chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: It's been 2 months since I got the first one; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (It's been 2 months since I got the first one) 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 29-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (It's been 2 months since I got the first one). At the time of the report, PRODUCT DOSE OMISSION ISSUE (It's been 2 months since I got the first one) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Jaw disorder, Toothache
Clinical narrative: extreme toothache; jaw pressure; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jun-2021 and was forwarded to Moderna on 29-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (extreme toothache) and JAW DISORDER (jaw pressure) 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, 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 TOOTHACHE (extreme toothache) and JAW DISORDER (jaw pressure). At the time of the report, TOOTHACHE (extreme toothache) and JAW DISORDER (jaw pressure) outcome was unknown.            No concomitant medication was provided.   No treatment medication were provided.   This case was linked to MOD-2021-240132 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got really sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got really sick) 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) (Intramuscular) 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 ILLNESS (got really sick). At the time of the report, ILLNESS (got really sick) outcome was unknown.            No concomitant medication were provided. No treatment  details were provided. Consent for fallow up declined.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: reporter Email address were added.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Headache, Influenza like illness, Pain in extremity
Clinical narrative: Shock symptom; drowsy; felt like she had the flu; odd reaction; shaking like cold extreme; hands hurt; legs hurt; stomach ache; chills; mild fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SHOCK (Shock symptom), SOMNOLENCE (drowsy), INFLUENZA LIKE ILLNESS (felt like she had the flu), UNEVALUABLE EVENT (odd reaction) and TREMOR (shaking like cold extreme) in a female patient of an unknown age 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 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 SHOCK (Shock symptom), SOMNOLENCE (drowsy), INFLUENZA LIKE ILLNESS (felt like she had the flu), UNEVALUABLE EVENT (odd reaction), TREMOR (shaking like cold extreme), PAIN IN EXTREMITY (hands hurt), PAIN IN EXTREMITY (legs hurt), ABDOMINAL PAIN UPPER (stomach ache), CHILLS (chills), PYREXIA (mild fever) and HEADACHE (Headache). At the time of the report, SHOCK (Shock symptom), SOMNOLENCE (drowsy), INFLUENZA LIKE ILLNESS (felt like she had the flu), UNEVALUABLE EVENT (odd reaction), TREMOR (shaking like cold extreme), PAIN IN EXTREMITY (hands hurt), PAIN IN EXTREMITY (legs hurt), ABDOMINAL PAIN UPPER (stomach ache), CHILLS (chills), PYREXIA (mild fever) and HEADACHE (Headache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment information were not provided by the reporter.  Concomitant medications were not reported by the reporter.  Company comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Shock, Somnolence, Tremor, Unevaluable event
Clinical narrative: Shock symptom; drowsy; felt like she had the flu; odd reaction; shaking like cold extreme; hands hurt; legs hurt; stomach ache; chills; mild fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SHOCK (Shock symptom), SOMNOLENCE (drowsy), INFLUENZA LIKE ILLNESS (felt like she had the flu), UNEVALUABLE EVENT (odd reaction) and TREMOR (shaking like cold extreme) in a female patient of an unknown age 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 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 SHOCK (Shock symptom), SOMNOLENCE (drowsy), INFLUENZA LIKE ILLNESS (felt like she had the flu), UNEVALUABLE EVENT (odd reaction), TREMOR (shaking like cold extreme), PAIN IN EXTREMITY (hands hurt), PAIN IN EXTREMITY (legs hurt), ABDOMINAL PAIN UPPER (stomach ache), CHILLS (chills), PYREXIA (mild fever) and HEADACHE (Headache). At the time of the report, SHOCK (Shock symptom), SOMNOLENCE (drowsy), INFLUENZA LIKE ILLNESS (felt like she had the flu), UNEVALUABLE EVENT (odd reaction), TREMOR (shaking like cold extreme), PAIN IN EXTREMITY (hands hurt), PAIN IN EXTREMITY (legs hurt), ABDOMINAL PAIN UPPER (stomach ache), CHILLS (chills), PYREXIA (mild fever) and HEADACHE (Headache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment information were not provided by the reporter.  Concomitant medications were not reported by the reporter.  Company comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got really sick; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jun-2021 and was forwarded to Moderna on 29-Jun-2021.    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 ILLNESS (got really sick) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 ILLNESS (got really sick). At the time of the report, ILLNESS (got really sick) outcome was unknown.            Concomitant medication use was not provided by reporter. Treatment medication use was not provided by reporter. "My daughter and son-in-law both got really sick after the second vaccine does my husband and myself did not have any side effects does that mean the vaccine will not work" this was reported by reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: No specific follow-up information recorded.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired dose for 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired dose for 2nd dose) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 022B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jun-2021, 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 EXPIRED PRODUCT ADMINISTERED (Received expired dose for 2nd dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired dose for 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Neck mass
Clinical narrative: lump in the left side of my neck; This spontaneous case was reported by a consumer and describes the occurrence of NECK MASS (lump in the left side of my neck) 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 NECK MASS (lump in the left side of my neck). At the time of the report, NECK MASS (lump in the left side of my neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: Jaw soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (Jaw 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 IN JAW (Jaw soreness). At the time of the report, PAIN IN JAW (Jaw soreness) 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 Reported For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) ,the reporter did not provide any causality assessment
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: I think the shot is in my joint & Tech gave shot very high up in shoulder & hit a nerve & perhaps the joint it is brutal; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (I think the shot is in my joint & Tech gave shot very high up in shoulder & hit a nerve & perhaps the joint it is brutal) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (I think the shot is in my joint & Tech gave shot very high up in shoulder & hit a nerve & perhaps the joint it is brutal). At the time of the report, PRODUCT ADMINISTRATION ERROR (I think the shot is in my joint & Tech gave shot very high up in shoulder & hit a nerve & perhaps the joint it is brutal) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Muscle Pain/ he could not get out of bed; Joint Pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle Pain/ he could not get out of bed) and ARTHRALGIA (Joint Pain) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 032620A) for COVID-19 vaccination.     Concomitant products included INSULIN GLARGINE (LANTUS), METFORMIN, ATORVASTATIN, LISINOPRIL, TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), ACETYLSALICYLIC ACID (BABY ASPIRIN) and SEMAGLUTIDE (OZEMPIC) for an unknown indication.   On 23-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced MYALGIA (Muscle Pain/ he could not get out of bed) and ARTHRALGIA (Joint Pain). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency. At the time of the report, MYALGIA (Muscle Pain/ he could not get out of bed) and ARTHRALGIA (Joint Pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-240177 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: arm redness; swelling / arm swelling; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm redness) and PERIPHERAL SWELLING (swelling / arm swelling) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 ERYTHEMA (arm redness) and PERIPHERAL SWELLING (swelling / arm swelling). At the time of the report, ERYTHEMA (arm redness) and PERIPHERAL SWELLING (swelling / arm swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient had declined Consent for follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: symptom; 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 (symptom) 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 (symptom). At the time of the report, VACCINATION COMPLICATION (symptom) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was Reported.  No Treatment information was Reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Muscle Pain; Joint Pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle Pain) and ARTHRALGIA (Joint Pain) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 032620A) for COVID-19 vaccination.     No Medical history was provided by Reporter.  Concomitant products included INSULIN GLARGINE (LANTUS), METFORMIN, ATORVASTATIN, LISINOPRIL, TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), ACETYLSALICYLIC ACID (BABY ASPIRIN) and SEMAGLUTIDE (OZEMPIC) for an unknown indication.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced MYALGIA (Muscle Pain) and ARTHRALGIA (Joint Pain). The patient was treated with PARACETAMOL (TYLENOL) for Arthritis, at an unspecified dose and frequency. At the time of the report, MYALGIA (Muscle Pain) and ARTHRALGIA (Joint Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-240171 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of dysgeusia (metal taste in my mouth mainly when I eat canned tomatoes) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Medical history not provided. On Jun 22, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced dysgeusia (metal taste in my mouth mainly when I eat canned tomatoes). At the time of the report, dysgeusia (metal taste in my mouth mainly when I eat canned tomatoes) outcome: unknown. No concomitant medication or treatment information reported. Action taken with mRNA-1273 in response to the events: not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue, SARS-CoV-2 test positive
Clinical narrative: Got first vaccine Jan 3 then diagnosed on Jan 21 positive, came home 54 days later. When is the 2nd dose needed. The doctor said 90 days. When do you get the 2nd dose after being positive; Got first vaccine Jan 3 then diagnosed on Jan 21 positive; 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 SARS-COV-2 TEST POSITIVE (Got first vaccine Jan 3 then diagnosed on Jan 21 positive) and PRODUCT DOSE OMISSION ISSUE (Got first vaccine Jan 3 then diagnosed on Jan 21 positive, came home 54 days later. When is the 2nd dose needed. The doctor said 90 days. When do you get the 2nd dose after being positive) 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 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Got first vaccine Jan 3 then diagnosed on Jan 21 positive). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Got first vaccine Jan 3 then diagnosed on Jan 21 positive, came home 54 days later. When is the 2nd dose needed. The doctor said 90 days. When do you get the 2nd dose after being positive). At the time of the report, SARS-COV-2 TEST POSITIVE (Got first vaccine Jan 3 then diagnosed on Jan 21 positive) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Got first vaccine Jan 3 then diagnosed on Jan 21 positive, came home 54 days later. When is the 2nd dose needed. The doctor said 90 days. When do you get the 2nd dose after being positive) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Gastric disorder
Clinical narrative: Diarhea; have people reported stomach problems; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarhea) and GASTRIC DISORDER (have people reported stomach problems) 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 DIARRHOEA (Diarhea) and GASTRIC DISORDER (have people reported stomach problems). At the time of the report, DIARRHOEA (Diarhea) and GASTRIC DISORDER (have people reported stomach problems) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication was  provided.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up received on  29-JUN-2021: New event gastric disorder was added
Sex: U
Vaccine: COVID19
Symptoms: Bedridden, Influenza like illness, Pyrexia
Clinical narrative: Flu like symptoms; I was bedridden for 4 days; High fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), BEDRIDDEN (I was bedridden for 4 days) and PYREXIA (High 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), BEDRIDDEN (I was bedridden for 4 days) and PYREXIA (High fever). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), BEDRIDDEN (I was bedridden for 4 days) and PYREXIA (High fever) outcome was unknown.            No concomitant medications were provided.  No treatment information provided.   This case was linked to MOD-2021-015748 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I took the first vaccine but I didn't take the second on time; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I took the first vaccine but I didn't take the second on time) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I took the first vaccine but I didn't take the second on time). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I took the first vaccine but I didn't take the second on time) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided by the reporter..
Sex: U
Vaccine: COVID19
Symptoms: C-reactive protein, C-reactive protein increased
Clinical narrative: high CRP; This spontaneous case was reported by a consumer and describes the occurrence of C-REACTIVE PROTEIN INCREASED (high CRP) 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 C-REACTIVE PROTEIN INCREASED (high CRP). At the time of the report, C-REACTIVE PROTEIN INCREASED (high CRP) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, C-reactive protein: high High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were reported. No Treatment Medications were reported.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Pain
Clinical narrative: Vaginal bleeding; vaginal cramping; had headache for first dose; Body ache; Fatigue; CHILLS; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (had headache for first dose), PAIN (Body ache), FATIGUE (Fatigue), CHILLS (CHILLS) and INJECTION SITE ERYTHEMA (Redness at injection site) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced HEADACHE (had headache for first dose), PAIN (Body ache), FATIGUE (Fatigue), CHILLS (CHILLS) and INJECTION SITE ERYTHEMA (Redness at injection site). On 24-Jun-2021, the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding) and VULVOVAGINAL PAIN (vaginal cramping). At the time of the report, HEADACHE (had headache for first dose), PAIN (Body ache), FATIGUE (Fatigue), CHILLS (CHILLS), INJECTION SITE ERYTHEMA (Redness at injection site), VAGINAL HAEMORRHAGE (Vaginal bleeding) and VULVOVAGINAL PAIN (vaginal cramping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-240235 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage, Vulvovaginal pain
Clinical narrative: Vaginal bleeding; vaginal cramping; had headache for first dose; Body ache; Fatigue; CHILLS; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (had headache for first dose), PAIN (Body ache), FATIGUE (Fatigue), CHILLS (CHILLS) and INJECTION SITE ERYTHEMA (Redness at injection site) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced HEADACHE (had headache for first dose), PAIN (Body ache), FATIGUE (Fatigue), CHILLS (CHILLS) and INJECTION SITE ERYTHEMA (Redness at injection site). On 24-Jun-2021, the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding) and VULVOVAGINAL PAIN (vaginal cramping). At the time of the report, HEADACHE (had headache for first dose), PAIN (Body ache), FATIGUE (Fatigue), CHILLS (CHILLS), INJECTION SITE ERYTHEMA (Redness at injection site), VAGINAL HAEMORRHAGE (Vaginal bleeding) and VULVOVAGINAL PAIN (vaginal cramping) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-240235 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of URTICARIA (hives) 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 URTICARIA (hives). At the time of the report, URTICARIA (hives) 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 medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: can the vaccine cause heart damage; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (can the vaccine cause heart damage) 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 CARDIAC DISORDER (can the vaccine cause heart damage). At the time of the report, CARDIAC DISORDER (can the vaccine cause heart damage) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment information was unknown.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Muscle spasms, Myalgia, Pyrexia
Clinical narrative: Second dose she had chills, fever, body aches, fatigue, and redness at the vaccination site.; Second dose she had chills, fever, body aches, fatigue, and redness at the injection site.; Body ache; Fatigue; Redness at vaccination site; After second caller had cramping, and spotting for a couple of days; After second caller had cramping, and spotting for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (After second caller had cramping, and spotting for a couple of days), MUSCLE SPASMS (After second caller had cramping, and spotting for a couple of days), CHILLS (Second dose she had chills, fever, body aches, fatigue, and redness at the vaccination site.), PYREXIA (Second dose she had chills, fever, body aches, fatigue, and redness at the injection site.) and MYALGIA (Body ache) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Polycystic ovarian syndrome.    On 27-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, the patient experienced VAGINAL HAEMORRHAGE (After second caller had cramping, and spotting for a couple of days) and MUSCLE SPASMS (After second caller had cramping, and spotting for a couple of days). On 25-Jun-2021, the patient experienced CHILLS (Second dose she had chills, fever, body aches, fatigue, and redness at the vaccination site.), PYREXIA (Second dose she had chills, fever, body aches, fatigue, and redness at the injection site.), MYALGIA (Body ache), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Redness at vaccination site). On 27-Jun-2021, CHILLS (Second dose she had chills, fever, body aches, fatigue, and redness at the vaccination site.), PYREXIA (Second dose she had chills, fever, body aches, fatigue, and redness at the injection site.), MYALGIA (Body ache), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Redness at vaccination site) had resolved. At the time of the report, VAGINAL HAEMORRHAGE (After second caller had cramping, and spotting for a couple of days) and MUSCLE SPASMS (After second caller had cramping, and spotting for a couple of days) outcome was unknown.            No concomitant medications are provided. Treatment to the events not provided.   This case was linked to MOD-2021-240214 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaginal haemorrhage
Clinical narrative: Second dose she had chills, fever, body aches, fatigue, and redness at the vaccination site.; Second dose she had chills, fever, body aches, fatigue, and redness at the injection site.; Body ache; Fatigue; Redness at vaccination site; After second caller had cramping, and spotting for a couple of days; After second caller had cramping, and spotting for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (After second caller had cramping, and spotting for a couple of days), MUSCLE SPASMS (After second caller had cramping, and spotting for a couple of days), CHILLS (Second dose she had chills, fever, body aches, fatigue, and redness at the vaccination site.), PYREXIA (Second dose she had chills, fever, body aches, fatigue, and redness at the injection site.) and MYALGIA (Body ache) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Polycystic ovarian syndrome.    On 27-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, the patient experienced VAGINAL HAEMORRHAGE (After second caller had cramping, and spotting for a couple of days) and MUSCLE SPASMS (After second caller had cramping, and spotting for a couple of days). On 25-Jun-2021, the patient experienced CHILLS (Second dose she had chills, fever, body aches, fatigue, and redness at the vaccination site.), PYREXIA (Second dose she had chills, fever, body aches, fatigue, and redness at the injection site.), MYALGIA (Body ache), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Redness at vaccination site). On 27-Jun-2021, CHILLS (Second dose she had chills, fever, body aches, fatigue, and redness at the vaccination site.), PYREXIA (Second dose she had chills, fever, body aches, fatigue, and redness at the injection site.), MYALGIA (Body ache), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Redness at vaccination site) had resolved. At the time of the report, VAGINAL HAEMORRHAGE (After second caller had cramping, and spotting for a couple of days) and MUSCLE SPASMS (After second caller had cramping, and spotting for a couple of days) outcome was unknown.            No concomitant medications are provided. Treatment to the events not provided.   This case was linked to MOD-2021-240214 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Vaccination site erythema, Vaccination site mass
Clinical narrative: Upper back hurts; Chest hurts; Huge red lump on arm from the injection; Huge red lump on arm from the injection; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Upper back hurts), CHEST PAIN (Chest hurts), VACCINATION SITE MASS (Huge red lump on arm from the injection) and VACCINATION SITE ERYTHEMA (Huge red lump on arm from the injection) 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 BACK PAIN (Upper back hurts), CHEST PAIN (Chest hurts), VACCINATION SITE MASS (Huge red lump on arm from the injection) and VACCINATION SITE ERYTHEMA (Huge red lump on arm from the injection). At the time of the report, BACK PAIN (Upper back hurts), CHEST PAIN (Chest hurts), VACCINATION SITE MASS (Huge red lump on arm from the injection) and VACCINATION SITE ERYTHEMA (Huge red lump on arm from the injection) 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.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A patient received an expired vaccine as a second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient received an expired vaccine as a second dose) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient received an expired vaccine as a second dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient received an expired vaccine as a second dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: lymph nodes under my arm are swollen; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph nodes under my arm are swollen) 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 LYMPHADENOPATHY (lymph nodes under my arm are swollen). At the time of the report, LYMPHADENOPATHY (lymph nodes under my arm are swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided. No treatment information was provided by the reporter.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: sore arm; cervical chain lymph nodes swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and LYMPHADENOPATHY (cervical chain lymph nodes swollen) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028120A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and LYMPHADENOPATHY (cervical chain lymph nodes swollen). On 28-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, LYMPHADENOPATHY (cervical chain lymph nodes swollen) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Patient stated using concomitant medication of eye drops.
Sex: U
Vaccine: COVID19
Symptoms: Gastric disorder
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of gastric disorder (stomach problems) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced gastric disorder (stomach problems). At the time of the report, gastric disorder (stomach problems) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (received expired 1st dose) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 024C21A) for COVID-19 immunization. No medical history reported. On Jun 29, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 29, 2021, patient administered expired product (received expired 1st dose). On Jun 29, 2021, administered expired product (received expired 1st dose) resolved. The action taken with mRNA-1273 (Moderna COVID-19  vaccine): unknown. The reporter did not provide any causality assessments, concomitant medications or treatment information.
Sex: U
Vaccine: COVID19
Symptoms: Feeling hot, Headache
Clinical narrative: feel over heated all the time; headaches daily; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (feel over heated all the time) and HEADACHE (headaches daily) 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 04-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jun-2021, the patient experienced FEELING HOT (feel over heated all the time) and HEADACHE (headaches daily). At the time of the report, FEELING HOT (feel over heated all the time) and HEADACHE (headaches daily) outcome was unknown.            Reporter did not allow further contact
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Amnesia, Anosmia, Chills, Headache
Clinical narrative: Memory Loss; Loss of smell; Loss of taste; Cold Chills; Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (Memory Loss), ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), CHILLS (Cold Chills) and HEADACHE (Bad headache) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 029A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-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 AMNESIA (Memory Loss), ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), CHILLS (Cold Chills) and HEADACHE (Bad headache). At the time of the report, AMNESIA (Memory Loss), ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), CHILLS (Cold Chills) and HEADACHE (Bad headache) outcome was unknown.            No concomitant medications were reported. Treatment information was not provided by the reporter.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Constricted affect, Cough, Feeling hot, Nausea, Secretion discharge
Clinical narrative: About 10-15 minutes after receiving vaccine, she started with heat; Constriction; Cough; Mucus Secretion; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (About 10-15 minutes after receiving vaccine, she started with heat), CONSTRICTED AFFECT (constriction), COUGH (Cough), SECRETION DISCHARGE (Mucus Secretion) and NAUSEA (Nausea) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced FEELING HOT (About 10-15 minutes after receiving vaccine, she started with heat), CONSTRICTED AFFECT (constriction), COUGH (Cough), SECRETION DISCHARGE (Mucus Secretion) and NAUSEA (Nausea). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. On 03-Jun-2021, FEELING HOT (About 10-15 minutes after receiving vaccine, she started with heat), CONSTRICTED AFFECT (constriction), COUGH (Cough), SECRETION DISCHARGE (Mucus Secretion) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Additional information contains no new information. On 29-Jun-2021: Additional information contains no new information. On 08-Jul-2021: Additional information contains no new information.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second moderna vaccine was given 3 months after first dose for health reasons not related to Covid; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second moderna vaccine was given 3 months after first dose for health reasons not related to Covid) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Asthma.    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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second moderna vaccine was given 3 months after first dose for health reasons not related to Covid). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second moderna vaccine was given 3 months after first dose for health reasons not related to Covid) had resolved.            No concomitant medications were reported.  Patient reported that her second moderna vaccine was given 3 months after first dose for health reasons not related to covid.  No treatment details were reported.   Reporter did not allow further contact