chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: First dose 4 month ago and missed second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First dose 4 month ago and missed second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (First dose 4 month ago and missed second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First dose 4 month ago and missed second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant products were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Second dose not yet administered - more than 36 to 42 days from first dose; 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 PRODUCT DOSE OMISSION ISSUE (Second dose not yet administered - more than 36 to 42 days from first dose) 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 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose not yet administered - more than 36 to 42 days from first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose not yet administered - more than 36 to 42 days from first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant products were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Blood corticotrophin increased, Pyrexia
Clinical narrative: Low grade fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Low grade fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 04421a) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Thyroid disorder NOS.   On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced PYREXIA (Low grade fever). At the time of the report, PYREXIA (Low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood corticotrophin increased: 497 (High) results was extremely high with hormone level of 497..         Patient received second of moderna vaccine on 05Jul2021. patient experienced low grade fever. patient was a lab data ATCH test and the result was extremely high with hormone level of 497. patient was received IV for steroids. Patient asked can the Moderna vaccine cause a false lab report. Patient asked will anyone reach out to her. Consent to Safety.Concomitant medication includes steroids, thyroid meds, blood pressure meds. treatment includes IV for steroids.Action taken with mRNA-1273 in response to the events were not applicable. Upon internal review on 05-Aug-2021, the age was confirmed to be unknown. Source document appears to contain erroneous data. Linked case for same patient captured date of birth as 21-May-1956.    This case was linked to MOD-2021-079067 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE, VALSARTAN (DIOVAN HCT) from 2015 to an unknown date for Blood pressure high, MONASCUS PURPUREUS, UBIDECARENONE (CHOLEAST) for High cholesterol, COLECALCIFEROL (VITAMIN D 3) for Vitamin D decreased.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (Fever). The patient was treated with ACETAMINOPHEN at a dose of 625 milligram. On 16-Feb-2021, PYREXIA (Fever) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2021, Body temperature: 100 (High) developed a fever of 100 during the night..         This case was linked to MOD-2021-013023 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 35 days after the first dose without receiving the second dose; This case was received via Regulatory Authority (Reference number: 119152) on 09-Jul-2021 and was forwarded to Moderna on 09-Jul-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) 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.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose). At the time of the report, 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.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. Treatment information was not provided.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Influenza like illness, Myalgia
Clinical narrative: cold; Runny nose; Sneezing; loss of sense of smell; Loss of taste; symptoms of flu; Chills; A little fever; A little body aching; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Chills), PYREXIA (A little fever), MYALGIA (A little body aching), NASOPHARYNGITIS (cold) and RHINORRHOEA (Runny nose) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced CHILLS (Chills), PYREXIA (A little fever) and MYALGIA (A little body aching). On 06-Jun-2021, the patient experienced NASOPHARYNGITIS (cold), RHINORRHOEA (Runny nose), SNEEZING (Sneezing), ANOSMIA (loss of sense of smell), AGEUSIA (Loss of taste) and INFLUENZA LIKE ILLNESS (symptoms of flu). On 04-Jun-2021, PYREXIA (A little fever) had resolved. At the time of the report, CHILLS (Chills), MYALGIA (A little body aching), NASOPHARYNGITIS (cold), RHINORRHOEA (Runny nose), SNEEZING (Sneezing), ANOSMIA (loss of sense of smell), AGEUSIA (Loss of taste) and INFLUENZA LIKE ILLNESS (symptoms of flu) outcome was unknown.            Concomitant product use was not provided by the reporter.   No treatment information was provided.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pyrexia, Rhinorrhoea, Sneezing
Clinical narrative: cold; Runny nose; Sneezing; loss of sense of smell; Loss of taste; symptoms of flu; Chills; A little fever; A little body aching; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Chills), PYREXIA (A little fever), MYALGIA (A little body aching), NASOPHARYNGITIS (cold) and RHINORRHOEA (Runny nose) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced CHILLS (Chills), PYREXIA (A little fever) and MYALGIA (A little body aching). On 06-Jun-2021, the patient experienced NASOPHARYNGITIS (cold), RHINORRHOEA (Runny nose), SNEEZING (Sneezing), ANOSMIA (loss of sense of smell), AGEUSIA (Loss of taste) and INFLUENZA LIKE ILLNESS (symptoms of flu). On 04-Jun-2021, PYREXIA (A little fever) had resolved. At the time of the report, CHILLS (Chills), MYALGIA (A little body aching), NASOPHARYNGITIS (cold), RHINORRHOEA (Runny nose), SNEEZING (Sneezing), ANOSMIA (loss of sense of smell), AGEUSIA (Loss of taste) and INFLUENZA LIKE ILLNESS (symptoms of flu) outcome was unknown.            Concomitant product use was not provided by the reporter.   No treatment information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Impaired work ability, Inappropriate schedule of product administration
Clinical narrative: Very dizzy; Weak; 4 months between administration of doses; Feeling very tired; Couldn't do anything; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED WORK ABILITY (Couldn't do anything), DIZZINESS (Very dizzy), ASTHENIA (Weak), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (4 months between administration of doses) and FATIGUE (Feeling very tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2021, the patient experienced IMPAIRED WORK ABILITY (Couldn't do anything), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (4 months between administration of doses) and FATIGUE (Feeling very tired). On 09-Jul-2021, the patient experienced DIZZINESS (Very dizzy) and ASTHENIA (Weak). On 08-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (4 months between administration of doses) had resolved. At the time of the report, IMPAIRED WORK ABILITY (Couldn't do anything), DIZZINESS (Very dizzy), ASTHENIA (Weak) and FATIGUE (Feeling very tired) outcome was unknown.            No concomitant products were provided by the reporter.  No treatment medication was provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite, Hypoaesthesia, Hypoaesthesia oral, Product dose omission issue, Rash
Clinical narrative: Didn't get second dose - almost 6 months; Rash the size of half a dollar below her breast and above her waist; Left side of face went numb; Numbness including lips; "Tick" where her left eyelid is; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Left side of face went numb), HYPOAESTHESIA ORAL (Numbness including lips), ARTHROPOD BITE ("Tick" where her left eyelid is), PRODUCT DOSE OMISSION ISSUE (Didn't get second dose - almost 6 months) and RASH (Rash the size of half a dollar below her breast and above her waist) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced HYPOAESTHESIA (Left side of face went numb), HYPOAESTHESIA ORAL (Numbness including lips), ARTHROPOD BITE ("Tick" where her left eyelid is) and RASH (Rash the size of half a dollar below her breast and above her waist). On 09-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Didn't get second dose - almost 6 months). At the time of the report, HYPOAESTHESIA (Left side of face went numb), HYPOAESTHESIA ORAL (Numbness including lips) and ARTHROPOD BITE ("Tick" where her left eyelid is) had resolved and PRODUCT DOSE OMISSION ISSUE (Didn't get second dose - almost 6 months) and RASH (Rash the size of half a dollar below her breast and above her waist) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment information provided included natural herbs.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up received 27-JUL-2021 contains NNI. Patient declined  for further follow up.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: 2-3 episodes of rapid heartbeat a few weeks after my second dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (2-3 episodes of rapid heartbeat a few weeks after my second dose of vaccine) in a 59-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (2-3 episodes of rapid heartbeat a few weeks after my second dose of vaccine). At the time of the report, HEART RATE INCREASED (2-3 episodes of rapid heartbeat a few weeks after my last dose of vaccine) outcome was unknown.            Patient did not have any problems since March.  Concomitant product information, if any, was not provided by the reporter. Treatment information, if any, was not provided by the reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Drug eruption
Clinical narrative: Lichenoid Reaction on skin; This spontaneous case was reported by a physician and describes the occurrence of DRUG ERUPTION (Lichenoid Reaction on skin) 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 DRUG ERUPTION (Lichenoid Reaction on skin). At the time of the report, DRUG ERUPTION (Lichenoid Reaction on skin) 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.   It was reported that after 5 months of vaccination patient experienced the event.  Concomitant product information, if any, was not provided by the reporter. Treatment information, if any, was not provided by the reporter.   Reporter did not allow further contact
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received vaccine from a vial that was punctured for more than 12hs; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received vaccine from a vial that was punctured for more than 12hs) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 939676) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received vaccine from a vial that was punctured for more than 12hs). On 09-Jul-2021, EXPIRED PRODUCT ADMINISTERED (patient received vaccine from a vial that was punctured for more than 12hs) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information, if any, was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza, Musculoskeletal discomfort, Vaccination site pain
Clinical narrative: if he has the flu; his joints are bothering him really bad; he has a headache that didn't go away with Ibuprofen; the injection site hurts; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (if he has the flu), MUSCULOSKELETAL DISCOMFORT (his joints are bothering him really bad), HEADACHE (he has a headache that didn't go away with Ibuprofen) and VACCINATION SITE PAIN (the injection site hurts) 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 08-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2021, the patient experienced INFLUENZA (if he has the flu), MUSCULOSKELETAL DISCOMFORT (his joints are bothering him really bad), HEADACHE (he has a headache that didn't go away with Ibuprofen) and VACCINATION SITE PAIN (the injection site hurts). The patient was treated with IBUPROFEN for Headache, at a dose of 1 dosage form. At the time of the report, INFLUENZA (if he has the flu), MUSCULOSKELETAL DISCOMFORT (his joints are bothering him really bad), HEADACHE (he has a headache that didn't go away with Ibuprofen) and VACCINATION SITE PAIN (the injection site hurts) outcome was unknown.            Concomitant product information, if any, was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: The vaccine at one point was stored in a home refrigerator and then moved to a refrigerator with a temperature log, vaccine was stored outside recommended refrigeration range; 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 TEMPERATURE EXCURSION ISSUE (The vaccine at one point was stored in a home refrigerator and then moved to a refrigerator with a temperature log, vaccine was stored outside recommended refrigeration range) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A and 041C21A) 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. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine at one point was stored in a home refrigerator and then moved to a refrigerator with a temperature log, vaccine was stored outside recommended refrigeration range). In 2021, PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine at one point was stored in a home refrigerator and then moved to a refrigerator with a temperature log, vaccine was stored outside recommended refrigeration range) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Moderna COVID-19 vaccine was given to 10 patients that was stored outside recommended storage conditions.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 years old; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 years old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information, if any, was not provided by the reporter.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Pharmacist said that they have 5 refrigerated vials that went the beyond use date of 8July2021; second dose given was beyond the use date (BUD) of 8July2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (second dose given was beyond the use date (BUD) of 8July2021) and PRODUCT STORAGE ERROR (Pharmacist said that they have 5 refrigerated vials that went the beyond use date of 8July2021) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (second dose given was beyond the use date (BUD) of 8July2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Pharmacist said that they have 5 refrigerated vials that went the beyond use date of 8July2021). On 09-Jul-2021, EXPIRED PRODUCT ADMINISTERED (second dose given was beyond the use date (BUD) of 8July2021) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Pharmacist said that they have 5 refrigerated vials that went the beyond use date of 8July2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were reported. Pharmacist said that 1 vial was used and 4 patients received a dose from a vial today 9-July-2021 and that was beyond the use date of 8- July-2021. Pharmacist said that the 4 other vials are still sealed, unused and for disposal. The pharmacist said that the patients are not yet aware of the concern. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Live follow-up information received on 12-JUL-2021 contains non-significant information. On 20-Jul-2021: Follow up received and the event outcome has been updated from unknown to resolved with respect to initial document.; Sender's Comments: Causality for events Expired product administered and Product storage error is not applicable.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Dizziness, Gait disturbance, Headache
Clinical narrative: having trouble when trying to move or walk; Aching all over; Felt like throwing up; Dizziness; Weakness; Upset Stomach; Terrible headaches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness), ABDOMINAL DISCOMFORT (Upset Stomach), GAIT DISTURBANCE (having trouble when trying to move or walk) and MYALGIA (Aching all over) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vertigo. Concomitant products included MULTIVITAMIN [ASCORBIC ACID;COLECALCIFEROL;DEXPANTHENOL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL PALMITATE;RIBOFLAVIN SODIUM PHOSPHATE;THIAMINE HYDROCHLORIDE] for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced HEADACHE (Terrible headaches). In July 2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness), ABDOMINAL DISCOMFORT (Upset Stomach), MYALGIA (Aching all over) and NAUSEA (Felt like throwing up). On an unknown date, the patient experienced GAIT DISTURBANCE (having trouble when trying to move or walk). On 09-Jul-2021, DIZZINESS (Dizziness), ASTHENIA (Weakness), ABDOMINAL DISCOMFORT (Upset Stomach), MYALGIA (Aching all over), NAUSEA (Felt like throwing up) and HEADACHE (Terrible headaches) had resolved. At the time of the report, GAIT DISTURBANCE (having trouble when trying to move or walk) had resolved.            The patient's past medical history included blood clot due to taking of oral testosterone booster.  Concomitant medications included Nitric Oxide Booster.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: onset date of the events updated, Email  Address added and patient prefers follow up via phone
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: having trouble when trying to move or walk; Aching all over; Felt like throwing up; Dizziness; Weakness; Upset Stomach; Terrible headaches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ASTHENIA (Weakness), ABDOMINAL DISCOMFORT (Upset Stomach), GAIT DISTURBANCE (having trouble when trying to move or walk) and MYALGIA (Aching all over) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vertigo. Concomitant products included MULTIVITAMIN [ASCORBIC ACID;COLECALCIFEROL;DEXPANTHENOL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL PALMITATE;RIBOFLAVIN SODIUM PHOSPHATE;THIAMINE HYDROCHLORIDE] for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced HEADACHE (Terrible headaches). In July 2021, the patient experienced DIZZINESS (Dizziness), ASTHENIA (Weakness), ABDOMINAL DISCOMFORT (Upset Stomach), MYALGIA (Aching all over) and NAUSEA (Felt like throwing up). On an unknown date, the patient experienced GAIT DISTURBANCE (having trouble when trying to move or walk). On 09-Jul-2021, DIZZINESS (Dizziness), ASTHENIA (Weakness), ABDOMINAL DISCOMFORT (Upset Stomach), MYALGIA (Aching all over), NAUSEA (Felt like throwing up) and HEADACHE (Terrible headaches) had resolved. At the time of the report, GAIT DISTURBANCE (having trouble when trying to move or walk) had resolved.            The patient's past medical history included blood clot due to taking of oral testosterone booster.  Concomitant medications included Nitric Oxide Booster.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: onset date of the events updated, Email  Address added and patient prefers follow up via phone
Age: 24.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received 2nd dose of the Moderna COVID-19 vaccine from a vial that had been first punctured on 07Jul2021 @ 3:42p with the syringe having been at room temperature approximately 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received 2nd dose of the Moderna COVID-19 vaccine from a vial that had been first punctured on 07Jul2021 @ 3:42p with the syringe having been at room temperature approximately 24 hours) in a 24-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received 2nd dose of the Moderna COVID-19 vaccine from a vial that had been first punctured on 07Jul2021 @ 3:42p with the syringe having been at room temperature approximately 24 hours). On 08-Jul-2021, EXPIRED PRODUCT ADMINISTERED (received 2nd dose of the Moderna COVID-19 vaccine from a vial that had been first punctured on 07Jul2021 @ 3:42p with the syringe having been at room temperature approximately 24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information, if any, was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: adverse event; 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 ADVERSE EVENT (adverse event) 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 ADVERSE EVENT (adverse event). At the time of the report, ADVERSE EVENT (adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was using profane language multiple times and would not give any further information. Limited AE Report. Concomitant medication use was unknown Treatment information was unknown
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: Syringe connection issue; Vaccine underdose; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (Syringe connection issue) and UNDERDOSE (Vaccine underdose) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jul-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 09-Jul-2021, the patient experienced DEVICE CONNECTION ISSUE (Syringe connection issue) and UNDERDOSE (Vaccine underdose). At the time of the report, DEVICE CONNECTION ISSUE (Syringe connection issue) and UNDERDOSE (Vaccine underdose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information was not provided.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Has not received a 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not received a 2nd dose) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received a 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not received a 2nd dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  As on 27-Jul-2021, patient has not yet received the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) and was looking forward to get the second dose on the upcoming Friday (30-Jul-2021).   This case was linked to MOD-2021-252740 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow-up document was received. Reporter's email was added. It contains non significant information.
Sex: U
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: skin 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 SKIN DISORDER (skin 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 SKIN DISORDER (skin issues). At the time of the report, SKIN DISORDER (skin issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information, if any, was not provided by the reporter. Treatment information, if any, was not provided by the reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Mobility decreased, Nasopharyngitis
Clinical narrative: Osteoarthritis; In beginning she couldn't bend; had  itchiness in joints; cold; had soreness in joints; fever(99-100F); chills; This spontaneous case was reported by a consumer and describes the occurrence of OSTEOARTHRITIS (Osteoarthritis), MOBILITY DECREASED (In beginning she couldn't bend), PRURITUS (had  itchiness in joints), NASOPHARYNGITIS (cold) and ARTHRALGIA (had soreness in joints) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced MOBILITY DECREASED (In beginning she couldn't bend), PRURITUS (had  itchiness in joints), NASOPHARYNGITIS (cold), ARTHRALGIA (had soreness in joints), PYREXIA (fever(99-100F)) and CHILLS (chills). In May 2021, the patient experienced OSTEOARTHRITIS (Osteoarthritis). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 09-Jul-2021 for Pain, at a dose of 1 dosage form. At the time of the report, OSTEOARTHRITIS (Osteoarthritis), MOBILITY DECREASED (In beginning she couldn't bend), PRURITUS (had  itchiness in joints), NASOPHARYNGITIS (cold), ARTHRALGIA (had soreness in joints), PYREXIA (fever(99-100F)) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: high (High) Fever-99-100F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details are not provided by the Reporter. On APR2021 Patient experienced chills, cold, and fever(99-100F). Also had soreness and itchiness in joints. since 25 JUNE 2021 Patient started experiencing joint pain in the right thumb. In the beginning she couldn't bend and pain was worse at night. Patient contacted a Rheumatologist and tried to use cream and Advil also used heat and cold but nothing changed. Patient has an appointment with a Rheumatologist on 16JUL2021.   This case was linked to MOD-2021-046299 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Osteoarthritis, Pruritus, Pyrexia
Clinical narrative: Osteoarthritis; In beginning she couldn't bend; had  itchiness in joints; cold; had soreness in joints; fever(99-100F); chills; This spontaneous case was reported by a consumer and describes the occurrence of OSTEOARTHRITIS (Osteoarthritis), MOBILITY DECREASED (In beginning she couldn't bend), PRURITUS (had  itchiness in joints), NASOPHARYNGITIS (cold) and ARTHRALGIA (had soreness in joints) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced MOBILITY DECREASED (In beginning she couldn't bend), PRURITUS (had  itchiness in joints), NASOPHARYNGITIS (cold), ARTHRALGIA (had soreness in joints), PYREXIA (fever(99-100F)) and CHILLS (chills). In May 2021, the patient experienced OSTEOARTHRITIS (Osteoarthritis). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 09-Jul-2021 for Pain, at a dose of 1 dosage form. At the time of the report, OSTEOARTHRITIS (Osteoarthritis), MOBILITY DECREASED (In beginning she couldn't bend), PRURITUS (had  itchiness in joints), NASOPHARYNGITIS (cold), ARTHRALGIA (had soreness in joints), PYREXIA (fever(99-100F)) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: high (High) Fever-99-100F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details are not provided by the Reporter. On APR2021 Patient experienced chills, cold, and fever(99-100F). Also had soreness and itchiness in joints. since 25 JUNE 2021 Patient started experiencing joint pain in the right thumb. In the beginning she couldn't bend and pain was worse at night. Patient contacted a Rheumatologist and tried to use cream and Advil also used heat and cold but nothing changed. Patient has an appointment with a Rheumatologist on 16JUL2021.   This case was linked to MOD-2021-046299 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Amnesia, Discomfort, Rash, Sensitive skin, Skin exfoliation
Clinical narrative: skin sensitivity; loss of memory; skin is peeling off/peeling of skin on fingers; He works a lot with his hands and it has been bothering him; reports skin rashes on his butt and skin; This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (skin sensitivity), AMNESIA (loss of memory), SKIN EXFOLIATION (skin is peeling off/peeling of skin on fingers), DISCOMFORT (He works a lot with his hands and it has been bothering him) and RASH (reports skin rashes on his butt and skin) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received 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 SENSITIVE SKIN (skin sensitivity), AMNESIA (loss of memory), SKIN EXFOLIATION (skin is peeling off/peeling of skin on fingers), DISCOMFORT (He works a lot with his hands and it has been bothering him) and RASH (reports skin rashes on his butt and skin). At the time of the report, SENSITIVE SKIN (skin sensitivity), AMNESIA (loss of memory), SKIN EXFOLIATION (skin is peeling off/peeling of skin on fingers) and RASH (reports skin rashes on his butt and skin) outcome was unknown and DISCOMFORT (He works a lot with his hands and it has been bothering him) had not resolved.            No concomitant drug details were reported.  Treatment information included an unspecified rash medicine and antibiotics.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: now it is like 47 days (after first dose to get second dose); This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (now it is like 47 days (after first dose to get second dose)) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) 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. On 09-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (now it is like 47 days (after first dose to get second dose)). On 09-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (now it is like 47 days (after first dose to get second dose)) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient was around 22-23 years old. No relevant concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea
Clinical narrative: upset stomach; dihera/diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach) and DIARRHOEA (dihera/diarrhea) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (upset stomach) and DIARRHOEA (dihera/diarrhea). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach) and DIARRHOEA (dihera/diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information, if any, was not provided by the reporter. Treatment information, if any, was not provided by the reporter.   Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear discomfort, Headache, Nausea
Clinical narrative: dizziness; pressure in my left ear; severe headache/ not as severe as before now; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), EAR DISCOMFORT (pressure in my left ear), HEADACHE (severe headache/ not as severe as before now) and NAUSEA (nausea) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, LIOTHYRONINE (NP THYROID) for an unknown indication.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (dizziness), EAR DISCOMFORT (pressure in my left ear), HEADACHE (severe headache/ not as severe as before now) and NAUSEA (nausea). At the time of the report, DIZZINESS (dizziness), EAR DISCOMFORT (pressure in my left ear), HEADACHE (severe headache/ not as severe as before now) and NAUSEA (nausea) outcome was unknown.            Other concomitant medications include a diuretic  Treatment information, if any, was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Muscular type problems - sore muscles; Fatigue; 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 MYALGIA (Muscular type problems - sore muscles) and FATIGUE (Fatigue) 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 MYALGIA (Muscular type problems - sore muscles) and FATIGUE (Fatigue). At the time of the report, MYALGIA (Muscular type problems - sore muscles) and FATIGUE (Fatigue) 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.   No relevant concomitant medications were reported. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Feeling hot, Hyperhidrosis, Myalgia
Clinical narrative: feeling hot; sweaty; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (feeling hot), HYPERHIDROSIS (sweaty) and MYALGIA (sore arm) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (feeling hot), HYPERHIDROSIS (sweaty) and MYALGIA (sore arm). At the time of the report, FEELING HOT (feeling hot), HYPERHIDROSIS (sweaty) and MYALGIA (sore arm) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.