chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Malaise, Rash
Clinical narrative: 4 months between first and second dose; feeling sick; Have a rash again; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (4 months between first and second dose), MALAISE (feeling sick) and RASH (Have a rash again) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (4 months between first and second dose) and MALAISE (feeling sick). 23-May-2021, the patient experienced RASH (Have a rash again). On 23-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (4 months between first and second dose) had resolved. At the time of the report, MALAISE (feeling sick) and RASH (Have a rash again) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drug was not reported. Treatment medication was not reported. Patient visited allergist and was recommended to take second dose late .   This case was linked to MOD-2021-163604 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medication history was provided.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: arm hurt; Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt) and LYMPHADENOPATHY (Swollen lymph nodes) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt) and LYMPHADENOPATHY (Swollen lymph nodes). At the time of the report, PAIN IN EXTREMITY (arm hurt) and LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown.            No concomitant medications were provided by the reporter. No treatment details were provided by the reporter.     This case was linked to MOD-2021-090479 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: didn't feel well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (didn't feel well) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 024C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-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 MALAISE (didn't feel well). At the time of the report, MALAISE (didn't feel well) outcome was unknown.            This case was linked to MOD-2021-163656 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: I have headache for 1 week since second shot. Is that normal?; 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 HEADACHE (I have headache for 1 week since second shot. Is that normal?) 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 HEADACHE (I have headache for 1 week since second shot. Is that normal?). At the time of the report, HEADACHE (I have headache for 1 week since second shot. Is that normal?) 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.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Nausea
Clinical narrative: extreme fatigue; nausea; body ache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (extreme fatigue), NAUSEA (nausea) and MYALGIA (body ache) 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 FATIGUE (extreme fatigue), NAUSEA (nausea) and MYALGIA (body ache). At the time of the report, FATIGUE (extreme fatigue), NAUSEA (nausea) and MYALGIA (body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Fall, Feeling hot, Joint swelling
Clinical narrative: fell to the ground; bolted for the emergency exit to breathe; joints began to ball up and hurt for 4 days; Started to get hot; Face started to tingle; joints began to ball up and hurt for 4 days; This spontaneous case was reported by a patient and describes the occurrence of FEELING HOT (Started to get hot), PARAESTHESIA (Face started to tingle), JOINT SWELLING (joints began to ball up and hurt for 4 days), FALL (fell to the ground) and DYSPNOEA (bolted for the emergency exit to breathe) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OXYCODONE, Fiorinal and ZOLMITRIPTAN (ZOMIG) for an unknown indication.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced FEELING HOT (Started to get hot), PARAESTHESIA (Face started to tingle), JOINT SWELLING (joints began to ball up and hurt for 4 days) and ARTHRALGIA (joints began to ball up and hurt for 4 days). On an unknown date, the patient experienced FALL (fell to the ground) and DYSPNOEA (bolted for the emergency exit to breathe). On 01-May-2021, JOINT SWELLING (joints began to ball up and hurt for 4 days) and ARTHRALGIA (joints began to ball up and hurt for 4 days) outcome was unknown. At the time of the report, FEELING HOT (Started to get hot), PARAESTHESIA (Face started to tingle), FALL (fell to the ground) and DYSPNOEA (bolted for the emergency exit to breathe) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient called 24May2021 to report side effects for 1st  vaccination of Moderna received 27Apr2021 in the left arm Lot Number for 1st vaccination:038B21A. Patient reported severe reactions within minutes after receiving the 1st vaccination while at the clinic. Patient reported 7 minutes after the administration they "started to get hot." Patient also stated that they felt like their wasn't much air, and that they felt as though they needed fresh air. Patient stated within 10 minutes their face started to tingle. 10 minutes passed and the patient stated that they bolted for the emergency exit to breathe. Patient stated that they used the wall in the hallway to try to hold themselves up and fell to the ground.  Patient also stated that about an hour and a half after the administration while in the car with wife joints began to ball up and hurt for 4 days. Patient wants to receive the second dose but doesn't know if they should based upon their reaction to the first vaccination. Patient provided consent for follow up for safety. Preferred Method contact telephone.  no treatment details reported.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: fell to the ground; bolted for the emergency exit to breathe; joints began to ball up and hurt for 4 days; Started to get hot; Face started to tingle; joints began to ball up and hurt for 4 days; This spontaneous case was reported by a patient and describes the occurrence of FEELING HOT (Started to get hot), PARAESTHESIA (Face started to tingle), JOINT SWELLING (joints began to ball up and hurt for 4 days), FALL (fell to the ground) and DYSPNOEA (bolted for the emergency exit to breathe) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OXYCODONE, Fiorinal and ZOLMITRIPTAN (ZOMIG) for an unknown indication.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced FEELING HOT (Started to get hot), PARAESTHESIA (Face started to tingle), JOINT SWELLING (joints began to ball up and hurt for 4 days) and ARTHRALGIA (joints began to ball up and hurt for 4 days). On an unknown date, the patient experienced FALL (fell to the ground) and DYSPNOEA (bolted for the emergency exit to breathe). On 01-May-2021, JOINT SWELLING (joints began to ball up and hurt for 4 days) and ARTHRALGIA (joints began to ball up and hurt for 4 days) outcome was unknown. At the time of the report, FEELING HOT (Started to get hot), PARAESTHESIA (Face started to tingle), FALL (fell to the ground) and DYSPNOEA (bolted for the emergency exit to breathe) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient called 24May2021 to report side effects for 1st  vaccination of Moderna received 27Apr2021 in the left arm Lot Number for 1st vaccination:038B21A. Patient reported severe reactions within minutes after receiving the 1st vaccination while at the clinic. Patient reported 7 minutes after the administration they "started to get hot." Patient also stated that they felt like their wasn't much air, and that they felt as though they needed fresh air. Patient stated within 10 minutes their face started to tingle. 10 minutes passed and the patient stated that they bolted for the emergency exit to breathe. Patient stated that they used the wall in the hallway to try to hold themselves up and fell to the ground.  Patient also stated that about an hour and a half after the administration while in the car with wife joints began to ball up and hurt for 4 days. Patient wants to receive the second dose but doesn't know if they should based upon their reaction to the first vaccination. Patient provided consent for follow up for safety. Preferred Method contact telephone.  no treatment details reported.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash all over  body; 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 RASH (rash all over  body) 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 RASH (rash all over  body). At the time of the report, RASH (rash all over  body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment was reported.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Intentional product use issue
Clinical narrative: received their first dose 109 days ago; This spontaneous case was reported by a health care professional and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (received their first dose 109 days ago) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (received their first dose 109 days ago). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (received their first dose 109 days ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Feeling hot, Rash erythematous, Rash macular
Clinical narrative: Red Rash; Red spot; feel Warm; 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 RASH ERYTHEMATOUS (Red Rash), RASH MACULAR (Red spot) and FEELING HOT (feel Warm) 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 RASH ERYTHEMATOUS (Red Rash), RASH MACULAR (Red spot) and FEELING HOT (feel Warm). At the time of the report, RASH ERYTHEMATOUS (Red Rash), RASH MACULAR (Red spot) and FEELING HOT (feel Warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that after the Vaccine, experienced a Red rash, Red spot , feels warm, and it is below the injection site. Concomitant medications and treatment information was not provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Vaccination in right thigh due to their timed release 7 day patches applied on their upper arm; all pain triggers were ramped up, all pain flared up/sore; unable to do anything, take care of myself; thigh hurt; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Vaccination in right thigh due to their timed release 7 day patches applied on their upper arm), PAIN (all pain triggers were ramped up, all pain flared up/sore), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to do anything, take care of myself) and PAIN IN EXTREMITY (thigh hurt) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 026B21A) for COVID-19 vaccination.     Concomitant products included BUPRENORPHINE (BUTRANS), MORPHINE, IBUPROFEN (MOTRIN [IBUPROFEN]) and MENTHOL (BIOFREEZE [MENTHOL]) for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Vaccination in right thigh due to their timed release 7 day patches applied on their upper arm), PAIN (all pain triggers were ramped up, all pain flared up/sore), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to do anything, take care of myself) and PAIN IN EXTREMITY (thigh hurt). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Vaccination in right thigh due to their timed release 7 day patches applied on their upper arm), PAIN (all pain triggers were ramped up, all pain flared up/sore), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (unable to do anything, take care of myself) and PAIN IN EXTREMITY (thigh hurt) outcome was unknown.            Concomitant medications include over the counter topical pain medications.   Treatment medications include Prescription Pain Medications, Pain Patches and Topical pain killers.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Non Significant Followup contains NNI
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue
Clinical narrative: diarrhea; chills; very tired; joints hurt; 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 DIARRHOEA (diarrhea), CHILLS (chills), FATIGUE (very tired) and ARTHRALGIA (joints hurt) 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 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2021, the patient experienced DIARRHOEA (diarrhea), CHILLS (chills), FATIGUE (very tired) and ARTHRALGIA (joints hurt). At the time of the report, DIARRHOEA (diarrhea) had not resolved and CHILLS (chills), FATIGUE (very tired) and ARTHRALGIA (joints hurt) outcome was unknown.            No concomitant medication or lab results were reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Very achy), PYREXIA (Have a fever of about 101), FATIGUE (Tired) and HEADACHE (Terrible headache) 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 PAIN (Very achy), PYREXIA (Have a fever of about 101), FATIGUE (Tired) and HEADACHE (Terrible headache). At the time of the report, PAIN (Very achy), PYREXIA (Have a fever of about 101), FATIGUE (Tired) and HEADACHE (Terrible headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter.  No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Headache, Herpes zoster, Limb discomfort, Myalgia
Clinical narrative: irritated area went away; looks like a spider bite 4 inches long\ looks like shingles; looks like a spider bite 4 inches long\ looks like shingles; dizziness; body aches; headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of HERPES ZOSTER (looks like a spider bite 4 inches long\ looks like shingles), DIZZINESS (dizziness), LIMB DISCOMFORT (irritated area went away), VACCINATION COMPLICATION (looks like a spider bite 4 inches long\ looks like shingles) and MYALGIA (body aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 05-May-2021, the patient experienced DIZZINESS (dizziness), MYALGIA (body aches) and HEADACHE (headache). On 07-May-2021, the patient experienced HERPES ZOSTER (looks like a spider bite 4 inches long\ looks like shingles) and VACCINATION COMPLICATION (looks like a spider bite 4 inches long\ looks like shingles). On an unknown date, the patient experienced LIMB DISCOMFORT (irritated area went away). The patient was treated with TRIAMCINOLONE at an unspecified dose and frequency; VALACYCLOVIR [VALACICLOVIR] at a dose of three times a day; ANTIHISTAMINES at an unspecified dose and frequency and MAGNESIUM SULFATE (EPSOM SALT) at a dose of baths. On 19-May-2021, HERPES ZOSTER (looks like a spider bite 4 inches long\ looks like shingles) and VACCINATION COMPLICATION (looks like a spider bite 4 inches long\ looks like shingles) had resolved. At the time of the report, DIZZINESS (dizziness), MYALGIA (body aches) and HEADACHE (headache) outcome was unknown and LIMB DISCOMFORT (irritated area went away) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided. No lab data has been provided by the reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: irritated area went away; looks like a spider bite 4 inches long\ looks like shingles; looks like a spider bite 4 inches long\ looks like shingles; dizziness; body aches; headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of HERPES ZOSTER (looks like a spider bite 4 inches long\ looks like shingles), DIZZINESS (dizziness), LIMB DISCOMFORT (irritated area went away), VACCINATION COMPLICATION (looks like a spider bite 4 inches long\ looks like shingles) and MYALGIA (body aches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 05-May-2021, the patient experienced DIZZINESS (dizziness), MYALGIA (body aches) and HEADACHE (headache). On 07-May-2021, the patient experienced HERPES ZOSTER (looks like a spider bite 4 inches long\ looks like shingles) and VACCINATION COMPLICATION (looks like a spider bite 4 inches long\ looks like shingles). On an unknown date, the patient experienced LIMB DISCOMFORT (irritated area went away). The patient was treated with TRIAMCINOLONE at an unspecified dose and frequency; VALACYCLOVIR [VALACICLOVIR] at a dose of three times a day; ANTIHISTAMINES at an unspecified dose and frequency and MAGNESIUM SULFATE (EPSOM SALT) at a dose of baths. On 19-May-2021, HERPES ZOSTER (looks like a spider bite 4 inches long\ looks like shingles) and VACCINATION COMPLICATION (looks like a spider bite 4 inches long\ looks like shingles) had resolved. At the time of the report, DIZZINESS (dizziness), MYALGIA (body aches) and HEADACHE (headache) outcome was unknown and LIMB DISCOMFORT (irritated area went away) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided. No lab data has been provided by the reported.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Product dose omission issue
Clinical narrative: 2nd dose of Moderna COVID-19 vaccine not administered 46 days after the first dose; 1st dose of Moderna COVID-19 vaccine administered to patient under 18 years old; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose of Moderna COVID-19 vaccine administered to patient under 18 years old) and PRODUCT DOSE OMISSION ISSUE (2nd dose of Moderna COVID-19 vaccine not administered 46 days after the first dose) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose of Moderna COVID-19 vaccine administered to patient under 18 years old). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose of Moderna COVID-19 vaccine not administered 46 days after the first dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose of Moderna COVID-19 vaccine administered to patient under 18 years old) and PRODUCT DOSE OMISSION ISSUE (2nd dose of Moderna COVID-19 vaccine not administered 46 days after the 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 treatment and concomitant product was reported.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: lost sense of smell and taste; lost sense of smell and taste; 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 ANOSMIA (lost sense of smell and taste) and AGEUSIA (lost sense of smell and taste) 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, 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 ANOSMIA (lost sense of smell and taste) and AGEUSIA (lost sense of smell and taste). At the time of the report, ANOSMIA (lost sense of smell and taste) and AGEUSIA (lost sense of smell and taste) outcome was unknown.            No concomitant medication reported. No treatment was provided. The action taken with mRNA-1273 in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: shooting pains in my legs/feet; shooting pain in legs/feet; 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 PAIN (shooting pains in my legs/feet) and PAIN IN EXTREMITY (shooting pain in legs/feet) 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 PAIN (shooting pains in my legs/feet) and PAIN IN EXTREMITY (shooting pain in legs/feet). At the time of the report, PAIN (shooting pains in my legs/feet) and PAIN IN EXTREMITY (shooting pain in legs/feet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.  Event outcome was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: "side effects are minor, but bothersome."; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION ("side effects are minor, but bothersome.") in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION ("side effects are minor, but bothersome."). At the time of the report, VACCINATION COMPLICATION ("side effects are minor, but bothersome.") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Myalgia, Pyrexia
Clinical narrative: Achy/ soreness; hips and shoulder hurt; 100 degree temperature; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Achy/ soreness), ARTHRALGIA (hips and shoulder hurt) and PYREXIA (100 degree temperature) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-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 MYALGIA (Achy/ soreness), ARTHRALGIA (hips and shoulder hurt) and PYREXIA (100 degree temperature). At the time of the report, MYALGIA (Achy/ soreness), ARTHRALGIA (hips and shoulder hurt) and PYREXIA (100 degree temperature) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) High.         Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.   This case was linked to MOD-2021-163637 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: Headache; shot site very sore; very tired; 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 HEADACHE (Headache), VACCINATION SITE PAIN (shot site very sore) and FATIGUE (very tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 HEADACHE (Headache), VACCINATION SITE PAIN (shot site very sore) and FATIGUE (very tired). At the time of the report, HEADACHE (Headache), VACCINATION SITE PAIN (shot site very sore) and FATIGUE (very tired) outcome was unknown.            No concomitant and treatment drugs were reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: runny nose; 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 RHINORRHOEA (runny nose) 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 RHINORRHOEA (runny nose). At the time of the report, RHINORRHOEA (runny nose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Where i got my shot it turned hot; Where i got my shot it turned itchy; Where i got my shot it swelkled up; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Where i got my shot it turned hot), VACCINATION SITE PRURITUS (Where i got my shot it turned itchy) and VACCINATION SITE SWELLING (Where i got my shot it swelkled up) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Where i got my shot it turned hot), VACCINATION SITE PRURITUS (Where i got my shot it turned itchy) and VACCINATION SITE SWELLING (Where i got my shot it swelkled up). At the time of the report, VACCINATION SITE WARMTH (Where i got my shot it turned hot), VACCINATION SITE PRURITUS (Where i got my shot it turned itchy) and VACCINATION SITE SWELLING (Where i got my shot it swelkled up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: aches; malaise; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), MALAISE (malaise) and PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 PAIN (aches), MALAISE (malaise) and PYREXIA (fever). At the time of the report, PAIN (aches), MALAISE (malaise) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.Treatment medication was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Diarrhoea, Headache
Clinical narrative: I feel a little weakness; diarrhea; headache; my joins hurts; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (I feel a little weakness), DIARRHOEA (diarrhea), HEADACHE (headache) and ARTHRALGIA (my joins hurts) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (I feel a little weakness), DIARRHOEA (diarrhea), HEADACHE (headache) and ARTHRALGIA (my joins hurts). At the time of the report, ASTHENIA (I feel a little weakness), DIARRHOEA (diarrhea), HEADACHE (headache) and ARTHRALGIA (my joins hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Vaccination site urticaria
Clinical narrative: Welt at the site; Tenderness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Welt at the site) and INJECTION SITE PAIN (Tenderness at the injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE URTICARIA (Welt at the site) and INJECTION SITE PAIN (Tenderness at the injection site). At the time of the report, VACCINATION SITE URTICARIA (Welt at the site) and INJECTION SITE PAIN (Tenderness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Vaccination complication
Clinical narrative: Shortness of breath; Some chest pain; Terrible side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), CHEST PAIN (Some chest pain) and VACCINATION COMPLICATION (Terrible side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 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 (Shortness of breath), CHEST PAIN (Some chest pain) and VACCINATION COMPLICATION (Terrible side effects). At the time of the report, DYSPNOEA (Shortness of breath), CHEST PAIN (Some chest pain) and VACCINATION COMPLICATION (Terrible side effects) outcome was unknown.            No concomitant medications were provided.  No treatment information provided.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Got covid infection positive after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got covid infection positive after 1st dose) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced COVID-19 (Got covid infection positive after 1st dose). At the time of the report, COVID-19 (Got covid infection positive after 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, SARS-CoV-2 test: unknown (Positive) Unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Soreness; 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 PAIN (Soreness) 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 PAIN (Soreness). At the time of the report, PAIN (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection arm is sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection arm is sore) 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Injection arm is sore). At the time of the report, VACCINATION SITE PAIN (Injection arm is sore) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia
Clinical narrative: slept for 2 days post second shot; 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 HYPERSOMNIA (slept for 2 days post second shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 HYPERSOMNIA (slept for 2 days post second shot). At the time of the report, HYPERSOMNIA (slept for 2 days post second shot) outcome was unknown.            Concomitant medications and treatment information was not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-163658 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: vaccinated 3 days ago and am still tired; 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 FATIGUE (vaccinated 3 days ago and am still tired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (vaccinated 3 days ago and am still tired). At the time of the report, FATIGUE (vaccinated 3 days ago and am still tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: loss of taste; 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 AGEUSIA (loss of taste) 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 AGEUSIA (loss of taste). At the time of the report, AGEUSIA (loss of taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 4 months since the first dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (4 months since the first dose) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, CETIRIZINE HYDROCHLORIDE (CETRIZINE), DOCUSATE SODIUM (COLACE), MORNIFLUMATE (FLOMAX [MORNIFLUMATE]), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), MACROGOL 3350 (MIRALAX), MELATONIN, NITROGLYCERIN, OMEPRAZOLE, TRAMADOL, TRAZODONE and RIVAROXABAN (XARELTO) for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (4 months since the first dose). On 24-May-2021, PRODUCT DOSE OMISSION ISSUE (4 months since the first 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.   Treatment medication use was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Nodule, Rash, Vaccination site nodule
Clinical narrative: Little bumps on left shoulder blade; Bumps on elbows as; Rash after the second dose.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NODULE (Little bumps on left shoulder blade), NODULE (Bumps on elbows as) and RASH (Rash after the second dose.) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE NODULE (Little bumps on left shoulder blade), NODULE (Bumps on elbows as) and RASH (Rash after the second dose.). At the time of the report, VACCINATION SITE NODULE (Little bumps on left shoulder blade), NODULE (Bumps on elbows as) and RASH (Rash after the second dose.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.   Reporter did not allow further contact