chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Dyspnoea, Fatigue, Neck pain
Clinical narrative: After 2nd dose, 3 days later, he started with chest pain; back pain in left side; pain in left arm; neck pain in left side; He had shortness of breath.; He also had fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (After 2nd dose, 3 days later, he started with chest pain), BACK PAIN (back pain in left side), PAIN IN EXTREMITY (pain in left arm), NECK PAIN (neck pain in left side) and DYSPNOEA (He had shortness of breath.) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jul-2021, the patient experienced CHEST PAIN (After 2nd dose, 3 days later, he started with chest pain), BACK PAIN (back pain in left side), PAIN IN EXTREMITY (pain in left arm), NECK PAIN (neck pain in left side), DYSPNOEA (He had shortness of breath.) and FATIGUE (He also had fatigue). The patient was treated with IBUPROFEN for Adverse event, at a dose of 600 mg every eight hours. At the time of the report, CHEST PAIN (After 2nd dose, 3 days later, he started with chest pain), BACK PAIN (back pain in left side), PAIN IN EXTREMITY (pain in left arm), NECK PAIN (neck pain in left side), DYSPNOEA (He had shortness of breath.) and FATIGUE (He also had fatigue) outcome was unknown.            The concomitant medication was not reported.  The reported events symptoms was on and off.   This case was linked to MOD-2021-270234 (Patient Link).
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: After 2nd dose, 3 days later, he started with chest pain; back pain in left side; pain in left arm; neck pain in left side; He had shortness of breath.; He also had fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (After 2nd dose, 3 days later, he started with chest pain), BACK PAIN (back pain in left side), PAIN IN EXTREMITY (pain in left arm), NECK PAIN (neck pain in left side) and DYSPNOEA (He had shortness of breath.) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jul-2021, the patient experienced CHEST PAIN (After 2nd dose, 3 days later, he started with chest pain), BACK PAIN (back pain in left side), PAIN IN EXTREMITY (pain in left arm), NECK PAIN (neck pain in left side), DYSPNOEA (He had shortness of breath.) and FATIGUE (He also had fatigue). The patient was treated with IBUPROFEN for Adverse event, at a dose of 600 mg every eight hours. At the time of the report, CHEST PAIN (After 2nd dose, 3 days later, he started with chest pain), BACK PAIN (back pain in left side), PAIN IN EXTREMITY (pain in left arm), NECK PAIN (neck pain in left side), DYSPNOEA (He had shortness of breath.) and FATIGUE (He also had fatigue) outcome was unknown.            The concomitant medication was not reported.  The reported events symptoms was on and off.   This case was linked to MOD-2021-270234 (Patient Link).
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Eye pain, Feeling of body temperature change, Hyperhidrosis, Malaise
Clinical narrative: Not feeling good; sweat; Sore throat; Chills; My body hurts; A lot of pain in my eyes; Feeling like hot and then cold; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling good), FEELING OF BODY TEMPERATURE CHANGE (Feeling like hot and then cold), HYPERHIDROSIS (sweat), EYE PAIN (A lot of pain in my eyes) and OROPHARYNGEAL PAIN (Sore throat) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jul-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Feeling like hot and then cold), EYE PAIN (A lot of pain in my eyes), CHILLS (Chills) and MYALGIA (My body hurts). On an unknown date, the patient experienced MALAISE (Not feeling good), HYPERHIDROSIS (sweat) and OROPHARYNGEAL PAIN (Sore throat). The patient was treated with IBUPROFEN for Chills, at a dose of 1 dosage form every six hours. At the time of the report, MALAISE (Not feeling good), FEELING OF BODY TEMPERATURE CHANGE (Feeling like hot and then cold), HYPERHIDROSIS (sweat), EYE PAIN (A lot of pain in my eyes), OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and MYALGIA (My body hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported.   It was reported that, on 25-Jul-2021, patient started with chills. Since then, he has to take every 6 hours an Ibuprofen pill which helps him not feel that cold. However, when the cold passes, he starts to feel hot. And it is like a cycle: the whole day patient is feeling cold and hot. He also stated that he is experiencing a lot of pain in the eyes and a lot of pain in the body. He mentioned that he has a sore throat, like there is an infection in the throat. He still has these symptoms to this day.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Added reporter details and events.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain
Clinical narrative: Not feeling good; sweat; Sore throat; Chills; My body hurts; A lot of pain in my eyes; Feeling like hot and then cold; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling good), FEELING OF BODY TEMPERATURE CHANGE (Feeling like hot and then cold), HYPERHIDROSIS (sweat), EYE PAIN (A lot of pain in my eyes) and OROPHARYNGEAL PAIN (Sore throat) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jul-2021, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Feeling like hot and then cold), EYE PAIN (A lot of pain in my eyes), CHILLS (Chills) and MYALGIA (My body hurts). On an unknown date, the patient experienced MALAISE (Not feeling good), HYPERHIDROSIS (sweat) and OROPHARYNGEAL PAIN (Sore throat). The patient was treated with IBUPROFEN for Chills, at a dose of 1 dosage form every six hours. At the time of the report, MALAISE (Not feeling good), FEELING OF BODY TEMPERATURE CHANGE (Feeling like hot and then cold), HYPERHIDROSIS (sweat), EYE PAIN (A lot of pain in my eyes), OROPHARYNGEAL PAIN (Sore throat), CHILLS (Chills) and MYALGIA (My body hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported.   It was reported that, on 25-Jul-2021, patient started with chills. Since then, he has to take every 6 hours an Ibuprofen pill which helps him not feel that cold. However, when the cold passes, he starts to feel hot. And it is like a cycle: the whole day patient is feeling cold and hot. He also stated that he is experiencing a lot of pain in the eyes and a lot of pain in the body. He mentioned that he has a sore throat, like there is an infection in the throat. He still has these symptoms to this day.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Added reporter details and events.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: I haven't received the 2nd dose.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I haven't received the 2nd dose.) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (I haven't received the 2nd dose.). On 29-Jul-2021, PRODUCT DOSE OMISSION ISSUE (I haven't received the 2nd dose.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       treatment and concomitant products information was not provided.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Myalgia, Product dose omission issue
Clinical narrative: never got the second dose of the vaccine; sore arm; lethargic; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), PRODUCT DOSE OMISSION ISSUE (never got the second dose of the vaccine) and MYALGIA (sore arm) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL PM) for an unknown indication.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, the patient experienced LETHARGY (lethargic) and MYALGIA (sore arm). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (never got the second dose of the vaccine). At the time of the report, LETHARGY (lethargic) and MYALGIA (sore arm) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (never got the second dose of the vaccine) 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.    treatment medication were not provided.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 28-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose) 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 relevant concomitant medications was reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Bleeding like on there periods; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Bleeding like on there periods) 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 VAGINAL HAEMORRHAGE (Bleeding like on there periods). At the time of the report, VAGINAL HAEMORRHAGE (Bleeding like on there periods) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and Treatment medications were not provided by reporter.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: Gastric Disturbances; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Gastric Disturbances) and DIARRHOEA (Diarrhea) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 091D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jul-2020, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jun-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jul-2021, the patient experienced ABDOMINAL DISCOMFORT (Gastric Disturbances) and DIARRHOEA (Diarrhea). At the time of the report, ABDOMINAL DISCOMFORT (Gastric Disturbances) and DIARRHOEA (Diarrhea) had not resolved.            Concomitant product details was not reported.  Treatment details was not reported .   This case was linked to MOD-2021-270691 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: second dose past 36 days; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (second dose past 36 days) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-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 (second dose past 36 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (second dose past 36 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment information were given by the reporter. No concomitant medication was provided.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Myalgia, Vaccination site pain
Clinical narrative: cannot raise his vaccine administered arm; pain; Soreness after 2nd dose; Tenderness after 2nd dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MOBILITY DECREASED (cannot raise his vaccine administered arm), VACCINATION SITE PAIN (pain), MYALGIA (Soreness after 2nd dose) and VACCINATION SITE PAIN (Tenderness after 2nd dose) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Gout, Hypertension and Hypercholesterolaemia.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (cannot raise his vaccine administered arm), VACCINATION SITE PAIN (pain), MYALGIA (Soreness after 2nd dose) and VACCINATION SITE PAIN (Tenderness after 2nd dose). At the time of the report, MOBILITY DECREASED (cannot raise his vaccine administered arm), VACCINATION SITE PAIN (pain), MYALGIA (Soreness after 2nd dose) and VACCINATION SITE PAIN (Tenderness after 2nd dose) had not resolved.            Concomitant medications included Unspecified Blood pressure medications, Cholesterol medications and Gout medications.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Stored in the freezer exceeded 5F and client involvement; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Stored in the freezer exceeded 5F and client involvement) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) 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 PRODUCT STORAGE ERROR (Stored in the freezer exceeded 5F and client involvement). At the time of the report, PRODUCT STORAGE ERROR (Stored in the freezer exceeded 5F and client involvement) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Mass
Clinical narrative: arm got a big bump; This spontaneous case was reported by a consumer and describes the occurrence of MASS (arm got a big bump) 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 MASS (arm got a big bump). At the time of the report, MASS (arm got a big bump) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jul-2021 and was forwarded to Moderna on 29-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A-1) for COVID-19 vaccination.     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 29-Jul-2021, the patient experienced MIGRAINE (Migraine). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 1 dosage form. At the time of the report, MIGRAINE (Migraine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was not taking any concomitant medications.   On 29-Jul-2021 patient woke up with a migraine. She reported that she gets it routinely around her menstrual cycle and she attributed her cycle for the reason for her migraine.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: Patient missed the second dose; Became infected with COVID-19 around the second week of April 2021; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jul-2021 and was forwarded to Moderna on 29-Jul-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Became infected with COVID-19 around the second week of April 2021) and PRODUCT DOSE OMISSION ISSUE (Patient missed the second dose) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     The patient's past medical history included Type 2 diabetes mellitus and Seizures.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. In April 2021, the patient experienced COVID-19 (Became infected with COVID-19 around the second week of April 2021). On 19-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient missed the second dose). On 19-Apr-2021, PRODUCT DOSE OMISSION ISSUE (Patient missed the second dose) had resolved. At the time of the report, COVID-19 (Became infected with COVID-19 around the second week of April 2021) 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 medication were not reported. The healthcare professional reported that the patient was overweight, but her exact weight was unknown. The healthcare professional reported that the patient was on a "a lot of medications" but did not report them. The patient's second dose was in the series and was schedule for 19Apr2021 but the patient missed the second dose because she became infected with COVID-19.  The HCP stated that she became infected with COVID-19 around the second week of April 2021. The patient was now (29Jul2021) requesting to receive the second dose.       Reporter did not allow further contact
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Eye discharge, Eye swelling, Illness, Neoplasm
Clinical narrative: discharge coming from her eye; neoplasm of unknown behavior/neoplasm lid leash; lump in her eye/Lump under eye; sick "like everyone else"; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jul-2021. The most recent information was received on 17-Aug-2021 and was forwarded to Moderna on 17-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick "like everyone else"), EYE DISCHARGE (discharge coming from her eye), NEOPLASM (neoplasm of unknown behavior/neoplasm lid leash) and EYE SWELLING (lump in her eye/Lump under eye) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy. Concomitant products included AMLODIPINE BESYLATE from 06-Jun-2019 to an unknown date for Blood pressure.    On 26-Mar-2021 at 2:37 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced ILLNESS (sick "like everyone else"). On 28-Mar-2021, the patient experienced EYE DISCHARGE (discharge coming from her eye), NEOPLASM (neoplasm of unknown behavior/neoplasm lid leash) and EYE SWELLING (lump in her eye/Lump under eye). The patient was treated with POLY-L-LACTIC ACID (SCULPTRA) for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (sick "like everyone else"), EYE DISCHARGE (discharge coming from her eye) and NEOPLASM (neoplasm of unknown behavior/neoplasm lid leash) outcome was unknown and EYE SWELLING (lump in her eye/Lump under eye) had resolved.            Patients was taking eye ointment with antibiotic and steroid as treatment medication .   This case was linked to MOD-2021-270779 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Follow up received contains patients demographic include height , weight, rash information , treatment medication, concomitant medication , Patient medical history,  updated event out com e
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: a patient received their first dose of the Moderna; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a patient received their first dose of the Moderna) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 28-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (a patient received their first dose of the Moderna). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a patient received their first dose of the Moderna) 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.   Description of Event or Problem was reported as : The syringe was drawn up on 27July2021 at 2:53 PM and administered on 28July2021 at 3:00PM . The syringe had been kept in the refrigerator prior to administration. No concomitant and treatment medications details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow-up document received on 02-AUG-2021 contain No New Information
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired Intramuscular Vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired Intramuscular Vaccine) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired Intramuscular Vaccine). On 27-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired Intramuscular Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    The patient received vaccine from the vial which had past 12 hours since it had been punctured. Hence the patient received an invalid dose.    No other adverse reactions were reported.  The vial did not undergo any temperature excursions.  No concomitant and treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Product dose omission issue, Vaccination complication
Clinical narrative: 6 months post first dose and has not received the second dose; Shortness of breath after first shot; Side Effects after first shot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jul-2021 and was forwarded to Moderna on 29-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath after first shot), VACCINATION COMPLICATION (Side Effects after first shot) and PRODUCT DOSE OMISSION ISSUE (6 months post first dose and has not received the second dose) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced DYSPNOEA (Shortness of breath after first shot) and VACCINATION COMPLICATION (Side Effects after first shot). On 29-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (6 months post first dose and has not received the second dose). In January 2021, DYSPNOEA (Shortness of breath after first shot) and VACCINATION COMPLICATION (Side Effects after first shot) had resolved. On 29-Jul-2021, PRODUCT DOSE OMISSION ISSUE (6 months post first dose and has not received the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment information was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: first dose in March and hasn't received second dose yet; 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 PRODUCT DOSE OMISSION ISSUE (first dose in March and hasn't received second dose yet) 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 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose in March and hasn't received second dose yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (first dose in March and hasn't received second dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Off label use, Pain in extremity, Paraesthesia oral
Clinical narrative: the second dose would be given late; face redness; tingling lips and tingling tongue; arm felt weird, it bothered the patient and it hurt; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jul-2021 and was forwarded to Moderna on 29-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (face redness), PARAESTHESIA ORAL (tingling lips and tingling tongue), PAIN IN EXTREMITY (arm felt weird, it bothered the patient and it hurt) and OFF LABEL USE (the second dose would be given late) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Sinus infection.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced ERYTHEMA (face redness), PARAESTHESIA ORAL (tingling lips and tingling tongue) and PAIN IN EXTREMITY (arm felt weird, it bothered the patient and it hurt). On an unknown date, the patient experienced OFF LABEL USE (the second dose would be given late). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Tingling mouth, at a dose of 1 dosage form. On 24-Feb-2021, PAIN IN EXTREMITY (arm felt weird, it bothered the patient and it hurt) had resolved. At the time of the report, ERYTHEMA (face redness) and PARAESTHESIA ORAL (tingling lips and tingling tongue) outcome was unknown and OFF LABEL USE (the second dose would be given late) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported by the reporter.  It was reported that the patient consulted her health care provider and an allergist for the symptoms that she experienced and both providers recommend her to get the second dose of vaccine even though the second dose would be given late.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Dyspnoea, Illness, Pain
Clinical narrative: He cannot breath; sick; pain; bones are aching; aching joints; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (He cannot breath), ILLNESS (sick), PAIN (pain), BONE PAIN (bones are aching) and ARTHRALGIA (aching joints) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (He cannot breath), ILLNESS (sick), PAIN (pain), BONE PAIN (bones are aching) and ARTHRALGIA (aching joints). The patient was treated with OXYGEN at an unspecified dose and frequency. At the time of the report, DYSPNOEA (He cannot breath), ILLNESS (sick), PAIN (pain), BONE PAIN (bones are aching) and ARTHRALGIA (aching joints) had not resolved.            No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received on 09-SEP-2021 contains NNI. On 09-Nov-2021: Non significant follow up received
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Product dose omission issue
Clinical narrative: couldn't get warm/had chills; felt tired; More than 35 days after the first dose without receiving the second dose; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (couldn't get warm/had chills), FATIGUE (felt tired) and PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039C21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included AMLODIPINE and LISINOPRIL for an unknown indication.    On 19-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (couldn't get warm/had chills), FATIGUE (felt tired) and PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose). At the time of the report, CHILLS (couldn't get warm/had chills) and FATIGUE (felt tired) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  Patient missed appointment for the second dose on 17-jul-2021.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Neck pain, Tremor
Clinical narrative: Pain in neck; Pain in shoulder; Shaking that he cannot control, uncontrollable shaking and Tremors; Chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking that he cannot control, uncontrollable shaking and Tremors), NECK PAIN (Pain in neck), CHILLS (Chills) and ARTHRALGIA (Pain in shoulder) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-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 TREMOR (Shaking that he cannot control, uncontrollable shaking and Tremors) and CHILLS (Chills). On 04-Apr-2021 at 2:30 AM, the patient experienced NECK PAIN (Pain in neck) and ARTHRALGIA (Pain in shoulder). At the time of the report, TREMOR (Shaking that he cannot control, uncontrollable shaking and Tremors), NECK PAIN (Pain in neck), CHILLS (Chills) and ARTHRALGIA (Pain in shoulder) outcome was unknown.            No concomitant medications were provided. Treatment medications were not provided. This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking that he cannot control, uncontrollable shaking and Tremors), NECK PAIN (Pain in neck), CHILLS (Chills) and ARTHRALGIA (Pain in shoulder) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-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 TREMOR (Shaking that he cannot control, uncontrollable shaking and Tremors) and CHILLS (Chills). On 04-Apr-2021 at 2:30 AM, the patient experienced NECK PAIN (Pain in neck) and ARTHRALGIA (Pain in shoulder). At the time of the report, TREMOR (Shaking that he cannot control, uncontrollable shaking and Tremors), NECK PAIN (Pain in neck), CHILLS (Chills) and ARTHRALGIA (Pain in shoulder) outcome was unknown.            No concomitant medications were provided. Treatment medications were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Product Storage Error; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Product Storage Error) 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 PRODUCT STORAGE ERROR (Product Storage Error). At the time of the report, PRODUCT STORAGE ERROR (Product Storage Error) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned. No treatment medication was mentioned.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore injection site left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site left arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011LT0A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore injection site left arm). At the time of the report, VACCINATION SITE PAIN (sore injection site left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-270792 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received first dose on 11MAY2021 and second dose today which is more than 42 days ago; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first dose on 11MAY2021 and second dose today which is more than 42 days ago) 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 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first dose on 11MAY2021 and second dose today which is more than 42 days ago). On 27-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received first dose on 11MAY2021 and second dose today which is more than 42 days ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dry throat, Fatigue, Oropharyngeal pain
Clinical narrative: Cough; Dry Throat; Sore Throat; Tired; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat), COUGH (Cough), DRY THROAT (Dry Throat) and FATIGUE (Tired) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, the patient experienced FATIGUE (Tired). On 27-Jul-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat) and DRY THROAT (Dry Throat). On 29-Jul-2021, the patient experienced COUGH (Cough). On 28-Jul-2021, FATIGUE (Tired) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore Throat), COUGH (Cough) and DRY THROAT (Dry Throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jul-2021 and was forwarded to Moderna on 29-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 CHILLS (chills). At the time of the report, CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient had enquired regarding the use of medicines to reduce chills.  No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fall, Gait disturbance, Groin pain, Hypoaesthesia
Clinical narrative: she cannot lay horizontal; pain in the joints in her legs; fell down twice; threw up twice; slept for 20 hours/fell asleep at the wheel/fell asleep in her car; felt incredible pain in her whole body; toes and feet felt numb; pain progressed to calves and thighs/she has pain in her hips, thighs, through her upper body; nerve damage that is escalating; nerve pain; she cannot walk; pain progressed horizontal through her midline and groin; pain progressed horizontal through her midline and groin; This spontaneous case was reported by a consumer and describes the occurrence of FALL (fell down twice), VOMITING (threw up twice), SOMNOLENCE (slept for 20 hours/fell asleep at the wheel/fell asleep in her car), PAIN (felt incredible pain in her whole body) and HYPOAESTHESIA (toes and feet felt numb) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced FALL (fell down twice), VOMITING (threw up twice), SOMNOLENCE (slept for 20 hours/fell asleep at the wheel/fell asleep in her car) and PAIN (felt incredible pain in her whole body). In April 2021, the patient experienced HYPOAESTHESIA (toes and feet felt numb), PAIN IN EXTREMITY (pain progressed to calves and thighs/she has pain in her hips, thighs, through her upper body), NEURALGIA (nerve pain), GAIT DISTURBANCE (she cannot walk) and NERVE INJURY (nerve damage that is escalating). In 2021, the patient experienced GROIN PAIN (pain progressed horizontal through her midline and groin) and RADIATION ASSOCIATED PAIN (pain progressed horizontal through her midline and groin). In July 2021, the patient experienced MOBILITY DECREASED (she cannot lay horizontal) and ARTHRALGIA (pain in the joints in her legs). On 16-Apr-2021, FALL (fell down twice) and SOMNOLENCE (slept for 20 hours/fell asleep at the wheel/fell asleep in her car) outcome was unknown, VOMITING (threw up twice) had resolved. At the time of the report, PAIN (felt incredible pain in her whole body), HYPOAESTHESIA (toes and feet felt numb), PAIN IN EXTREMITY (pain progressed to calves and thighs/she has pain in her hips, thighs, through her upper body), GROIN PAIN (pain progressed horizontal through her midline and groin), NEURALGIA (nerve pain), GAIT DISTURBANCE (she cannot walk), MOBILITY DECREASED (she cannot lay horizontal), ARTHRALGIA (pain in the joints in her legs), NERVE INJURY (nerve damage that is escalating) and RADIATION ASSOCIATED PAIN (pain progressed horizontal through her midline and groin) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.