chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Breast discomfort, Breast pain, Breast tenderness, Fatigue, Vaccination site pain
Clinical narrative: pain in her breasts became worse; tenderness in her breasts became worse; depression in skin like a hole on the side of her breast; pain at the injection site; couldn't function due to being tired,couldn't function due to being run down; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (pain in her breasts became worse), BREAST TENDERNESS (tenderness in her breasts became worse), BREAST DISCOMFORT (depression in skin like a hole on the side of her breast), VACCINATION SITE PAIN (pain at the injection site) and FATIGUE (couldn't function due to being tired,couldn't function due to being run down) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025c21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CALCIUM and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 21-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 21-May-2021, the patient experienced BREAST PAIN (pain in her breasts became worse), BREAST TENDERNESS (tenderness in her breasts became worse), BREAST DISCOMFORT (depression in skin like a hole on the side of her breast), VACCINATION SITE PAIN (pain at the injection site) and FATIGUE (couldn't function due to being tired,couldn't function due to being run down). On 23-May-2021, VACCINATION SITE PAIN (pain at the injection site) and FATIGUE (couldn't function due to being tired,couldn't function due to being run down) had resolved. At the time of the report, BREAST PAIN (pain in her breasts became worse), BREAST TENDERNESS (tenderness in her breasts became worse) and BREAST DISCOMFORT (depression in skin like a hole on the side of her breast) outcome was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dizziness, Dry mouth, Fatigue
Clinical narrative: chills; muscle pain; slight headache; have been in bed all day.; slight dizziness; mouth is dry; coughing; feel a little bit warm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (slight dizziness), DRY MOUTH (mouth is dry), COUGH (coughing), FEELING HOT (feel a little bit warm) and CHILLS (chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and Viral infection. Concomitant products included LOSARTAN and METOPROLOL for Blood pressure high.   On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced DIZZINESS (slight dizziness), DRY MOUTH (mouth is dry), COUGH (coughing), FEELING HOT (feel a little bit warm), MYALGIA (muscle pain), HEADACHE (slight headache) and FATIGUE (have been in bed all day.). On 11-Jun-2021 at 7:00 AM, the patient experienced CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (slight dizziness), DRY MOUTH (mouth is dry), COUGH (coughing), FEELING HOT (feel a little bit warm), CHILLS (chills), MYALGIA (muscle pain), HEADACHE (slight headache) and FATIGUE (have been in bed all day.) outcome was unknown.            Concomitant medications included unspecified medicine for viral infection.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Myalgia
Clinical narrative: chills; muscle pain; slight headache; have been in bed all day.; slight dizziness; mouth is dry; coughing; feel a little bit warm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (slight dizziness), DRY MOUTH (mouth is dry), COUGH (coughing), FEELING HOT (feel a little bit warm) and CHILLS (chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure and Viral infection. Concomitant products included LOSARTAN and METOPROLOL for Blood pressure high.   On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced DIZZINESS (slight dizziness), DRY MOUTH (mouth is dry), COUGH (coughing), FEELING HOT (feel a little bit warm), MYALGIA (muscle pain), HEADACHE (slight headache) and FATIGUE (have been in bed all day.). On 11-Jun-2021 at 7:00 AM, the patient experienced CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIZZINESS (slight dizziness), DRY MOUTH (mouth is dry), COUGH (coughing), FEELING HOT (feel a little bit warm), CHILLS (chills), MYALGIA (muscle pain), HEADACHE (slight headache) and FATIGUE (have been in bed all day.) outcome was unknown.            Concomitant medications included unspecified medicine for viral infection.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Gait inability, Headache, Influenza like illness
Clinical narrative: Muscle pain in legs (hard to walk); Night sweats; flu like symptoms; Muscle pain in  arms; low grade fever 99 F; Chills; Headaches; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (Muscle pain in legs (hard to walk)), NIGHT SWEATS (Night sweats), INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (Muscle pain in  arms) and PYREXIA (low grade fever 99 F) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-May-2021, the patient experienced GAIT INABILITY (Muscle pain in legs (hard to walk)), NIGHT SWEATS (Night sweats), INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (Muscle pain in  arms), PYREXIA (low grade fever 99 F), CHILLS (Chills), HEADACHE (Headaches) and NAUSEA (Nausea). At the time of the report, GAIT INABILITY (Muscle pain in legs (hard to walk)), NIGHT SWEATS (Night sweats), MYALGIA (Muscle pain in  arms), PYREXIA (low grade fever 99 F), CHILLS (Chills), HEADACHE (Headaches) and NAUSEA (Nausea) outcome was unknown and INFLUENZA LIKE ILLNESS (flu like symptoms) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-May-2021, Body temperature: 99 (abnormal) Low grade fever of 99F.         No concomitant and treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Significant follow up: Event outcome for influenza like illness changed to not recovered, action taken for one event was added from initial document
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Night sweats, Pyrexia
Clinical narrative: Muscle pain in legs (hard to walk); Night sweats; flu like symptoms; Muscle pain in  arms; low grade fever 99 F; Chills; Headaches; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (Muscle pain in legs (hard to walk)), NIGHT SWEATS (Night sweats), INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (Muscle pain in  arms) and PYREXIA (low grade fever 99 F) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-May-2021, the patient experienced GAIT INABILITY (Muscle pain in legs (hard to walk)), NIGHT SWEATS (Night sweats), INFLUENZA LIKE ILLNESS (flu like symptoms), MYALGIA (Muscle pain in  arms), PYREXIA (low grade fever 99 F), CHILLS (Chills), HEADACHE (Headaches) and NAUSEA (Nausea). At the time of the report, GAIT INABILITY (Muscle pain in legs (hard to walk)), NIGHT SWEATS (Night sweats), MYALGIA (Muscle pain in  arms), PYREXIA (low grade fever 99 F), CHILLS (Chills), HEADACHE (Headaches) and NAUSEA (Nausea) outcome was unknown and INFLUENZA LIKE ILLNESS (flu like symptoms) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-May-2021, Body temperature: 99 (abnormal) Low grade fever of 99F.         No concomitant and treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Significant follow up: Event outcome for influenza like illness changed to not recovered, action taken for one event was added from initial document
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: swelling at the injection site, lasted for 1-2 weeks; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling at the injection site, lasted for 1-2 weeks) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swelling at the injection site, lasted for 1-2 weeks). At the time of the report, VACCINATION SITE SWELLING (swelling at the injection site, lasted for 1-2 weeks) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The patient had no concomitant medications.  No treatment medication was taken by the patient.   This case was linked to MOD-2021-219762 (Patient Link).
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Blood blister, Erythema, Headache, Hyperkeratosis, Peripheral swelling
Clinical narrative: keratosis; left arm swollen; blood blister; itching; redness; scab; Rash/red rash; Headache/headcahe back of head; This spontaneous case was reported by a consumer and describes the occurrence of HYPERKERATOSIS (keratosis), PERIPHERAL SWELLING (left arm swollen), BLOOD BLISTER (blood blister), PRURITUS (itching) and ERYTHEMA (redness) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Skin cancer (Returned 2010- 2019) and Keratosis in 2010. Previously administered products included for an unreported indication: FLU VACCINE VII (first time getting a reaction from this shot. Rash- swollen arm) since 10-Jun-2020. Concurrent medical conditions included Hypersensitivity reaction, Drug allergy (Nausea), Drug allergy (Nausea), Drug allergy (Diarrhea), Bronchiectasis and Pseudomonas aeruginosa infection NOS. Concomitant products included MULTIVITAMIN [VITAMINS NOS], CHARCOAL, VITAMIN B12 [VITAMIN B12 NOS], AMLODIPINE, HYDROCHLOROTHIAZIDE and ATORVASTATIN for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERKERATOSIS (keratosis), PERIPHERAL SWELLING (left arm swollen), BLOOD BLISTER (blood blister), PRURITUS (itching), ERYTHEMA (redness), SCAB (scab), RASH (Rash/red rash) and HEADACHE (Headache/headcahe back of head). At the time of the report, HYPERKERATOSIS (keratosis) was resolving, PERIPHERAL SWELLING (left arm swollen), PRURITUS (itching), ERYTHEMA (redness) and SCAB (scab) outcome was unknown and BLOOD BLISTER (blood blister), RASH (Rash/red rash) and HEADACHE (Headache/headcahe back of head) had resolved.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up received on 14 Jun 2021, included no new information On 02-Jul-2021: Significant Follow-up appended- medical history added, allergies, and outcome
Age: 72.0
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash, Scab
Clinical narrative: keratosis; left arm swollen; blood blister; itching; redness; scab; Rash/red rash; Headache/headcahe back of head; This spontaneous case was reported by a consumer and describes the occurrence of HYPERKERATOSIS (keratosis), PERIPHERAL SWELLING (left arm swollen), BLOOD BLISTER (blood blister), PRURITUS (itching) and ERYTHEMA (redness) in a 72-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Skin cancer (Returned 2010- 2019) and Keratosis in 2010. Previously administered products included for an unreported indication: FLU VACCINE VII (first time getting a reaction from this shot. Rash- swollen arm) since 10-Jun-2020. Concurrent medical conditions included Hypersensitivity reaction, Drug allergy (Nausea), Drug allergy (Nausea), Drug allergy (Diarrhea), Bronchiectasis and Pseudomonas aeruginosa infection NOS. Concomitant products included MULTIVITAMIN [VITAMINS NOS], CHARCOAL, VITAMIN B12 [VITAMIN B12 NOS], AMLODIPINE, HYDROCHLOROTHIAZIDE and ATORVASTATIN for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERKERATOSIS (keratosis), PERIPHERAL SWELLING (left arm swollen), BLOOD BLISTER (blood blister), PRURITUS (itching), ERYTHEMA (redness), SCAB (scab), RASH (Rash/red rash) and HEADACHE (Headache/headcahe back of head). At the time of the report, HYPERKERATOSIS (keratosis) was resolving, PERIPHERAL SWELLING (left arm swollen), PRURITUS (itching), ERYTHEMA (redness) and SCAB (scab) outcome was unknown and BLOOD BLISTER (blood blister), RASH (Rash/red rash) and HEADACHE (Headache/headcahe back of head) had resolved.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up received on 14 Jun 2021, included no new information On 02-Jul-2021: Significant Follow-up appended- medical history added, allergies, and outcome
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Unexpected benefit; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Unexpected benefit) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Unexpected benefit). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Unexpected benefit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.    Reporter did not allow further contact
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Headache, Muscular weakness
Clinical narrative: feeling very cold; both legs felt a bit weak than usual; Mild headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (feeling very cold), MUSCULAR WEAKNESS (both legs felt a bit weak than usual) and HEADACHE (Mild headache) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jun-2021, the patient experienced FEELING COLD (feeling very cold), MUSCULAR WEAKNESS (both legs felt a bit weak than usual) and HEADACHE (Mild headache). At the time of the report, FEELING COLD (feeling very cold), MUSCULAR WEAKNESS (both legs felt a bit weak than usual) and HEADACHE (Mild headache) outcome was unknown.            No concomitant medication was reported.  No treatment medication was reported.  For mRNA-1273 (COVID 19 Vaccine Moderna), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-219706 (Patient Link).
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Productive cough, Pruritus, Sinusitis, Vaccination site discolouration
Clinical narrative: bump has gone but is blue and black and looks like an old spider bite; sinus infection; flehm in her throat; like a small mosquito bite at the injection site/bump started to grow1 week later; itchy; entire arm tingled; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (bump has gone but is blue and black and looks like an old spider bite), SINUSITIS (sinus infection), PARAESTHESIA (entire arm tingled), PRODUCTIVE COUGH (flehm in her throat) and PRURITUS (itchy) in a 29-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 Arthritis and Allergy NOS. Concomitant products included CEFIXIME (FLEXERIL [CEFIXIME]) and CELECOXIB (CELEBREX) for Arthritis, IRON and OMEGA-3 NOS for an unknown indication.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced PARAESTHESIA (entire arm tingled) and PRURITUS (itchy). On 15-May-2021, the patient experienced VACCINATION SITE SWELLING (like a small mosquito bite at the injection site/bump started to grow1 week later). On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (bump has gone but is blue and black and looks like an old spider bite), SINUSITIS (sinus infection) and PRODUCTIVE COUGH (flehm in her throat). The patient was treated with Manual therapy (Cold compress) for Paraesthesia and Manual therapy (Cold compress) for Pruritus. At the time of the report, VACCINATION SITE DISCOLOURATION (bump has gone but is blue and black and looks like an old spider bite), SINUSITIS (sinus infection), PARAESTHESIA (entire arm tingled), PRODUCTIVE COUGH (flehm in her throat), PRURITUS (itchy) and VACCINATION SITE SWELLING (like a small mosquito bite at the injection site/bump started to grow1 week later) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided by reporter.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: bump has gone but is blue and black and looks like an old spider bite; sinus infection; flehm in her throat; like a small mosquito bite at the injection site/bump started to grow1 week later; itchy; entire arm tingled; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (bump has gone but is blue and black and looks like an old spider bite), SINUSITIS (sinus infection), PARAESTHESIA (entire arm tingled), PRODUCTIVE COUGH (flehm in her throat) and PRURITUS (itchy) in a 29-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 Arthritis and Allergy NOS. Concomitant products included CEFIXIME (FLEXERIL [CEFIXIME]) and CELECOXIB (CELEBREX) for Arthritis, IRON and OMEGA-3 NOS for an unknown indication.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced PARAESTHESIA (entire arm tingled) and PRURITUS (itchy). On 15-May-2021, the patient experienced VACCINATION SITE SWELLING (like a small mosquito bite at the injection site/bump started to grow1 week later). On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (bump has gone but is blue and black and looks like an old spider bite), SINUSITIS (sinus infection) and PRODUCTIVE COUGH (flehm in her throat). The patient was treated with Manual therapy (Cold compress) for Paraesthesia and Manual therapy (Cold compress) for Pruritus. At the time of the report, VACCINATION SITE DISCOLOURATION (bump has gone but is blue and black and looks like an old spider bite), SINUSITIS (sinus infection), PARAESTHESIA (entire arm tingled), PRODUCTIVE COUGH (flehm in her throat), PRURITUS (itchy) and VACCINATION SITE SWELLING (like a small mosquito bite at the injection site/bump started to grow1 week later) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided by reporter.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: First dose was 44 days ago; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose was 44 days ago) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose was 44 days ago). On 28-Apr-2021, PRODUCT DOSE OMISSION ISSUE (First dose was 44 days ago) 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 medication use was provided by the reporter.  No treatment of events was reported.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose) 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 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose). On 30-Apr-2021, PRODUCT DOSE OMISSION ISSUE (Missed second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  Patient reported he missed his second dose on 30-Apr-2021 because his mother passed away and was still there due to travel restrictions at the time of this report.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Non Significant follow up
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Experiencing numbness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Experiencing numbness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Experiencing numbness). At the time of the report, HYPOAESTHESIA (Experiencing numbness) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not reported Treatment medication information were not reported   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow up document received on 14-Jun-2021 provides no new information.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Heart rate, Heart rate decreased
Clinical narrative: low heart rate 30 beats per minute; extreme weakness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (extreme weakness) and HEART RATE DECREASED (low heart rate 30 beats per minute) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (extreme weakness) and HEART RATE DECREASED (low heart rate 30 beats per minute). At the time of the report, ASTHENIA (extreme weakness) had resolved and HEART RATE DECREASED (low heart rate 30 beats per minute) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 30 (Low) 30 beats per minute.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Didn't eat prior/drank a lot of water/have good health/feel like I'm getting better every day/got my 2nd dose...next day I felt so great/arm didn't get sore; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Didn't eat prior/drank a lot of water/have good health/feel like I'm getting better every day/got my 2nd dose...next day I felt so great/arm didn't get sore) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Concussion (Patient said that the concussion doesn't help with her blood pressure.) on 24-Jun-2020. Concomitant products included ESOMEPRAZOLE SODIUM and VITAMINS NOS for an unknown indication.   On 24-Apr-2021 at 12:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Didn't eat prior/drank a lot of water/have good health/feel like I'm getting better every day/got my 2nd dose...next day I felt so great/arm didn't get sore). On 24-Apr-2021, THERAPEUTIC RESPONSE UNEXPECTED (Didn't eat prior/drank a lot of water/have good health/feel like I'm getting better every day/got my 2nd dose..next day I felt so great/arm didn't get sore) had resolved.            No treatment details were reported.  Consent for follow-up with safety with the patient was not obtained. Consent for follow-up with primary care physician was declined.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Arm swelling with redness and warmth; Lowgrade fever; Chills; Arm swelling with redness and warmth; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH (Arm swelling with redness and warmth), PYREXIA (Lowgrade fever), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Arm swelling with redness and warmth) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to drug, Allergic reaction to drug, Allergic reaction to drug, Migraine since 1988 and High cholesterol since 2018. Concomitant products included CETIRIZINE for Allergy, MECLIZINE HCL for Dizzy, SIMVASTATIN for High cholesterol, TOPIRAMATE (TOPAMAX) for Migraine, FAMOTIDINE for Reflux esophagitis.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-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 VACCINATION SITE WARMTH (Arm swelling with redness and warmth), PYREXIA (Lowgrade fever), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Arm swelling with redness and warmth). At the time of the report, VACCINATION SITE WARMTH (Arm swelling with redness and warmth), PYREXIA (Lowgrade fever), CHILLS (Chills) and VACCINATION SITE ERYTHEMA (Arm swelling with redness and warmth) 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.   The reporter stated that the patient experienced the same symptoms with both vaccination doses, however, the events were not as severe with the second dose.   This case was linked to MOD-2021-008504 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 23 patients given expired doses; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (23 patients given expired doses) 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 11-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (23 patients given expired doses). At the time of the report, EXPIRED PRODUCT ADMINISTERED (23 patients given expired doses) outcome 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 medications were reported. Identities of patients were not provided.  Action taken with mRNA-1273 was not applicable.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Breast mass, Inappropriate schedule of product administration, Mammogram, Ultrasound breast
Clinical narrative: LT Breast Mass/Cyst; Received second dose more than 35 days apart from the first; This spontaneous case was reported by a consumer and describes the occurrence of BREAST MASS (LT Breast Mass/Cyst) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 35 days apart from the first) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) from 03-Feb-2013 to an unknown date and AMLODIPINE MESILATE;OLMESARTAN MEDOXOMIL from 21-Mar-2011 to an unknown date for Hypertension.   On 07-Jan-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021 at 11:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 35 days apart from the first). On 21-May-2021 at 10:30 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BREAST MASS (LT Breast Mass/Cyst). On 26-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose more than 35 days apart from the first) had resolved. On 06-Jun-2021, BREAST MASS (LT Breast Mass/Cyst) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Mammogram: incomplete additional imaging evaluation needed (Inconclusive) The focal asymmetry in the left breast is indeterminate. 3D spot compression imaging and possible ultrasound is recommended.. On 10-May-2021, Mammogram: ultrasound is recommended. (Inconclusive) The focal asymmetry in the left breast is indeterminate.. On 10-May-2021, Ultrasound breast: an ultrasound guided biopsy is recommended. (Inconclusive) The 1.4 cm oval mass in the left breast is suspicious of malignancy..         This case was linked to US-MODERNATX, INC.-MOD-2021-004328 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: No new information received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-004328:Dose 1
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Burning on my face and neck; dryness; local itching/ generalized itching; red eyes; itchy eyes; prickling/ tingling sensation; hoarseness; local rash; spot on my forehead and neck; hypersensitivity reaction; Redness on face and neck,redness,face began to have splotchy red places,local redness; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (spot on my forehead and neck), HYPERSENSITIVITY (hypersensitivity reaction), ERYTHEMA (Redness on face and neck,redness,face began to have splotchy red places,local redness), BURNING SENSATION (Burning on my face and neck) and DRY SKIN (dryness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Previously administered products included for Infection: doxycycline in May 1985. Past adverse reactions to the above products included Redness generalised with doxycycline.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced RASH MACULAR (spot on my forehead and neck), HYPERSENSITIVITY (hypersensitivity reaction), ERYTHEMA (Redness on face and neck,redness,face began to have splotchy red places,local redness), DRY SKIN (dryness), PRURITUS (local itching/ generalized itching), OCULAR HYPERAEMIA (red eyes), EYE PRURITUS (itchy eyes), PARAESTHESIA (prickling/ tingling sensation), DYSPHONIA (hoarseness) and RASH (local rash). On an unknown date, the patient experienced BURNING SENSATION (Burning on my face and neck). The patient was treated with HYDROCORTISONE ongoing from 06-Apr-2021 at an unspecified dose and frequency and TIRBANIBULIN (KLISYRI) at an unspecified dose and frequency. At the time of the report, RASH MACULAR (spot on my forehead and neck) and HYPERSENSITIVITY (hypersensitivity reaction) had not resolved and ERYTHEMA (Redness on face and neck,redness,face began to have splotchy red places,local redness), BURNING SENSATION (Burning on my face and neck), DRY SKIN (dryness), PRURITUS (local itching/ generalized itching), OCULAR HYPERAEMIA (red eyes), EYE PRURITUS (itchy eyes), PARAESTHESIA (prickling/ tingling sensation), DYSPHONIA (hoarseness) and RASH (local rash) outcome was unknown.            Concomitant medication of the patient was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Patient information, past medical history, suspect drug dosage details, facility information were updated. New events of rash macular, hypersensitivity, dry skin, pruritus, ocular hyperaemia, eye pruritus, paranesthesia, dysphonia and rash were added. On 04-Aug-2021: Follow-up information included no new information. On 04-Aug-2021: Follow-up information included no new information.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: my 2 doses should be tomorrow June 12th but I can't travel again till July 10th; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (my 2 doses should be tomorrow June 12th but I can't travel again till July 10th) 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 (my 2 doses should be tomorrow June 12th but I can't travel again till July 10th). At the time of the report, PRODUCT DOSE OMISSION ISSUE (my 2 doses should be tomorrow June 12th but I can't travel again till July 10th) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: got the Modern and Pfizer shots; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (got the Modern and Pfizer shots) 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 ADMINISTRATION ERROR (got the Modern and Pfizer shots). At the time of the report, PRODUCT ADMINISTRATION ERROR (got the Modern and Pfizer shots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Fatigue, Gait inability, Myalgia
Clinical narrative: woke up with her legs burning on fire; fatigue; body aches; Chills; went to bed and slept through the night; 1.5 hours of sleep a night because of the constant pain around the clock; The burning turned to pins and needles feeling that started at the top of; could not wal; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (went to bed and slept through the night), BURNING SENSATION (woke up with her legs burning on fire), PAIN (1.5 hours of sleep a night because of the constant pain around the clock), PARAESTHESIA (The burning turned to pins and needles feeling that started at the top of) and GAIT INABILITY (could not wal) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21a and 004M20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced SOMNOLENCE (went to bed and slept through the night), FATIGUE (fatigue), MYALGIA (body aches) and CHILLS (Chills). On 04-Mar-2021, the patient experienced BURNING SENSATION (woke up with her legs burning on fire). In March 2021, the patient experienced PAIN (1.5 hours of sleep a night because of the constant pain around the clock), PARAESTHESIA (The burning turned to pins and needles feeling that started at the top of) and GAIT INABILITY (could not wal). At the time of the report, SOMNOLENCE (went to bed and slept through the night), BURNING SENSATION (woke up with her legs burning on fire), PAIN (1.5 hours of sleep a night because of the constant pain around the clock), PARAESTHESIA (The burning turned to pins and needles feeling that started at the top of), FATIGUE (fatigue), MYALGIA (body aches) and CHILLS (Chills) outcome was unknown and GAIT INABILITY (could not wal) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2021-051146 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Somnolence
Clinical narrative: woke up with her legs burning on fire; fatigue; body aches; Chills; went to bed and slept through the night; 1.5 hours of sleep a night because of the constant pain around the clock; The burning turned to pins and needles feeling that started at the top of; could not wal; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (went to bed and slept through the night), BURNING SENSATION (woke up with her legs burning on fire), PAIN (1.5 hours of sleep a night because of the constant pain around the clock), PARAESTHESIA (The burning turned to pins and needles feeling that started at the top of) and GAIT INABILITY (could not wal) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21a and 004M20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced SOMNOLENCE (went to bed and slept through the night), FATIGUE (fatigue), MYALGIA (body aches) and CHILLS (Chills). On 04-Mar-2021, the patient experienced BURNING SENSATION (woke up with her legs burning on fire). In March 2021, the patient experienced PAIN (1.5 hours of sleep a night because of the constant pain around the clock), PARAESTHESIA (The burning turned to pins and needles feeling that started at the top of) and GAIT INABILITY (could not wal). At the time of the report, SOMNOLENCE (went to bed and slept through the night), BURNING SENSATION (woke up with her legs burning on fire), PAIN (1.5 hours of sleep a night because of the constant pain around the clock), PARAESTHESIA (The burning turned to pins and needles feeling that started at the top of), FATIGUE (fatigue), MYALGIA (body aches) and CHILLS (Chills) outcome was unknown and GAIT INABILITY (could not wal) had resolved.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2021-051146 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia, Rash
Clinical narrative: had a really sore arm; advised that if the rash doesn't seem to get better over next few weeks or worsens it could be due to vaccine; chills; fever; This spontaneous case was reported by an other (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (had a really sore arm), RASH (advised that if the rash doesn't seem to get better over next few weeks or worsens it could be due to vaccine), CHILLS (chills) and PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (had a really sore arm), RASH (advised that if the rash doesn't seem to get better over next few weeks or worsens it could be due to vaccine), CHILLS (chills) and PYREXIA (fever). At the time of the report, PAIN IN EXTREMITY (had a really sore arm), CHILLS (chills) and PYREXIA (fever) had resolved and RASH (advised that if the rash doesn't seem to get better over next few weeks or worsens it could be due to vaccine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient spoke with a pharmacist and stated he was planning to get the second dose of Moderna vaccine that same day and the pharmacist advised the patient to space out his treatment with Dupixent about one week from the vaccine. It is unknown at the time of this report if treatment with Dupixent had already been initiated or if it was first dispensed during this encounter with the pharmacist. The pharmacist stated other patients had reported symptom flare up after receiving COVID vaccines. The patient was advised by the pharmacist that if the rash did not get better over the next few weeks or if it worsened, it possibly could be due to the vaccine. The patient stated he had a really sore arm, fever, and chills with the first dose of COVID vaccine.  No treatment information was provided regarding events of sore arm, fever, and chills. Treatment for the rash is currently unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects; 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 VACCINATION COMPLICATION (side effects) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  Treatment information was not reported.