISTURBANCE (Had to walk in a stooped position) and PAIN (Pain throughout the body) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     It was reported that the patient did not have any acute or chronic long standing health conditions at the time of vaccination.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for Nutritional supplement.   On 23-Mar-2021 at 4:05 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced MUSCLE SPASMS (Cramps to her earlobes), PAIN IN EXTREMITY (Pain at left arm), ELECTRIC SHOCK SENSATION (Felt electric shock pain in bilateral ears) and GAIT DISTURBANCE (Had to walk in a stooped position). 21-Apr-2021, the patient experienced HEADACHE (Headache/ inability to touch her head due to sensitivity/head cramps). 21-Apr-2021, the patient experienced PYREXIA (Temperature began to rise). On 24-Apr-2021, the patient experienced MYALGIA (Muscle aches). On 24-Apr-2021 at 8:00 AM, the patient experienced PAIN (Pain throughout the body). On 25-Apr-2021, PAIN (Pain throughout the body), MYALGIA (Muscle aches) and HEADACHE (Headache/ inability to touch her head due to sensitivity/head cramps) had resolved. At the time of the report, MUSCLE SPASMS (Cramps to her earlobes), PAIN IN EXTREMITY (Pain at left arm), ELECTRIC SHOCK SENSATION (Felt electric shock pain in bilateral ears), GAIT DISTURBANCE (Had to walk in a stooped position) and PYREXIA (Temperature began to rise) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 - 103 (High) High.         . No treatment information was provided.    This case was linked to MOD-2021-059509 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: Heaviness on arm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Heaviness on arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Heaviness on arm). At the time of the report, LIMB DISCOMFORT (Heaviness on arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old given vaccine; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old given vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old given vaccine). On 14-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old given vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  The reporter stated that the patient tolerated the second dose vaccine well   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up received on 15-JUN-2021contains: Second dose details were added. On 13-Jul-2021: Follow up received on 13-JUL-2021 contains added ethnicity and statement of tolerance.
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea; 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 NAUSEA (Nausea) 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 12-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea). At the time of the report, NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Menopausal symptoms
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of menopausal symptoms (menopausal women get their period out of the blue) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. 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 had menopausal symptoms (menopausal women get their period out of the blue). At the time of the report, menopausal symptoms (menopausal women get their period out of the blue) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No medical history, concomitant or treatment information provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 025B21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced CHILLS (Chills) and PYREXIA (Fever). On 14-May-2021, the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Body temperature: 100-101 (High) High. On an unknown date, Body temperature: 101-106 (High) High. No concomitant medications reported.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Breast pain, Erythema, Herpes zoster, Skin lesion
Clinical narrative: Shingles; Redness all around breasts and back; Pain all around the redness; Pain all around the redness; Small red bumps; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles), ERYTHEMA (Redness all around breasts and back), BACK PAIN (Pain all around the redness), BREAST PAIN (Pain all around the redness) and SKIN LESION (Small red bumps) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 11-May-2021, the patient experienced SKIN LESION (Small red bumps). On 13-May-2021, the patient experienced ERYTHEMA (Redness all around breasts and back), BACK PAIN (Pain all around the redness) and BREAST PAIN (Pain all around the redness). On 14-May-2021, the patient experienced HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles), ERYTHEMA (Redness all around breasts and back), BACK PAIN (Pain all around the redness), BREAST PAIN (Pain all around the redness) and SKIN LESION (Small red bumps) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Patient sent pictures to her doctor, who confirmed that the bumps are shingles. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up correspondence received on 13 Jul 2021 and does not contain new information.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Eye irritation, Hypersensitivity, Rhinorrhoea, Sneezing, Vaccination site pain
Clinical narrative: eye irritation; runny nose; sneezing; allergy in the eyes and nose / some allergies; pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (eye irritation), RHINORRHOEA (runny nose), SNEEZING (sneezing), HYPERSENSITIVITY (allergy in the eyes and nose / some allergies) and VACCINATION SITE PAIN (pain in the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product sitax for an unknown indication.    No Medical History information was reported.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started sitax (unknown route) at an unspecified dose. On an unknown date, the patient experienced EYE IRRITATION (eye irritation), RHINORRHOEA (runny nose), SNEEZING (sneezing), HYPERSENSITIVITY (allergy in the eyes and nose / some allergies) and VACCINATION SITE PAIN (pain in the injection site). At the time of the report, EYE IRRITATION (eye irritation), RHINORRHOEA (runny nose), SNEEZING (sneezing), HYPERSENSITIVITY (allergy in the eyes and nose / some allergies) and VACCINATION SITE PAIN (pain in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication provided was Sitax V 1tab every 3 days. Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Patient email address is updated. Patient treatment medication is also updated
Sex: F
Vaccine: COVID19
Symptoms: Blister, Feeling abnormal, Joint swelling, Rash macular
Clinical narrative: it is really bad; Ankles are swollen; Bumps on feet; red spot on face and hands; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Ankles are swollen), BLISTER (Bumps on feet), RASH MACULAR (red spot on face and hands) and FEELING ABNORMAL (it is really bad) 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 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced JOINT SWELLING (Ankles are swollen), BLISTER (Bumps on feet) and RASH MACULAR (red spot on face and hands). On an unknown date, the patient experienced FEELING ABNORMAL (it is really bad). At the time of the report, JOINT SWELLING (Ankles are swollen), BLISTER (Bumps on feet), RASH MACULAR (red spot on face and hands) and FEELING ABNORMAL (it is really bad) outcome was unknown. Not Provided          No concomitant medication information reported. No treatment information was provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Feeling hot, Musculoskeletal discomfort, Pain
Clinical narrative: heat going across back near bra strap; Still having discomfort from left shoulder to back of where the bra goes on; Pain has moved up and down on her left side; little pimple appeared; started having issues where she felt warmth in left breast; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (started having issues where she felt warmth in left breast), FEELING HOT (heat going across back near bra strap), MUSCULOSKELETAL DISCOMFORT (Still having discomfort from left shoulder to back of where the bra goes on), PAIN (Pain has moved up and down on her left side) and ACNE (little pimple appeared) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 011L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Breast lump removal. Concomitant products included SIMVASTATIN, DILTIAZEM, LEVOTHYROXINE, SPIRONOLACTONE, GLUCOSAMINE, UBIDECARENONE (COQ) and MULTIVITE FM OMEGA for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING HOT (started having issues where she felt warmth in left breast). On 01-May-2021, the patient experienced FEELING HOT (heat going across back near bra strap), MUSCULOSKELETAL DISCOMFORT (Still having discomfort from left shoulder to back of where the bra goes on), PAIN (Pain has moved up and down on her left side) and ACNE (little pimple appeared). The patient was treated with IBUPROFEN at an unspecified dose and frequency; GABAPENTIN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING HOT (started having issues where she felt warmth in left breast), FEELING HOT (heat going across back near bra strap), MUSCULOSKELETAL DISCOMFORT (Still having discomfort from left shoulder to back of where the bra goes on), PAIN (Pain has moved up and down on her left side) and ACNE (little pimple appeared) outcome was unknown. Not Provided
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: < 18 years old; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (< 18 years old) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (< 18 years old). On 14-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (< 18 years old) had resolved. Not Provided      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 medications were not reported. Treatment was not reported.