chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Blood culture, Blood test, Body temperature, Chills
Clinical narrative: severe hip pain on her left joint side; cannot move her leg a lot; cannot walk; muscle pain; fever; chills; headache; abdominal pain; nausea; This spontaneous case was reported by a physician and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (severe hip pain on her left joint side), LIMB DISCOMFORT (cannot move her leg a lot), GAIT DISTURBANCE (cannot walk), MYALGIA (muscle pain) and PYREXIA (fever) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.     On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (severe hip pain on her left joint side), LIMB DISCOMFORT (cannot move her leg a lot), GAIT DISTURBANCE (cannot walk), MYALGIA (muscle pain), PYREXIA (fever), CHILLS (chills), HEADACHE (headache), ABDOMINAL PAIN (abdominal pain) and NAUSEA (nausea). The patient was treated with TRAMADOL for Adverse event, at an unspecified dose and frequency; ONDANSETRON (ZOFRAN [ONDANSETRON]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN SODIUM (IBUPROFEN [IBUPROFEN SODIUM]) (oral) for Adverse event, at a dose of 600 milligram. At the time of the report, MUSCULOSKELETAL DISCOMFORT (severe hip pain on her left joint side), LIMB DISCOMFORT (cannot move her leg a lot), GAIT DISTURBANCE (cannot walk), MYALGIA (muscle pain), PYREXIA (fever), CHILLS (chills), HEADACHE (headache), ABDOMINAL PAIN (abdominal pain) and NAUSEA (nausea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, Body temperature: 103 (High) Patient had fever of 103. On 04-Jun-2021, SARS-CoV-2 test positive: positive (Positive) Patient was sick/symptomatic for 11 days due to COVID-19. On an unknown date, Blood culture: pending Inconclusive. On an unknown date, Blood test: pending Inconclusive. On an unknown date, X-ray: pending Inconclusive.     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.   Concomitants were not provided. Patient's treatment plan included 2 Liters of IV fluids.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Headache, Limb discomfort, Musculoskeletal discomfort, Myalgia
Clinical narrative: severe hip pain on her left joint side; cannot move her leg a lot; cannot walk; muscle pain; fever; chills; headache; abdominal pain; nausea; This spontaneous case was reported by a physician and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (severe hip pain on her left joint side), LIMB DISCOMFORT (cannot move her leg a lot), GAIT DISTURBANCE (cannot walk), MYALGIA (muscle pain) and PYREXIA (fever) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.     On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (severe hip pain on her left joint side), LIMB DISCOMFORT (cannot move her leg a lot), GAIT DISTURBANCE (cannot walk), MYALGIA (muscle pain), PYREXIA (fever), CHILLS (chills), HEADACHE (headache), ABDOMINAL PAIN (abdominal pain) and NAUSEA (nausea). The patient was treated with TRAMADOL for Adverse event, at an unspecified dose and frequency; ONDANSETRON (ZOFRAN [ONDANSETRON]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN SODIUM (IBUPROFEN [IBUPROFEN SODIUM]) (oral) for Adverse event, at a dose of 600 milligram. At the time of the report, MUSCULOSKELETAL DISCOMFORT (severe hip pain on her left joint side), LIMB DISCOMFORT (cannot move her leg a lot), GAIT DISTURBANCE (cannot walk), MYALGIA (muscle pain), PYREXIA (fever), CHILLS (chills), HEADACHE (headache), ABDOMINAL PAIN (abdominal pain) and NAUSEA (nausea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, Body temperature: 103 (High) Patient had fever of 103. On 04-Jun-2021, SARS-CoV-2 test positive: positive (Positive) Patient was sick/symptomatic for 11 days due to COVID-19. On an unknown date, Blood culture: pending Inconclusive. On an unknown date, Blood test: pending Inconclusive. On an unknown date, X-ray: pending Inconclusive.     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.   Concomitants were not provided. Patient's treatment plan included 2 Liters of IV fluids.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, SARS-CoV-2 test positive, X-ray
Clinical narrative: severe hip pain on her left joint side; cannot move her leg a lot; cannot walk; muscle pain; fever; chills; headache; abdominal pain; nausea; This spontaneous case was reported by a physician and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (severe hip pain on her left joint side), LIMB DISCOMFORT (cannot move her leg a lot), GAIT DISTURBANCE (cannot walk), MYALGIA (muscle pain) and PYREXIA (fever) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History was provided by the reporter.     On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (severe hip pain on her left joint side), LIMB DISCOMFORT (cannot move her leg a lot), GAIT DISTURBANCE (cannot walk), MYALGIA (muscle pain), PYREXIA (fever), CHILLS (chills), HEADACHE (headache), ABDOMINAL PAIN (abdominal pain) and NAUSEA (nausea). The patient was treated with TRAMADOL for Adverse event, at an unspecified dose and frequency; ONDANSETRON (ZOFRAN [ONDANSETRON]) for Adverse event, at an unspecified dose and frequency and IBUPROFEN SODIUM (IBUPROFEN [IBUPROFEN SODIUM]) (oral) for Adverse event, at a dose of 600 milligram. At the time of the report, MUSCULOSKELETAL DISCOMFORT (severe hip pain on her left joint side), LIMB DISCOMFORT (cannot move her leg a lot), GAIT DISTURBANCE (cannot walk), MYALGIA (muscle pain), PYREXIA (fever), CHILLS (chills), HEADACHE (headache), ABDOMINAL PAIN (abdominal pain) and NAUSEA (nausea) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, Body temperature: 103 (High) Patient had fever of 103. On 04-Jun-2021, SARS-CoV-2 test positive: positive (Positive) Patient was sick/symptomatic for 11 days due to COVID-19. On an unknown date, Blood culture: pending Inconclusive. On an unknown date, Blood test: pending Inconclusive. On an unknown date, X-ray: pending Inconclusive.     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.   Concomitants were not provided. Patient's treatment plan included 2 Liters of IV fluids.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site cellulitis
Clinical narrative: Cellulitis reaction at the injection site was warm, firm, red, and getting bigger; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE CELLULITIS (Cellulitis reaction at the injection site was warm, firm, red, and getting bigger) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE CELLULITIS (Cellulitis reaction at the injection site was warm, firm, red, and getting bigger). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site cellulitis, at a dose of UNK dosage form; IBUPROFEN for Vaccination site cellulitis, at a dose of UNK dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Vaccination site cellulitis, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE CELLULITIS (Cellulitis reaction at the injection site was warm, firm, red, and getting bigger) had not 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 medication was not reported. The cellulitis was is warm, firm, red, and getting bigger despite taking Tylenol, ibuprofen, and Benadryl.; Sender's Comments: This case concerns a patient of unknown age and gender with nonserious unexpected vaccination site cellulitis.  Event onset with unknown latency after first dose mRNA-1273. Treatment with paracetamol, ibuprofen and diphenhydramine. Events ongoing. Based on 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: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Flushing, Pyrexia, Vaccination site erythema
Clinical narrative: Cheeks really red; Redness at the injection site; Chills in the middle of the night; Fever of 103; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Cheeks really red), VACCINATION SITE ERYTHEMA (Redness at the injection site), CHILLS (Chills in the middle of the night) and PYREXIA (Fever of 103) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced FLUSHING (Cheeks really red), VACCINATION SITE ERYTHEMA (Redness at the injection site), CHILLS (Chills in the middle of the night) and PYREXIA (Fever of 103). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FLUSHING (Cheeks really red), VACCINATION SITE ERYTHEMA (Redness at the injection site), CHILLS (Chills in the middle of the night) and PYREXIA (Fever of 103) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Body temperature: 103 (High) 103.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.; 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.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Body aches, not constant but on and off; Fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN (Body aches, not constant but on and off) and FATIGUE (Fatigue) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (COVID-19 Infection) on 30-Dec-2020. Concomitant products included METOPROLOL, SIMVASTATIN and FLUOXETINE HYDROCHLORIDE (PROZAC) for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN (Body aches, not constant but on and off) and FATIGUE (Fatigue). At the time of the report, PAIN (Body aches, not constant but on and off) and FATIGUE (Fatigue) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment details were provided    Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up received and contain significant information: changed events outcome from unknown to recovering.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Pain, Vaccination site bruising
Clinical narrative: Vaccination site bruising; Anxiety; Ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Vaccination site bruising), ANXIETY (Anxiety) and PAIN (Ache) 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 (No medical history reported.). Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D), METOPROLOL, OXYBUTYNIN, TELMISARTAN, OMEPRAZOLE and CENTRUM SILVER +50 for an unknown indication.    On 13-Jan-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced ANXIETY (Anxiety) and PAIN (Ache). On 13-Jan-2021 at 2:30 PM, the patient experienced VACCINATION SITE BRUISING (Vaccination site bruising). At the time of the report, VACCINATION SITE BRUISING (Vaccination site bruising), ANXIETY (Anxiety) and PAIN (Ache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dysgeusia, Hot flush
Clinical narrative: burning sensation; metallic taste; Hot flashes; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning sensation ), DYSGEUSIA (metallic taste) and HOT FLUSH (Hot flashes) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037k20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced BURNING SENSATION (burning sensation ) and DYSGEUSIA (metallic taste). On an unknown date, the patient experienced HOT FLUSH (Hot flashes). At the time of the report, BURNING SENSATION (burning sensation ), DYSGEUSIA (metallic taste) and HOT FLUSH (Hot flashes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity, Paraesthesia, Paraesthesia oral
Clinical narrative: Pain on arm; Dizziness/feel light headed; Tingling on face; Tingling on lips; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling on face), PARAESTHESIA ORAL (Tingling on lips), PAIN IN EXTREMITY (Pain on arm) and DIZZINESS (Dizziness/feel light headed) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011220a) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced PARAESTHESIA (Tingling on face), PARAESTHESIA ORAL (Tingling on lips) and DIZZINESS (Dizziness/feel light headed). On 15-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain on arm). At the time of the report, PARAESTHESIA (Tingling on face), PARAESTHESIA ORAL (Tingling on lips), PAIN IN EXTREMITY (Pain on arm) and DIZZINESS (Dizziness/feel light headed) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment related information has been reported.; 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.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Could not sleep; Left arm to wrist swollen; Left arm to wrist had incredibly bad itchy feeling; Left arm to wrist turned red; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Could not sleep), VACCINATION SITE SWELLING (Left arm to wrist swollen), VACCINATION SITE PRURITUS (Left arm to wrist had incredibly bad itchy feeling) and VACCINATION SITE ERYTHEMA (Left arm to wrist turned red) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K204(4 or A)) for COVID-19 vaccination.     The patient's past medical history included High cholesterol since an unknown date and Retinal tear (in both eyes.). Concurrent medical conditions included Seasonal allergy, Egg allergy and Herbal allergy. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced INSOMNIA (Could not sleep), VACCINATION SITE SWELLING (Left arm to wrist swollen), VACCINATION SITE PRURITUS (Left arm to wrist had incredibly bad itchy feeling) and VACCINATION SITE ERYTHEMA (Left arm to wrist turned red). At the time of the report, INSOMNIA (Could not sleep), VACCINATION SITE SWELLING (Left arm to wrist swollen), VACCINATION SITE PRURITUS (Left arm to wrist had incredibly bad itchy feeling) and VACCINATION SITE ERYTHEMA (Left arm to wrist turned red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Reporter'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
Age: 70.0
Sex: F
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 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN, ATORVASTATIN, LEVOTHYROXINE SODIUM (SYNTHROID), METOPROLOL and ACETYLSALICYLIC ACID (ASPIRIN) for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure systolic, Fatigue, Feeling abnormal, Headache, Hypertension
Clinical narrative: Hypertensive; felt dazed out; did not feel to answer/talk; Tachycardia; palpations; Fatigue; Headache; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (Hypertensive), FATIGUE (Fatigue), HEADACHE (Headache), FEELING ABNORMAL (felt dazed out; did not feel to answer/talk) and TACHYCARDIA (Tachycardia; palpations) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     It was reported that the patient took no medication and had no allergies.     On 29-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced HYPERTENSION (Hypertensive), FATIGUE (Fatigue), HEADACHE (Headache), FEELING ABNORMAL (felt dazed out; did not feel to answer/talk) and TACHYCARDIA (Tachycardia; palpations). At the time of the report, HYPERTENSION (Hypertensive), FATIGUE (Fatigue), HEADACHE (Headache), FEELING ABNORMAL (felt dazed out; did not feel to answer/talk) and TACHYCARDIA (Tachycardia; palpations) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, Blood pressure systolic: 176 (High) 176, 160 (High) 160, 150 (High) 150 and 130 (High) gradually lowered to 130.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment medication was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: Hypertensive; felt dazed out; did not feel to answer/talk; Tachycardia; palpations; Fatigue; Headache; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of HYPERTENSION (Hypertensive), FATIGUE (Fatigue), HEADACHE (Headache), FEELING ABNORMAL (felt dazed out; did not feel to answer/talk) and TACHYCARDIA (Tachycardia; palpations) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     It was reported that the patient took no medication and had no allergies.     On 29-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced HYPERTENSION (Hypertensive), FATIGUE (Fatigue), HEADACHE (Headache), FEELING ABNORMAL (felt dazed out; did not feel to answer/talk) and TACHYCARDIA (Tachycardia; palpations). At the time of the report, HYPERTENSION (Hypertensive), FATIGUE (Fatigue), HEADACHE (Headache), FEELING ABNORMAL (felt dazed out; did not feel to answer/talk) and TACHYCARDIA (Tachycardia; palpations) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, Blood pressure systolic: 176 (High) 176, 160 (High) 160, 150 (High) 150 and 130 (High) gradually lowered to 130.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment medication was not reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itching; Bulls eye rash; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itching) and RASH (Bulls eye rash) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Bursitis. Concomitant products included MELOXICAM for an unknown indication.    On 16-Jan-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PRURITUS (Itching). 16-Jan-2021, the patient experienced RASH (Bulls eye rash). At the time of the report, PRURITUS (Itching) and RASH (Bulls eye rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of Breath; A spontaneous report  was received from a consumer, concerning herself, an 85-year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced shortness of breath.   The patient's medical history was not provided. The patient had no concomitant medications.   On 22-Jan-2021 at 02:00PM, prior to the onset of event, the patient received the first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On an unspecified date in Jan-2021, 1 week after the first shot of the Moderna vaccine the patient experienced shortness of breath. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event shortness of breath was not provided.; Reporter's Comments: This spontaneous report concerns an 85-year-old female patient who experienced the event of shortness of breath 1 week after the administration of the first dose of the mRNA-1273 vaccine (Lot #: unknown, expiration date-unknown).  No treatment was reported, and outcome is unknown. There is not enough information of assess the causal association between he reported event and the administration of mRNA-1273 vaccine.  Patient is of an advanced age and critical details regarding the patient's medical history is lacking. Main field defaults to possibly related'
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Positive covid test; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive covid test) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive covid test). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive covid test) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, SARS-CoV-2 test: negative (Negative) Negative. On 15-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of Covid-19 test positive after vaccination, this event is assessed as unlikely related to mRNA-1273.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: 3 inch redness on the injection site; Rash on injection site; Swelling on the injection site looks like half a baseball size/bumpy injection site; Hard on injection site; Injection area is firm/ Painful to touch; Hot on the injection site; Itching on the injection area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot on the injection site), VACCINATION SITE PRURITUS (Itching on the injection area), VACCINATION SITE ERYTHEMA (3 inch redness on the injection site), VACCINATION SITE RASH (Rash on injection site) and VACCINATION SITE SWELLING (Swelling on the injection site looks like half a baseball size/bumpy injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Palpitation. Concomitant products included METOPROLOL for Palpitation.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching on the injection area). On 13-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot on the injection site), VACCINATION SITE ERYTHEMA (3 inch redness on the injection site), VACCINATION SITE RASH (Rash on injection site), VACCINATION SITE SWELLING (Swelling on the injection site looks like half a baseball size/bumpy injection site), VACCINATION SITE INDURATION (Hard on injection site) and VACCINATION SITE PAIN (Injection area is firm/ Painful to touch). On 15-Jan-2021, VACCINATION SITE SWELLING (Swelling on the injection site looks like half a baseball size/bumpy injection site) and VACCINATION SITE INDURATION (Hard on injection site) had resolved. At the time of the report, VACCINATION SITE WARMTH (Hot on the injection site), VACCINATION SITE ERYTHEMA (3 inch redness on the injection site) and VACCINATION SITE PAIN (Injection area is firm/ Painful to touch) outcome was unknown and VACCINATION SITE PRURITUS (Itching on the injection area) and VACCINATION SITE RASH (Rash on injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: 3 inch redness on the injection site; Rash on injection site; Swelling on the injection site looks like half a baseball size/bumpy injection site; Hard on injection site; Injection area is firm/ Painful to touch; Hot on the injection site; Itching on the injection area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot on the injection site), VACCINATION SITE PRURITUS (Itching on the injection area), VACCINATION SITE ERYTHEMA (3 inch redness on the injection site), VACCINATION SITE RASH (Rash on injection site) and VACCINATION SITE SWELLING (Swelling on the injection site looks like half a baseball size/bumpy injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Palpitation. Concomitant products included METOPROLOL for Palpitation.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching on the injection area). On 13-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot on the injection site), VACCINATION SITE ERYTHEMA (3 inch redness on the injection site), VACCINATION SITE RASH (Rash on injection site), VACCINATION SITE SWELLING (Swelling on the injection site looks like half a baseball size/bumpy injection site), VACCINATION SITE INDURATION (Hard on injection site) and VACCINATION SITE PAIN (Injection area is firm/ Painful to touch). On 15-Jan-2021, VACCINATION SITE SWELLING (Swelling on the injection site looks like half a baseball size/bumpy injection site) and VACCINATION SITE INDURATION (Hard on injection site) had resolved. At the time of the report, VACCINATION SITE WARMTH (Hot on the injection site), VACCINATION SITE ERYTHEMA (3 inch redness on the injection site) and VACCINATION SITE PAIN (Injection area is firm/ Painful to touch) outcome was unknown and VACCINATION SITE PRURITUS (Itching on the injection area) and VACCINATION SITE RASH (Rash on injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Itching really bad at injection site; Very red at injection site (3 by 2"); Hard at injection site; Very hot at injection site; Rash in wrist area of same arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash in wrist area of same arm of injection), VACCINATION SITE PRURITUS (Itching really bad at injection site), VACCINATION SITE ERYTHEMA (Very red at injection site (3 by 2")), VACCINATION SITE INDURATION (Hard at injection site) and VACCINATION SITE WARMTH (Very hot at injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced RASH (Rash in wrist area of same arm of injection). On 15-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching really bad at injection site), VACCINATION SITE ERYTHEMA (Very red at injection site (3 by 2")), VACCINATION SITE INDURATION (Hard at injection site) and VACCINATION SITE WARMTH (Very hot at injection site). On 09-Jan-2021, RASH (Rash in wrist area of same arm of injection) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itching really bad at injection site), VACCINATION SITE ERYTHEMA (Very red at injection site (3 by 2")), VACCINATION SITE INDURATION (Hard at injection site) and VACCINATION SITE WARMTH (Very hot at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.; 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.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dysgeusia, Hot flush
Clinical narrative: Hot flashes; Burning sensation; metallic taste; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation), DYSGEUSIA (metallic taste) and HOT FLUSH (Hot flashes) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced BURNING SENSATION (Burning sensation) and DYSGEUSIA (metallic taste). On an unknown date, the patient experienced HOT FLUSH (Hot flashes). At the time of the report, BURNING SENSATION (Burning sensation), DYSGEUSIA (metallic taste) and HOT FLUSH (Hot flashes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Red spot the size of half dollar around where injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red spot the size of half dollar around where injection site) 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 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red spot the size of half dollar around where injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red spot the size of half dollar around where injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.; 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: Dyspnoea, Insomnia
Clinical narrative: Having hard time breathing; Hardly slept; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Having hard time breathing) and INSOMNIA (Hardly slept) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced DYSPNOEA (Having hard time breathing) and INSOMNIA (Hardly slept). At the time of the report, DYSPNOEA (Having hard time breathing) and INSOMNIA (Hardly slept) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Photopsia
Clinical narrative: Flashing light reaction; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPSIA (Flashing light reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PHOTOPSIA (Flashing light reaction). At the time of the report, PHOTOPSIA (Flashing light reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Injection site pruritus, Injection site rash, Injection site swelling, Lip swelling
Clinical narrative: Swelling around her eyes, lips, and cheeks; Swelling around her eyes, lips, and cheeks; Swelling at the injection site; Itchiness at the injection site; Facial swelling; Rash developed around the injection site; A spontaneous report was received from a healthcare professional, concerning a 58-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced facial swelling, rash developed around the injection site, swelling around her eyes, lips, and cheeks, swelling at the injection site and itchiness at the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 07 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  On 12 Jan 2021, the patient experienced facial swelling and rash developed around the injection site. On an unknown date, the patient experienced swelling around her eyes, lips, and cheeks, swelling at the injection site and itchiness at the injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.   At the time of this report, the outcome of the event facial swelling was resolved and the outcome of events rash developed around the injection site, swelling around her eyes, lips, and cheeks, swelling at the injection site and itchiness at the injection site were unknown.; 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.
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Swelling around her eyes, lips, and cheeks; Swelling around her eyes, lips, and cheeks; Swelling at the injection site; Itchiness at the injection site; Facial swelling; Rash developed around the injection site; A spontaneous report was received from a healthcare professional, concerning a 58-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced facial swelling, rash developed around the injection site, swelling around her eyes, lips, and cheeks, swelling at the injection site and itchiness at the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 07 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  On 12 Jan 2021, the patient experienced facial swelling and rash developed around the injection site. On an unknown date, the patient experienced swelling around her eyes, lips, and cheeks, swelling at the injection site and itchiness at the injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.   At the time of this report, the outcome of the event facial swelling was resolved and the outcome of events rash developed around the injection site, swelling around her eyes, lips, and cheeks, swelling at the injection site and itchiness at the injection site were unknown.; 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.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain
Clinical narrative: Got really sick after; Aches and pains; severe chills; fever around 100.05 f; Terrible headache; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Got really sick after), PAIN (Aches and pains), CHILLS (severe chills), PYREXIA (fever around 100.05 f) and HEADACHE (Terrible headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid disorder, High cholesterol and Seizure.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION COMPLICATION (Got really sick after), PAIN (Aches and pains), CHILLS (severe chills), PYREXIA (fever around 100.05 f), HEADACHE (Terrible headache) and FATIGUE (Extreme fatigue). On 09-Jan-2021, PYREXIA (fever around 100.05 f) had resolved. At the time of the report, VACCINATION COMPLICATION (Got really sick after), PAIN (Aches and pains), CHILLS (severe chills), HEADACHE (Terrible headache) and FATIGUE (Extreme fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, Body temperature: 100.05 100.05 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination complication
Clinical narrative: Got really sick after; Aches and pains; severe chills; fever around 100.05 f; Terrible headache; Extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Got really sick after), PAIN (Aches and pains), CHILLS (severe chills), PYREXIA (fever around 100.05 f) and HEADACHE (Terrible headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Thyroid disorder, High cholesterol and Seizure.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION COMPLICATION (Got really sick after), PAIN (Aches and pains), CHILLS (severe chills), PYREXIA (fever around 100.05 f), HEADACHE (Terrible headache) and FATIGUE (Extreme fatigue). On 09-Jan-2021, PYREXIA (fever around 100.05 f) had resolved. At the time of the report, VACCINATION COMPLICATION (Got really sick after), PAIN (Aches and pains), CHILLS (severe chills), HEADACHE (Terrible headache) and FATIGUE (Extreme fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, Body temperature: 100.05 100.05 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19 test is positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 test is positive) in a 43-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 (No medical history provided). Concomitant products included ISOTRETINOIN and IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced COVID-19 (COVID-19 test is positive). At the time of the report, COVID-19 (COVID-19 test is positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Vaccination site rash
Clinical narrative: Scratchy throat; Injection site rash; This spontaneous case was reported by an other health care professional and describes the occurrence of THROAT IRRITATION (Scratchy throat) and VACCINATION SITE RASH (Injection site rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 07-Jan-2021 at 12:26 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE RASH (Injection site rash). On 14-Jan-2021 at 12:26 PM, the patient experienced THROAT IRRITATION (Scratchy throat). At the time of the report, THROAT IRRITATION (Scratchy throat) and VACCINATION SITE RASH (Injection site rash) 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.   Concomitant product use was not provided by the reporter. No treatment information was provided.