chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Feeling "clammy"; feels like crap, feeling yucky; Body ache; Low grade fever 99F; Headache; Nauseated; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (Feeling "clammy"), FEELING ABNORMAL (feels like crap, feeling yucky), MYALGIA (Body ache), PYREXIA (Low grade fever 99F) and HEADACHE (Headache) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Jan-2021 at 2:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced COLD SWEAT (Feeling "clammy"), FEELING ABNORMAL (feels like crap, feeling yucky), MYALGIA (Body ache), PYREXIA (Low grade fever 99F), HEADACHE (Headache) and NAUSEA (Nauseated). At the time of the report, COLD SWEAT (Feeling "clammy"), FEELING ABNORMAL (feels like crap, feeling yucky), MYALGIA (Body ache), PYREXIA (Low grade fever 99F), HEADACHE (Headache) and NAUSEA (Nauseated) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Body temperature: 99 °F (Low) (99F).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been 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 events, a causal relationship cannot be excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Warm to touch at the injection site; A very big , red area at the injection site; Injection site which is also swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to touch at the injection site), VACCINATION SITE ERYTHEMA (A very big , red area at the injection site) and VACCINATION SITE SWELLING (Injection site which is also swollen) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-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 WARMTH (Warm to touch at the injection site), VACCINATION SITE ERYTHEMA (A very big , red area at the injection site) and VACCINATION SITE SWELLING (Injection site which is also swollen). At the time of the report, VACCINATION SITE WARMTH (Warm to touch at the injection site), VACCINATION SITE ERYTHEMA (A very big , red area at the injection site) and VACCINATION SITE SWELLING (Injection site which is also swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       There was no concomitant medication reported. There was no relevant treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up was received on 29-JUN-2021, contain significant information. Changed the outcome of all the events,from unknown  to recovered/resolved.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: nauseous; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous) and VOMITING (vomiting) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-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 NAUSEA (nauseous) and VOMITING (vomiting). At the time of the report, NAUSEA (nauseous) and VOMITING (vomiting) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Updated Onset date of mRNA-1273 first dose from 02-Feb-2021 to 14-Feb-2021.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: broke up in hives; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of URTICARIA (broke up in hives) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 25J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-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 URTICARIA (broke up in hives). At the time of the report, URTICARIA (broke up in hives) 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.   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.   Reporter did not allow further contact; 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: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive for Covid; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for Covid) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for Covid). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for Covid) 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.   Based on the current available information and the mechanism of action of mRNA-1273 vaccine, the event of positive for SARS-CoV-2, are assessed as unlikely related. Further information has been requested.; Sender's Comments: Based on the current available information and the mechanism of action of mRNA-1273 vaccine, the event of positive for SARS-CoV-2, are assessed as unlikely related. Further information has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Gastrooesophageal reflux disease, Headache, Nausea
Clinical narrative: Acid reflux; Arms started feeling achy; Random chills; Headache; Mild nausea in the morning; Fatigue; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), PAIN IN EXTREMITY (Arms started feeling achy), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Mild nausea in the morning) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Gastric irritation, Hypothyroidism and Allergy. Concurrent medical conditions included Hypertension. Concomitant products included FAMOTIDINE, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), LEVOTHYROXINE SODIUM (SYNTHROID) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 15-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 VACCINATION SITE PAIN (Injection site pain). On 18-Jan-2021, the patient experienced FATIGUE (Fatigue). On 19-Jan-2021, the patient experienced HEADACHE (Headache) and NAUSEA (Mild nausea in the morning). On 20-Jan-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), PAIN IN EXTREMITY (Arms started feeling achy) and CHILLS (Random chills). On 16-Jan-2021, VACCINATION SITE PAIN (Injection site pain) had resolved. At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), PAIN IN EXTREMITY (Arms started feeling achy), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Mild nausea in the morning) and CHILLS (Random chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication detail was reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: The follow up document contain no new information.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Acid reflux; Arms started feeling achy; Random chills; Headache; Mild nausea in the morning; Fatigue; Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), PAIN IN EXTREMITY (Arms started feeling achy), FATIGUE (Fatigue), HEADACHE (Headache) and NAUSEA (Mild nausea in the morning) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Gastric irritation, Hypothyroidism and Allergy. Concurrent medical conditions included Hypertension. Concomitant products included FAMOTIDINE, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), LEVOTHYROXINE SODIUM (SYNTHROID) and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.    On 15-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 VACCINATION SITE PAIN (Injection site pain). On 18-Jan-2021, the patient experienced FATIGUE (Fatigue). On 19-Jan-2021, the patient experienced HEADACHE (Headache) and NAUSEA (Mild nausea in the morning). On 20-Jan-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), PAIN IN EXTREMITY (Arms started feeling achy) and CHILLS (Random chills). On 16-Jan-2021, VACCINATION SITE PAIN (Injection site pain) had resolved. At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux), PAIN IN EXTREMITY (Arms started feeling achy), FATIGUE (Fatigue), HEADACHE (Headache), NAUSEA (Mild nausea in the morning) and CHILLS (Random chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication detail was reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: The follow up document contain no new information.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pruritus, Rash, Rash vesicular
Clinical narrative: rash is raised bumps; Blister; Itches; Severe rash on both of my arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH VESICULAR (rash is raised bumps), BLISTER (Blister), PRURITUS (Itches) and RASH (Severe rash on both of my arms) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history). Concomitant products included METHYLPREDNISOLONE SODIUM SUCCINATE (SOLU MEDROL), LEVOTHYROXINE, DIPHENHYDRAMINE, ESCITALOPRAM and NIACIN for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced RASH VESICULAR (rash is raised bumps), BLISTER (Blister), PRURITUS (Itches) and RASH (Severe rash on both of my arms). At the time of the report, RASH VESICULAR (rash is raised bumps), BLISTER (Blister), PRURITUS (Itches) and RASH (Severe rash on both of my arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact; 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: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Nausea
Clinical narrative: A spontaneous report was received from a consumer, concerning his wife, a 72-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe headache, body ache, chills, fever, nausea, and vomiting.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 23 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) in the left arm for prophylaxis of COVID-19 infection.  On 24 Jan 2021, after vaccination, the patient experienced severe headache, body ache and chills. On 26 Jan 2021, she also experienced fever of 104f. Additionally, on 27 Jan 2021 she developed severe nausea and vomiting. On an unknown date in 2021, she was bed ridden. No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of event(s), severe headache, body ache, chills, fever of 104f, severe nausea, vomiting were not resolved and ongoing at the time of this report.; 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.; Sender's Comments:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: A spontaneous report was received from a consumer, concerning his wife, a 72-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe headache, body ache, chills, fever, nausea, and vomiting.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 23 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) in the left arm for prophylaxis of COVID-19 infection.  On 24 Jan 2021, after vaccination, the patient experienced severe headache, body ache and chills. On 26 Jan 2021, she also experienced fever of 104f. Additionally, on 27 Jan 2021 she developed severe nausea and vomiting. On an unknown date in 2021, she was bed ridden. No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of event(s), severe headache, body ache, chills, fever of 104f, severe nausea, vomiting were not resolved and ongoing at the time of this report.; 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.; Sender's Comments:
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Pyrexia
Clinical narrative: COVID-19; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), PYREXIA (fever) and CHILLS (chills) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included OMEPRAZOLE, SIMVASTATIN, AMLODIPINE, DOXEPIN, HYDROCHLOROTHIAZIDE, FISH OIL, CALCIUM CITRATE (CITRACAL [CALCIUM CITRATE]), VITAMIN D3, GUAIFENESIN (MUCINEX) and MACROGOL 3350 (MIRALAX) for an unknown indication.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 14-Jan-2021, CHILLS (chills) had resolved. On 16-Jan-2021, PYREXIA (fever) had resolved. At the time of the report, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, COVID-19: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included antibody infusion ER.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: At the injection site and it's a bit warm; At the injection site and it's a bit warm and hard; Big red circle on my arm at the injection site; A spontaneous report was received from a consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events red circle on arm at the injection site (injection site redness) and it's a bit warm (injection site warmth) and hard (injection site warmth). The patient's medical history was not provided. No relevant concomitant medications were reported. On 18 Jan 2021, prior to the onset of the events the patient received their dose of mRNA-1273 (Batch Number: Not provided) for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the patient experienced big red circle on arm at the injection site (injection site redness) and it's a bit warm (injection site warmth) and hard (injection site induration).  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events red circle on arm at the injection site (injection site redness) and it's a bit warm (injection site warmth) and hard (injection site induration) was not reported.; Reporter's Comments: Based on the information provided and the established safety profile of mRNA-1273 vaccine, a causal association between the events reported and the product use cannot be excluded. Injection site redness and Injection site induration are consistent with the known safety profile of the vaccine
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Antibody test negative
Clinical narrative: antibody assay with negative results; This spontaneous case was reported by a physician and describes the occurrence of ANTIBODY TEST NEGATIVE (antibody assay with negative results) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-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 16-Feb-2021, the patient experienced ANTIBODY TEST NEGATIVE (antibody assay with negative results). At the time of the report, ANTIBODY TEST NEGATIVE (antibody assay with negative results) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, Antibody test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided. No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow up received contains No new information
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Body temperature, Chills, Fatigue, Gait disturbance
Clinical narrative: hunches over when she walks; migraine, a horrible headache; feels like a weight on her stomach; did not sleep all night because of how bad she feels; urinating but not a lot; feels so nauseous that she cannot eat anything; tired/exhausted; feverish (101°F fever); worse chills ever; This spontaneous case was reported by a nurse and describes the occurrence of GAIT DISTURBANCE (hunches over when she walks), MIGRAINE (migraine, a horrible headache), ABDOMINAL DISCOMFORT (feels like a weight on her stomach), INSOMNIA (did not sleep all night because of how bad she feels) and URINE OUTPUT DECREASED (urinating but not a lot) in a 59-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 information was reported.   On 18-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) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced GAIT DISTURBANCE (hunches over when she walks), MIGRAINE (migraine, a horrible headache), ABDOMINAL DISCOMFORT (feels like a weight on her stomach), INSOMNIA (did not sleep all night because of how bad she feels), URINE OUTPUT DECREASED (urinating but not a lot), NAUSEA (feels so nauseous that she cannot eat anything), FATIGUE (tired/exhausted), PYREXIA (feverish (101°F fever)) and CHILLS (worse chills ever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (hunches over when she walks), MIGRAINE (migraine, a horrible headache), ABDOMINAL DISCOMFORT (feels like a weight on her stomach), INSOMNIA (did not sleep all night because of how bad she feels), URINE OUTPUT DECREASED (urinating but not a lot), NAUSEA (feels so nauseous that she cannot eat anything), FATIGUE (tired/exhausted), PYREXIA (feverish (101°F fever)) and CHILLS (worse chills ever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 101 (High) 101°F. On 18-Feb-2021, Urine output: decreased (Low) Decreased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitants medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: follow up received on 13 JUL 2021 in which Contact information is updated. On 04-Aug-2021: Follow up received included laboratory data was added.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Migraine, Nausea, Pyrexia, Urine output
Clinical narrative: hunches over when she walks; migraine, a horrible headache; feels like a weight on her stomach; did not sleep all night because of how bad she feels; urinating but not a lot; feels so nauseous that she cannot eat anything; tired/exhausted; feverish (101°F fever); worse chills ever; This spontaneous case was reported by a nurse and describes the occurrence of GAIT DISTURBANCE (hunches over when she walks), MIGRAINE (migraine, a horrible headache), ABDOMINAL DISCOMFORT (feels like a weight on her stomach), INSOMNIA (did not sleep all night because of how bad she feels) and URINE OUTPUT DECREASED (urinating but not a lot) in a 59-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 information was reported.   On 18-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) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced GAIT DISTURBANCE (hunches over when she walks), MIGRAINE (migraine, a horrible headache), ABDOMINAL DISCOMFORT (feels like a weight on her stomach), INSOMNIA (did not sleep all night because of how bad she feels), URINE OUTPUT DECREASED (urinating but not a lot), NAUSEA (feels so nauseous that she cannot eat anything), FATIGUE (tired/exhausted), PYREXIA (feverish (101°F fever)) and CHILLS (worse chills ever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (hunches over when she walks), MIGRAINE (migraine, a horrible headache), ABDOMINAL DISCOMFORT (feels like a weight on her stomach), INSOMNIA (did not sleep all night because of how bad she feels), URINE OUTPUT DECREASED (urinating but not a lot), NAUSEA (feels so nauseous that she cannot eat anything), FATIGUE (tired/exhausted), PYREXIA (feverish (101°F fever)) and CHILLS (worse chills ever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 101 (High) 101°F. On 18-Feb-2021, Urine output: decreased (Low) Decreased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitants medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: follow up received on 13 JUL 2021 in which Contact information is updated. On 04-Aug-2021: Follow up received included laboratory data was added.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Urine output decreased
Clinical narrative: hunches over when she walks; migraine, a horrible headache; feels like a weight on her stomach; did not sleep all night because of how bad she feels; urinating but not a lot; feels so nauseous that she cannot eat anything; tired/exhausted; feverish (101°F fever); worse chills ever; This spontaneous case was reported by a nurse and describes the occurrence of GAIT DISTURBANCE (hunches over when she walks), MIGRAINE (migraine, a horrible headache), ABDOMINAL DISCOMFORT (feels like a weight on her stomach), INSOMNIA (did not sleep all night because of how bad she feels) and URINE OUTPUT DECREASED (urinating but not a lot) in a 59-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 information was reported.   On 18-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) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced GAIT DISTURBANCE (hunches over when she walks), MIGRAINE (migraine, a horrible headache), ABDOMINAL DISCOMFORT (feels like a weight on her stomach), INSOMNIA (did not sleep all night because of how bad she feels), URINE OUTPUT DECREASED (urinating but not a lot), NAUSEA (feels so nauseous that she cannot eat anything), FATIGUE (tired/exhausted), PYREXIA (feverish (101°F fever)) and CHILLS (worse chills ever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (hunches over when she walks), MIGRAINE (migraine, a horrible headache), ABDOMINAL DISCOMFORT (feels like a weight on her stomach), INSOMNIA (did not sleep all night because of how bad she feels), URINE OUTPUT DECREASED (urinating but not a lot), NAUSEA (feels so nauseous that she cannot eat anything), FATIGUE (tired/exhausted), PYREXIA (feverish (101°F fever)) and CHILLS (worse chills ever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Feb-2021, Body temperature: 101 (High) 101°F. On 18-Feb-2021, Urine output: decreased (Low) Decreased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitants medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: follow up received on 13 JUL 2021 in which Contact information is updated. On 04-Aug-2021: Follow up received included laboratory data was added.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Injection site was itching; Red Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site was itching) and VACCINATION SITE ERYTHEMA (Red Injection Site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction (No reported medical history).    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site was itching) and VACCINATION SITE ERYTHEMA (Red Injection Site). At the time of the report, VACCINATION SITE PRURITUS (Injection site was itching) and VACCINATION SITE ERYTHEMA (Red Injection Site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant list is provided. No treatment is given.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: No information is provided in the attached document of the additional information. On 29-Apr-2021: Additional info-2
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Headache, Heart rate increased, Pyrexia
Clinical narrative: face flushed; really fast heart rate; bad headaches; Temperature; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (face flushed), HEART RATE INCREASED (really fast heart rate), HEADACHE (bad headaches) and PYREXIA (Temperature) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 04120A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced FLUSHING (face flushed), HEART RATE INCREASED (really fast heart rate), HEADACHE (bad headaches) and PYREXIA (Temperature). On 18-Feb-2021, FLUSHING (face flushed) and HEART RATE INCREASED (really fast heart rate) had resolved. At the time of the report, HEADACHE (bad headaches) and PYREXIA (Temperature) outcome was unknown.            No treatment medication was provided.  Concomitant medications reported were Heart pills   Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: Follow up report received included no new information.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: Pain at the injection site; Feel fatigued; Tired; Slight headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Feel fatigued), FATIGUE (Tired) and HEADACHE (Slight 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 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 VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Feel fatigued), FATIGUE (Tired) and HEADACHE (Slight headache). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Feel fatigued), FATIGUE (Tired) and HEADACHE (Slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.  As per client, MO error in DOB capture
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (no other symptoms except some arm soreness/stiffness the next day) and musculoskeletal stiffness (no other symptoms except some arm soreness/stiffness the next day) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Feb 19, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 20, 2021, patient experienced pain in extremity (no other symptoms except some arm soreness/stiffness the next day) and musculoskeletal stiffness (no other symptoms except some arm soreness/stiffness the next day). At the time of the report, pain in extremity (no other symptoms except some arm soreness/stiffness the next day) and  musculoskeletal stiffness (no other symptoms except some arm soreness/stiffness the next day) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications or treatment information reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pruritus, Pyrexia, Rash, Urticaria
Clinical narrative: Full body hives/urticaria; itching; hot to touch; Full body rashes; low grade fever of 98-102 deg F; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Full body hives/urticaria), PRURITUS (itching), FEELING HOT (hot to touch), RASH (Full body rashes) and PYREXIA (low grade fever of 98-102 deg F) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     Concomitant products included PREDNISONE, CETIRIZINE and RANITIDINE HYDROCHLORIDE (ZANTAC) for an unknown indication.    On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced URTICARIA (Full body hives/urticaria), PRURITUS (itching), FEELING HOT (hot to touch), RASH (Full body rashes) and PYREXIA (low grade fever of 98-102 deg F). At the time of the report, URTICARIA (Full body hives/urticaria), PRURITUS (itching), FEELING HOT (hot to touch), RASH (Full body rashes) and PYREXIA (low grade fever of 98-102 deg F) outcome was unknown.            No treatment medication information was provided   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up information received on 06-jul-2021 contains non-significant information- added reporter's email and address
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: The swelling of cubital area of the left arm; A spontaneous report was received from a consumer concerning a 58-years-old female patient who received first dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced events swelling of cubital area of the left arm/ vaccination site swelling..  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 3 Feb 2021, the patient experienced swelling of cubital area of the left arm.Treatment details included diphenhydramine.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of event swelling of cubital area of the left arm was unknown.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain in extremity, Somnolence
Clinical narrative: Fatigue; sleeps all the time; headache; muscle aches; arm soreness; warm; pinkish; Little swollen below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), SOMNOLENCE (sleeps all the time), HEADACHE (headache), MYALGIA (muscle aches) and PAIN IN EXTREMITY (arm soreness) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CENTRUM VITAMINTS for Immune disorder (NOS), TAMSULOSIN for Prostate, GLUCOSAMINE and VITAMIN C [ASCORBIC ACID] for an unknown indication.  On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced FATIGUE (Fatigue), SOMNOLENCE (sleeps all the time), HEADACHE (headache), MYALGIA (muscle aches), PAIN IN EXTREMITY (arm soreness), VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (pinkish) and VACCINATION SITE SWELLING (Little swollen below the injection site). At the time of the report, FATIGUE (Fatigue), SOMNOLENCE (sleeps all the time), HEADACHE (headache), MYALGIA (muscle aches), PAIN IN EXTREMITY (arm soreness), VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (pinkish) and VACCINATION SITE SWELLING (Little swollen below the injection site) outcome was unknown.      Treatment for the events: None.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Fatigue; sleeps all the time; headache; muscle aches; arm soreness; warm; pinkish; Little swollen below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), SOMNOLENCE (sleeps all the time), HEADACHE (headache), MYALGIA (muscle aches) and PAIN IN EXTREMITY (arm soreness) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included CENTRUM VITAMINTS for Immune disorder (NOS), TAMSULOSIN for Prostate, GLUCOSAMINE and VITAMIN C [ASCORBIC ACID] for an unknown indication.  On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced FATIGUE (Fatigue), SOMNOLENCE (sleeps all the time), HEADACHE (headache), MYALGIA (muscle aches), PAIN IN EXTREMITY (arm soreness), VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (pinkish) and VACCINATION SITE SWELLING (Little swollen below the injection site). At the time of the report, FATIGUE (Fatigue), SOMNOLENCE (sleeps all the time), HEADACHE (headache), MYALGIA (muscle aches), PAIN IN EXTREMITY (arm soreness), VACCINATION SITE WARMTH (warm), VACCINATION SITE ERYTHEMA (pinkish) and VACCINATION SITE SWELLING (Little swollen below the injection site) outcome was unknown.      Treatment for the events: None.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose, Vaccination site discharge
Clinical narrative: felt some of the vaccine run down his arm; got about 90% of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCHARGE (felt some of the vaccine run down his arm) and UNDERDOSE (got about 90% of the vaccine) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE DISCHARGE (felt some of the vaccine run down his arm) and UNDERDOSE (got about 90% of the vaccine). At the time of the report, VACCINATION SITE DISCHARGE (felt some of the vaccine run down his arm) and UNDERDOSE (got about 90% of the vaccine) 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 medication was not reported.  Treatment medication was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jul-2021: Correspondence email attached
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site warmth
Clinical narrative: Huge red welt at the injection site; Arm was also very warm; Burning rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm was also very warm), VACCINATION SITE RASH (Burning rash at injection site) and VACCINATION SITE ERYTHEMA (Huge red welt at the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) 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 24-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Arm was also very warm) and VACCINATION SITE RASH (Burning rash at injection site). On 30-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Huge red welt at the injection site). On 30-Jan-2021, VACCINATION SITE RASH (Burning rash at injection site) had resolved. At the time of the report, VACCINATION SITE WARMTH (Arm was also very warm) and VACCINATION SITE ERYTHEMA (Huge red welt at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Follow-up information received captured reporter contact details. On 08-Apr-2021: Follow-up information received captured no new information.; 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: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Injection site swelling, Swelling
Clinical narrative: injection site enlarged; swelling; this real warm sensation in the chest immediately after receiving the shot; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of FEELING HOT (this real warm sensation in the chest immediately after receiving the shot), INJECTION SITE SWELLING (injection site enlarged) and SWELLING (swelling) 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. Concomitant products included METOPROLOL for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced FEELING HOT (this real warm sensation in the chest immediately after receiving the shot). On an unknown date, the patient experienced INJECTION SITE SWELLING (injection site enlarged) and SWELLING (swelling). On 29-Jan-2021, FEELING HOT (this real warm sensation in the chest immediately after receiving the shot) outcome was unknown. At the time of the report, INJECTION SITE SWELLING (injection site enlarged) and SWELLING (swelling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment information was not provided. Upon internal review on 4-Aug-21, the age was corrected to 67 years.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects from second vaccination; A spontaneous report was received from a Consumer concerning a female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and reported the events side effects from second vaccination(vaccine complication).  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 their first of two planned doses of mRNA-1273 (unknown batch number) intramuscularly for prophylaxis of COVID-19 infection. No adverse events were reported to the first dose of vaccine.  On unknown date, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (batch number provided) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient reported event side effects from second vaccination(vaccine complication)  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event side effects from second vaccination was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Vaccination site pain
Clinical narrative: Red spot on arm about 1.5 inch diameter; Sore arm after injection; This spontaneous case was reported by a patient and describes the occurrence of RASH MACULAR (Red spot on arm about 1.5 inch diameter) and VACCINATION SITE PAIN (Sore arm after injection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (Red spot on arm about 1.5 inch diameter) and VACCINATION SITE PAIN (Sore arm after injection). At the time of the report, RASH MACULAR (Red spot on arm about 1.5 inch diameter) and VACCINATION SITE PAIN (Sore arm after injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Reporter contact details(email address) added. Non-sig information.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A little soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (A little soreness in her 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 01-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (A little soreness in her arm). At the time of the report, PAIN IN EXTREMITY (A little soreness in her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication provided. No concomitant medication provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up received on 18 May 2021 included no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.