chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dry mouth, Flushing, Nausea, Pain in extremity
Clinical narrative: Itching all over body; Nausea; Warm flush over my head; Throat was tightening; Abdominal cramping; Super dried mouth; Pains and needles in hands and feet; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itching all over body), NAUSEA (Nausea), FLUSHING (Warm flush over my head), THROAT TIGHTNESS (Throat was tightening) and ABDOMINAL PAIN (Abdominal cramping) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol. Concomitant products included PANTOPRAZOLE and CICLESONIDE for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PRURITUS (Itching all over body), NAUSEA (Nausea), FLUSHING (Warm flush over my head), THROAT TIGHTNESS (Throat was tightening), ABDOMINAL PAIN (Abdominal cramping), DRY MOUTH (Super dried mouth) and PAIN IN EXTREMITY (Pains and needles in hands and feet). The patient was treated with OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) at a dose of UNK dosage form. On 07-Jan-2021, FLUSHING (Warm flush over my head), THROAT TIGHTNESS (Throat was tightening), ABDOMINAL PAIN (Abdominal cramping) and DRY MOUTH (Super dried mouth) had resolved. On 17-Jan-2021, PRURITUS (Itching all over body) and PAIN IN EXTREMITY (Pains and needles in hands and feet) had resolved. On 21-Jan-2021, NAUSEA (Nausea) had resolved.        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.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jan-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Throat tightness
Clinical narrative: Itching all over body; Nausea; Warm flush over my head; Throat was tightening; Abdominal cramping; Super dried mouth; Pains and needles in hands and feet; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itching all over body), NAUSEA (Nausea), FLUSHING (Warm flush over my head), THROAT TIGHTNESS (Throat was tightening) and ABDOMINAL PAIN (Abdominal cramping) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol. Concomitant products included PANTOPRAZOLE and CICLESONIDE for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PRURITUS (Itching all over body), NAUSEA (Nausea), FLUSHING (Warm flush over my head), THROAT TIGHTNESS (Throat was tightening), ABDOMINAL PAIN (Abdominal cramping), DRY MOUTH (Super dried mouth) and PAIN IN EXTREMITY (Pains and needles in hands and feet). The patient was treated with OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) at a dose of UNK dosage form. On 07-Jan-2021, FLUSHING (Warm flush over my head), THROAT TIGHTNESS (Throat was tightening), ABDOMINAL PAIN (Abdominal cramping) and DRY MOUTH (Super dried mouth) had resolved. On 17-Jan-2021, PRURITUS (Itching all over body) and PAIN IN EXTREMITY (Pains and needles in hands and feet) had resolved. On 21-Jan-2021, NAUSEA (Nausea) had resolved.        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.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jan-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Rhinalgia, Tenderness
Clinical narrative: weakness; nasal pack hurts; soreness in the arm; headache; tiredness; A spontaneous report was received from a Non-Health Professional concerning a female patient, of 67-year-old, who was administered Moderna COVID-19 vaccine and experienced soreness in the arm, headache, nasal pack hurts, tiredness and weakness  The patient's medical history was not reported. No relevant concomitant medications were reported.  On 12-JAN-2021, The patient received her first of two planned doses of mRNA-1273 (Batch number: 041L20A) through intramuscular route in her right arm for prophylaxis of COVID-19 infection. On 13-JAN-2021, The patient experienced soreness in the arm, headache, nasal pack hurts, tiredness and weakness.  The patient took Aleve as a treatment medication for the events, soreness in the arm, headache, nasal pack hurts, tiredness and weakness. The patient was also about to had Tylenol as a treatment medication.  The action taken for Moderna COVID-19 vaccine was unknown.  The outcome of the events, soreness in the arm, headache, nasal pack hurts, tiredness and weakness were unknown.  The Non-Health Professional did not declared any relatedness between the events, soreness in the arm, headache, nasal pack hurts, tiredness and weakness and Moderna COVID-19 vaccine.; 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: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Sore throat; Runny nose; Fatigue; Headache; This spontaneous case was reported by a nurse and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), HEADACHE (Headache) and FATIGUE (Fatigue) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced HEADACHE (Headache). On 13-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) on 08-Jan-2021 for Headache, at a dose of 1 dosage form. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), HEADACHE (Headache) and FATIGUE (Fatigue) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, SARS-CoV-2 test: unknown (Positive) unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear pain, Fatigue, Headache, Pharyngeal swelling
Clinical narrative: I  have a lump in my throat; chills; soreness in arm; fatigue; headache; earache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in arm), EAR PAIN (earache), HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills) in a 68-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 12-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 VACCINATION SITE PAIN (soreness in arm), EAR PAIN (earache), HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills). On an unknown date, the patient experienced PHARYNGEAL SWELLING (I  have a lump in my throat). At the time of the report, VACCINATION SITE PAIN (soreness in arm), EAR PAIN (earache), HEADACHE (headache), FATIGUE (fatigue), CHILLS (chills) and PHARYNGEAL SWELLING (I  have a lump in my throat) outcome was unknown.        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 dates of the events, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I  have a lump in my throat; chills; soreness in arm; fatigue; headache; earache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness in arm), EAR PAIN (earache), HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills) in a 68-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 12-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 VACCINATION SITE PAIN (soreness in arm), EAR PAIN (earache), HEADACHE (headache), FATIGUE (fatigue) and CHILLS (chills). On an unknown date, the patient experienced PHARYNGEAL SWELLING (I  have a lump in my throat). At the time of the report, VACCINATION SITE PAIN (soreness in arm), EAR PAIN (earache), HEADACHE (headache), FATIGUE (fatigue), CHILLS (chills) and PHARYNGEAL SWELLING (I  have a lump in my throat) outcome was unknown.        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 dates of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: Sweating; Chills; Headache; Mild fever of 99.2; Slightly sore arm; This spontaneous case was reported by a non-health professional and describes the occurrence of HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Slightly sore arm), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Mild fever of 99.2) 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 COVID-19 in December 2020.    On 10-Jan-2021 at 10:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced VACCINATION SITE PAIN (Slightly sore arm). On 11-Jan-2021, the patient experienced HYPERHIDROSIS (Sweating), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Mild fever of 99.2). At the time of the report, HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Slightly sore arm), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Mild fever of 99.2) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, Body temperature: 99.2 (High) Increased to 99.7.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included Tylenol and ibuprofen.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sweating; Chills; Headache; Mild fever of 99.2; Slightly sore arm; This spontaneous case was reported by a non-health professional and describes the occurrence of HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Slightly sore arm), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Mild fever of 99.2) 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 COVID-19 in December 2020.    On 10-Jan-2021 at 10:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced VACCINATION SITE PAIN (Slightly sore arm). On 11-Jan-2021, the patient experienced HYPERHIDROSIS (Sweating), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Mild fever of 99.2). At the time of the report, HYPERHIDROSIS (Sweating), VACCINATION SITE PAIN (Slightly sore arm), CHILLS (Chills), HEADACHE (Headache) and PYREXIA (Mild fever of 99.2) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, Body temperature: 99.2 (High) Increased to 99.7.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included Tylenol and ibuprofen.; 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: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Heart rate, Heart rate increased, Vaccination complication
Clinical narrative: shortness of breath; rapid heart rate; severe coughing; felt like Covid symptoms; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), HEART RATE INCREASED (rapid heart rate), COUGH (severe coughing) and VACCINATION COMPLICATION (felt like Covid symptoms) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (The patient was hospitalized from October to November and was given Remdesivir.) in October 2020. Concurrent medical conditions included Lung disorder (damaged lungs due to his occupation).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced DYSPNOEA (shortness of breath), HEART RATE INCREASED (rapid heart rate), COUGH (severe coughing) and VACCINATION COMPLICATION (felt like Covid symptoms). At the time of the report, DYSPNOEA (shortness of breath), HEART RATE INCREASED (rapid heart rate), COUGH (severe coughing) and VACCINATION COMPLICATION (felt like Covid symptoms) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, Heart rate: rapid (High) Rapid.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional information: The caregiver stated that she did take him to the emergency room due to his side effects. She is wondering if they should skip the second dose for him.  Concomitant and treatment information 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: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L2a) for COVID-19 vaccination.     No medical history was provided by the reporter. .  Concomitant products included GEMFIBROZIL, TERAZOSIN and SIMVASTATIN for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow-up information received on 03-JUN-2021, outcome of event updated. On 01-Jul-2021: No New Information was received.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Nausea, Vaccination site pain
Clinical narrative: had little appetite; arm is a bit sore; light-headedness; nauseous; This spontaneous case was reported by a physician and describes the occurrence of DECREASED APPETITE (had little appetite), DIZZINESS (light-headedness), NAUSEA (nauseous) and VACCINATION SITE PAIN (arm is a bit sore) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced NAUSEA (nauseous). On 13-Jan-2021, the patient experienced DIZZINESS (light-headedness). On an unknown date, the patient experienced DECREASED APPETITE (had little appetite) and VACCINATION SITE PAIN (arm is a bit sore). At the time of the report, DECREASED APPETITE (had little appetite), DIZZINESS (light-headedness), NAUSEA (nauseous) and VACCINATION SITE PAIN (arm is a bit sore) 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity
Clinical narrative: sore arm; body ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN (body ache) and HEADACHE (headache) 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 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced  PAIN (body ache), HEADACHE (headache) and PAIN IN EXTREMITY (sore arm), and. At the time of the report,  PAIN (body ache), HEADACHE (headache) and PAIN IN EXTREMITY (sore arm), outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information 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 these events, a causal relationship cannot be excluded.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: headache; injection site was hot; injection site was itchy; injection site was red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site was hot), VACCINATION SITE PRURITUS (injection site was itchy), VACCINATION SITE ERYTHEMA (injection site was red) and HEADACHE (headache) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE WARMTH (injection site was hot), VACCINATION SITE PRURITUS (injection site was itchy) and VACCINATION SITE ERYTHEMA (injection site was red). On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, VACCINATION SITE WARMTH (injection site was hot), VACCINATION SITE PRURITUS (injection site was itchy), VACCINATION SITE ERYTHEMA (injection site was red) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment medications included ibuprofen, aspirin, acetaminophen, caffeine, diphenhydramine.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2021: No specific follow-up information recorded.; 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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy, Vaccination site pain
Clinical narrative: soreness of the arm,; Huge swelling of the lymph node under her arm, too bad she can not put her arm down; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness of the arm,) and VACCINATION SITE LYMPHADENOPATHY (Huge swelling of the lymph node under her arm, too bad she can not put her arm down) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Allergy pill treatment).    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2020, the patient experienced VACCINATION SITE PAIN (soreness of the arm,) and VACCINATION SITE LYMPHADENOPATHY (Huge swelling of the lymph node under her arm, too bad she can not put her arm down). At the time of the report, VACCINATION SITE PAIN (soreness of the arm,) and VACCINATION SITE LYMPHADENOPATHY (Huge swelling of the lymph node under her arm, too bad she can not put her arm down) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       o No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: 5 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (5 weeks pregnant) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (5 weeks pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (5 weeks pregnant) had resolved.        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.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 25-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: Hot at the injection site; Hard at the injection site; area of the injection that her arm was swollen; Red at the injection site; Slightly tender at the injection site; muscle in that area was also slightly sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE INDURATION (Hard at the injection site), VACCINATION SITE SWELLING (area of the injection that her arm was swollen), VACCINATION SITE ERYTHEMA (Red at the injection site) and VACCINATION SITE PAIN (Slightly tender at the injection site) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE INDURATION (Hard at the injection site), VACCINATION SITE SWELLING (area of the injection that her arm was swollen), VACCINATION SITE ERYTHEMA (Red at the injection site), VACCINATION SITE PAIN (Slightly tender at the injection site) and MYALGIA (muscle in that area was also slightly sore). At the time of the report, VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE INDURATION (Hard at the injection site), VACCINATION SITE SWELLING (area of the injection that her arm was swollen), VACCINATION SITE ERYTHEMA (Red at the injection site), VACCINATION SITE PAIN (Slightly tender at the injection site) and MYALGIA (muscle in that area was also slightly sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.   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.   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 these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Hot at the injection site; Hard at the injection site; area of the injection that her arm was swollen; Red at the injection site; Slightly tender at the injection site; muscle in that area was also slightly sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE INDURATION (Hard at the injection site), VACCINATION SITE SWELLING (area of the injection that her arm was swollen), VACCINATION SITE ERYTHEMA (Red at the injection site) and VACCINATION SITE PAIN (Slightly tender at the injection site) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE INDURATION (Hard at the injection site), VACCINATION SITE SWELLING (area of the injection that her arm was swollen), VACCINATION SITE ERYTHEMA (Red at the injection site), VACCINATION SITE PAIN (Slightly tender at the injection site) and MYALGIA (muscle in that area was also slightly sore). At the time of the report, VACCINATION SITE WARMTH (Hot at the injection site), VACCINATION SITE INDURATION (Hard at the injection site), VACCINATION SITE SWELLING (area of the injection that her arm was swollen), VACCINATION SITE ERYTHEMA (Red at the injection site), VACCINATION SITE PAIN (Slightly tender at the injection site) and MYALGIA (muscle in that area was also slightly sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.   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.   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 these events, a causal relationship cannot be excluded.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Influenza like illness
Clinical narrative: Flu-like symptoms; Severe abdominal pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), ABDOMINAL PAIN (Severe abdominal pain) and CHILLS (Chills) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), ABDOMINAL PAIN (Severe abdominal pain) and CHILLS (Chills). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), ABDOMINAL PAIN (Severe abdominal pain) and CHILLS (Chills) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.; 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 events, a causal relationship cannot be excluded.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: numbness; This spontaneous case was reported by a health care professional and describes the occurrence of HYPOAESTHESIA (numbness) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced HYPOAESTHESIA (numbness). On 08-Jan-2021, HYPOAESTHESIA (numbness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   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 event, a causal relationship cannot be excluded.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Vaccination site pain
Clinical narrative: Tightness on the middle of his chest and a sharp pain; Tightness on the middle of his chest and a sharp pain; Injection site pain; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Injection site pain), CHEST DISCOMFORT (Tightness on the middle of his chest and a sharp pain) and CHEST PAIN (Tightness on the middle of his chest and a sharp pain) in a 29-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 reported medical history).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (Injection site pain). On 13-Jan-2021, the patient experienced CHEST DISCOMFORT (Tightness on the middle of his chest and a sharp pain) and CHEST PAIN (Tightness on the middle of his chest and a sharp pain). At the time of the report, VACCINATION SITE PAIN (Injection site pain), CHEST DISCOMFORT (Tightness on the middle of his chest and a sharp pain) and CHEST PAIN (Tightness on the middle of his chest and a sharp pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Treatment information was not provided.; 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 events, a causal relationship cannot be excluded.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Flatulence
Clinical narrative: Diarrhea; Gas; Intestinal distress; This spontaneous case was reported by a health care professional and describes the occurrence of ABDOMINAL DISCOMFORT (Intestinal distress), DIARRHOEA (Diarrhea) and FLATULENCE (Gas) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concomitant products included EPINEPHRINE (EPIPEN) for Bee sting, TESTOSTERONE, MONTELUKAST and HYDROCHLOROTHIAZIDE for an unknown indication.    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 ABDOMINAL DISCOMFORT (Intestinal distress) and FLATULENCE (Gas). On 13-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, ABDOMINAL DISCOMFORT (Intestinal distress), DIARRHOEA (Diarrhea) and FLATULENCE (Gas) 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.   Treatment information was not provided.   This case was linked to MOD-2021-242170 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Added Reporter Email address and concomitant medication EpiPen was added
Sex: F
Vaccine: COVID19
Symptoms: Headache, Tinnitus
Clinical narrative: ringing in ears; Headache; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing in ears) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced TINNITUS (ringing in ears) and HEADACHE (Headache). At the time of the report, TINNITUS (ringing in ears) and HEADACHE (Headache) 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.; 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 events, a causal relationship cannot be excluded.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Initial insomnia, Wheezing
Clinical narrative: having trouble breathing; he is coughing; can´t get to sleep; he's wheezing in his chest; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (having trouble breathing), COUGH (he is coughing), INITIAL INSOMNIA (can´t get to sleep) and WHEEZING (he's wheezing in his chest) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced DYSPNOEA (having trouble breathing), COUGH (he is coughing), INITIAL INSOMNIA (can´t get to sleep) and WHEEZING (he's wheezing in his chest). At the time of the report, DYSPNOEA (having trouble breathing), COUGH (he is coughing), INITIAL INSOMNIA (can´t get to sleep) and WHEEZING (he's wheezing in his chest) outcome was unknown. Not Provided      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: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Sinus disorder, Swelling face
Clinical narrative: swelling in her face; redness in both of her cheeks / redness in the left arm all the way down passed her elbow; sinuses; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swelling in her face), ERYTHEMA (redness in both of her cheeks / redness in the left arm all the way down passed her elbow) and SINUS DISORDER (sinuses) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, LEVOTHYROXINE, AMITRIPTYLINE, METFORMIN, FAMOTIDINE, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), MAGNESIUM, VITAMIN D NOS and POTASSIUM (POTASIUM M) 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 12-Jan-2021, the patient experienced SWELLING FACE (swelling in her face), ERYTHEMA (redness in both of her cheeks / redness in the left arm all the way down passed her elbow) and SINUS DISORDER (sinuses). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 13-Jan-2021 for Adverse event, at a dose of UNK dosage form and PREDNISONE on 11-Jan-2021 for Sinus disorder NOS, at a dose of UNK dosage form. At the time of the report, SWELLING FACE (swelling in her face), ERYTHEMA (redness in both of her cheeks / redness in the left arm all the way down passed her elbow) and SINUS DISORDER (sinuses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included asthma inhaler.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: on 8 JUN 2021 follow up received contain no new information. Patient stated she was  doing fine and doesn't want any further FUs.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Peripheral swelling
Clinical narrative: swollen arm; severe swollen axillary lymph node; A spontaneous report  was received from a consumer concerning a 48 year  old female patient, who received second dose of Moderna's COVID-19 vaccine (mRNA-1273) and developed swollen arm, severe swollen axillary lymph node.  The patient's medical history was not provided. No relevant concomitant medications were provided.  On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection.   On 07 Jan 2021, with onset latency of two days, the patient developed swollen arm and a severe swollen axillary lymph node.  No Laboratory details were provided.The Treatment medication included Acetaminophen.  Action taken with mRNA-1273 in response to the other events was unknown.  At the time of this report, the outcome of the events, swollen arm, severe swollen axillary lymph node was resolving/recovering.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Headache, Myalgia, Pain in extremity, Retching
Clinical narrative: pain in left leg; dry heaving; bloating; headache; paiin in left hip; This spontaneous case was reported by an other caregiver and describes the occurrence of PAIN IN EXTREMITY (pain in left leg), RETCHING (dry heaving), ABDOMINAL DISTENSION (bloating), HEADACHE (headache) and MYALGIA (paiin in left hip) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in left leg), RETCHING (dry heaving), ABDOMINAL DISTENSION (bloating), HEADACHE (headache) and MYALGIA (paiin in left hip). On 22-Jan-2021, PAIN IN EXTREMITY (pain in left leg), RETCHING (dry heaving), ABDOMINAL DISTENSION (bloating) and MYALGIA (paiin in left hip) had resolved. At the time of the report, HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Nov-2020, SARS-CoV-2 test: 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.   No concomitant medications were reported. Treatment details include Tylenol daily and a few doses of tramadol for pain..   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: No specific follow-up information recorded.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: pain in left leg; dry heaving; bloating; headache; paiin in left hip; This spontaneous case was reported by an other caregiver and describes the occurrence of PAIN IN EXTREMITY (pain in left leg), RETCHING (dry heaving), ABDOMINAL DISTENSION (bloating), HEADACHE (headache) and MYALGIA (paiin in left hip) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in left leg), RETCHING (dry heaving), ABDOMINAL DISTENSION (bloating), HEADACHE (headache) and MYALGIA (paiin in left hip). On 22-Jan-2021, PAIN IN EXTREMITY (pain in left leg), RETCHING (dry heaving), ABDOMINAL DISTENSION (bloating) and MYALGIA (paiin in left hip) had resolved. At the time of the report, HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Nov-2020, SARS-CoV-2 test: 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.   No concomitant medications were reported. Treatment details include Tylenol daily and a few doses of tramadol for pain..   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Sore 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 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) for Pain, at an unspecified dose and frequency. On 12-Jan-2021, VACCINATION SITE PAIN (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the 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 event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Hypersensitivity, Rhinorrhoea, Sinus disorder, Sneezing
Clinical narrative: Runny nose; Sneezing; Dry cough; allergy; sinus; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), SNEEZING (Sneezing), COUGH (Dry cough), HYPERSENSITIVITY (allergy) and SINUS DISORDER (sinus) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Bleeding since 12-Jan-2021. Concomitant products included DABIGATRAN ETEXILATE MESILATE (PRADAXA), HYDRALAZINE, METFORMIN and ATORVASTATIN 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 12-Jan-2021, the patient experienced RHINORRHOEA (Runny nose), SNEEZING (Sneezing), COUGH (Dry cough), HYPERSENSITIVITY (allergy) and SINUS DISORDER (sinus). On 13-Jan-2021, RHINORRHOEA (Runny nose), SNEEZING (Sneezing) and COUGH (Dry cough) had resolved. At the time of the report, HYPERSENSITIVITY (allergy) outcome was unknown and SINUS DISORDER (sinus) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment related information has been reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jan-2021: Event (Sinus PT) linking updated as per MR request; case inadvertently locked without making the changes.; 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.