chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness postural, Peripheral swelling, Rash, Vaccination site rash
Clinical narrative: Swollen arm; Extremely dizzy when standing; Patches on face at night; Rash around injection site; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm), DIZZINESS POSTURAL (Extremely dizzy when standing), RASH (Patches on face at night) and VACCINATION SITE RASH (Rash around injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen arm), DIZZINESS POSTURAL (Extremely dizzy when standing), RASH (Patches on face at night) and VACCINATION SITE RASH (Rash around injection site). At the time of the report, PERIPHERAL SWELLING (Swollen arm), DIZZINESS POSTURAL (Extremely dizzy when standing), RASH (Patches on face at night) and VACCINATION SITE RASH (Rash around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: has not received the 2nd vaccine; A spontaneous report  was received from a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had not received the second vaccine.  The patient's medical history and concomitant medications were not provided.  On 18-JAN-2021, the patient received her first of two planned doses of mRNA-1273 (lot number: unavailable) intramuscularly for prophylaxis of COVID-19 infection.  On 27-FEB-2021, the patient reported that she had not received the second dose of the vaccine yet.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, had not received the second vaccine, was considered resolved.; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot# unavailable, with no associated adverse events.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: 3 to 4 drops leaked; 3 to 4 drops leaked out of syringe; A spontaneous report was received from a consumer who was also a 44-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event 3 to 4 drops leaked out of syringe.   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.   On 26 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On Feb 2021, the patient observed that about 3 to 4 drops leaked out of the vaccination syringe. No adverse event was reported by the patient after being given the vaccine. Treatment information was not provided.   The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.   The outcomes of the events were considered recovered on 26 Feb 2021.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273 (lot # unknown) with no associated AEs reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: blotches on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (blotches on arm) 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 17-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 RASH (blotches on arm). At the time of the report, VACCINATION SITE RASH (blotches on arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Vaccination site haemorrhage
Clinical narrative: Blood was running down after injection; Stiff arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (Blood was running down after injection) and MUSCULOSKELETAL STIFFNESS (Stiff arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (Blood was running down after injection) and MUSCULOSKELETAL STIFFNESS (Stiff arm). At the time of the report, VACCINATION SITE HAEMORRHAGE (Blood was running down after injection) and MUSCULOSKELETAL STIFFNESS (Stiff arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included blood thinner. No treatment information was provided
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Feeling abnormal, Headache, Myalgia
Clinical narrative: having reactions to the shot; Not feeling good; Weak; headache; chills; achy muscles; rash on legs and thighs; Sore and achy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (having reactions to the shot), FEELING ABNORMAL (Not feeling good), ASTHENIA (Weak), HEADACHE (headache) and CHILLS (chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy (Allergy to Sulfa.) and Allergic reaction to analgesics (Celebrex and Percocet).    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION COMPLICATION (having reactions to the shot), FEELING ABNORMAL (Not feeling good), ASTHENIA (Weak), HEADACHE (headache), CHILLS (chills), MYALGIA (achy muscles), RASH (rash on legs and thighs) and MYALGIA (Sore and achy). At the time of the report, VACCINATION COMPLICATION (having reactions to the shot), FEELING ABNORMAL (Not feeling good), ASTHENIA (Weak), HEADACHE (headache), CHILLS (chills), MYALGIA (achy muscles), RASH (rash on legs and thighs) and MYALGIA (Sore and achy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was included. Treatment medication included Tylenol..
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination complication
Clinical narrative: having reactions to the shot; Not feeling good; Weak; headache; chills; achy muscles; rash on legs and thighs; Sore and achy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (having reactions to the shot), FEELING ABNORMAL (Not feeling good), ASTHENIA (Weak), HEADACHE (headache) and CHILLS (chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy (Allergy to Sulfa.) and Allergic reaction to analgesics (Celebrex and Percocet).    On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION COMPLICATION (having reactions to the shot), FEELING ABNORMAL (Not feeling good), ASTHENIA (Weak), HEADACHE (headache), CHILLS (chills), MYALGIA (achy muscles), RASH (rash on legs and thighs) and MYALGIA (Sore and achy). At the time of the report, VACCINATION COMPLICATION (having reactions to the shot), FEELING ABNORMAL (Not feeling good), ASTHENIA (Weak), HEADACHE (headache), CHILLS (chills), MYALGIA (achy muscles), RASH (rash on legs and thighs) and MYALGIA (Sore and achy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was included. Treatment medication included Tylenol..
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Pyrexia, Somnolence
Clinical narrative: slept all day; I was miserable; I woke with huge swollen hives; I had chills; ran a low-grade fever; tired all day; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Feb-2021 and was forwarded to Moderna on 27-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept all day), FEELING ABNORMAL (I was miserable), URTICARIA (I woke with huge swollen hives), CHILLS (I had chills) and PYREXIA (ran a low-grade fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (slept all day), FEELING ABNORMAL (I was miserable), URTICARIA (I woke with huge swollen hives), CHILLS (I had chills), PYREXIA (ran a low-grade fever) and FATIGUE (tired all day). At the time of the report, SOMNOLENCE (slept all day), FEELING ABNORMAL (I was miserable), URTICARIA (I woke with huge swollen hives), CHILLS (I had chills), PYREXIA (ran a low-grade fever) and FATIGUE (tired all day) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: slept all day; I was miserable; I woke with huge swollen hives; I had chills; ran a low-grade fever; tired all day; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Feb-2021 and was forwarded to Moderna on 27-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept all day), FEELING ABNORMAL (I was miserable), URTICARIA (I woke with huge swollen hives), CHILLS (I had chills) and PYREXIA (ran a low-grade fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Rheumatoid arthritis.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (slept all day), FEELING ABNORMAL (I was miserable), URTICARIA (I woke with huge swollen hives), CHILLS (I had chills), PYREXIA (ran a low-grade fever) and FATIGUE (tired all day). At the time of the report, SOMNOLENCE (slept all day), FEELING ABNORMAL (I was miserable), URTICARIA (I woke with huge swollen hives), CHILLS (I had chills), PYREXIA (ran a low-grade fever) and FATIGUE (tired all day) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: left arm swollen; right arm swollen; right arm itchy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (left arm swollen), VACCINATION SITE SWELLING (right arm swollen) and VACCINATION SITE PRURITUS (right arm itchy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 004M20A) for COVID-19 vaccination.     The patient's past medical history included Breast conserving surgery (She had breast surgery on left side) and Lymph node excision (removed lymph nodes).   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PERIPHERAL SWELLING (left arm swollen), VACCINATION SITE SWELLING (right arm swollen) and VACCINATION SITE PRURITUS (right arm itchy). At the time of the report, PERIPHERAL SWELLING (left arm swollen), VACCINATION SITE SWELLING (right arm swollen) and VACCINATION SITE PRURITUS (right arm itchy) outcome was unknown.            No concomitant medication details were reported.  No treatment medication details were reported.   This case was linked to MOD-2021-056299, MOD-2021-056299 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: No new information was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurt) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm hurt). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PAIN (Arm hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Caused Migraine headache to come back; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Feb-2021 and was forwarded to Moderna on 28-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Caused Migraine headache to come back) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 002A21A) for COVID-19 vaccination.     The patient's past medical history included Migraine. Concomitant products included BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET).   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced MIGRAINE (Caused Migraine headache to come back). On 26-Feb-2021, MIGRAINE (Caused Migraine headache to come back) had resolved.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Blood pressure measurement, Body temperature fluctuation, Diarrhoea
Clinical narrative: BP (198/100)/BP is on peak; essentially weaken, she is going weaker; Diarrhea; temperature on and off; Lots of GI symptoms; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (BP (198/100)/BP is on peak), ASTHENIA (essentially weaken, she is going weaker), DIARRHOEA (Diarrhea), BODY TEMPERATURE FLUCTUATION (temperature on and off) and ABDOMINAL DISCOMFORT (Lots of GI symptoms) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced HYPERTENSION (BP (198/100)/BP is on peak), ASTHENIA (essentially weaken, she is going weaker), DIARRHOEA (Diarrhea), BODY TEMPERATURE FLUCTUATION (temperature on and off) and ABDOMINAL DISCOMFORT (Lots of GI symptoms). At the time of the report, HYPERTENSION (BP (198/100)/BP is on peak) had not resolved and ASTHENIA (essentially weaken, she is going weaker), DIARRHOEA (Diarrhea), BODY TEMPERATURE FLUCTUATION (temperature on and off) and ABDOMINAL DISCOMFORT (Lots of GI symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood pressure measurement: 198/100 (High) BP is on peak..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: BP (198/100)/BP is on peak; essentially weaken, she is going weaker; Diarrhea; temperature on and off; Lots of GI symptoms; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (BP (198/100)/BP is on peak), ASTHENIA (essentially weaken, she is going weaker), DIARRHOEA (Diarrhea), BODY TEMPERATURE FLUCTUATION (temperature on and off) and ABDOMINAL DISCOMFORT (Lots of GI symptoms) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced HYPERTENSION (BP (198/100)/BP is on peak), ASTHENIA (essentially weaken, she is going weaker), DIARRHOEA (Diarrhea), BODY TEMPERATURE FLUCTUATION (temperature on and off) and ABDOMINAL DISCOMFORT (Lots of GI symptoms). At the time of the report, HYPERTENSION (BP (198/100)/BP is on peak) had not resolved and ASTHENIA (essentially weaken, she is going weaker), DIARRHOEA (Diarrhea), BODY TEMPERATURE FLUCTUATION (temperature on and off) and ABDOMINAL DISCOMFORT (Lots of GI symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Blood pressure measurement: 198/100 (High) BP is on peak..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Significant reaction; A spontaneous report was received from a healthcare professional concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an event, significant reaction/vaccination complication.  The patient's medical history was not provided. Concomitant medications reported were gabapentin for unknown indication.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event, significant reaction. Treatment details were not provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event significant reaction was not reported.; Reporter'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. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: a sore arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a sore arm) and HEADACHE (headache) 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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (a sore arm) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (a sore arm) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Headache
Clinical narrative: asthma flare up initial shot; headache initial shot; This spontaneous case was reported by a physician and describes the occurrence of ASTHMA (asthma flare up initial shot) and HEADACHE (headache initial shot) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 031M20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced ASTHMA (asthma flare up initial shot) and HEADACHE (headache initial shot). On 15-Jan-2021, ASTHMA (asthma flare up initial shot) and HEADACHE (headache initial shot) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details included nebulizer treatment, rescue inhaler, and 2 steroid inhalers.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: migraine; sea sick like nausea; fever; sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Feb-2021 and was forwarded to Moderna on 28-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine), VACCINATION SITE PAIN (sore arm), NAUSEA (sea sick like nausea) and PYREXIA (fever) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 27-Feb-2021, the patient experienced MIGRAINE (migraine), NAUSEA (sea sick like nausea) and PYREXIA (fever). On 27-Feb-2021, MIGRAINE (migraine), VACCINATION SITE PAIN (sore arm), NAUSEA (sea sick like nausea) and PYREXIA (fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side Effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side Effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 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. In February 2021, the patient experienced VACCINATION COMPLICATION (Side Effects). At the time of the report, VACCINATION COMPLICATION (Side Effects) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.  Action taken with mRNA-1273 in response to events was not applicable.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Product administration error
Clinical narrative: Headache; Vaccine was drawn up into a plastic syringe and left out for 3 hours; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Vaccine was drawn up into a plastic syringe and left out for 3 hours) and HEADACHE (Headache) 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 (No adverse event reported).   On 04-Feb-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-Feb-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Vaccine was drawn up into a plastic syringe and left out for 3 hours). On an unknown date, the patient experienced HEADACHE (Headache). On 04-Feb-2021, PRODUCT ADMINISTRATION ERROR (Vaccine was drawn up into a plastic syringe and left out for 3 hours) had resolved. At the time of the report, HEADACHE (Headache) outcome was unknown.            Very limited information regarding this event/s has been provided at this time.  Further information has been requested.   This case was linked to MOD-2021-065749 (Patient Link).; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pruritus
Clinical narrative: rash on arm my for 4 days; arm was achy at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (arm was achy at the injection site) and RASH (rash on arm my for 4 days) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (arm was achy at the injection site). On 09-Feb-2021, the patient experienced RASH (rash on arm my for 4 days). At the time of the report, VACCINATION SITE PRURITUS (arm was achy at the injection site) and RASH (rash on arm my for 4 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthma, Back pain, Headache
Clinical narrative: asthma flare up after second shot; headache second shot; back ache; Hip ache; This spontaneous case was reported by a nurse and describes the occurrence of ASTHMA (asthma flare up after second shot), BACK PAIN (back ache), ARTHRALGIA (Hip ache) and HEADACHE (headache second shot) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced BACK PAIN (back ache) and ARTHRALGIA (Hip ache). On 25-Feb-2021, the patient experienced ASTHMA (asthma flare up after second shot) and HEADACHE (headache second shot). On 25-Feb-2021, BACK PAIN (back ache) and ARTHRALGIA (Hip ache) had resolved. At the time of the report, ASTHMA (asthma flare up after second shot) and HEADACHE (headache second shot) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included nebulizer treatment, rescue inhaler, 2 steroid inhaler.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling, Vaccination site pruritus, Vaccination site urticaria
Clinical narrative: At the injection site, it is itching a lot, a little puffy; welts at the injection site; itching area is getting wider and wider; swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (At the injection site, it is itching a lot, a little puffy), VACCINATION SITE URTICARIA (welts at the injection site), PRURITUS (itching area is getting wider and wider) and SWELLING (swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (At the injection site, it is itching a lot, a little puffy), VACCINATION SITE URTICARIA (welts at the injection site), PRURITUS (itching area is getting wider and wider) and SWELLING (swollen). At the time of the report, VACCINATION SITE PRURITUS (At the injection site, it is itching a lot, a little puffy), VACCINATION SITE URTICARIA (welts at the injection site), PRURITUS (itching area is getting wider and wider) and SWELLING (swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information use was not reported.  Treatment information was not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Cold sweat, Myalgia, Pyrexia
Clinical narrative: cold sweats; arms and legs no strength; muscle aches; low grade fever 100.5F; chills; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweats), ASTHENIA (arms and legs no strength), MYALGIA (muscle aches), PYREXIA (low grade fever 100.5F) and CHILLS (chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00F20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced COLD SWEAT (cold sweats), ASTHENIA (arms and legs no strength), MYALGIA (muscle aches), PYREXIA (low grade fever 100.5F) and CHILLS (chills). At the time of the report, COLD SWEAT (cold sweats), ASTHENIA (arms and legs no strength), MYALGIA (muscle aches), PYREXIA (low grade fever 100.5F) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Additional information received on 29-Apr-2021 content no new information.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Pruritus, Rash, Vaccination site erythema
Clinical narrative: itching; diarrhea; rash; big red spot on my arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), DIARRHOEA (diarrhea), RASH (rash) and VACCINATION SITE ERYTHEMA (big red spot on my arm) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy.    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 PRURITUS (itching), DIARRHOEA (diarrhea), RASH (rash) and VACCINATION SITE ERYTHEMA (big red spot on my arm). At the time of the report, PRURITUS (itching), DIARRHOEA (diarrhea), RASH (rash) and VACCINATION SITE ERYTHEMA (big red spot on my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Dizziness, Fall, Vision blurred
Clinical narrative: so dizzy like she couldn't see; having a hard time seeing; wanting to go back down since she was dizzy; fell two weeks ago and hit her behind; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (so dizzy like she couldn't see), VISION BLURRED (having a hard time seeing), ADVERSE REACTION (wanting to go back down since she was dizzy) and FALL (fell two weeks ago and hit her behind) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (so dizzy like she couldn't see), VISION BLURRED (having a hard time seeing), ADVERSE REACTION (wanting to go back down since she was dizzy) and FALL (fell two weeks ago and hit her behind). At the time of the report, DIZZINESS (so dizzy like she couldn't see), VISION BLURRED (having a hard time seeing), ADVERSE REACTION (wanting to go back down since she was dizzy) and FALL (fell two weeks ago and hit her behind) outcome was unknown.            Treatment information was not reported. Concomitant medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: She has been experiencing tingling and needles in all of her extremities; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (She has been experiencing tingling and needles in all of her extremities) 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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (She has been experiencing tingling and needles in all of her extremities). At the time of the report, PARAESTHESIA (She has been experiencing tingling and needles in all of her extremities) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information use was not reported.  Treatment information was not provided.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Dizziness, Fatigue, Somnolence, Vaccination site pain
Clinical narrative: Little discomfort on muscle; Felt very sleepy; Eye lids feel tired, they feel heavy; Dizziness/Lightheaded when she gets up; Felt very tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Little discomfort on muscle), SOMNOLENCE (Felt very sleepy), ASTHENOPIA (Eye lids feel tired, they feel heavy), DIZZINESS (Dizziness/Lightheaded when she gets up) and FATIGUE (Felt very tired) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced DIZZINESS (Dizziness/Lightheaded when she gets up) and FATIGUE (Felt very tired). On 27-Feb-2021, the patient experienced VACCINATION SITE PAIN (Little discomfort on muscle), SOMNOLENCE (Felt very sleepy) and ASTHENOPIA (Eye lids feel tired, they feel heavy). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Little discomfort on muscle), SOMNOLENCE (Felt very sleepy), ASTHENOPIA (Eye lids feel tired, they feel heavy), DIZZINESS (Dizziness/Lightheaded when she gets up) and FATIGUE (Felt very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test, Ultrasound foetal
Clinical narrative: Vaccine administered to pregnant patient; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient) in a 38-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025M20A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Ex-alcohol user (Prior to pregnancy 3 drinks/week.).   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 20-Jul-2020 and the estimated date of delivery was 02-May-2021. On 23-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-sixth week of the pregnancy.  On 20-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Aug-2020, Pregnancy test: positive (Positive) Positive. On 15-Dec-2020, Ultrasound foetal: unknown (normal) normal.         Concomitant product use was not provided by the reporter.  The patient's estimated date of conception was 06 Aug 2020.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Nausea, Swelling, Vaccination site pruritus
Clinical narrative: huge red area on upper part of the arm; swelling; itching at injection site; nausea; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (huge red area on upper part of the arm), SWELLING (swelling), VACCINATION SITE PRURITUS (itching at injection site), NAUSEA (nausea) and HEADACHE (slight headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (melons), Seasonal allergy and Asthma.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced NAUSEA (nausea) and HEADACHE (slight headache). On 23-Feb-2021, the patient experienced ERYTHEMA (huge red area on upper part of the arm), SWELLING (swelling) and VACCINATION SITE PRURITUS (itching at injection site). At the time of the report, ERYTHEMA (huge red area on upper part of the arm), SWELLING (swelling), VACCINATION SITE PRURITUS (itching at injection site), NAUSEA (nausea) and HEADACHE (slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided by the reporter.  Treatment information was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: Sore arm; Developed rash 8-9 days later; A spontaneous report was received from a consumer concerning a 65-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, developed rash 8-9 days later.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Sore arm, Developed rash 8-9 days later.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sore arm, developed rash 8-9 days later was unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Muscular weakness, Myalgia, Vaccination complication, White blood cell count increased
Clinical narrative: Achiness; Couldn't get out of bed; Lost strength in legs; Leg weakness; White count was up a little bit; This spontaneous case was reported by a physician and describes the occurrence of MYALGIA (Achiness), VACCINATION COMPLICATION (Couldn't get out of bed), LIMB DISCOMFORT (Lost strength in legs), MUSCULAR WEAKNESS (Leg weakness) and WHITE BLOOD CELL COUNT INCREASED (White count was up a little bit) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stroke. Concurrent medical conditions included Cancer (chemotheraphy for cancer).   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced MYALGIA (Achiness), VACCINATION COMPLICATION (Couldn't get out of bed), LIMB DISCOMFORT (Lost strength in legs), MUSCULAR WEAKNESS (Leg weakness) and WHITE BLOOD CELL COUNT INCREASED (White count was up a little bit). At the time of the report, MYALGIA (Achiness), VACCINATION COMPLICATION (Couldn't get out of bed), LIMB DISCOMFORT (Lost strength in legs), MUSCULAR WEAKNESS (Leg weakness) and WHITE BLOOD CELL COUNT INCREASED (White count was up a little bit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old who was vaccinated and scheduled for the 2nd dose; A spontaneous report was received from a Health care professional concerning a 17 year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) at 17 years of age (17 year old who was vaccinated and scheduled for the 2nd dose).  The patient's medical history was not provided by the reporter. No concomitant medications was reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, the patient was vaccinated at 17 years of age (17 year old who was vaccinated and scheduled for the 2nd dose) and scheduled for a second dose on 27-FEB- 2021.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of 17 year old who was vaccinated and scheduled for the 2nd dose was unknown.; Reporter's Comments: This report refers to a case of 17 year old who was vaccinated and scheduled for the 2nd dose for mRNA-1273 (lot # unknown) with no associated adverse events.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extreme Tiredness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Extreme Tiredness) and FATIGUE (Fatigue) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included METOPROLOL, ATORVASTATIN, GABAPENTIN and OXCARBAZEPINE for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced FATIGUE (Extreme Tiredness) and FATIGUE (Fatigue). At the time of the report, FATIGUE (Extreme Tiredness) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication details was reported.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm) 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 27-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 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness in arm). At the time of the report, PAIN IN EXTREMITY (soreness in arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medicines were reported. No treatment information reported.    This case was linked to MOD-2021-028353, MOD-2021-005637, MOD-2021-004512 (E2B Linked Report). This case was linked to MOD-2021-028539 (Patient Link).; Sender's Comments:  MOD-2021-028353:same reporter, different patient- MOD21-040066 MOD-2021-005637:same reporter, different patient - MOD21-04067