chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: injection site - hot; injection site - red; soreness at the site of the injection; A spontaneous report was received from a healthcare professional concerning a 84-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soreness at the site of the injection, injection site - red, injection site - hot.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 23 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 014M20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 23 Feb 2021, the patient experienced the event(s) soreness at the site of the injection. On 4 Mar 2021, the patient experienced the event(s) injection site - red. On an unknown date, the patient experienced the event(s) injection site - hot.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On 25 Feb 2021 the outcome of event(s), soreness at the site of the injection was resolved. On4 Mar 2021 the outcome of event(s), injection site - red was resolved. The outcome of event(s), injection site - hot was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose of vaccine was given on day 22; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of vaccine was given on day 22) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 09-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) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of vaccine was given on day 22). On 03-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of vaccine was given on day 22) had resolved.        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 was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second shot 47 days after the first one; A spontaneous report was received from a reporter consumer) concerning a concerning  female patient of unspecified age , who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event, inappropriate schedule of product administration .  The patient's medical history was not provided .Concomitant medications were not provided .  On 11 Feb 2021, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection  On an unspecified date , the patient had  gotten appointment for her second dose of mRNA-1273(Lot/batch: unknown), 47 days after the first shot (inappropriate schedule of product administration).   Laboratory details was not provided . Treatment information was also not provided .  Action taken with mRNA-1273 in response to the events was not reported.   At the time of the report, outcome of event, inappropriate was considered  recovered .; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # unk own  with no associated AEs.; Sender's Comments:  MOD-2021-040271:Reporter's husband US-MODERNATX, INC.-MOD-2021-040271:Wife's case
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: Cold symptoms in head; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold symptoms in head) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was provided.).    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced NASOPHARYNGITIS (Cold symptoms in head). At the time of the report, NASOPHARYNGITIS (Cold symptoms in head) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy
Clinical narrative: Swelling in lymph nodes in same arm of injection; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Swelling in lymph nodes in same arm of injection) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Swelling in lymph nodes in same arm of injection). At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Swelling in lymph nodes in same arm of injection) 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.   Treatment and concomitant medicines were not provided  Action taken with mRNA-1273 in response to the event was unknown
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Peripheral swelling
Clinical narrative: Hot to touch skin around injection site; Red circle on injection site; Itchy injection site; Arm was swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen), INJECTION SITE WARMTH (Hot to touch skin around injection site), INJECTION SITE ERYTHEMA (Red circle on injection site) and INJECTION SITE PRURITUS (Itchy injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     no medical history was provided by reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen). On 02-Mar-2021, the patient experienced INJECTION SITE WARMTH (Hot to touch skin around injection site), INJECTION SITE ERYTHEMA (Red circle on injection site) and INJECTION SITE PRURITUS (Itchy injection site). At the time of the report, PERIPHERAL SWELLING (Arm was swollen), INJECTION SITE WARMTH (Hot to touch skin around injection site), INJECTION SITE ERYTHEMA (Red circle on injection site) and INJECTION SITE PRURITUS (Itchy injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: nurse who was very ill each time she took the injection; 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 MALAISE (nurse who was very ill each time she took the injection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (nurse who was very ill each time she took the injection). At the time of the report, MALAISE (nurse who was very ill each time she took the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.     patient doesn't know whether it was the Moderna or other covid-19 shot.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), HEADACHE (Severe headache) and FATIGUE (Tired) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN (Achy), HEADACHE (Severe headache) and FATIGUE (Tired). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN (Achy), HEADACHE (Severe headache) and FATIGUE (Tired) 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.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Impaired work ability
Clinical narrative: Out of work for 2 days; Dizziness; Headache; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED WORK ABILITY (Out of work for 2 days), DIZZINESS (Dizziness) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028l20a) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced IMPAIRED WORK ABILITY (Out of work for 2 days), DIZZINESS (Dizziness) and HEADACHE (Headache). At the time of the report, IMPAIRED WORK ABILITY (Out of work for 2 days), DIZZINESS (Dizziness) and HEADACHE (Headache) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.  Concomitant and treatment medications were not provided.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: general body aches; soreness at the site of injection; A spontaneous report was received from a consumer concerning a 71-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events general body aches, soreness at the site of injection.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031M20A) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) general body aches, soreness at the site of injection.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), general body aches, soreness at the site of injection was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Nausea, Somnolence
Clinical narrative: sleepy; little dizzy; lit headache; nauseate; felt heavy, want to go to sleep; This spontaneous case was reported by an other health care professional and describes the occurrence of SOMNOLENCE (sleepy), DIZZINESS (little dizzy), HEADACHE (lit headache), NAUSEA (nauseate) and FATIGUE (felt heavy, want to go to sleep) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced SOMNOLENCE (sleepy), DIZZINESS (little dizzy), HEADACHE (lit headache), NAUSEA (nauseate) and FATIGUE (felt heavy, want to go to sleep). At the time of the report, SOMNOLENCE (sleepy), DIZZINESS (little dizzy), HEADACHE (lit headache), NAUSEA (nauseate) and FATIGUE (felt heavy, want to go to sleep) 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.   Concomitant products included a lot of medications. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: My friend had a rash on her back; This spontaneous case was reported by a consumer and describes the occurrence of RASH (My friend had a rash on her back) 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (My friend had a rash on her back). At the time of the report, RASH (My friend had a rash on her back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-033406 (Patient Link).   Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: Headaches; Nausea; Fatigue; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), HEADACHE (Headaches), NAUSEA (Nausea) and FATIGUE (Fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 03-Mar-2021, the patient experienced HEADACHE (Headaches), NAUSEA (Nausea) and FATIGUE (Fatigue). On 28-Feb-2021, PAIN IN EXTREMITY (Sore Arm) had resolved. At the time of the report, HEADACHE (Headaches), NAUSEA (Nausea) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. Concomitant medications were not provided.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Fatigue, Headache, Swelling, Swelling face
Clinical narrative: Swollen face; Swollen neck; Concentration is off; Headaches; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swollen face), SWELLING (Swollen neck), DISTURBANCE IN ATTENTION (Concentration is off), HEADACHE (Headaches) and FATIGUE (Tiredness) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic eosinophilia (Highly eosinophilic and very allergic. ). Concomitant products included FLUTICASONE PROPIONATE (FLOVENT), ALBUTEROL [SALBUTAMOL], CETIRIZINE HYDROCHLORIDE (CETRIZINE), MOMETASONE FUROATE (NASONEX), OMEPRAZOLE and VITAMIN D NOS for an unknown indication.    On 21-Feb-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 SWELLING FACE (Swollen face), SWELLING (Swollen neck), DISTURBANCE IN ATTENTION (Concentration is off), HEADACHE (Headaches) and FATIGUE (Tiredness). At the time of the report, SWELLING FACE (Swollen face), SWELLING (Swollen neck), DISTURBANCE IN ATTENTION (Concentration is off), HEADACHE (Headaches) and FATIGUE (Tiredness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache
Clinical narrative: Headache; Fatigue; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 102A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced HEADACHE (Headache), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain). At the time of the report, HEADACHE (Headache), FATIGUE (Fatigue) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment details were provided
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cold-stimulus headache, Dysgeusia, Erythema, Feeling abnormal, Nausea
Clinical narrative: runny nose; nausea; sore arm; seeing tinted green; chemical taste in mouth; brain not working; Face turned red; Trouble speaking; This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA (Face turned red), VACCINATION COMPLICATION (Trouble speaking), PAIN IN EXTREMITY (sore arm), RHINORRHOEA (runny nose) and DYSGEUSIA (chemical taste in mouth) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 11-Feb-2021, the patient experienced ERYTHEMA (Face turned red), VACCINATION COMPLICATION (Trouble speaking), DYSGEUSIA (chemical taste in mouth) and COLD-STIMULUS HEADACHE (brain not working). On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FEELING ABNORMAL (seeing tinted green). On 14-Feb-2021, the patient experienced RHINORRHOEA (runny nose) and NAUSEA (nausea). On 11-Feb-2021, ERYTHEMA (Face turned red) had resolved. On 12-Feb-2021, VACCINATION COMPLICATION (Trouble speaking), PAIN IN EXTREMITY (sore arm), COLD-STIMULUS HEADACHE (brain not working) and FEELING ABNORMAL (seeing tinted green) had resolved. On 14-Feb-2021, RHINORRHOEA (runny nose) and NAUSEA (nausea) had resolved. On 17-Feb-2021, DYSGEUSIA (chemical taste in mouth) 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 information were not provided by the reporter. Treatment information were not provided by the reporter.   This case was linked to MOD-2021-034937 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rhinorrhoea, Vaccination complication
Clinical narrative: runny nose; nausea; sore arm; seeing tinted green; chemical taste in mouth; brain not working; Face turned red; Trouble speaking; This spontaneous case was reported by a physician and describes the occurrence of ERYTHEMA (Face turned red), VACCINATION COMPLICATION (Trouble speaking), PAIN IN EXTREMITY (sore arm), RHINORRHOEA (runny nose) and DYSGEUSIA (chemical taste in mouth) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 11-Feb-2021, the patient experienced ERYTHEMA (Face turned red), VACCINATION COMPLICATION (Trouble speaking), DYSGEUSIA (chemical taste in mouth) and COLD-STIMULUS HEADACHE (brain not working). On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FEELING ABNORMAL (seeing tinted green). On 14-Feb-2021, the patient experienced RHINORRHOEA (runny nose) and NAUSEA (nausea). On 11-Feb-2021, ERYTHEMA (Face turned red) had resolved. On 12-Feb-2021, VACCINATION COMPLICATION (Trouble speaking), PAIN IN EXTREMITY (sore arm), COLD-STIMULUS HEADACHE (brain not working) and FEELING ABNORMAL (seeing tinted green) had resolved. On 14-Feb-2021, RHINORRHOEA (runny nose) and NAUSEA (nausea) had resolved. On 17-Feb-2021, DYSGEUSIA (chemical taste in mouth) 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 information were not provided by the reporter. Treatment information were not provided by the reporter.   This case was linked to MOD-2021-034937 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: body ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body ache) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (body ache) and HEADACHE (headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, MYALGIA (body ache) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Lethargy
Clinical narrative: headache; stomachache; cannot get out of bed; A spontaneous report  was received from a caregiver concerning a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, stomachache, cannot get out of bed.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) headache, stomachache, cannot get out of bed.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), headache, stomachache, cannot get out of bed was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pruritus, Rash
Clinical narrative: itching; more bumps as the days go on; headaches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itching), RASH (more bumps as the days go on) and HEADACHE (headaches) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No historical conditions were reported.  Concomitant products included VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced HEADACHE (headaches). On 16-Feb-2021, the patient experienced PRURITUS (itching) and RASH (more bumps as the days go on). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency; HYDROXYZINE for Itching, at an unspecified dose and frequency and TRIAMCINOLONE (topical) for Rash, at an unspecified dose and frequency. At the time of the report, PRURITUS (itching), RASH (more bumps as the days go on) and HEADACHE (headaches) 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.   Concomitant drugs include blood pressure medication and cholesterol medication.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash macular, Vaccination site erythema
Clinical narrative: Very itchy; Pinkish red spot; Red patch at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Very itchy), RASH MACULAR (Pinkish red spot) and VACCINATION SITE ERYTHEMA (Red patch at the injection site) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (allergic to sulfa), Drug allergy (allergic to Bactrim) and Allergy to venom.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced PRURITUS (Very itchy), RASH MACULAR (Pinkish red spot) and VACCINATION SITE ERYTHEMA (Red patch at the injection site). At the time of the report, PRURITUS (Very itchy), RASH MACULAR (Pinkish red spot) and VACCINATION SITE ERYTHEMA (Red patch at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Nausea, Pain in extremity, Vertigo
Clinical narrative: Room spinning; Dizzy; Nauseous; Tired; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Room spinning), PAIN IN EXTREMITY (Arm soreness), DIZZINESS (Dizzy), NAUSEA (Nauseous) and FATIGUE (Tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE, ATORVASTATIN CALCIUM (LIPITOR), LISINOPRIL, AMITRIPTYLINE HYDROCHLORIDE (ELAVIL [AMITRIPTYLINE HYDROCHLORIDE]) and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and FATIGUE (Tired). On 04-Mar-2021, the patient experienced VERTIGO (Room spinning), DIZZINESS (Dizzy) and NAUSEA (Nauseous). The patient was treated with CLONAZEPAM (KLONOPIN) at an unspecified dose and frequency. On 28-Feb-2021, PAIN IN EXTREMITY (Arm soreness) and FATIGUE (Tired) had resolved. At the time of the report, VERTIGO (Room spinning), DIZZINESS (Dizzy) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) 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 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm). At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported Treatment medications was not provided
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination site pain
Clinical narrative: Redness; Itching; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), PRURITUS (Itching) and VACCINATION SITE PAIN (Soreness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Adhesive tape allergy and Arthritis in 2017. Concomitant products included TELMISARTAN for Blood pressure high, AMITRIPTYLINE for Sleep disorder.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021 at 2:05 AM, the patient experienced ERYTHEMA (Redness) and PRURITUS (Itching). 02-Apr-2021 at 2:05 AM, the patient experienced VACCINATION SITE PAIN (Soreness). At the time of the report, ERYTHEMA (Redness), PRURITUS (Itching) and VACCINATION SITE PAIN (Soreness) had resolved.            The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable   This case was linked to MOD-2021-031827 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: ADR form - FU added
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Feeling abnormal, Myalgia, Pain
Clinical narrative: NOT FEELING TOO GOOD; ACHING ALL OVER; VERY UNCOMFORTABLE; MUSCLE ACHES; FEVER OF 99.6; CHILLS; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (NOT FEELING TOO GOOD), PAIN (ACHING ALL OVER), DISCOMFORT (VERY UNCOMFORTABLE), MYALGIA (MUSCLE ACHES) and PYREXIA (FEVER OF 99.6) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (NOT FEELING TOO GOOD), PAIN (ACHING ALL OVER), DISCOMFORT (VERY UNCOMFORTABLE), MYALGIA (MUSCLE ACHES), PYREXIA (FEVER OF 99.6) and CHILLS (CHILLS). At the time of the report, FEELING ABNORMAL (NOT FEELING TOO GOOD), PAIN (ACHING ALL OVER), DISCOMFORT (VERY UNCOMFORTABLE), MYALGIA (MUSCLE ACHES), PYREXIA (FEVER OF 99.6) and CHILLS (CHILLS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported. Treatment medication was not provided.   This case was linked to MOD21-044754 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: NOT FEELING TOO GOOD; ACHING ALL OVER; VERY UNCOMFORTABLE; MUSCLE ACHES; FEVER OF 99.6; CHILLS; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (NOT FEELING TOO GOOD), PAIN (ACHING ALL OVER), DISCOMFORT (VERY UNCOMFORTABLE), MYALGIA (MUSCLE ACHES) and PYREXIA (FEVER OF 99.6) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (NOT FEELING TOO GOOD), PAIN (ACHING ALL OVER), DISCOMFORT (VERY UNCOMFORTABLE), MYALGIA (MUSCLE ACHES), PYREXIA (FEVER OF 99.6) and CHILLS (CHILLS). At the time of the report, FEELING ABNORMAL (NOT FEELING TOO GOOD), PAIN (ACHING ALL OVER), DISCOMFORT (VERY UNCOMFORTABLE), MYALGIA (MUSCLE ACHES), PYREXIA (FEVER OF 99.6) and CHILLS (CHILLS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported. Treatment medication was not provided.   This case was linked to MOD21-044754 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Nausea, Pain
Clinical narrative: body aches; shoulder is really sore; some dizziness; felt nauseated; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), ARTHRALGIA (shoulder is really sore), DIZZINESS (some dizziness) and NAUSEA (felt nauseated) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for an unknown indication.     The patient's past medical history included No adverse event.   On 03-Mar-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 an unknown date, the patient experienced PAIN (body aches), ARTHRALGIA (shoulder is really sore), DIZZINESS (some dizziness) and NAUSEA (felt nauseated). At the time of the report, PAIN (body aches), ARTHRALGIA (shoulder is really sore), DIZZINESS (some dizziness) and NAUSEA (felt nauseated) outcome was unknown.            Reporter did not allow further contact
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Pyrexia
Clinical narrative: Cough bringing clear phlegm; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough bringing clear phlegm), PYREXIA (Fever) and CHILLS (Chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced COUGH (Cough bringing clear phlegm), PYREXIA (Fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency. At the time of the report, COUGH (Cough bringing clear phlegm), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not provided by the reporter.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Nausea, Pain in jaw, Swelling, Swelling face
Clinical narrative: lymphedema on her left arm and left breast tissue, her cancer site is all swollen; upset stomach; jaw is hurting significantly and is swollen, she looks like a chipmunk; jaw is hurting significantly and is swollen, she looks like a chipmunk; significant nausea; vomiting; redness at the injection site; pain at the injection site; A spontaneous report (United States) was received from a consumer, concerning a unknown gender patient of 49 years old, who received Moderna's COVID-19 vaccine and experienced vaccination site pain, vaccination site erythema, nausea, abdominal discomfort, vomiting, swelling face, peripheral swelling, swelling NOS and jaw was hurting significantly and is swollen, she looks like a chipmunk.  The patient's medical history provided by the reporter cholesterol. Concomitant product use was Tamoxifen and cholesterol pill.  On 26-FEB-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number 013M20A) via unknown route for COVID-19 infection prophylaxis.   On an unknown date, the patient experienced vaccination site pain, vaccination site erythema, nausea, abdominal discomfort, vomiting, swelling face, peripheral swelling, swelling and jaw was hurting significantly and was swollen, she looks like a chipmunk.  She has lymphedema on her left arm and left breast tissue, she was injected on the right arm because of that, her cancer site was all swollen.  Treatment medication reported was unknown.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events were unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vomiting
Clinical narrative: lymphedema on her left arm and left breast tissue, her cancer site is all swollen; upset stomach; jaw is hurting significantly and is swollen, she looks like a chipmunk; jaw is hurting significantly and is swollen, she looks like a chipmunk; significant nausea; vomiting; redness at the injection site; pain at the injection site; A spontaneous report (United States) was received from a consumer, concerning a unknown gender patient of 49 years old, who received Moderna's COVID-19 vaccine and experienced vaccination site pain, vaccination site erythema, nausea, abdominal discomfort, vomiting, swelling face, peripheral swelling, swelling NOS and jaw was hurting significantly and is swollen, she looks like a chipmunk.  The patient's medical history provided by the reporter cholesterol. Concomitant product use was Tamoxifen and cholesterol pill.  On 26-FEB-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number 013M20A) via unknown route for COVID-19 infection prophylaxis.   On an unknown date, the patient experienced vaccination site pain, vaccination site erythema, nausea, abdominal discomfort, vomiting, swelling face, peripheral swelling, swelling and jaw was hurting significantly and was swollen, she looks like a chipmunk.  She has lymphedema on her left arm and left breast tissue, she was injected on the right arm because of that, her cancer site was all swollen.  Treatment medication reported was unknown.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events were unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) 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 medication not provided.  Treatment information not provided.   This case was linked to MOD-2021-034941, MOD-2021-038454 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood count, Blood glucose, Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma since January 1989 and Alcohol use (once a week). Concomitant products included OMEPRAZOLE for Heartburn.    On 02-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 08-Aug-2020 and the estimated date of delivery was 15-May-2021. On 02-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-ninth week of the pregnancy.  On 02-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Sep-2020, Pregnancy test: positive (Positive) positive. On 30-Dec-2020, Ultrasound scan: (normal) Patient's ultrasound scanning results were normal.. On 24-Feb-2021, Blood count: (normal) Patient's blood panel results were normal.. On 24-Feb-2021, Blood glucose: (normal) Patient's glucose test results were normal.. On 24-Feb-2021, Ultrasound scan: (normal) Patient's ultrasound scanning results were normal..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported. Patient used to intake alcohol once a week prior to her pregnancy. Patient's was tested positive for pregnancy on 02-Sep-2020 and estimated date of conception was 18-Aug-2020. Patient's prenatal care was established. No complications or acute illnesses and no history of subfertility.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site warmth, Lymphadenopathy, Neuralgia
Clinical narrative: shooting nerve pain for three days; random itching and aching; random itching and aching; hot to the touch; headache; swollen lymph nodes; fatigue; red, swollen lump; red, swollen lump; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (red, swollen lump), NEURALGIA (shooting nerve pain for three days), PRURITUS (random itching and aching), PAIN (random itching and aching) and INJECTION SITE WARMTH (hot to the touch) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE MASS (red, swollen lump) and VACCINATION SITE ERYTHEMA (red, swollen lump). On an unknown date, the patient experienced NEURALGIA (shooting nerve pain for three days), PRURITUS (random itching and aching), PAIN (random itching and aching), INJECTION SITE WARMTH (hot to the touch), HEADACHE (headache), LYMPHADENOPATHY (swollen lymph nodes) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE MASS (red, swollen lump), NEURALGIA (shooting nerve pain for three days), PRURITUS (random itching and aching), PAIN (random itching and aching), INJECTION SITE WARMTH (hot to the touch), VACCINATION SITE ERYTHEMA (red, swollen lump), HEADACHE (headache), LYMPHADENOPATHY (swollen lymph nodes) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment medication provided. No concomitant medications provided.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Vaccination site erythema, Vaccination site mass
Clinical narrative: shooting nerve pain for three days; random itching and aching; random itching and aching; hot to the touch; headache; swollen lymph nodes; fatigue; red, swollen lump; red, swollen lump; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (red, swollen lump), NEURALGIA (shooting nerve pain for three days), PRURITUS (random itching and aching), PAIN (random itching and aching) and INJECTION SITE WARMTH (hot to the touch) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE MASS (red, swollen lump) and VACCINATION SITE ERYTHEMA (red, swollen lump). On an unknown date, the patient experienced NEURALGIA (shooting nerve pain for three days), PRURITUS (random itching and aching), PAIN (random itching and aching), INJECTION SITE WARMTH (hot to the touch), HEADACHE (headache), LYMPHADENOPATHY (swollen lymph nodes) and FATIGUE (fatigue). At the time of the report, VACCINATION SITE MASS (red, swollen lump), NEURALGIA (shooting nerve pain for three days), PRURITUS (random itching and aching), PAIN (random itching and aching), INJECTION SITE WARMTH (hot to the touch), VACCINATION SITE ERYTHEMA (red, swollen lump), HEADACHE (headache), LYMPHADENOPATHY (swollen lymph nodes) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment medication provided. No concomitant medications provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) and FATIGUE (extreme fatigue) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concomitant products included FLECAINIDE ACETATE, OMEPRAZOLE, ACETYLSALICYLIC ACID (BABY ASPIRIN) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue) and FATIGUE (extreme fatigue). At the time of the report, FATIGUE (fatigue) and FATIGUE (extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: Rash on injection arm; Redness on injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash on injection arm) and VACCINATION SITE ERYTHEMA (Redness on injection arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash on injection arm) and VACCINATION SITE ERYTHEMA (Redness on injection arm). At the time of the report, VACCINATION SITE RASH (Rash on injection arm) and VACCINATION SITE ERYTHEMA (Redness on injection arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided. Concomitant medications not provided.