chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Feeling abnormal, Limb discomfort, Neck pain
Clinical narrative: chest  painon the right side; pain from neck to shoulder; difficultly moving his arm; body pain in his side; felt weird; shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest  painon the right side), NECK PAIN (pain from neck to shoulder), LIMB DISCOMFORT (difficultly moving his arm), PAIN (body pain in his side) and FEELING ABNORMAL (felt weird) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jul-2021 at 2:40 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced CHEST PAIN (chest  painon the right side), NECK PAIN (pain from neck to shoulder), LIMB DISCOMFORT (difficultly moving his arm), PAIN (body pain in his side), FEELING ABNORMAL (felt weird) and ARTHRALGIA (shoulder pain). At the time of the report, CHEST PAIN (chest  painon the right side), NECK PAIN (pain from neck to shoulder), LIMB DISCOMFORT (difficultly moving his arm), PAIN (body pain in his side), FEELING ABNORMAL (felt weird) and ARTHRALGIA (shoulder pain) had not resolved.        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 provided.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: chest  painon the right side; pain from neck to shoulder; difficultly moving his arm; body pain in his side; felt weird; shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest  painon the right side), NECK PAIN (pain from neck to shoulder), LIMB DISCOMFORT (difficultly moving his arm), PAIN (body pain in his side) and FEELING ABNORMAL (felt weird) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jul-2021 at 2:40 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced CHEST PAIN (chest  painon the right side), NECK PAIN (pain from neck to shoulder), LIMB DISCOMFORT (difficultly moving his arm), PAIN (body pain in his side), FEELING ABNORMAL (felt weird) and ARTHRALGIA (shoulder pain). At the time of the report, CHEST PAIN (chest  painon the right side), NECK PAIN (pain from neck to shoulder), LIMB DISCOMFORT (difficultly moving his arm), PAIN (body pain in his side), FEELING ABNORMAL (felt weird) and ARTHRALGIA (shoulder pain) had not resolved.        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 provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Headache, Illness, Nausea
Clinical narrative: ever sick; Vertigo; Headaches; Stomach not normal; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach not normal), VERTIGO (Vertigo), FATIGUE (Fatigue), NAUSEA (Nausea) and HEADACHE (Headaches) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach not normal), FATIGUE (Fatigue) and NAUSEA (Nausea). On 26-Jun-2021, the patient experienced VERTIGO (Vertigo) and HEADACHE (Headaches). On an unknown date, the patient experienced ILLNESS (ever sick). The patient was treated with CHLORPHENIRAMINE [CHLORPHENAMINE] at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 14-May-2021, ABDOMINAL DISCOMFORT (Stomach not normal), FATIGUE (Fatigue) and NAUSEA (Nausea) had resolved. At the time of the report, VERTIGO (Vertigo), HEADACHE (Headaches) and ILLNESS (ever sick) outcome was unknown.            The concomitant medication was not reported. Patient stated that the headaches are getting better,and slowly getting better.   This case was linked to MOD-2021-060849.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow up  received on 03-Aug-2021 with no new information(NNI)
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: ever sick; Vertigo; Headaches; Stomach not normal; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach not normal), VERTIGO (Vertigo), FATIGUE (Fatigue), NAUSEA (Nausea) and HEADACHE (Headaches) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach not normal), FATIGUE (Fatigue) and NAUSEA (Nausea). On 26-Jun-2021, the patient experienced VERTIGO (Vertigo) and HEADACHE (Headaches). On an unknown date, the patient experienced ILLNESS (ever sick). The patient was treated with CHLORPHENIRAMINE [CHLORPHENAMINE] at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 14-May-2021, ABDOMINAL DISCOMFORT (Stomach not normal), FATIGUE (Fatigue) and NAUSEA (Nausea) had resolved. At the time of the report, VERTIGO (Vertigo), HEADACHE (Headaches) and ILLNESS (ever sick) outcome was unknown.            The concomitant medication was not reported. Patient stated that the headaches are getting better,and slowly getting better.   This case was linked to MOD-2021-060849.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow up  received on 03-Aug-2021 with no new information(NNI)
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: After injection it was swollen; After injection it was swollen and hurt, tender the second day; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE SWELLING (After injection it was swollen) and VACCINATION SITE PAIN (After injection it was swollen and hurt, tender the second day) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Fat redistribution: Sculptra (Had sculptra 6 years ago for fat loss). Concurrent medical conditions included HIV disease, Neuropathy, Sulfonamide allergy (Sulfa allergy) and Blood pressure management (Blood pressure issues NOS). Concomitant products included POLY-L-LACTIC ACID (SCULPTRA) for an unknown indication.    In April 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 VACCINATION SITE SWELLING (After injection it was swollen) and VACCINATION SITE PAIN (After injection it was swollen and hurt, tender the second day). At the time of the report, VACCINATION SITE SWELLING (After injection it was swollen) and VACCINATION SITE PAIN (After injection it was swollen and hurt, tender the second day) had resolved.        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 also included HIV medication, blood pressure medication, antioxidant face cream and supplements NOS. No treatment medication was provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Burning sensation, Dry skin, Paraesthesia, Rash
Clinical narrative: It was like she had needles on her; A little blister came up and then they were like ring worms; The first day it burned; The first day it burned, and now it kind of gets real dry; Some of the rash are raised; she broke out in this weird looking rash/it popped, and then it got rounder and straight on her side, a straight line on her side from his breast down, and it looks like coded in ring worms/the rash is everywhere in her body/broke out in this rash; Knot on her arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Knot on her arm), PARAESTHESIA (It was like she had needles on her), BLISTER (A little blister came up and then they were like ring worms), BURNING SENSATION (The first day it burned) and DRY SKIN (The first day it burned, and now it kind of gets real dry) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jul-2021, the patient experienced SWELLING (Knot on her arm). On 02-Jul-2021, the patient experienced PARAESTHESIA (It was like she had needles on her), BURNING SENSATION (The first day it burned), DRY SKIN (The first day it burned, and now it kind of gets real dry), RASH PAPULAR (Some of the rash are raised) and RASH (she broke out in this weird looking rash/it popped, and then it got rounder and straight on her side, a straight line on her side from his breast down, and it looks like coded in ring worms/the rash is everywhere in her body/broke out in this rash). 02-Jul-2021, the patient experienced BLISTER (A little blister came up and then they were like ring worms). At the time of the report, SWELLING (Knot on her arm), PARAESTHESIA (It was like she had needles on her), BLISTER (A little blister came up and then they were like ring worms), BURNING SENSATION (The first day it burned) and DRY SKIN (The first day it burned, and now it kind of gets real dry) outcome was unknown and RASH PAPULAR (Some of the rash are raised) and RASH (she broke out in this weird looking rash/it popped, and then it got rounder and straight on her side, a straight line on her side from his breast down, and it looks like coded in ring worms/the rash is everywhere in her body/broke out in this rash) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No relevant concomitant medications were reported Treatment medications included shampoo and an ointment.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular, Swelling
Clinical narrative: It was like she had needles on her; A little blister came up and then they were like ring worms; The first day it burned; The first day it burned, and now it kind of gets real dry; Some of the rash are raised; she broke out in this weird looking rash/it popped, and then it got rounder and straight on her side, a straight line on her side from his breast down, and it looks like coded in ring worms/the rash is everywhere in her body/broke out in this rash; Knot on her arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Knot on her arm), PARAESTHESIA (It was like she had needles on her), BLISTER (A little blister came up and then they were like ring worms), BURNING SENSATION (The first day it burned) and DRY SKIN (The first day it burned, and now it kind of gets real dry) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jul-2021, the patient experienced SWELLING (Knot on her arm). On 02-Jul-2021, the patient experienced PARAESTHESIA (It was like she had needles on her), BURNING SENSATION (The first day it burned), DRY SKIN (The first day it burned, and now it kind of gets real dry), RASH PAPULAR (Some of the rash are raised) and RASH (she broke out in this weird looking rash/it popped, and then it got rounder and straight on her side, a straight line on her side from his breast down, and it looks like coded in ring worms/the rash is everywhere in her body/broke out in this rash). 02-Jul-2021, the patient experienced BLISTER (A little blister came up and then they were like ring worms). At the time of the report, SWELLING (Knot on her arm), PARAESTHESIA (It was like she had needles on her), BLISTER (A little blister came up and then they were like ring worms), BURNING SENSATION (The first day it burned) and DRY SKIN (The first day it burned, and now it kind of gets real dry) outcome was unknown and RASH PAPULAR (Some of the rash are raised) and RASH (she broke out in this weird looking rash/it popped, and then it got rounder and straight on her side, a straight line on her side from his breast down, and it looks like coded in ring worms/the rash is everywhere in her body/broke out in this rash) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No relevant concomitant medications were reported Treatment medications included shampoo and an ointment.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cardiac discomfort, Heart rate, Product dose omission issue, Vaccination site mass
Clinical narrative: received it last 18-May-2021/recommended not to take the second dose; Heart felt weird; Lump has fluid in it; Lump is warm to touch; Lump on the injection site for about six inches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARDIAC DISCOMFORT (Heart felt weird), VACCINATION SITE OEDEMA (Lump has fluid in it), VACCINATION SITE WARMTH (Lump is warm to touch), VACCINATION SITE MASS (Lump on the injection site for about six inches) and PRODUCT DOSE OMISSION ISSUE (received it last 18-May-2021/recommended not to take the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Low blood pressure.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced CARDIAC DISCOMFORT (Heart felt weird), VACCINATION SITE OEDEMA (Lump has fluid in it), VACCINATION SITE WARMTH (Lump is warm to touch) and VACCINATION SITE MASS (Lump on the injection site for about six inches). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (received it last 18-May-2021/recommended not to take the second dose). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, CARDIAC DISCOMFORT (Heart felt weird), VACCINATION SITE OEDEMA (Lump has fluid in it), VACCINATION SITE WARMTH (Lump is warm to touch) and VACCINATION SITE MASS (Lump on the injection site for about six inches) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (received it last 18-May-2021/recommended not to take the second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Blood pressure measurement: low (Low) her usual low blood pressure was lower than expected.. On 24-May-2021, Heart rate: high (High) High.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No relevant concomitant medications were reported.  Patient was also instructed to take two Tylenol but she did not take.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site oedema, Vaccination site warmth
Clinical narrative: received it last 18-May-2021/recommended not to take the second dose; Heart felt weird; Lump has fluid in it; Lump is warm to touch; Lump on the injection site for about six inches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARDIAC DISCOMFORT (Heart felt weird), VACCINATION SITE OEDEMA (Lump has fluid in it), VACCINATION SITE WARMTH (Lump is warm to touch), VACCINATION SITE MASS (Lump on the injection site for about six inches) and PRODUCT DOSE OMISSION ISSUE (received it last 18-May-2021/recommended not to take the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Low blood pressure.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced CARDIAC DISCOMFORT (Heart felt weird), VACCINATION SITE OEDEMA (Lump has fluid in it), VACCINATION SITE WARMTH (Lump is warm to touch) and VACCINATION SITE MASS (Lump on the injection site for about six inches). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (received it last 18-May-2021/recommended not to take the second dose). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, CARDIAC DISCOMFORT (Heart felt weird), VACCINATION SITE OEDEMA (Lump has fluid in it), VACCINATION SITE WARMTH (Lump is warm to touch) and VACCINATION SITE MASS (Lump on the injection site for about six inches) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (received it last 18-May-2021/recommended not to take the second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Blood pressure measurement: low (Low) her usual low blood pressure was lower than expected.. On 24-May-2021, Heart rate: high (High) High.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No relevant concomitant medications were reported.  Patient was also instructed to take two Tylenol but she did not take.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Inappropriate schedule of product administration, Rash, Swelling face
Clinical narrative: Allergy on face and neck; Face and Neck swollen; Patient took first dose on 5-MAY-2021,Second dose on  June 20, 2021; Rash; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HYPERSENSITIVITY (Allergy on face and neck), SWELLING FACE (Face and Neck swollen), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose on 5-MAY-2021,Second dose on  June 20, 2021) and RASH (Rash) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03AB21A and 021Z21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced HYPERSENSITIVITY (Allergy on face and neck), SWELLING FACE (Face and Neck swollen), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient took first dose on 5-MAY-2021,Second dose on  June 20, 2021) and RASH (Rash). At the time of the report, HYPERSENSITIVITY (Allergy on face and neck), SWELLING FACE (Face and Neck swollen) and RASH (Rash) outcome was unknown.            Patient Medical History and Allergies were reported as None.  Treatment information and concomitant medication information was not reported.  The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Not applicable) was Not applicable.   This case was linked to MOD-2021-272393 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 2nd dose not yet received/The pharmacist stated that since it is past 42 days period; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose not yet received/The pharmacist stated that since it is past 42 days period) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-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 (2nd dose not yet received/The pharmacist stated that since it is past 42 days period). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd dose not yet received/The pharmacist stated that since it is past 42 days period) 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.   Reporter stated that the patient was going to receive 2nd dose on 30 JUL 2021.  No relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Muscle disorder
Clinical narrative: Imbalance; Muscle issues; 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 BALANCE DISORDER (Imbalance) and MUSCLE DISORDER (Muscle issues) 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 BALANCE DISORDER (Imbalance) and MUSCLE DISORDER (Muscle issues). At the time of the report, BALANCE DISORDER (Imbalance) and MUSCLE DISORDER (Muscle issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medications were not reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Pyrexia
Clinical narrative: high fever; body aches and pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high fever) and MYALGIA (body aches and pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (high fever) and MYALGIA (body aches and pain). The patient was treated with IBUPROFEN for Adverse event NOS, at an unspecified dose and frequency. At the time of the report, PYREXIA (high fever) and MYALGIA (body aches and pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) 102°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested postive with Covid-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Tested postive with Covid-19) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested postive with Covid-19). At the time of the report, COVID-19 (Tested postive with Covid-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) Positive.     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 relevant concomitant medications were provided.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects; 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: bell's palsy; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BELL'S PALSY (bell's palsy) 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) at an unspecified dose. On an unknown date, the patient experienced BELL'S PALSY (bell's palsy). At the time of the report, BELL'S PALSY (bell's palsy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was provided  Company Comment: Very limited information regarding this event has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: All patients who received the vaccine between 7/16/21 and 7/28/21 received the vaccine after 30 days BUD; 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 (All patients who received the vaccine between 7/16/21 and 7/28/21 received the vaccine after 30 days BUD) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) 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 EXPIRED PRODUCT ADMINISTERED (All patients who received the vaccine between 7/16/21 and 7/28/21 received the vaccine after 30 days BUD). At the time of the report, EXPIRED PRODUCT ADMINISTERED (All patients who received the vaccine between 7/16/21 and 7/28/21 received the vaccine after 30 days BUD) had resolved.        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.   there were 100 vials (1000 doses) received and kept at appropriate refrigeration temp 2C-8C since the morning of 6/15/21. Unfortunately, at 30 days after the storage in appropriate refrigeration temp, the vials continued to be used in the clinic and administered to patients. There were no temperature excursions from 6/15/21 through 7/28/21, but all patients who received the vaccine between 7/16/21 and 7/28/21 received the vaccine after 30 days. The vials were removed from refrigeration after each day of use, and were administered or wasted within 8 hours at room temp (21C-22C).  No concomitant medications were reported.  No treatment information was provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Neck surgery
Clinical narrative: patient stated having surgery, a neck fusion, a week ago - before second dose; This spontaneous case was reported by a consumer and describes the occurrence of NECK SURGERY (patient stated having surgery, a neck fusion, a week ago - before second dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     Concomitant products included CYCLOBENZAPRINE, BENAZEPRIL and METOPROLOL for an unknown indication.    On 01-Jul-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 NECK SURGERY (patient stated having surgery, a neck fusion, a week ago - before second dose). At the time of the report, NECK SURGERY (patient stated having surgery, a neck fusion, a week ago - before second dose) outcome was unknown.            Treatment information was not provided by the reporter.  Company Comment: Very limited information regarding the event has been provided at this time. Patient stated that she had no adverse events after the first dose. Further information has been requested.   This case was linked to MOD-2021-272329 (Patient Link).; Sender's Comments: Very limited information regarding the event has been provided at this time. Patient stated that she had no adverse events after the first dose. Further information has been requested.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: under 18 years; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years). On 14-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (under 18 years) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment information provided.   This case was linked to MOD-2021-272958 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Full blood count, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Swollen glands on her neck; Red band all around the site of the injection; Swollen lymph nodes on her  left armpit; Itching at the area of the injection; Swelling at the area of the injection/whole upper left arm is larger; Whole biceps was hot; Whole biceps was red; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Whole biceps was hot), ERYTHEMA (Whole biceps was red), LYMPHADENOPATHY (Swollen glands on her neck), VACCINATION SITE PRURITUS (Itching at the area of the injection) and VACCINATION SITE SWELLING (Swelling at the area of the injection/whole upper left arm is larger) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced FEELING HOT (Whole biceps was hot), ERYTHEMA (Whole biceps was red), VACCINATION SITE PRURITUS (Itching at the area of the injection), VACCINATION SITE SWELLING (Swelling at the area of the injection/whole upper left arm is larger) and LYMPHADENOPATHY (Swollen lymph nodes on her  left armpit). On 02-Aug-2021, the patient experienced LYMPHADENOPATHY (Swollen glands on her neck) and VACCINATION SITE ERYTHEMA (Red band all around the site of the injection). At the time of the report, FEELING HOT (Whole biceps was hot), ERYTHEMA (Whole biceps was red), LYMPHADENOPATHY (Swollen glands on her neck), VACCINATION SITE PRURITUS (Itching at the area of the injection), VACCINATION SITE SWELLING (Swelling at the area of the injection/whole upper left arm is larger), VACCINATION SITE ERYTHEMA (Red band all around the site of the injection) and LYMPHADENOPATHY (Swollen lymph nodes on her  left armpit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood count: negative (Negative) Negative. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Monospot test was done and results were negative.   No laboratory data was reported. No Treatment information was reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Swollen glands on her neck; Red band all around the site of the injection; Swollen lymph nodes on her  left armpit; Itching at the area of the injection; Swelling at the area of the injection/whole upper left arm is larger; Whole biceps was hot; Whole biceps was red; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Whole biceps was hot), ERYTHEMA (Whole biceps was red), LYMPHADENOPATHY (Swollen glands on her neck), VACCINATION SITE PRURITUS (Itching at the area of the injection) and VACCINATION SITE SWELLING (Swelling at the area of the injection/whole upper left arm is larger) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced FEELING HOT (Whole biceps was hot), ERYTHEMA (Whole biceps was red), VACCINATION SITE PRURITUS (Itching at the area of the injection), VACCINATION SITE SWELLING (Swelling at the area of the injection/whole upper left arm is larger) and LYMPHADENOPATHY (Swollen lymph nodes on her  left armpit). On 02-Aug-2021, the patient experienced LYMPHADENOPATHY (Swollen glands on her neck) and VACCINATION SITE ERYTHEMA (Red band all around the site of the injection). At the time of the report, FEELING HOT (Whole biceps was hot), ERYTHEMA (Whole biceps was red), LYMPHADENOPATHY (Swollen glands on her neck), VACCINATION SITE PRURITUS (Itching at the area of the injection), VACCINATION SITE SWELLING (Swelling at the area of the injection/whole upper left arm is larger), VACCINATION SITE ERYTHEMA (Red band all around the site of the injection) and LYMPHADENOPATHY (Swollen lymph nodes on her  left armpit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood count: negative (Negative) Negative. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Monospot test was done and results were negative.   No laboratory data was reported. No Treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: had reactions; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had reactions) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had reactions). At the time of the report, VACCINATION COMPLICATION (had reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  Treatment information was not provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Peripheral swelling
Clinical narrative: Arm  is swelling; Has nodes under armpit/makes painful; Has nodes under armpit; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm  is swelling), LYMPH NODE PAIN (Has nodes under armpit/makes painful) and LYMPHADENOPATHY (Has nodes under armpit) 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 25-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm  is swelling), LYMPH NODE PAIN (Has nodes under armpit/makes painful) and LYMPHADENOPATHY (Has nodes under armpit). At the time of the report, PERIPHERAL SWELLING (Arm  is swelling), LYMPH NODE PAIN (Has nodes under armpit/makes painful) and LYMPHADENOPATHY (Has nodes under armpit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot
Clinical narrative: Hot; Super fatigued; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Hot) and FATIGUE (Super fatigued) 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 02-Aug-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced FEELING HOT (Hot) and FATIGUE (Super fatigued). At the time of the report, FEELING HOT (Hot) and FATIGUE (Super fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Vaccination site pain
Clinical narrative: Left arm hurting at site of injection; left arm swelling; half dollar size/quarter size redness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left arm swelling), ERYTHEMA (half dollar size/quarter size redness) and VACCINATION SITE PAIN (Left arm hurting at site of injection) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, the patient experienced PERIPHERAL SWELLING (left arm swelling) and ERYTHEMA (half dollar size/quarter size redness). On 01-Aug-2021, the patient experienced VACCINATION SITE PAIN (Left arm hurting at site of injection). In June 2021, PERIPHERAL SWELLING (left arm swelling) and ERYTHEMA (half dollar size/quarter size redness) had resolved. At the time of the report, VACCINATION SITE PAIN (Left arm hurting at site of injection) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant information was provided.  The patient reported arm swelling and redness got better prior to his second injection. The patient reported hurting in left arm at injection site goes down to muscle when he pressed down about an inch.  The patient had not taken anything for treatment.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Consumer answered "Yes" when the computer program asked if they had received the Moderna COVID-19 Vaccine and experienced a side effect.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Consumer answered "Yes" when the computer program asked if they had received the Moderna COVID-19 Vaccine and experienced 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 VACCINATION COMPLICATION (Consumer answered "Yes" when the computer program asked if they had received the Moderna COVID-19 Vaccine and experienced a side effect.). At the time of the report, VACCINATION COMPLICATION (Consumer answered "Yes" when the computer program asked if they had received the Moderna COVID-19 Vaccine and experienced a side effect.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication was reported.   No treatment information was provided.   No laboratory data was provided
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Feeling arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Feeling arm pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included CARBAMAZEPINE, GABAPENTIN, LAMOTRIGINE, METOPROLOL, HYDROXYCARBAMIDE (HYDROXYUREA) and CALCIUM for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Feeling arm pain). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at a dose of 1 dosage form. On 05-Feb-2021, PAIN IN EXTREMITY (Feeling arm pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient consented for a followup from the safety team and preferred method of contact was telephone.   This case was linked to MOD-2021-272923 (Patient Link).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Fear of injection, Illness, Mobility decreased, Product dose omission issue
Clinical narrative: first dose of the Moderna Covid-19 vaccine on 15PAR2021 and got scared to receive the second dose; Felt tired; Got scared/kind of scared him; It made him sick, put him down for a day kind of scared him; Put him down for a day kind of scared him; This spontaneous case was reported by a consumer and describes the occurrence of FEAR OF INJECTION (Got scared/kind of scared him), ILLNESS (It made him sick, put him down for a day kind of scared him), MOBILITY DECREASED (Put him down for a day kind of scared him), PRODUCT DOSE OMISSION ISSUE (first dose of the Moderna Covid-19 vaccine on 15PAR2021 and got scared to receive the second dose) and FATIGUE (Felt tired) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045AZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Hypertension. Concomitant products included METFORMIN, FINASTERIDE, GABAPENTIN and TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced FEAR OF INJECTION (Got scared/kind of scared him), ILLNESS (It made him sick, put him down for a day kind of scared him) and MOBILITY DECREASED (Put him down for a day kind of scared him). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose of the Moderna Covid-19 vaccine on 15PAR2021 and got scared to receive the second dose) and FATIGUE (Felt tired). At the time of the report, FEAR OF INJECTION (Got scared/kind of scared him), ILLNESS (It made him sick, put him down for a day kind of scared him), MOBILITY DECREASED (Put him down for a day kind of scared him) and FATIGUE (Felt tired) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (first dose of the Moderna Covid-19 vaccine on 15PAR2021 and got scared to receive the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient got scared to receive the second dose. Caller states that a couple of hours after receiving the first dose of the vaccine, it made him sick, put him down for a day and kind of scared him, felt tired and the feeling lasted a day. Patient did not take any medication because he is diabetic and has high blood pressure. No treatment information was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Myalgia, Neck pain
Clinical narrative: neck pain that is shooting down the arm; muscle ache, muscle pain; Headache; fatigue; weakness; Arm Pain; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), NECK PAIN (neck pain that is shooting down the arm), PAIN IN EXTREMITY (Arm Pain), MYALGIA (muscle ache, muscle pain) and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CARBAMAZEPINE, GABAPENTIN, LAMOTRIGINE, METOPROLOL, HYDROXYCARBAMIDE (HYDROXYUREA) and CALCIUM 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 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain). On 03-Mar-2021, the patient experienced ASTHENIA (weakness), HEADACHE (Headache) and FATIGUE (fatigue). On an unknown date, the patient experienced NECK PAIN (neck pain that is shooting down the arm) and MYALGIA (muscle ache, muscle pain). On 05-Feb-2021, PAIN IN EXTREMITY (Arm Pain) had resolved. On 04-Mar-2021, ASTHENIA (weakness) and HEADACHE (Headache) had resolved. At the time of the report, NECK PAIN (neck pain that is shooting down the arm), MYALGIA (muscle ache, muscle pain) and FATIGUE (fatigue) had resolved.            Treatment information was also not reported. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Not applicable) was Not applicable.   This case was linked to MOD-2021-272911 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: significant FU- AE outcome updated to resolved.