chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness in the her right arm at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in the her right arm at the site of the injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 VACCINATION SITE PAIN (soreness in the her right arm at the site of the injection). At the time of the report, VACCINATION SITE PAIN (soreness in the her right arm at the site of the injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Pruritus, Rash, Rash macular
Clinical narrative: One spot on the face turned scabby; Light Headedness; Chills; Itchy; 2 spots one on each side of the face; Rash on the neck; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), SCAB (One spot on the face turned scabby), DIZZINESS (Light Headedness), RASH MACULAR (2 spots one on each side of the face) and RASH (Rash on the neck) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LOSARTAN and SIMVASTATIN for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 02-Apr-2021, the patient experienced PRURITUS (Itchy), RASH MACULAR (2 spots one on each side of the face) and RASH (Rash on the neck). On 03-Apr-2021, the patient experienced CHILLS (Chills). On 06-Apr-2021, the patient experienced DIZZINESS (Light Headedness). On an unknown date, the patient experienced SCAB (One spot on the face turned scabby). The patient was treated with AVENA SATIVA (EUCERIN ECZEMA RELIEF) for Eczema, at an unspecified dose and frequency. On 06-Apr-2021, PRURITUS (Itchy), RASH (Rash on the neck) and CHILLS (Chills) had resolved. At the time of the report, SCAB (One spot on the face turned scabby) and RASH MACULAR (2 spots one on each side of the face) outcome was unknown and DIZZINESS (Light Headedness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Scab
Clinical narrative: One spot on the face turned scabby; Light Headedness; Chills; Itchy; 2 spots one on each side of the face; Rash on the neck; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), SCAB (One spot on the face turned scabby), DIZZINESS (Light Headedness), RASH MACULAR (2 spots one on each side of the face) and RASH (Rash on the neck) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included LOSARTAN and SIMVASTATIN for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 02-Apr-2021, the patient experienced PRURITUS (Itchy), RASH MACULAR (2 spots one on each side of the face) and RASH (Rash on the neck). On 03-Apr-2021, the patient experienced CHILLS (Chills). On 06-Apr-2021, the patient experienced DIZZINESS (Light Headedness). On an unknown date, the patient experienced SCAB (One spot on the face turned scabby). The patient was treated with AVENA SATIVA (EUCERIN ECZEMA RELIEF) for Eczema, at an unspecified dose and frequency. On 06-Apr-2021, PRURITUS (Itchy), RASH (Rash on the neck) and CHILLS (Chills) had resolved. At the time of the report, SCAB (One spot on the face turned scabby) and RASH MACULAR (2 spots one on each side of the face) outcome was unknown and DIZZINESS (Light Headedness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: cough; This spontaneous case was reported by a non-health professional and describes the occurrence of COUGH (cough) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (cough). At the time of the report, COUGH (cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no treatment details reported. no concomitant details reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-068381 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068381:wife case
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Headache, Induration, Injection site pruritus, Pain in extremity
Clinical narrative: arm is hard, red, warm and itching at injection site,; headache; arm is hard, red, warm and itching at injection site,; arm is hard, red, warm and itching at injection site,; arm is hard, red, warm and itching at injection site,; arm is in pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is in pain), ERYTHEMA (arm is hard, red, warm and itching at injection site,), HEADACHE (headache), VACCINATION SITE WARMTH (arm is hard, red, warm and itching at injection site,) and INJECTION SITE PRURITUS (arm is hard, red, warm and itching at injection site,) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm is in pain). On 30-Mar-2021, the patient experienced ERYTHEMA (arm is hard, red, warm and itching at injection site,), HEADACHE (headache), VACCINATION SITE WARMTH (arm is hard, red, warm and itching at injection site,), INJECTION SITE PRURITUS (arm is hard, red, warm and itching at injection site,) and INDURATION (arm is hard, red, warm and itching at injection site,). On 01-Apr-2021, PAIN IN EXTREMITY (arm is in pain) had resolved. At the time of the report, ERYTHEMA (arm is hard, red, warm and itching at injection site,), HEADACHE (headache), VACCINATION SITE WARMTH (arm is hard, red, warm and itching at injection site,), INJECTION SITE PRURITUS (arm is hard, red, warm and itching at injection site,) and INDURATION (arm is hard, red, warm and itching at injection site,) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment products information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: arm is hard, red, warm and itching at injection site,; headache; arm is hard, red, warm and itching at injection site,; arm is hard, red, warm and itching at injection site,; arm is hard, red, warm and itching at injection site,; arm is in pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is in pain), ERYTHEMA (arm is hard, red, warm and itching at injection site,), HEADACHE (headache), VACCINATION SITE WARMTH (arm is hard, red, warm and itching at injection site,) and INJECTION SITE PRURITUS (arm is hard, red, warm and itching at injection site,) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm is in pain). On 30-Mar-2021, the patient experienced ERYTHEMA (arm is hard, red, warm and itching at injection site,), HEADACHE (headache), VACCINATION SITE WARMTH (arm is hard, red, warm and itching at injection site,), INJECTION SITE PRURITUS (arm is hard, red, warm and itching at injection site,) and INDURATION (arm is hard, red, warm and itching at injection site,). On 01-Apr-2021, PAIN IN EXTREMITY (arm is in pain) had resolved. At the time of the report, ERYTHEMA (arm is hard, red, warm and itching at injection site,), HEADACHE (headache), VACCINATION SITE WARMTH (arm is hard, red, warm and itching at injection site,), INJECTION SITE PRURITUS (arm is hard, red, warm and itching at injection site,) and INDURATION (arm is hard, red, warm and itching at injection site,) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment products information was provided.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old got the first dose of the Moderna Covid 19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got the first dose of the Moderna Covid 19 vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got the first dose of the Moderna Covid 19 vaccine). On 05-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old got the first dose of the Moderna Covid 19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.  This report refers to a case of product administered to patient of inappropriate age (16 year old) for mRNA-1273 (lot number 019B21A) with no associated AEs reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow-up received does not contain any significant information. On 28-Apr-2021: Follow-up received does not contain any significant information.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old) for mRNA-1273 (lot number 019B21A) with no associated AEs reported.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 years of age, were inadvertently administered the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age, were inadvertently administered the Moderna COVID-19 vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age, were inadvertently administered the Moderna COVID-19 vaccine). On 03-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years of age, were inadvertently administered the Moderna COVID-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medications reported. no treatment details reported.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product administration interrupted, Product availability issue
Clinical narrative: Sore arm; Administration of second dose of vaccine past 36 days post first dose of vaccine; Administration of second dose of vaccine past 36 days post first dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PRODUCT AVAILABILITY ISSUE (Administration of second dose of vaccine past 36 days post first dose of vaccine) and PRODUCT ADMINISTRATION INTERRUPTED (Administration of second dose of vaccine past 36 days post first dose of vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history 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), PRODUCT AVAILABILITY ISSUE (Administration of second dose of vaccine past 36 days post first dose of vaccine) and PRODUCT ADMINISTRATION INTERRUPTED (Administration of second dose of vaccine past 36 days post first dose of vaccine). At the time of the report, PAIN IN EXTREMITY (Sore arm) and PRODUCT AVAILABILITY ISSUE (Administration of second dose of vaccine past 36 days post first dose of vaccine) outcome was unknown and PRODUCT ADMINISTRATION INTERRUPTED (Administration of second dose of vaccine past 36 days post first dose of vaccine) had resolved. Not Provided      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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: F/U received on 16-jun-2021 .No New Information reported.. Declined consent for follow up.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Myalgia, Pyrexia, Rash
Clinical narrative: low grade fever; body ache; chills; sweating; rash all over body; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever), MYALGIA (body ache), CHILLS (chills), HYPERHIDROSIS (sweating) and RASH (rash all over body) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (low grade fever), MYALGIA (body ache), CHILLS (chills), HYPERHIDROSIS (sweating) and RASH (rash all over body). At the time of the report, PYREXIA (low grade fever), MYALGIA (body ache), CHILLS (chills), HYPERHIDROSIS (sweating) and RASH (rash all over body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications reported. no treatment details reported.
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Pyrexia
Clinical narrative: Headaches described as migraine; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Headaches described as migraine) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 029K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever). On 14-Feb-2021, the patient experienced MIGRAINE (Headaches described as migraine). At the time of the report, MIGRAINE (Headaches described as migraine) had not resolved and PYREXIA (Fever) outcome was unknown.            No concomitant medication reported.  no treatment drugs included  Patient mentioned that his headaches have not gone away and it's been more than 3 months.   This case was linked to US-MODERNATX, INC.-MOD-2021-073520 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Clinical information and outcome of the event updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073520:
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Vision blurred
Clinical narrative: Serious dizziness; Blurry vision; chest pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Apr-2021 and was forwarded to Moderna on 06-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Serious dizziness), VISION BLURRED (Blurry vision) and CHEST PAIN (chest pain) 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 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced DIZZINESS (Serious dizziness), VISION BLURRED (Blurry vision) and CHEST PAIN (chest pain). On 05-Apr-2021, DIZZINESS (Serious dizziness), VISION BLURRED (Blurry vision) and CHEST PAIN (chest pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not reported.  Treatment medication not reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Follow up attached Added newevent chest pain.Updated reporter contact information.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Joint swelling, Pain in extremity, Skin discolouration
Clinical narrative: skin become purple color; Left wrist swollen upto all fingers knuckles/Skin is dark red in color and puffy; Skin is dark red in color; Swollen areas hurts on pressing; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Left wrist swollen upto all fingers knuckles/Skin is dark red in color and puffy), ERYTHEMA (Skin is dark red in color), PAIN IN EXTREMITY (Swollen areas hurts on pressing) and SKIN DISCOLOURATION (skin become purple color) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 026A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced JOINT SWELLING (Left wrist swollen upto all fingers knuckles/Skin is dark red in color and puffy), ERYTHEMA (Skin is dark red in color) and PAIN IN EXTREMITY (Swollen areas hurts on pressing). On 24-Mar-2021, the patient experienced SKIN DISCOLOURATION (skin become purple color). At the time of the report, JOINT SWELLING (Left wrist swollen upto all fingers knuckles/Skin is dark red in color and puffy), ERYTHEMA (Skin is dark red in color), PAIN IN EXTREMITY (Swollen areas hurts on pressing) and SKIN DISCOLOURATION (skin become purple color) outcome was unknown. Not Provided          no concomitant medications reported. no treatment details reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain, Product dose omission issue
Clinical narrative: Couldn't get the second dose/2nd Dose more than  35 days after 1st Dose; out of protocol; Patient was scheduled to receive 2nd Dose; missed appointment.; was hurt; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Couldn't get the second dose/2nd Dose more than  35 days after 1st Dose; out of protocol), PRODUCT DOSE OMISSION ISSUE (Patient was scheduled to receive 2nd Dose; missed appointment.) and PAIN (was hurt) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: TETANUS VACCINE (received a tetanus shot) on 25-Mar-2021.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN (was hurt). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Couldn't get the second dose/2nd Dose more than  35 days after 1st Dose; out of protocol) and PRODUCT DOSE OMISSION ISSUE (Patient was scheduled to receive 2nd Dose; missed appointment.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Couldn't get the second dose/2nd Dose more than  35 days after 1st Dose; out of protocol), PRODUCT DOSE OMISSION ISSUE (Patient was scheduled to receive 2nd Dose; missed appointment.) and PAIN (was hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: NNI
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Peripheral swelling, Somnolence, Stress
Clinical narrative: light headed; sleepy; feeling stressed out; left foot swole up; fatigue; tired; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headed), SOMNOLENCE (sleepy), STRESS (feeling stressed out), PERIPHERAL SWELLING (left foot swole up) and FATIGUE (fatigue) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-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 DIZZINESS (light headed), SOMNOLENCE (sleepy), STRESS (feeling stressed out), PERIPHERAL SWELLING (left foot swole up), FATIGUE (fatigue) and FATIGUE (tired). The patient was treated with GABAPENTIN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DIZZINESS (light headed), SOMNOLENCE (sleepy), STRESS (feeling stressed out), PERIPHERAL SWELLING (left foot swole up), FATIGUE (fatigue) and FATIGUE (tired) outcome was unknown. Not Provided          concomitant medication included father john medication, ashwangandha.
Sex: M
Vaccine: COVID19
Symptoms: Intentional product use issue
Clinical narrative: Caller was in the hospital when his second dose was scheduled and missed that dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Caller was in the hospital when his second dose was scheduled and missed that dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Diverticulitis (because of his diverticulitis an infection occurred causing a resection of his large intestine and an ileostomy) since an unknown date.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Caller was in the hospital when his second dose was scheduled and missed that dose). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (Caller was in the hospital when his second dose was scheduled and missed that dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had pre-planned hospitalization to undergo surgery due to underlying historical medical condition of diverticulitis. Treatment included surgery of the large intestines, ileostomy and aspiration. This report refers to a case of incomplete course of vaccination for mRNA-1273,  with no associated AEs. Follow-up received on 14-APR-2021 included no new information   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: NNI
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Chills; Fever; Mild Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Mild Headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Mild Headache). At the time of the report, CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Mild Headache) outcome was unknown. Not Provided          no concomitant medications reported. no treatment details reported.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Vaccine that had temperature excursion administered to 69 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine that had temperature excursion administered to 69 patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 026B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine that had temperature excursion administered to 69 patients). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine that had temperature excursion administered to 69 patients) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported   No treatment medication reported
Sex: M
Vaccine: COVID19, UNK
Symptoms: Headache, SARS-CoV-2 test positive, Sinus disorder
Clinical narrative: headache; sinus disorder; COVID-19 virus test positive; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), SINUS DISORDER (sinus disorder) and SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive). On an unknown date, the patient experienced HEADACHE (headache) and SINUS DISORDER (sinus disorder). At the time of the report, HEADACHE (headache), SINUS DISORDER (sinus disorder) and SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-068687 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: No specific follow-up information recorded.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-068687:
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: some deep muscle pain at injection site after 1st dose; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (some deep muscle pain at injection site after 1st dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 002B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 03-Mar-2021, the patient experienced VACCINATION SITE PAIN (some deep muscle pain at injection site after 1st dose). At the time of the report, VACCINATION SITE PAIN (some deep muscle pain at injection site after 1st dose) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   no concomitant medications reported. no treatment details reported.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: f/u received on 16-jun-2021, No new information reported.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Chills, Decreased appetite, Feeling cold
Clinical narrative: does not feel good; sick to stomach; feels very cold; cannot eat; lots of chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (does not feel good), ABDOMINAL DISCOMFORT (sick to stomach), FEELING COLD (feels very cold), DECREASED APPETITE (cannot eat) and CHILLS (lots of chills) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03AB21A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer. Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), LEVOTHYROXINE SODIUM (SYNTHROID), ASPIRIN [ACETYLSALICYLIC ACID], CALCIUM, LOSARTAN, APIXABAN (ELIQUIS) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced MALAISE (does not feel good), ABDOMINAL DISCOMFORT (sick to stomach), FEELING COLD (feels very cold), DECREASED APPETITE (cannot eat) and CHILLS (lots of chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, MALAISE (does not feel good), ABDOMINAL DISCOMFORT (sick to stomach), FEELING COLD (feels very cold), DECREASED APPETITE (cannot eat) and CHILLS (lots of chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, Body temperature: 99 to 101 (Inconclusive) temperature 99F to 101F..     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.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: does not feel good; sick to stomach; feels very cold; cannot eat; lots of chills; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (does not feel good), ABDOMINAL DISCOMFORT (sick to stomach), FEELING COLD (feels very cold), DECREASED APPETITE (cannot eat) and CHILLS (lots of chills) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03AB21A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer. Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), LEVOTHYROXINE SODIUM (SYNTHROID), ASPIRIN [ACETYLSALICYLIC ACID], CALCIUM, LOSARTAN, APIXABAN (ELIQUIS) and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced MALAISE (does not feel good), ABDOMINAL DISCOMFORT (sick to stomach), FEELING COLD (feels very cold), DECREASED APPETITE (cannot eat) and CHILLS (lots of chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, MALAISE (does not feel good), ABDOMINAL DISCOMFORT (sick to stomach), FEELING COLD (feels very cold), DECREASED APPETITE (cannot eat) and CHILLS (lots of chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, Body temperature: 99 to 101 (Inconclusive) temperature 99F to 101F..     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.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dysstasia, Fatigue, Feeling abnormal
Clinical narrative: Allergies; Could not stand up weakness in legs; Head Foggy; Very tired, lot of time in bed; Could not stand up, weakness in legs; hypersensitive reaction; Concurrent medical conditions included Allergy and Sinus infection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MULTIPLE ALLERGIES (Allergies), DIZZINESS (dizziness), DYSSTASIA (Could not stand up weakness in legs), SINUSITIS (Sinus infection) and ASTHENIA (Could not stand up, weakness in legs) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   On 05-Mar-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced MULTIPLE ALLERGIES (Allergies), DIZZINESS (dizziness), DYSSTASIA (Could not stand up weakness in legs), SINUSITIS (Sinus infection), ASTHENIA (Could not stand up, weakness in legs) and FATIGUE (Very tired, lot of time in bed). On an unknown date, the patient experienced VACCINATION COMPLICATION (hypersensitive reaction) and FEELING ABNORMAL (Head Foggy). At the time of the report, MULTIPLE ALLERGIES (Allergies), DIZZINESS (dizziness), DYSSTASIA (Could not stand up weakness in legs), SINUSITIS (Sinus infection), ASTHENIA (Could not stand up, weakness in legs), VACCINATION COMPLICATION (hypersensitive reaction), FEELING ABNORMAL (Head Foggy) and FATIGUE (Very tired, lot of time in bed) outcome was unknown.            Relevant concomitant products were not provided  by the reporter.  Treatment details  included antibiotics.  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.   This case was linked to MOD-2021-068731, MOD-2021-069660 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Added VAERS and additional event On 29-Jul-2021: NNI; 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Multiple allergies, Sinusitis, Vaccination complication
Clinical narrative: Allergies; Could not stand up weakness in legs; Head Foggy; Very tired, lot of time in bed; Could not stand up, weakness in legs; hypersensitive reaction; Concurrent medical conditions included Allergy and Sinus infection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MULTIPLE ALLERGIES (Allergies), DIZZINESS (dizziness), DYSSTASIA (Could not stand up weakness in legs), SINUSITIS (Sinus infection) and ASTHENIA (Could not stand up, weakness in legs) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   On 05-Mar-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced MULTIPLE ALLERGIES (Allergies), DIZZINESS (dizziness), DYSSTASIA (Could not stand up weakness in legs), SINUSITIS (Sinus infection), ASTHENIA (Could not stand up, weakness in legs) and FATIGUE (Very tired, lot of time in bed). On an unknown date, the patient experienced VACCINATION COMPLICATION (hypersensitive reaction) and FEELING ABNORMAL (Head Foggy). At the time of the report, MULTIPLE ALLERGIES (Allergies), DIZZINESS (dizziness), DYSSTASIA (Could not stand up weakness in legs), SINUSITIS (Sinus infection), ASTHENIA (Could not stand up, weakness in legs), VACCINATION COMPLICATION (hypersensitive reaction), FEELING ABNORMAL (Head Foggy) and FATIGUE (Very tired, lot of time in bed) outcome was unknown.            Relevant concomitant products were not provided  by the reporter.  Treatment details  included antibiotics.  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.   This case was linked to MOD-2021-068731, MOD-2021-069660 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Added VAERS and additional event On 29-Jul-2021: NNI; 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: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Deviation from recommended age group; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Deviation from recommended age group) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Deviation from recommended age group). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Deviation from recommended age group) 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.   This case was linked to MOD21-069812, MOD21-069804, MOD21-069810, MOD21-069811, MOD21-069813, MOD21-069814, MOD21-070440 (E2B Linked Report).; Sender's Comments:  MOD21-069812: MOD21-069804: MOD21-069810: MOD21-069811: MOD21-069813: MOD21-069814: MOD21-070440:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pruritus, Swelling, Vaccination site erythema, Vaccination site induration
Clinical narrative: Tiny bubbles near injection site; Hot to touch left arm; Headache; Redness; Itching; Injection site hardness left arm; Swelling "bullseye"; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), VACCINATION SITE WARMTH (Hot to touch left arm), VACCINATION SITE VESICLES (Tiny bubbles near injection site), VACCINATION SITE INDURATION (Injection site hardness left arm) and SWELLING (Swelling "bullseye") in a 52-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.     Concurrent medical conditions included Seasonal allergy.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PRURITUS (Itching), VACCINATION SITE INDURATION (Injection site hardness left arm) and SWELLING (Swelling "bullseye"). On 04-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness). On 05-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Hot to touch left arm) and HEADACHE (Headache). On 06-Apr-2021, the patient experienced VACCINATION SITE VESICLES (Tiny bubbles near injection site). The patient was treated with IBUPROFEN at a dose of 2 doses. At the time of the report, PRURITUS (Itching), VACCINATION SITE WARMTH (Hot to touch left arm), VACCINATION SITE VESICLES (Tiny bubbles near injection site), VACCINATION SITE INDURATION (Injection site hardness left arm), SWELLING (Swelling "bullseye"), HEADACHE (Headache) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site vesicles, Vaccination site warmth
Clinical narrative: Tiny bubbles near injection site; Hot to touch left arm; Headache; Redness; Itching; Injection site hardness left arm; Swelling "bullseye"; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), VACCINATION SITE WARMTH (Hot to touch left arm), VACCINATION SITE VESICLES (Tiny bubbles near injection site), VACCINATION SITE INDURATION (Injection site hardness left arm) and SWELLING (Swelling "bullseye") in a 52-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.     Concurrent medical conditions included Seasonal allergy.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PRURITUS (Itching), VACCINATION SITE INDURATION (Injection site hardness left arm) and SWELLING (Swelling "bullseye"). On 04-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness). On 05-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Hot to touch left arm) and HEADACHE (Headache). On 06-Apr-2021, the patient experienced VACCINATION SITE VESICLES (Tiny bubbles near injection site). The patient was treated with IBUPROFEN at a dose of 2 doses. At the time of the report, PRURITUS (Itching), VACCINATION SITE WARMTH (Hot to touch left arm), VACCINATION SITE VESICLES (Tiny bubbles near injection site), VACCINATION SITE INDURATION (Injection site hardness left arm), SWELLING (Swelling "bullseye"), HEADACHE (Headache) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2021, COVID-19: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was initially told to take Vitamin C and Zinc. The patient was prescribed with antibiotics and steroids.  Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of  COVID-19 is assessed as unlikely related.   This case was linked to US-MODERNATX, INC.-MOD-2021-068675 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Follow-up information was received which included date of event and treatment.; Sender's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of  COVID-19 is assessed as unlikely related. US-MODERNATX, INC.-MOD-2021-068675:
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Never received second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Never received second dose) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-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 PRODUCT DOSE OMISSION ISSUE (Never received second dose). On 28-Feb-2021, PRODUCT DOSE OMISSION ISSUE (Never received second dose) had resolved. Not Provided          no treatment medications were reported concomitants medications were not reported
Sex: F
Vaccine: COVID19
Symptoms: Skin mass
Clinical narrative: she noticed a weird lump near her collar bone.; This spontaneous case was reported by a patient and describes the occurrence of SKIN MASS (she noticed a weird lump near her collar bone.) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ETHINYLESTRADIOL, LEVONORGESTREL (SRONYX) for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 UNK. On an unknown date, the patient experienced SKIN MASS (she noticed a weird lump near her collar bone.). At the time of the report, SKIN MASS (she noticed a weird lump near her collar bone.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no treatment details reported.