chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: I started menstrual bleeding the night I got first shot; This spontaneous case was reported by a consumer and describes the occurrence of INTERMENSTRUAL BLEEDING (I started menstrual bleeding the night I got first shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTERMENSTRUAL BLEEDING (I started menstrual bleeding the night I got first shot). At the time of the report, INTERMENSTRUAL BLEEDING (I started menstrual bleeding the night I got first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was not provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Fatigue, Gout, Headache
Clinical narrative: Gout were off worse; Worse balance; Fatigue level was higher/fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (Gout were off worse), BALANCE DISORDER (Worse balance), FATIGUE (Fatigue level was higher/fatigue) and HEADACHE (Headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 051C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 22-Mar-2021. Concurrent medical conditions included Multiple sclerosis since 01-Jun-2008. Concomitant products included BACLOFEN, AMPYRA, TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), MYRBETRIQ, PROVIGIL, CRESTOR, SINGULAIR, TELMISARTAN, DILTIAZEM, ONGLYZA, ATIVAN, ALBUTEROL, VITAMIN D, CALCIUM, SAW PALMETTO [SERENOA REPENS], METHOTREXATE, RITUXIMAB (RITUXAN) and METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) for an unknown indication.   On 30-Jun-2021 at 7:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021 at 2:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jul-2021 at 10:00 PM, the patient experienced GOUT (Gout were off worse), BALANCE DISORDER (Worse balance), FATIGUE (Fatigue level was higher/fatigue) and HEADACHE (Headache). On 30-Jul-2021, GOUT (Gout were off worse), BALANCE DISORDER (Worse balance), FATIGUE (Fatigue level was higher/fatigue) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered GOUT (Gout were off worse), BALANCE DISORDER (Worse balance), FATIGUE (Fatigue level was higher/fatigue) and HEADACHE (Headache) to be possibly related.    No treatment information was provided by the reporter.   This case was linked to MOD-2021-244820 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, Arthralgia, Burning sensation, Dyspnoea, Fatigue
Clinical narrative: Shortness of breath; Loss of voice; Feels like on fire; Neck pain; Left shoulder pain; Pain at injection site (left arm); Fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of DYSPNOEA (Shortness of breath), APHONIA (Loss of voice), BURNING SENSATION (Feels like on fire), NECK PAIN (Neck pain) and ARTHRALGIA (Left shoulder pain) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 26-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced DYSPNOEA (Shortness of breath), APHONIA (Loss of voice), BURNING SENSATION (Feels like on fire), NECK PAIN (Neck pain), ARTHRALGIA (Left shoulder pain), VACCINATION SITE PAIN (Pain at injection site (left arm)) and FATIGUE (Fatigue). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at a dose of 2 tablets. At the time of the report, DYSPNOEA (Shortness of breath), APHONIA (Loss of voice), BURNING SENSATION (Feels like on fire), NECK PAIN (Neck pain), ARTHRALGIA (Left shoulder pain), VACCINATION SITE PAIN (Pain at injection site (left arm)) and FATIGUE (Fatigue) 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.   Concomitant medication includes Multivitamins with collagen.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Vaccination site pain
Clinical narrative: Shortness of breath; Loss of voice; Feels like on fire; Neck pain; Left shoulder pain; Pain at injection site (left arm); Fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of DYSPNOEA (Shortness of breath), APHONIA (Loss of voice), BURNING SENSATION (Feels like on fire), NECK PAIN (Neck pain) and ARTHRALGIA (Left shoulder pain) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 26-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced DYSPNOEA (Shortness of breath), APHONIA (Loss of voice), BURNING SENSATION (Feels like on fire), NECK PAIN (Neck pain), ARTHRALGIA (Left shoulder pain), VACCINATION SITE PAIN (Pain at injection site (left arm)) and FATIGUE (Fatigue). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at a dose of 2 tablets. At the time of the report, DYSPNOEA (Shortness of breath), APHONIA (Loss of voice), BURNING SENSATION (Feels like on fire), NECK PAIN (Neck pain), ARTHRALGIA (Left shoulder pain), VACCINATION SITE PAIN (Pain at injection site (left arm)) and FATIGUE (Fatigue) 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.   Concomitant medication includes Multivitamins with collagen.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever) 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 31-Jul-2021, the patient experienced PYREXIA (low grade fever). At the time of the report, PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs provided.  No treatment drugs provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Skin mass, Swelling
Clinical narrative: arm hurt a little after second dose; little lump after second dose; a bit swollen after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt a little after second dose), SKIN MASS (little lump after second dose) and SWELLING (a bit swollen after second dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Autoimmune disorder. Concomitant products included HYDROCORTISONE, PREDNISONE, FLUDROCORTISONE, VENLAFAXINE HYDROCHLORIDE (EFFEXOR), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), LORAZEPAM (ATIVAN), POTASSIUM CHLORIDE, OXYTOCIN and DOMPERIDONE (NAUSEA) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt a little after second dose), SKIN MASS (little lump after second dose) and SWELLING (a bit swollen after second dose). At the time of the report, PAIN IN EXTREMITY (arm hurt a little after second dose), SKIN MASS (little lump after second dose) and SWELLING (a bit swollen after second dose) outcome was unknown.            Medical history includes IG deficiency Concomitant medication also include B12 injection, vitamin, asthma medication, migraine medication, itchy skin medication, IBS stomach medication.  No treatment medication was reported. No lab data was provided by the reporter   This case was linked to MOD-2021-272094.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: I had my first dose but have missed the window of recommended time to receive my second dose.  What should I do?  I wish to be fully vaccinated.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I had my first dose but have missed the window of recommended time to receive my second dose.  What should I do?  I wish to be fully vaccinated.) 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 PRODUCT DOSE OMISSION ISSUE (I had my first dose but have missed the window of recommended time to receive my second dose.  What should I do?  I wish to be fully vaccinated.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I had my first dose but have missed the window of recommended time to receive my second dose.  What should I do?  I wish to be fully vaccinated.) had resolved.            No concomitant medications were reported. No treatment information were reported.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Is Diarrhea a side effect?; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Is Diarrhea a side effect?) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Is Diarrhea a side effect?). At the time of the report, DIARRHOEA (Is Diarrhea a side effect?) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication was provided.  No treatment medication was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Diarrhea; Stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and ABDOMINAL PAIN UPPER (Stomach pain) 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 DIARRHOEA (Diarrhea) and ABDOMINAL PAIN UPPER (Stomach pain). At the time of the report, DIARRHOEA (Diarrhea) and ABDOMINAL PAIN UPPER (Stomach pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site pain, Vaccination site warmth
Clinical narrative: lump becoming bigger everyday/hard lump on the injection site; hot to touch lump; large, reddish, hard lump on the injection site; painful lump; pain scale of 5; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump becoming bigger everyday/hard lump on the injection site), VACCINATION SITE WARMTH (hot to touch lump), VACCINATION SITE ERYTHEMA (large, reddish, hard lump on the injection site) and VACCINATION SITE PAIN (painful lump; pain scale of 5) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 29-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced VACCINATION SITE MASS (lump becoming bigger everyday/hard lump on the injection site), VACCINATION SITE WARMTH (hot to touch lump), VACCINATION SITE ERYTHEMA (large, reddish, hard lump on the injection site) and VACCINATION SITE PAIN (painful lump; pain scale of 5). The patient was treated with IBUPROFEN for Adverse event, at a dose of Every 4 hours and PARACETAMOL (TYLENOL) for Adverse event, at a dose of 2 tablets Tylenol cold compress. At the time of the report, VACCINATION SITE MASS (lump becoming bigger everyday/hard lump on the injection site) and VACCINATION SITE WARMTH (hot to touch lump) had not resolved and VACCINATION SITE ERYTHEMA (large, reddish, hard lump on the injection site) and VACCINATION SITE PAIN (painful lump; pain scale of 5) outcome was unknown.            The pain scale is 5 even if she took pain relievers every 4 hours.  The patient took 2 tablets of Ibuprofen every 4 hours alternate with 2 tablets of Tylenol and applied cold compress.   This case was linked to MOD-2021-272055 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: Nosebleed; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nosebleed) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history were reported. .     On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, the patient experienced EPISTAXIS (Nosebleed). At the time of the report, EPISTAXIS (Nosebleed) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient reported experiencing nosebleed on 28-Jul-2021 and again on 30-Jul-2021.  No Concomitant medication were reported.  No treatment medication were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: I got side effects when taken moderne vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I got side effects when taken moderne vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I got side effects when taken moderne vaccine). At the time of the report, VACCINATION COMPLICATION (I got side effects when taken moderne vaccine) 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.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Hard to open hand; joint pain in his fingers on both hand; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (Hard to open hand) and ARTHRALGIA (joint pain in his fingers on both hand) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Hard to open hand) and ARTHRALGIA (joint pain in his fingers on both hand). At the time of the report, PAIN IN EXTREMITY (Hard to open hand) and ARTHRALGIA (joint pain in his fingers on both hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication and treatment information were not reported.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: Got a Moderna vaccine and later mentioned they already have had a Janssen vaccine one month before or so.; This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Got a Moderna vaccine and later mentioned they already have had a Janssen vaccine one month before or so.) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced OFF LABEL USE (Got a Moderna vaccine and later mentioned they already have had a Janssen vaccine one month before or so.). At the time of the report, OFF LABEL USE (Got a Moderna vaccine and later mentioned they already have had a Janssen vaccine one month before or so.) 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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient got a Moderna vaccine on 29Jul2021, later mentioned already had a Janssen vaccine one month before or so. The patient was monitored after getting the Moderna vaccine and presented no side effects. The patient had started a detox program 3 weeks before and was not receiving any medication at the time of the injection.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow-up information included no new information.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Metamorphopsia, Muscle spasms, Myalgia, Vision blurred
Clinical narrative: Blurred and distorted vision that has progressed; Blurred and distorted vision that has progressed; Full bloom pain and spasms in left arm in muscle; Arm pain in muscle; This case was received via  Medicines Agency (Reference number: US-irms-MOD21-124942) on 30-Jul-2021 and was forwarded to Moderna on 30-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of METAMORPHOPSIA (Blurred and distorted vision that has progressed), VISION BLURRED (Blurred and distorted vision that has progressed), MUSCLE SPASMS (Full bloom pain and spasms in left arm in muscle) and MYALGIA (Arm pain in muscle) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A2A1 and 021B21A) 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) dosage was changed to 1 dosage form. On 31-Jul-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 received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced METAMORPHOPSIA (Blurred and distorted vision that has progressed), VISION BLURRED (Blurred and distorted vision that has progressed), MUSCLE SPASMS (Full bloom pain and spasms in left arm in muscle) and MYALGIA (Arm pain in muscle). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, METAMORPHOPSIA (Blurred and distorted vision that has progressed), VISION BLURRED (Blurred and distorted vision that has progressed), MUSCLE SPASMS (Full bloom pain and spasms in left arm in muscle) and MYALGIA (Arm pain in muscle) had not resolved.            Patient reported that between the 1st and 2nd dose she started having distorted and blurred vision that has now progressed and states that she does not wear glasses. She had pain in both arms in the muscle of which right arm has gotten better but her left arm is still in pain. No concomitant medications were mentioned.  Treatment medications included using ointments   This case was linked to MOD-2021-271794 (Patient Link).
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Vaccinated twice with the first dose of Moderna Covid19.had been given the vaccine 15 days apart; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccinated twice with the first dose of Moderna Covid19.had been given the vaccine 15 days apart) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccinated twice with the first dose of Moderna Covid19.had been given the vaccine 15 days apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccinated twice with the first dose of Moderna Covid19.had been given the vaccine 15 days apart) outcome was unknown. No concomitant drug details were reported. No treatment details were reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: After vaccination the patient is experiencing headache off; the site of injection is sore; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (After vaccination the patient is experiencing headache off) and VACCINATION SITE PAIN (the site of injection is sore) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (After vaccination the patient is experiencing headache off) and VACCINATION SITE PAIN (the site of injection is sore). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, HEADACHE (After vaccination the patient is experiencing headache off) and VACCINATION SITE PAIN (the site of injection is sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 2 recipients who got the vaccine were 16 and 17; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2 recipients who got the vaccine were 16 and 17) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2 recipients who got the vaccine were 16 and 17). On 29-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (2 recipients who got the vaccine were 16 and 17) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.  No adverse reactions had been reported by the patient.   This case was linked to MOD-2021-271735 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow-up received contains updated contact details of reporter.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Vaccination site pain
Clinical narrative: Pain from shoulder to her hand; Pain from shoulder to her hand; Sore left arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain from shoulder to her hand), ARTHRALGIA (Pain from shoulder to her hand) and VACCINATION SITE PAIN (Sore left arm at injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, the patient experienced VACCINATION SITE PAIN (Sore left arm at injection site). On 29-Jul-2021, the patient experienced PAIN IN EXTREMITY (Pain from shoulder to her hand) and ARTHRALGIA (Pain from shoulder to her hand). At the time of the report, PAIN IN EXTREMITY (Pain from shoulder to her hand), ARTHRALGIA (Pain from shoulder to her hand) and VACCINATION SITE PAIN (Sore left arm at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No treatment information was provided.   This case was linked to US-irms-MOD21-272190 (E2B Linked Report).; Sender's Comments:  US-irms-MOD21-272190:
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination complication, Vomiting
Clinical narrative: side effects 10 days after the first  in a shot I'm right; Throwing up; 10 days later my son and husband have fevers; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects 10 days after the first in a shot I'm right), VOMITING (Throwing up), PYREXIA (10 days later my son and husband have fevers) and MYALGIA (Body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects 10 days after the first  in a shot I'm right), VOMITING (Throwing up), PYREXIA (10 days later my son and husband have fevers) and MYALGIA (Body aches). At the time of the report, VACCINATION COMPLICATION (side effects 10 days after the first  in a shot I'm right), VOMITING (Throwing up), PYREXIA (10 days later my son and husband have fevers) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided.  No treatment medications provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Vaccination site pruritus; Vaccination site swelling; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE SWELLING (Vaccination site swelling) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 23-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jul-2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On 30-Jul-2021, the patient experienced VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE SWELLING (Vaccination site swelling). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Vaccination site pain), VACCINATION SITE PRURITUS (Vaccination site pruritus) and VACCINATION SITE SWELLING (Vaccination site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No further treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I know people who have had the second shot and got real sick; 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 ILLNESS (I know people who have had the second shot and got real sick) 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 ILLNESS (I know people who have had the second shot and got real sick). At the time of the report, ILLNESS (I know people who have had the second shot and got real sick) 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: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: covid vaccine was placed in refrigerator and was expired past 30 days; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (covid vaccine was placed in refrigerator and was expired past 30 days) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (covid vaccine was placed in refrigerator and was expired past 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (covid vaccine was placed in refrigerator and was expired past 30 days) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment information were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Follow-up received with patient demographics, date of vaccine administration were added.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Product administration error
Clinical narrative: patient got total of three doses of Moderna Vaccine; patient received two doses of Moderna vaccine half hour apart in addition to a first vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (patient received two doses of Moderna vaccine half hour apart in addition to a first vaccine) and PRODUCT ADMINISTRATION ERROR (patient got total of three doses of Moderna Vaccine) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 053C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (patient received two doses of Moderna vaccine half hour apart in addition to a first vaccine). On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (patient got total of three doses of Moderna Vaccine). On 30-Jul-2021, EXTRA DOSE ADMINISTERED (patient received two doses of Moderna vaccine half hour apart in addition to a first vaccine) had resolved. At the time of the report, PRODUCT ADMINISTRATION ERROR (patient got total of three doses of Moderna Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was reported.
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Covid vaccine was placed in refrigerator and was expired past 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Covid vaccine was placed in refrigerator and was expired past 30 days) in a 30-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Covid vaccine was placed in refrigerator and was expired past 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Covid vaccine was placed in refrigerator and was expired past 30 days) had resolved.        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: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Inappropriate schedule of product administration, Psychomotor hyperactivity
Clinical narrative: hyper - feels like I consumed several cans of Red Bull. Inappropriate schedule of vaccine administered; chills; This spontaneous case was reported by a consumer and describes the occurrence of PSYCHOMOTOR HYPERACTIVITY (hyper - feels like I consumed several cans of Red Bull.), CHILLS (chills) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 051C21A) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy, Allergy to antibiotic (Allergy to Erythromycin), House dust mite allergy, Allergic to cats, Allergic to dogs, Allergy to feathers, Cockroach allergy, Grass allergy, Ragweed allergy, Allergy to plants (Allergy to Sorrel, English Plantain, Lamb's Quarters, Pigweed, Cockelbur, Nettle, Palm trees, Melaleuca, Australian Pine, White Pine, Live Oak, Red Cedar Elm, Maple, Ash Cottonwood and Brazilian Pepper tree), Allergy to molds (Allergy to Hormodendrum, Alternaria, Helminhosporium, Fusarium, Pullaria, Aspergillus, Epicoccum, Stemphylium and Curvularia) and Heart murmur (More heart fluttering after first vax, slight heavyness on left side radiating to back.). Concomitant products included BUDESONIDE (RHINOCORT [BUDESONIDE]) for Multiple allergies, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from an unknown date to 30-Jul-2021 for Prophylaxis. On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021 at 1:43 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jul-2021, the patient experienced PSYCHOMOTOR HYPERACTIVITY (hyper - feels like I consumed several cans of Red Bull.), CHILLS (chills) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 31-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, PSYCHOMOTOR HYPERACTIVITY (hyper - feels like I consumed several cans of Red Bull.) and CHILLS (chills) outcome was unknown. The patient was not diagnosed with or tested positive for COVID-19. The patient had none acute illness at the time of vaccination and up to one month before. The patient received the second dose the previous day and had not been 24 hours yet. She had been experiencing chills and was hyper felt like she consumed several cans of energy drinks.  No treatment medications were reported.   This case was linked to MOD-2021-241605 (Patient Link).
Age: 51.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: covid vaccine was placed in refrigerator and was expired past 30 days; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (covid vaccine was placed in refrigerator and was expired past 30 days) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (covid vaccine was placed in refrigerator and was expired past 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (covid vaccine was placed in refrigerator and was expired past 30 days) 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 medications were not provided by reporter. No Treatment medications were provided by reporter.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neuralgia, Pain, Vaccination site pain, Vaccination site warmth
Clinical narrative: After receiving the second dose, she started to have an excruciating pain at the injection site, described it as radiating pain from shoulder to her arm, pain scale of 10/10 and got worse over time; Stiff injection site (left); Warm to touch; experience nerve pain; After receiving the second dose, she started to have an excruciating pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (After receiving the second dose, she started to have an excruciating pain at the injection site, described it as radiating pain from shoulder to her arm, pain scale of 10/10 and got worse over time), MUSCULOSKELETAL STIFFNESS (Stiff injection site (left)), VACCINATION SITE WARMTH (Warm to touch), NEURALGIA (experience nerve pain) and VACCINATION SITE PAIN (After receiving the second dose, she started to have an excruciating pain at the injection site) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 015M20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included INSULIN for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PAIN (After receiving the second dose, she started to have an excruciating pain at the injection site, described it as radiating pain from shoulder to her arm, pain scale of 10/10 and got worse over time), MUSCULOSKELETAL STIFFNESS (Stiff injection site (left)), VACCINATION SITE WARMTH (Warm to touch), NEURALGIA (experience nerve pain) and VACCINATION SITE PAIN (After receiving the second dose, she started to have an excruciating pain at the injection site). The patient was treated with MELOXICAM for Adverse event, at an unspecified dose and frequency; METHYLPREDNISOLONE for Adverse event, at a dose of tapered doses for a week and IBUPROFEN for Pain, at a dose of 1 dosage form twice a day. At the time of the report, PAIN (After receiving the second dose, she started to have an excruciating pain at the injection site, described it as radiating pain from shoulder to her arm, pain scale of 10/10 and got worse over time), MUSCULOSKELETAL STIFFNESS (Stiff injection site (left)), VACCINATION SITE WARMTH (Warm to touch), NEURALGIA (experience nerve pain) and VACCINATION SITE PAIN (After receiving the second dose, she started to have an excruciating pain at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 28.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: covid vaccine was placed in refrigerator and was expired past 30 days; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (covid vaccine was placed in refrigerator and was expired past 30 days) in a 28-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) 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 EXPIRED PRODUCT ADMINISTERED (covid vaccine was placed in refrigerator and was expired past 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (covid vaccine was placed in refrigerator and was expired past 30 days) 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.   No concomitant medications reported . No treatment information provided .
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: I got my initial moderna shot on may 4th and have not had the time to get my second; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I got my initial moderna shot on may 4th and have not had the time to get my second) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I got my initial Moderna shot on May 4th and have not had the time to get my second). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I got my initial moderna shot on may 4th and have not had the time to get my second) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant information was provided by the reporter. No treatment information was provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Peripheral swelling
Clinical narrative: feeling a little hot sometimes, but claims "that's just me."; arm was a light colored red; arm swelled up a little bit; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm swelled up a little bit), ERYTHEMA (arm was a light colored red) and FEELING HOT (feeling a little hot sometimes, but claims "that's just me.") in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included THYROID and PARACETAMOL (TYLENOL) for an unknown indication.    On 21-Jul-2021 at 4:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced PERIPHERAL SWELLING (arm swelled up a little bit). On 29-Jul-2021, the patient experienced ERYTHEMA (arm was a light colored red). On an unknown date, the patient experienced FEELING HOT (feeling a little hot sometimes, but claims "that's just me."). On 24-Jul-2021, PERIPHERAL SWELLING (arm swelled up a little bit) had resolved. At the time of the report, ERYTHEMA (arm was a light colored red) and FEELING HOT (feeling a little hot sometimes, but claims "that's just me.") 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.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Arm pain; Fever; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (Arm pain) and PYREXIA (Fever) 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 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm pain) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Arm pain) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.