chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pain in extremity
Clinical narrative: little sore arm; She is 32 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (She is 32 weeks pregnant) and PAIN IN EXTREMITY (little sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 27-Aug-2020 and the estimated date of delivery was 03-Jun-2021. On 06-Apr-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (She is 32 weeks pregnant). On an unknown date, the patient experienced PAIN IN EXTREMITY (little sore arm). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy.  On 06-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (She is 32 weeks pregnant) had resolved. At the time of the report, PAIN IN EXTREMITY (little sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were Baby aspirin, Prenatal. Treatment medication were not reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint dislocation, Joint stiffness, Joint swelling, Mobility decreased
Clinical narrative: Misalignment of jaws; increasing and progressive swelling; Joint stiffness; Joint swelling; limited use & range of motion; Swollen feet; Painful feet; Exacerbated Neurological condition; sore joints / joint pain; This spontaneous case was reported by a consumer and describes the occurrence of JOINT DISLOCATION (Misalignment of jaws), SWELLING (increasing and progressive swelling), JOINT STIFFNESS (Joint stiffness), JOINT SWELLING (Joint swelling) and MOBILITY DECREASED (limited use & range of motion) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced ARTHRALGIA (sore joints / joint pain). On 03-Apr-2021, the patient experienced JOINT DISLOCATION (Misalignment of jaws), SWELLING (increasing and progressive swelling), JOINT STIFFNESS (Joint stiffness), JOINT SWELLING (Joint swelling), MOBILITY DECREASED (limited use & range of motion), PERIPHERAL SWELLING (Swollen feet), PAIN IN EXTREMITY (Painful feet) and NERVOUS SYSTEM DISORDER (Exacerbated Neurological condition). At the time of the report, JOINT DISLOCATION (Misalignment of jaws), SWELLING (increasing and progressive swelling), JOINT STIFFNESS (Joint stiffness), JOINT SWELLING (Joint swelling), MOBILITY DECREASED (limited use & range of motion), PERIPHERAL SWELLING (Swollen feet), PAIN IN EXTREMITY (Painful feet), NERVOUS SYSTEM DISORDER (Exacerbated Neurological condition) and ARTHRALGIA (sore joints / joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug was not reported. Treatment for the event included Ibuprofen and Aleve.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Significant follow up appended to AER
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Nervous system disorder, Pain in extremity, Peripheral swelling, Swelling
Clinical narrative: Misalignment of jaws; increasing and progressive swelling; Joint stiffness; Joint swelling; limited use & range of motion; Swollen feet; Painful feet; Exacerbated Neurological condition; sore joints / joint pain; This spontaneous case was reported by a consumer and describes the occurrence of JOINT DISLOCATION (Misalignment of jaws), SWELLING (increasing and progressive swelling), JOINT STIFFNESS (Joint stiffness), JOINT SWELLING (Joint swelling) and MOBILITY DECREASED (limited use & range of motion) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced ARTHRALGIA (sore joints / joint pain). On 03-Apr-2021, the patient experienced JOINT DISLOCATION (Misalignment of jaws), SWELLING (increasing and progressive swelling), JOINT STIFFNESS (Joint stiffness), JOINT SWELLING (Joint swelling), MOBILITY DECREASED (limited use & range of motion), PERIPHERAL SWELLING (Swollen feet), PAIN IN EXTREMITY (Painful feet) and NERVOUS SYSTEM DISORDER (Exacerbated Neurological condition). At the time of the report, JOINT DISLOCATION (Misalignment of jaws), SWELLING (increasing and progressive swelling), JOINT STIFFNESS (Joint stiffness), JOINT SWELLING (Joint swelling), MOBILITY DECREASED (limited use & range of motion), PERIPHERAL SWELLING (Swollen feet), PAIN IN EXTREMITY (Painful feet), NERVOUS SYSTEM DISORDER (Exacerbated Neurological condition) and ARTHRALGIA (sore joints / joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug was not reported. Treatment for the event included Ibuprofen and Aleve.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Significant follow up appended to AER
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pain in extremity
Clinical narrative: Sore arm; Felt "like I´m sick again with COVID...real tired!"; Felt "like I´m sick again with COVID...real tired!"; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MALAISE (Felt "like I´m sick again with COVID...real tired!") and FATIGUE (Felt "like I´m sick again with COVID...real tired!") in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 14-Nov-2020.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), MALAISE (Felt "like I´m sick again with COVID...real tired!") and FATIGUE (Felt "like I´m sick again with COVID...real tired!"). At the time of the report, PAIN IN EXTREMITY (Sore arm), MALAISE (Felt "like I´m sick again with COVID..real tired!") and FATIGUE (Felt "like I´m sick again with COVID..real tired!") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: fatigue; muscle pain; chills; fever; Tired; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Apr-2021 and was forwarded to Moderna on 07-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), MYALGIA (muscle pain), CHILLS (chills), PYREXIA (fever) and FATIGUE (Tired) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue), MYALGIA (muscle pain), CHILLS (chills), PYREXIA (fever) and FATIGUE (Tired). At the time of the report, FATIGUE (fatigue), MYALGIA (muscle pain), CHILLS (chills), PYREXIA (fever) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.  No treatment medication information was provided   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Event outcome provided, declined further follow-up
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Incorrect route of product administration, Underdose, Vaccination site haemorrhage
Clinical narrative: it started bleeding a lot; She is not sure if the vaccine made it all the way to the muscle; not sure if she received a full dose; a lot of the vaccine was dripping down her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (it started bleeding a lot), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (She is not sure if the vaccine made it all the way to the muscle), UNDERDOSE (not sure if she received a full dose) and DEVICE CONNECTION ISSUE (a lot of the vaccine was dripping down her arm) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (it started bleeding a lot), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (She is not sure if the vaccine made it all the way to the muscle), UNDERDOSE (not sure if she received a full dose) and DEVICE CONNECTION ISSUE (a lot of the vaccine was dripping down her arm). On 07-Apr-2021, VACCINATION SITE HAEMORRHAGE (it started bleeding a lot), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (She is not sure if the vaccine made it all the way to the muscle), UNDERDOSE (not sure if she received a full dose) and DEVICE CONNECTION ISSUE (a lot of the vaccine was dripping down her arm) had resolved. Not Provided          Concomitant medications were not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-223820 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Patient clarified this case concerns 2nd dose not 1st, information given for another case concerning third vaccination
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Joint swelling, Myalgia, Oral herpes
Clinical narrative: left knee swelling; right hip pain; Cold sore on lip; Redness; Swelling; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), SWELLING (Swelling), MYALGIA (Body aches), ORAL HERPES (Cold sore on lip) and JOINT SWELLING (left knee swelling) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced ERYTHEMA (Redness), SWELLING (Swelling) and MYALGIA (Body aches). On 07-Apr-2021, the patient experienced ORAL HERPES (Cold sore on lip). On an unknown date, the patient experienced JOINT SWELLING (left knee swelling) and ARTHRALGIA (right hip pain). At the time of the report, ERYTHEMA (Redness), SWELLING (Swelling), MYALGIA (Body aches), ORAL HERPES (Cold sore on lip), JOINT SWELLING (left knee swelling) and ARTHRALGIA (right hip pain) outcome was unknown. Not Provided          no treatment information was provided  no concomitant medication was reported   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up received on 18-MAY-2021, contains significant information, added events.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: left knee swelling; right hip pain; Cold sore on lip; Redness; Swelling; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), SWELLING (Swelling), MYALGIA (Body aches), ORAL HERPES (Cold sore on lip) and JOINT SWELLING (left knee swelling) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced ERYTHEMA (Redness), SWELLING (Swelling) and MYALGIA (Body aches). On 07-Apr-2021, the patient experienced ORAL HERPES (Cold sore on lip). On an unknown date, the patient experienced JOINT SWELLING (left knee swelling) and ARTHRALGIA (right hip pain). At the time of the report, ERYTHEMA (Redness), SWELLING (Swelling), MYALGIA (Body aches), ORAL HERPES (Cold sore on lip), JOINT SWELLING (left knee swelling) and ARTHRALGIA (right hip pain) outcome was unknown. Not Provided          no treatment information was provided  no concomitant medication was reported   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up received on 18-MAY-2021, contains significant information, added events.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: Blood sugar went up to 596; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLOOD GLUCOSE INCREASED (Blood sugar went up to 596) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included INSULIN HUMAN (NOVOLIN R) and INSULIN HUMAN INJECTION, ISOPHANE (NOVOLIN N) for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (Blood sugar went up to 596). The patient was treated with INSULIN for Hyperglycemia, at an unspecified dose and frequency. On 11-Feb-2021, BLOOD GLUCOSE INCREASED (Blood sugar went up to 596) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Blood glucose: 596 (High) Blood sugar went up to 596.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medication also included fluids to decrease blood sugar. .   This case was linked to MOD-2021-069678 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up information received on 18-MAY-2021 contains significant information: Treatment medications added. The outcome of the event changed from unknown to resolved.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant at time of vaccination; This spontaneous retrospective pregnancy case was reported by a physician and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant at time of vaccination) in a female patient of an unknown age (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pregnancy.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant at time of vaccination). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant at time of vaccination) had resolved. Not Provided      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 medications were not reported. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Internal review on 24-Jun-21 resulted in updates to pregnancy details.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Mild itching near injection site; Mild redness near injection site; Red round rash at injection; Mild swelling near injection site; Little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Little sore arm), VACCINATION SITE PRURITUS (Mild itching near injection site), VACCINATION SITE ERYTHEMA (Mild redness near injection site), VACCINATION SITE RASH (Red round rash at injection) and VACCINATION SITE SWELLING (Mild swelling near injection site) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     Concomitant products included FISH OIL (OMEGA 3 [FISH OIL]), ASCORBIC ACID (ESTER-C [ASCORBIC ACID]) and MAGNESIUM GLYCINATE for an unknown indication.    On 30-Mar-2021 at 5:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (Little sore arm). On 06-Apr-2021 at 6:00 PM, the patient experienced VACCINATION SITE PRURITUS (Mild itching near injection site), VACCINATION SITE ERYTHEMA (Mild redness near injection site), VACCINATION SITE RASH (Red round rash at injection) and VACCINATION SITE SWELLING (Mild swelling near injection site). The patient was treated with HYDROCORTISONE (topical) for Itching and Redness, at an unspecified dose and frequency. On 01-Apr-2021, PAIN IN EXTREMITY (Little sore arm) had resolved. On 08-Apr-2021, VACCINATION SITE PRURITUS (Mild itching near injection site), VACCINATION SITE ERYTHEMA (Mild redness near injection site), VACCINATION SITE RASH (Red round rash at injection) and VACCINATION SITE SWELLING (Mild swelling near injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list also included My Kind Organics Women's Once Daily Vitamins, 1 per day, oral for daily maintenance.    Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Reporter contact details were updated, patient demographics were updated, re and de challenge fields were updated, vaccine facility details were updated, new event; developed red round rash at injection site was added and event outcomes were updated from unknown to recovered/resolved.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Flank pain, Flushing, Headache, Oral discomfort
Clinical narrative: Face got flushed; Warm face; Outline of lips started tingling; Outline of her lips felt irritated; Flank pain on her right side; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Face got flushed), FEELING HOT (Warm face), PARAESTHESIA ORAL (Outline of lips started tingling), ORAL DISCOMFORT (Outline of her lips felt irritated) and FLANK PAIN (Flank pain on her right side) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMIN D NOS for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced FLUSHING (Face got flushed), FEELING HOT (Warm face), PARAESTHESIA ORAL (Outline of lips started tingling), ORAL DISCOMFORT (Outline of her lips felt irritated), FLANK PAIN (Flank pain on her right side) and HEADACHE (Headache). On 11-Mar-2021, FLUSHING (Face got flushed), FEELING HOT (Warm face), PARAESTHESIA ORAL (Outline of lips started tingling) and ORAL DISCOMFORT (Outline of her lips felt irritated) had resolved. At the time of the report, FLANK PAIN (Flank pain on her right side) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment includes :seasick drug and Claritin
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Face got flushed; Warm face; Outline of lips started tingling; Outline of her lips felt irritated; Flank pain on her right side; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Face got flushed), FEELING HOT (Warm face), PARAESTHESIA ORAL (Outline of lips started tingling), ORAL DISCOMFORT (Outline of her lips felt irritated) and FLANK PAIN (Flank pain on her right side) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and VITAMIN D NOS for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced FLUSHING (Face got flushed), FEELING HOT (Warm face), PARAESTHESIA ORAL (Outline of lips started tingling), ORAL DISCOMFORT (Outline of her lips felt irritated), FLANK PAIN (Flank pain on her right side) and HEADACHE (Headache). On 11-Mar-2021, FLUSHING (Face got flushed), FEELING HOT (Warm face), PARAESTHESIA ORAL (Outline of lips started tingling) and ORAL DISCOMFORT (Outline of her lips felt irritated) had resolved. At the time of the report, FLANK PAIN (Flank pain on her right side) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment includes :seasick drug and Claritin
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pain, Rash
Clinical narrative: super aggressive, rash covering great part of the body, a lot of pain; super aggressive, rash covering great part of the body, a lot of pain; shingles on the left side of her body; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (shingles on the left side of her body), RASH (super aggressive, rash covering great part of the body, a lot of pain) and PAIN (super aggressive, rash covering great part of the body, a lot of pain) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     The patient's past medical history included Shingles.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced HERPES ZOSTER (shingles on the left side of her body). On an unknown date, the patient experienced RASH (super aggressive, rash covering great part of the body, a lot of pain) and PAIN (super aggressive, rash covering great part of the body, a lot of pain). At the time of the report, HERPES ZOSTER (shingles on the left side of her body), RASH (super aggressive, rash covering great part of the body, a lot of pain) and PAIN (super aggressive, rash covering great part of the body, a lot of pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant Medications were not provided. Treatment includes valtrax.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product dose omission issue
Clinical narrative: patient has not received 2nd dose of the vaccine yet; patient has not received 2nd dose of the vaccine yet; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (patient has not received 2nd dose of the vaccine yet) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient has not received 2nd dose of the vaccine yet) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (patient has not received 2nd dose of the vaccine yet) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient has not received 2nd dose of the vaccine yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patient has not received 2nd dose of the vaccine yet) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient has not received 2nd dose of the vaccine yet) outcome was unknown. Not Provided      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 Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: flu-like symptoms; fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms) and PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2020.    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 INFLUENZA LIKE ILLNESS (flu-like symptoms) and PYREXIA (fever). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment was unknown.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Headache, Pruritus, Pyrexia
Clinical narrative: Real itchy arm / big part of arm is all itchy; Big part of arm is all red / red area size of hand on arm; Upper shoulder has little bumps; Headache; Fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Real itchy arm / big part of arm is all itchy), ERYTHEMA (Big part of arm is all red / red area size of hand on arm), RASH (Upper shoulder has little bumps), HEADACHE (Headache) and FATIGUE (Fatigue) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Fever). On 07-Apr-2021, the patient experienced PRURITUS (Real itchy arm / big part of arm is all itchy), ERYTHEMA (Big part of arm is all red / red area size of hand on arm) and RASH (Upper shoulder has little bumps). On 01-Apr-2021, HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Fever) had resolved. At the time of the report, PRURITUS (Real itchy arm / big part of arm is all itchy), ERYTHEMA (Big part of arm is all red / red area size of hand on arm) and RASH (Upper shoulder has little bumps) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Real itchy arm / big part of arm is all itchy; Big part of arm is all red / red area size of hand on arm; Upper shoulder has little bumps; Headache; Fatigue; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Real itchy arm / big part of arm is all itchy), ERYTHEMA (Big part of arm is all red / red area size of hand on arm), RASH (Upper shoulder has little bumps), HEADACHE (Headache) and FATIGUE (Fatigue) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Fever). On 07-Apr-2021, the patient experienced PRURITUS (Real itchy arm / big part of arm is all itchy), ERYTHEMA (Big part of arm is all red / red area size of hand on arm) and RASH (Upper shoulder has little bumps). On 01-Apr-2021, HEADACHE (Headache), FATIGUE (Fatigue) and PYREXIA (Fever) had resolved. At the time of the report, PRURITUS (Real itchy arm / big part of arm is all itchy), ERYTHEMA (Big part of arm is all red / red area size of hand on arm) and RASH (Upper shoulder has little bumps) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine given to 17 year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to 17 year old) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to 17 year old). On 12-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to 17 year old) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment for the events were not provided.  This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # unknow,  with no associated AEs.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # unknow,  with no associated AEs.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Visual impairment
Clinical narrative: Sore arm; Vision problems; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VISUAL IMPAIRMENT (Vision problems) and HEADACHE (Headache) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), VISUAL IMPAIRMENT (Vision problems) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arm), VISUAL IMPAIRMENT (Vision problems) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: This spontaneous case reported by a nurse, describes the occurrence of pain (ache) and pyrexia (fever) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 025B21A) for COVID-19 immunization. No medical history reported. On Mar 30, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 30, 2021, patient experienced pain (ache) and pyrexia (fever). On Apr 6, 2021, pain (ache) and pyrexia (fever) resolved. The action taken with mRNA-1273 (Moderna COVID-19  vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant medication use or treatment information. Most recent follow-up information incorporated: On Jun 16, 2021: Attachment.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Itchy rash on her leg and on her arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash on her leg and on her arm) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Itchy rash on her leg and on her arm). The patient was treated with CETIRIZINE ongoing since an unknown date for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Itchy rash on her leg and on her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        .
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis
Clinical narrative: Woke up today can hardly bend her knees; joints are painful: affecting ankles, knees and shoulders; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Woke up today can hardly bend her knees) and ARTHRALGIA (joints are painful: affecting ankles, knees and shoulders) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02A21A and 025A21A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), SIMVASTATIN (ZOCOR) and POTASSIUM for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced ARTHRALGIA (joints are painful: affecting ankles, knees and shoulders). On 07-Apr-2021, the patient experienced ARTHRITIS (Woke up today can hardly bend her knees). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, ARTHRITIS (Woke up today can hardly bend her knees) and ARTHRALGIA (joints are painful: affecting ankles, knees and shoulders) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included bi-flex.  Treatment medication included half an aspirin at night.  Action taken with mRNA-1273 Moderna vaccine was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow up information was received on 19-MAY-2021, additional information was updated.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain
Clinical narrative: Achy bones; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Achy bones) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced BONE PAIN (Achy bones). The patient was treated with PARACETAMOL (TYLENOL) for Bone pain, at an unspecified dose and frequency. At the time of the report, BONE PAIN (Achy bones) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.    Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow up information was received on 16 Jun 2021 : outcome of the event updated from unknown to recovering/resolving.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness after receiving the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness after receiving the 1st dose) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010U20A and 040A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for COVID-19 vaccination.   On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm soreness after receiving the 1st dose). At the time of the report, PAIN IN EXTREMITY (Arm soreness after receiving the 1st dose) had resolved.            No treatment information reported.  Based on the current available information and temporal association between the use of the product and the start date of the event, 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 event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19 Positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19 Positive) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced COVID-19 (Covid-19 Positive). On 17-Feb-2021, COVID-19 (Covid-19 Positive) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant Medications were not provided by the reporter. Treatment includes Treatment for COVID-19 disease.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Chills, Myalgia, Nausea
Clinical narrative: COVID test this morning, and found out that she was positive; fever; shaking and chills; nauseated; possible body aches; shaking and chills; all my bones hurt; real sore right arm; felt little sluggish; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (real sore right arm), SLUGGISHNESS (felt little sluggish), TREMOR (shaking and chills), BONE PAIN (all my bones hurt) and SARS-COV-2 TEST POSITIVE (COVID test this morning, and found out that she was positive) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fibromyalgia, Arthritis and Autoimmune disorder. Concurrent medical conditions included Diabetes.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (real sore right arm) and SLUGGISHNESS (felt little sluggish). On 06-Apr-2021, the patient experienced TREMOR (shaking and chills), BONE PAIN (all my bones hurt), PYREXIA (fever), CHILLS (shaking and chills), NAUSEA (nauseated) and MYALGIA (possible body aches). On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (COVID test this morning, and found out that she was positive). At the time of the report, PAIN IN EXTREMITY (real sore right arm), SLUGGISHNESS (felt little sluggish), TREMOR (shaking and chills), BONE PAIN (all my bones hurt), PYREXIA (fever), CHILLS (shaking and chills), NAUSEA (nauseated) and MYALGIA (possible body aches) had not resolved and SARS-COV-2 TEST POSITIVE (COVID test this morning, and found out that she was positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 101-102 degree Celsius 101-102 degrees.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       the concomitant history was not reported.  the treatment taken by the patient was Tylenol (paracetamol).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: No specific follow-up information recorded.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, SARS-CoV-2 test positive, Sluggishness, Tremor
Clinical narrative: COVID test this morning, and found out that she was positive; fever; shaking and chills; nauseated; possible body aches; shaking and chills; all my bones hurt; real sore right arm; felt little sluggish; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (real sore right arm), SLUGGISHNESS (felt little sluggish), TREMOR (shaking and chills), BONE PAIN (all my bones hurt) and SARS-COV-2 TEST POSITIVE (COVID test this morning, and found out that she was positive) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fibromyalgia, Arthritis and Autoimmune disorder. Concurrent medical conditions included Diabetes.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (real sore right arm) and SLUGGISHNESS (felt little sluggish). On 06-Apr-2021, the patient experienced TREMOR (shaking and chills), BONE PAIN (all my bones hurt), PYREXIA (fever), CHILLS (shaking and chills), NAUSEA (nauseated) and MYALGIA (possible body aches). On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (COVID test this morning, and found out that she was positive). At the time of the report, PAIN IN EXTREMITY (real sore right arm), SLUGGISHNESS (felt little sluggish), TREMOR (shaking and chills), BONE PAIN (all my bones hurt), PYREXIA (fever), CHILLS (shaking and chills), NAUSEA (nauseated) and MYALGIA (possible body aches) had not resolved and SARS-COV-2 TEST POSITIVE (COVID test this morning, and found out that she was positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 101-102 degree Celsius 101-102 degrees.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       the concomitant history was not reported.  the treatment taken by the patient was Tylenol (paracetamol).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: No specific follow-up information recorded.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site rash
Clinical narrative: fever; rash at injection site; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PYREXIA (fever) and VACCINATION SITE RASH (rash at injection site) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A.) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced PYREXIA (fever) and VACCINATION SITE RASH (rash at injection site). At the time of the report, PYREXIA (fever) and VACCINATION SITE RASH (rash at injection site) 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 medication reported.  No treatment medication reported.  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.