chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Fatigue, Feeling abnormal, Headache, Pain
Clinical narrative: Feeling bad; An intense intense heartburn in my ribcage in the front and breast area , and in between the breast and out , lasted probably for 3 hours/lay out in the couch and intensified the symptom/¨But is still there , not as intense,  it has subsided¨; Feeling achy; Headache; Tired; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Feeling bad), DYSPEPSIA (An intense intense heartburn in my ribcage in the front and breast area , and in between the breast and out , lasted probably for 3 hours/lay out in the couch and intensified the symptom/¨But is still there , not as intense,  it has subsided¨), PAIN (Feeling achy), HEADACHE (Headache) and FATIGUE (Tired) in a 62-year-old female patient who received mRNA-1273 (batch nos. 032B21A, 032B21A and 032B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Apr-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 09-May-2021, received second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced FEELING ABNORMAL (Feeling bad), DYSPEPSIA (An intense intense heartburn in my ribcage in the front and breast area , and in between the breast and out , lasted probably for 3 hours/lay out in the couch and intensified the symptom/¨But is still there , not as intense,  it has subsided¨), PAIN (Feeling achy), HEADACHE (Headache) and FATIGUE (Tired). At the time of the report, FEELING ABNORMAL (Feeling bad), PAIN (Feeling achy), HEADACHE (Headache) and FATIGUE (Tired) outcome was unknown and DYSPEPSIA (An intense intense heartburn in my ribcage in the front and breast area , and in between the breast and out , lasted probably for 3 hours/lay out in the couch and intensified the symptom/¨But is still there , not as intense,  it has subsided¨) had resolved.        For mRNA-1273 (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable Concomitant products include medicines for constipation. No treatment medication was mentioned.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; 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 PAIN IN EXTREMITY (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 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 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.       No concomitant medication details was reported No treatment medication details was reported
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Nausea, Nervousness, Vaccination site pruritus
Clinical narrative: area of the injection site "itched and itched and itched"; extremely tired; felt just a little queezy; "was nervous"; slept like a day and a half; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS ("was nervous"), HYPERSOMNIA (slept like a day and a half), VACCINATION SITE PRURITUS (area of the injection site "itched and itched and itched"), FATIGUE (extremely tired) and NAUSEA (felt just a little queezy) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced NERVOUSNESS ("was nervous"), HYPERSOMNIA (slept like a day and a half), FATIGUE (extremely tired) and NAUSEA (felt just a little queezy). On 09-May-2021, the patient experienced VACCINATION SITE PRURITUS (area of the injection site "itched and itched and itched"). The patient was treated with HYDROCORTISONE (CORTIZONE 10) (topical) from 09-May-2021 to 11-May-2021 for Injection site itching, at a dose of UNK dosage form. On 11-May-2021, VACCINATION SITE PRURITUS (area of the injection site "itched and itched and itched") had resolved. At the time of the report, NERVOUSNESS ("was nervous"), HYPERSOMNIA (slept like a day and a half), FATIGUE (extremely tired) and NAUSEA (felt just a little queezy) 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 medication included Tylenol and reported As needed for arthritis. Treatment included  Aloe. Patient reported the events lasted for 3 to 5 days then completely resolved and she did not seek medical treatment.   This case was linked to MOD-2021-118017 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow-Up received on 09-JUL-2021 included events information.
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: 5 patients administered double the dose (1mL); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (5 patients administered double the dose (1mL)) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced ACCIDENTAL OVERDOSE (5 patients administered double the dose (1mL)). At the time of the report, ACCIDENTAL OVERDOSE (5 patients administered double the dose (1mL)) 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 product use was not provided. Treatment information was not provided.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: Her injection site is red; Has rash on injected left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Her injection site is red) and VACCINATION SITE RASH (Has rash on injected left arm) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-May-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 an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Her injection site is red) and VACCINATION SITE RASH (Has rash on injected left arm). At the time of the report, VACCINATION SITE ERYTHEMA (Her injection site is red) and VACCINATION SITE RASH (Has rash on injected left arm) had not resolved.            The patient post receiving their vaccine reported that their injection site was red and had rash on injected arm.  No Concomitant product use was reported.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose was scheduled on 2nd April 2021,But taken on 16thApril2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was scheduled on 2nd April 2021,But taken on 16thApril2021) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-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 16-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was scheduled on 2nd April 2021,But taken on 16thApril2021). On 16-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose was scheduled on 2nd April 2021,But taken on 16thApril2021) had resolved. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication was provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival blister, Lip blister, Vaccination site pain
Clinical narrative: Blister on her Gum; Giant Blister on the Bottom Lip for 1 to 1.5 weeks; injection site hurt for 3 to 4 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GINGIVAL BLISTER (Blister on her Gum), LIP BLISTER (Giant Blister on the Bottom Lip for 1 to 1.5 weeks) and VACCINATION SITE PAIN (injection site hurt for 3 to 4 days) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 037B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced GINGIVAL BLISTER (Blister on her Gum), LIP BLISTER (Giant Blister on the Bottom Lip for 1 to 1.5 weeks) and VACCINATION SITE PAIN (injection site hurt for 3 to 4 days). On 23-Mar-2021, VACCINATION SITE PAIN (injection site hurt for 3 to 4 days) had resolved. On 29-Mar-2021, GINGIVAL BLISTER (Blister on her Gum) and LIP BLISTER (Giant Blister on the Bottom Lip for 1 to 1.5 weeks) had resolved.            Concomitant medication use was not reported.  Treatment information pertaining to these specific events was not reported.   It was noted by the patient that her dentist told her he has "not seen anything like it ever." It is unclear if the patient was actually seen and evaluated by her dentist.  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: 20.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tonsillar hypertrophy
Clinical narrative: inflammation of the tonsils; This spontaneous case was reported by a consumer and describes the occurrence of TONSILLAR HYPERTROPHY (inflammation of the tonsils) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     Concurrent medical conditions included COVID-19.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, the patient experienced TONSILLAR HYPERTROPHY (inflammation of the tonsils). The patient was treated with LORATADINE at a dose of 1 dosage form. At the time of the report, TONSILLAR HYPERTROPHY (inflammation of the tonsils) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information, if any, was not provided by the reporter.
Age: 52.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site pain
Clinical narrative: injection arm  pain; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE PAIN (injection arm  pain) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.    Co-suspect product included non-company product ALBUTEROL [SALBUTAMOL] inhaler for an unknown indication.    No medical history was provided by the reporter.  Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) and METFORMIN for an unknown indication.   On 10-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 ALBUTEROL [SALBUTAMOL] (unknown route) at an unspecified dose. On 10-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (injection arm  pain). The patient was treated with MONTELUKAST SODIUM (SINGULAIR) at an unspecified dose and frequency. On 12-Apr-2021, VACCINATION SITE PAIN (injection arm  pain) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication include oral birth control.   This case was linked to MOD-2021-118363 (Patient Link).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Injection site warmth, Pain in extremity, Pyrexia
Clinical narrative: she feels off; arm was hot; arm was sore; fatigue/felt tired/extreme fatigue; Feverish; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she feels off), INJECTION SITE WARMTH (arm was hot), PAIN IN EXTREMITY (arm was sore), FATIGUE (fatigue/felt tired/extreme fatigue) and PYREXIA (Feverish) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002CZ1A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IUD                                                            Birth control for an unknown indication.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced FATIGUE (fatigue/felt tired/extreme fatigue) and PYREXIA (Feverish). On 27-Apr-2021, the patient experienced INJECTION SITE WARMTH (arm was hot) and PAIN IN EXTREMITY (arm was sore). On 11-May-2021, the patient experienced FEELING ABNORMAL (she feels off). At the time of the report, FEELING ABNORMAL (she feels off), INJECTION SITE WARMTH (arm was hot), PAIN IN EXTREMITY (arm was sore), FATIGUE (fatigue/felt tired/extreme fatigue) and PYREXIA (Feverish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain, Vaccination site erythema
Clinical narrative: arm was bright red; tired; wave of nausea; arm felt really sore, hot, and hard at the shot spot; bad headache; body ache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (wave of nausea), VACCINATION SITE PAIN (arm felt really sore, hot, and hard at the shot spot), HEADACHE (bad headache), PAIN (body ache) and VACCINATION SITE ERYTHEMA (arm was bright red) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced NAUSEA (wave of nausea), VACCINATION SITE PAIN (arm felt really sore, hot, and hard at the shot spot), HEADACHE (bad headache), PAIN (body ache) and FATIGUE (tired). On 07-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm was bright red). The patient was treated with ACETAMINOPHEN on 07-May-2021 for Headache, at a dose of 1 dosage form once. On 07-May-2021, NAUSEA (wave of nausea) had resolved. At the time of the report, VACCINATION SITE PAIN (arm felt really sore, hot, and hard at the shot spot), HEADACHE (bad headache), PAIN (body ache), VACCINATION SITE ERYTHEMA (arm was bright red) and FATIGUE (tired) outcome was unknown.            No concomitant medications were reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm was bright red; tired; wave of nausea; arm felt really sore, hot, and hard at the shot spot; bad headache; body ache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (wave of nausea), VACCINATION SITE PAIN (arm felt really sore, hot, and hard at the shot spot), HEADACHE (bad headache), PAIN (body ache) and VACCINATION SITE ERYTHEMA (arm was bright red) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced NAUSEA (wave of nausea), VACCINATION SITE PAIN (arm felt really sore, hot, and hard at the shot spot), HEADACHE (bad headache), PAIN (body ache) and FATIGUE (tired). On 07-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm was bright red). The patient was treated with ACETAMINOPHEN on 07-May-2021 for Headache, at a dose of 1 dosage form once. On 07-May-2021, NAUSEA (wave of nausea) had resolved. At the time of the report, VACCINATION SITE PAIN (arm felt really sore, hot, and hard at the shot spot), HEADACHE (bad headache), PAIN (body ache), VACCINATION SITE ERYTHEMA (arm was bright red) and FATIGUE (tired) outcome was unknown.            No concomitant medications were reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Body temperature, Chest pain, Cough, Pyrexia
Clinical narrative: Rash on abdomen; low grade fever of 99; Asthma started getting bad; chest pain; Coughing; This spontaneous case was reported by a health care professional and describes the occurrence of ASTHMA (Asthma started getting bad), CHEST PAIN (chest pain), COUGH (Coughing), RASH (Rash on abdomen) and PYREXIA (low grade fever of 99) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 046B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) and METFORMIN for an unknown indication.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced ASTHMA (Asthma started getting bad), CHEST PAIN (chest pain) and COUGH (Coughing). On 11-May-2021, the patient experienced RASH (Rash on abdomen) and PYREXIA (low grade fever of 99). At the time of the report, ASTHMA (Asthma started getting bad) outcome was unknown and CHEST PAIN (chest pain), COUGH (Coughing), RASH (Rash on abdomen) and PYREXIA (low grade fever of 99) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, Body temperature: 99 (High) Low grade fever of 99.     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 of event asthma aggravated included, albuterol inhaler, singulair. Action taken with mRNA-1273 in response to the events was not applicable. Products known to have been used by the patient, within two weeks prior to the event, included oral birth control medicine.   This case was linked to MOD-2021-118335 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on abdomen; low grade fever of 99; Asthma started getting bad; chest pain; Coughing; This spontaneous case was reported by a health care professional and describes the occurrence of ASTHMA (Asthma started getting bad), CHEST PAIN (chest pain), COUGH (Coughing), RASH (Rash on abdomen) and PYREXIA (low grade fever of 99) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 046B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) and METFORMIN for an unknown indication.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced ASTHMA (Asthma started getting bad), CHEST PAIN (chest pain) and COUGH (Coughing). On 11-May-2021, the patient experienced RASH (Rash on abdomen) and PYREXIA (low grade fever of 99). At the time of the report, ASTHMA (Asthma started getting bad) outcome was unknown and CHEST PAIN (chest pain), COUGH (Coughing), RASH (Rash on abdomen) and PYREXIA (low grade fever of 99) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, Body temperature: 99 (High) Low grade fever of 99.     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 of event asthma aggravated included, albuterol inhaler, singulair. Action taken with mRNA-1273 in response to the events was not applicable. Products known to have been used by the patient, within two weeks prior to the event, included oral birth control medicine.   This case was linked to MOD-2021-118335 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Muscle tightness, Pyrexia
Clinical narrative: Tightness in Calves and Hamstring; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (Tightness in Calves and Hamstring) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-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 30-Apr-2021, the patient experienced MUSCLE TIGHTNESS (Tightness in Calves and Hamstring) and PYREXIA (Fever). On 01-May-2021, PYREXIA (Fever) had resolved. At the time of the report, MUSCLE TIGHTNESS (Tightness in Calves and Hamstring) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable.  No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). At the time of the report, PAIN IN EXTREMITY (Arm was sore) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient received their first dose and reported that their arm was sore.  No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-118436 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Myalgia
Clinical narrative: Felt like a very strong flu without high temperature,; Whole body was sore and in pain; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Felt like a very strong flu without high temperature,) and MYALGIA (Whole body was sore and in pain) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced INFLUENZA (Felt like a very strong flu without high temperature,) and MYALGIA (Whole body was sore and in pain). On 24-Apr-2021, INFLUENZA (Felt like a very strong flu without high temperature,) and MYALGIA (Whole body was sore and in pain) had resolved.            Patient transferred from Customer Care (case#00163238) got both doses of the Moderna vaccine and wants to know if it safe to take prednisone for poison ivy after receiving the vaccine. First dose was on 20Mar2021 and second dose was on 23Apr2021 (lot#045B21A), both on the left arm. Patient mentions after getting the first dose the had a sore arm, with a little pain for 12 hours. after getting the second dose the felt like a very strong flu without high temperature, and their whole body was sore and in pain, for about 12 hours. Patient provides consent for Safety to follow up.   This case was linked to MOD-2021-118176 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Lymph node pain, Myalgia, Pain in extremity, Vaccination site lymphadenopathy
Clinical narrative: Arm ache; Pain in the lymph nodes on the same arm of injection; Swelling in the lymph nodes on the same arm of injection; Shoulder pain; Muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm ache), LYMPH NODE PAIN (Pain in the lymph nodes on the same arm of injection), VACCINATION SITE LYMPHADENOPATHY (Swelling in the lymph nodes on the same arm of injection), ARTHRALGIA (Shoulder pain) and MYALGIA (Muscle ache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm ache), LYMPH NODE PAIN (Pain in the lymph nodes on the same arm of injection), VACCINATION SITE LYMPHADENOPATHY (Swelling in the lymph nodes on the same arm of injection), ARTHRALGIA (Shoulder pain) and MYALGIA (Muscle ache). At the time of the report, PAIN IN EXTREMITY (Arm ache), LYMPH NODE PAIN (Pain in the lymph nodes on the same arm of injection), VACCINATION SITE LYMPHADENOPATHY (Swelling in the lymph nodes on the same arm of injection), ARTHRALGIA (Shoulder pain) and MYALGIA (Muscle ache) outcome was unknown. Not Provided          Medication for high Cholesterol was reported in Concomitant medication. No Treatment information was provided.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: arm hurt; little bit tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt) and FATIGUE (little bit tired) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 045B21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMINS NOS for an unknown indication.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm hurt) and FATIGUE (little bit tired). At the time of the report, PAIN IN EXTREMITY (arm hurt) and FATIGUE (little bit tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported. .   This case was linked to MOD-2021-118214 (Patient Link).
Age: 16.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Administration Error (Invalid Dose); This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Administration Error (Invalid Dose)) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Administration Error (Invalid Dose)). At the time of the report, INCORRECT DOSE ADMINISTERED (Administration Error (Invalid Dose)) 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.   No concomitant medication was reported.  Treatment information not provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gingival blister, Headache, Nausea, Oral herpes
Clinical narrative: Blister on the Gum; Cold Sore on upper and bottom lips started again; Body aches/achy and Sore all over the body; injection site was swollen again; Tired; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL BLISTER (Blister on the Gum), ORAL HERPES (Cold Sore on upper and bottom lips started again), PAIN (Body aches/achy and Sore all over the body), VACCINATION SITE SWELLING (injection site was swollen again) and FATIGUE (Tired) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced VACCINATION SITE SWELLING (injection site was swollen again), FATIGUE (Tired), NAUSEA (Nausea) and HEADACHE (Headache). On 03-May-2021, the patient experienced GINGIVAL BLISTER (Blister on the Gum), ORAL HERPES (Cold Sore on upper and bottom lips started again), PAIN (Body aches/achy and Sore all over the body) and FATIGUE (Tired/Fatigue). On 23-Apr-2021, FATIGUE (Tired) had resolved. At the time of the report, GINGIVAL BLISTER (Blister on the Gum), ORAL HERPES (Cold Sore on upper and bottom lips started again), PAIN (Body aches/achy and Sore all over the body), VACCINATION SITE SWELLING (injection site was swollen again), FATIGUE (Tired/Fatigue), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.            No concomitant drugs were reported.   Treatment included antibiotic Keflex in case if she was dealing with any type of infection and Tylenol for pain by the MD.   This case was linked to MOD-2021-118327 (Patient Link).; 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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site swelling
Clinical narrative: Blister on the Gum; Cold Sore on upper and bottom lips started again; Body aches/achy and Sore all over the body; injection site was swollen again; Tired; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL BLISTER (Blister on the Gum), ORAL HERPES (Cold Sore on upper and bottom lips started again), PAIN (Body aches/achy and Sore all over the body), VACCINATION SITE SWELLING (injection site was swollen again) and FATIGUE (Tired) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced VACCINATION SITE SWELLING (injection site was swollen again), FATIGUE (Tired), NAUSEA (Nausea) and HEADACHE (Headache). On 03-May-2021, the patient experienced GINGIVAL BLISTER (Blister on the Gum), ORAL HERPES (Cold Sore on upper and bottom lips started again), PAIN (Body aches/achy and Sore all over the body) and FATIGUE (Tired/Fatigue). On 23-Apr-2021, FATIGUE (Tired) had resolved. At the time of the report, GINGIVAL BLISTER (Blister on the Gum), ORAL HERPES (Cold Sore on upper and bottom lips started again), PAIN (Body aches/achy and Sore all over the body), VACCINATION SITE SWELLING (injection site was swollen again), FATIGUE (Tired/Fatigue), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.            No concomitant drugs were reported.   Treatment included antibiotic Keflex in case if she was dealing with any type of infection and Tylenol for pain by the MD.   This case was linked to MOD-2021-118327 (Patient Link).; 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: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Influenza, Vaccination site pain
Clinical narrative: Bad flu after receiving the vaccine; Mild soreness in the arm at the injection site; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Bad flu after receiving the vaccine), VACCINATION SITE PAIN (Mild soreness in the arm at the injection site), CHILLS (chills) and FATIGUE (fatigue) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced VACCINATION SITE PAIN (Mild soreness in the arm at the injection site), CHILLS (chills) and FATIGUE (fatigue). On an unknown date, the patient experienced INFLUENZA (Bad flu after receiving the vaccine). In May 2021, CHILLS (chills) and FATIGUE (fatigue) had resolved. At the time of the report, INFLUENZA (Bad flu after receiving the vaccine) and VACCINATION SITE PAIN (Mild soreness in the arm at the injection site) outcome was unknown.            No concomitants were reported. No treatment was reported.   This case was linked to MOD21-089318, MOD21-073020, MOD21-073037, MOD21-073047 (E2B Linked Report). This case was linked to MOD-2021-073552 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: AE updated.; Sender's Comments:  MOD21-089318: MOD21-073020: MOD21-073037: MOD21-073047:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: injection site itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site itchy) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced VACCINATION SITE PRURITUS (injection site itchy). At the time of the report, VACCINATION SITE PRURITUS (injection site itchy) outcome was unknown. Not Provided          Concomitant product information, if any, was not provided by the reporter. Treatment information, if any, was not provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-118383 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: diagnose with UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (diagnose with UTI) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included vitamins occasionally and tylenol if in pain for an unknown indication.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, the patient experienced URINARY TRACT INFECTION (diagnose with UTI). At the time of the report, URINARY TRACT INFECTION (diagnose with UTI) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Tachycardia
Clinical narrative: legs started to itch; right hand started itching and the it went up her arm; left arm started to itch real bad; rapid heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (rapid heartbeat), PRURITUS (legs started to itch) and PRURITUS (right hand started itching and the it went up her arm; left arm started to itch real bad) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 10-May-2021, the patient experienced TACHYCARDIA (rapid heartbeat). On 10-May-2021 at 6:00 PM, the patient experienced PRURITUS (right hand started itching and the it went up her arm; left arm started to itch real bad). On 11-May-2021 at 5:00 AM, the patient experienced PRURITUS (legs started to itch). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itch, at an unspecified dose and frequency and CORTISONE (topical) for Itch, at an unspecified dose and frequency. On 10-May-2021, TACHYCARDIA (rapid heartbeat) had resolved. On 11-May-2021 at 6:00 AM, PRURITUS (legs started to itch) and PRURITUS (right hand started itching and the it went up her arm; left arm started to itch real bad) had resolved.            Concomitant medications were not reported. Patient reported that she did not experience any adverse event after the second dose.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up does not contain any new information. On 09-Jul-2021: Updated second dose information.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased, Rash
Clinical narrative: developed a rash on her leg; difficulty breathing; fast heartbeat; This spontaneous case was reported by a pharmacist and describes the occurrence of RASH (developed a rash on her leg), DYSPNOEA (difficulty breathing) and HEART RATE INCREASED (fast heartbeat) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 RASH (developed a rash on her leg), DYSPNOEA (difficulty breathing) and HEART RATE INCREASED (fast heartbeat). At the time of the report, RASH (developed a rash on her leg), DYSPNOEA (difficulty breathing) and HEART RATE INCREASED (fast heartbeat) 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.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Dyspnoea, Erythema, Heart rate irregular, Induration
Clinical narrative: Rhythm was off; Hard to swallow; Shortness of breath; Fever; She also had a laceration linear scab, hardlike erythema at the injection site; She also had a laceration linear scab, hardlike erythema at the injection site; She also had a laceration linear scab, hardlike erythema at the injection site; Ulcer in the back of her throat; Sore arm; Can't lift her arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MOBILITY DECREASED (Can't lift her arm), HEART RATE IRREGULAR (Rhythm was off), INDURATION (She also had a laceration linear scab, hardlike erythema at the injection site) and SCAB (She also had a laceration linear scab, hardlike erythema at the injection site) in a 44-year-old female patient 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 was reported by the reporter.  Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) and SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]) for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and MOBILITY DECREASED (Can't lift her arm). On 09-Apr-2021, the patient experienced INDURATION (She also had a laceration linear scab, hardlike erythema at the injection site), SCAB (She also had a laceration linear scab, hardlike erythema at the injection site), ERYTHEMA (She also had a laceration linear scab, hardlike erythema at the injection site), PHARYNGEAL ULCERATION (Ulcer in the back of her throat) and PYREXIA (Fever). On 10-Apr-2021, the patient experienced HEART RATE IRREGULAR (Rhythm was off), DYSPHAGIA (Hard to swallow) and DYSPNOEA (Shortness of breath). At the time of the report, PAIN IN EXTREMITY (Sore arm), MOBILITY DECREASED (Can't lift her arm), HEART RATE IRREGULAR (Rhythm was off), INDURATION (She also had a laceration linear scab, hardlike erythema at the injection site), SCAB (She also had a laceration linear scab, hardlike erythema at the injection site), ERYTHEMA (She also had a laceration linear scab, hardlike erythema at the injection site), PHARYNGEAL ULCERATION (Ulcer in the back of her throat), DYSPHAGIA (Hard to swallow), DYSPNOEA (Shortness of breath) and PYREXIA (Fever) outcome was unknown. 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.   Treatment included Tylenol.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity, Pharyngeal ulceration, Pyrexia, Scab
Clinical narrative: Rhythm was off; Hard to swallow; Shortness of breath; Fever; She also had a laceration linear scab, hardlike erythema at the injection site; She also had a laceration linear scab, hardlike erythema at the injection site; She also had a laceration linear scab, hardlike erythema at the injection site; Ulcer in the back of her throat; Sore arm; Can't lift her arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MOBILITY DECREASED (Can't lift her arm), HEART RATE IRREGULAR (Rhythm was off), INDURATION (She also had a laceration linear scab, hardlike erythema at the injection site) and SCAB (She also had a laceration linear scab, hardlike erythema at the injection site) in a 44-year-old female patient 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 was reported by the reporter.  Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) and SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]) for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and MOBILITY DECREASED (Can't lift her arm). On 09-Apr-2021, the patient experienced INDURATION (She also had a laceration linear scab, hardlike erythema at the injection site), SCAB (She also had a laceration linear scab, hardlike erythema at the injection site), ERYTHEMA (She also had a laceration linear scab, hardlike erythema at the injection site), PHARYNGEAL ULCERATION (Ulcer in the back of her throat) and PYREXIA (Fever). On 10-Apr-2021, the patient experienced HEART RATE IRREGULAR (Rhythm was off), DYSPHAGIA (Hard to swallow) and DYSPNOEA (Shortness of breath). At the time of the report, PAIN IN EXTREMITY (Sore arm), MOBILITY DECREASED (Can't lift her arm), HEART RATE IRREGULAR (Rhythm was off), INDURATION (She also had a laceration linear scab, hardlike erythema at the injection site), SCAB (She also had a laceration linear scab, hardlike erythema at the injection site), ERYTHEMA (She also had a laceration linear scab, hardlike erythema at the injection site), PHARYNGEAL ULCERATION (Ulcer in the back of her throat), DYSPHAGIA (Hard to swallow), DYSPNOEA (Shortness of breath) and PYREXIA (Fever) outcome was unknown. 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.   Treatment included Tylenol.