chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: severe reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (severe reaction) 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 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION COMPLICATION (severe reaction). At the time of the report, VACCINATION COMPLICATION (severe reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: a reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (a reaction) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (a reaction). At the time of the report, VACCINATION COMPLICATION (a reaction) 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 for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Jan-2021 and was forwarded to the company on 29-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (a reaction) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (a reaction). At the time of the report, VACCINATION COMPLICATION (a reaction) 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 for the event was provided.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Red; Itchy; Swollen; Arm was hurting a lot; A spontaneous report was received from a consumer concerning a 70-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273)  experienced arm was hurting a lot, red, itchy, swollen.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 17 Jan 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.    On 17-JAN-2021 the patient experienced arm was hurting a lot and on an unknown date the patient experienced red, itchy, swollen.  No treatment information was provided.  Action taken with RNA-1273 in response to the events was unknown.  The outcome of the event arm was hurting a lot was resolved. The outcome of the events red, itchy and swollen was unknown.; Reporter's Comments: This case concerns a 70-year-old female who experienced nonserious expected events of limb discomfort, injection site swelling, injection site erythema, injection site pruritus. The events occurred the same day as the first dose of mRNA-1273. Treatment not reported.  Arm discomfort resolved, but other event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Inflammation, Influenza like illness
Clinical narrative: Flu like symptoms; Inflammation; Chills; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, flu like symptoms and inflammation.  The patient's medical was not provided. No relevant concomitant medications were reported.  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced chills, flu like symptoms and inflammation.  Treatment for the event included Benadryl.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events chills, flu like symptoms and inflammation was not reported.; Reporter's Comments: This case concerns a female of unknown age who experienced nonserious unexpected events of influenza-like illness and inflammation along with and a nonserious expected event of chills.  The events occurred with unknown latency after the first dose of mRNA-1273. Treatment included Benadryl. Event outcome not reported. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history information was reported.     On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg. At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jan-2021 and was forwarded to Moderna on 28-Jan-2021.    This spontaneous case was reported by a consumer 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) (batch no. Unknown) for COVID-19 vaccination.     No medical history information was reported.     On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg. At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Nausea, Pyrexia
Clinical narrative: diarrhea; felt tired; fever; chills; threw up; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), FATIGUE (felt tired), PYREXIA (fever), CHILLS (chills) and VOMITING (threw up) in a 29-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 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced DIARRHOEA (diarrhea), FATIGUE (felt tired), PYREXIA (fever), CHILLS (chills), VOMITING (threw up) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea) and NAUSEA (nausea) had not resolved and FATIGUE (felt tired), PYREXIA (fever), CHILLS (chills) and VOMITING (threw up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Jan-2021 and was forwarded to Moderna on 28-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), FATIGUE (felt tired), PYREXIA (fever), CHILLS (chills) and VOMITING (threw up) in a 29-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 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced DIARRHOEA (diarrhea), FATIGUE (felt tired), PYREXIA (fever), CHILLS (chills), VOMITING (threw up) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea) and NAUSEA (nausea) had not resolved and FATIGUE (felt tired), PYREXIA (fever), CHILLS (chills) and VOMITING (threw up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: diarrhea; felt tired; fever; chills; threw up; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), FATIGUE (felt tired), PYREXIA (fever), CHILLS (chills) and VOMITING (threw up) in a 29-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 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced DIARRHOEA (diarrhea), FATIGUE (felt tired), PYREXIA (fever), CHILLS (chills), VOMITING (threw up) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea) and NAUSEA (nausea) had not resolved and FATIGUE (felt tired), PYREXIA (fever), CHILLS (chills) and VOMITING (threw up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Jan-2021 and was forwarded to Moderna on 28-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), FATIGUE (felt tired), PYREXIA (fever), CHILLS (chills) and VOMITING (threw up) in a 29-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 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced DIARRHOEA (diarrhea), FATIGUE (felt tired), PYREXIA (fever), CHILLS (chills), VOMITING (threw up) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea) and NAUSEA (nausea) had not resolved and FATIGUE (felt tired), PYREXIA (fever), CHILLS (chills) and VOMITING (threw up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Condition aggravated, Vaccination site pain
Clinical narrative: Feeling less energetic; Condition worsened; Minor pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Feeling less energetic), CONDITION AGGRAVATED (Condition worsened) and VACCINATION SITE PAIN (Minor pain at injection site) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included Energy decreased (history of going through periods of feeling more energetic and less energetic.) and Energy increased (history of going through periods of feeling more energetic and less energetic.).    On 06-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 ASTHENIA (Feeling less energetic), CONDITION AGGRAVATED (Condition worsened) and VACCINATION SITE PAIN (Minor pain at injection site). At the time of the report, ASTHENIA (Feeling less energetic), CONDITION AGGRAVATED (Condition worsened) and VACCINATION SITE PAIN (Minor pain at injection site) 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 start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site bruising
Clinical narrative: black-blue" spot of approximately 5 inches, below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (black-blue" spot of approximately 5 inches, below the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO medical history information was reported.     On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE BRUISING (black-blue" spot of approximately 5 inches, below the injection site). At the time of the report, VACCINATION SITE BRUISING (black-blue" spot of approximately 5 inches, below the injection site) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Feb-2021 and was forwarded to Moderna on 04-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (black-blue" spot of approximately 5 inches, below the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     NO medical history information was reported.     On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE BRUISING (black-blue" spot of approximately 5 inches, below the injection site). At the time of the report, VACCINATION SITE BRUISING (black-blue" spot of approximately 5 inches, below the injection site) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Body temperature increased, Chills, Fatigue
Clinical narrative: wrist joint paint / hip joint pain; temperature reached 101.6 degrees; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), FATIGUE (fatigue), ARTHRALGIA (wrist joint paint / hip joint pain) and BODY TEMPERATURE INCREASED (temperature reached 101.6 degrees) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced CHILLS (chills) and FATIGUE (fatigue). On 29-Jan-2021, the patient experienced ARTHRALGIA (wrist joint paint / hip joint pain) and BODY TEMPERATURE INCREASED (temperature reached 101.6 degrees). At the time of the report, CHILLS (chills), FATIGUE (fatigue), ARTHRALGIA (wrist joint paint / hip joint pain) and BODY TEMPERATURE INCREASED (temperature reached 101.6 degrees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Body temperature: 101.6 (abnormal) Abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: woke up with a red ,large ,round mark like being hit with a baseball; woke up with a red ,large ,round mark like being hit with a baseball; sored left arm; This spontaneous case was reported by a dentist (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sored left arm), INJECTION SITE SWELLING (woke up with a red ,large ,round mark like being hit with a baseball) and INJECTION SITE ERYTHEMA (woke up with a red ,large ,round mark like being hit with a baseball) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. oK6L2017) for COVID-19 vaccination.     Concurrent medical conditions included Immunodeficiency (start/stop date, ongoing not provided) and Polychondritis (start/stop date, ongoing not provided).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (sored left arm). On 27-Jan-2021, the patient experienced INJECTION SITE SWELLING (woke up with a red ,large ,round mark like being hit with a baseball) and INJECTION SITE ERYTHEMA (woke up with a red ,large ,round mark like being hit with a baseball). The patient was treated with IMMUNOGLOBULIN HUMAN NORMAL (HIZENTRA) (subcutaneous) ongoing since an unknown date for Immunocompromised, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (sored left arm), INJECTION SITE SWELLING (woke up with a red ,large ,round mark like being hit with a baseball) and INJECTION SITE ERYTHEMA (woke up with a red ,large ,round mark like being hit with a baseball) 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 medications included immunocompromised medication ( every day with different medications), steroid medication for outbreak and Hizentra infusion SC.   This case was linked to MOD-2021-106521 (Patient Link).   Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: soreness at the right arm , which was the injection site , 10 days after receiving the first dose of Moderna COVID-19 vaccine/pain at the right arm , which was the injection site , 10 days after receiving the first dose of Moderna COVID-19 vaccine; itches at the right arm , which was the injection site , 10 days after receiving the first dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at the right arm , which was the injection site , 10 days after receiving the first dose of Moderna COVID-19 vaccine/pain at the right arm , which was the injection site , 10 days after receiving the first dose of Moderna COVID-19 vaccine) and VACCINATION SITE PRURITUS (itches at the right arm , which was the injection site , 10 days after receiving the first dose of Moderna COVID-19 vaccine) in a 73-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 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness at the right arm , which was the injection site , 10 days after receiving the first dose of Moderna COVID-19 vaccine/pain at the right arm , which was the injection site , 10 days after receiving the first dose of Moderna COVID-19 vaccine) and VACCINATION SITE PRURITUS (itches at the right arm , which was the injection site , 10 days after receiving the first dose of Moderna COVID-19 vaccine). At the time of the report, VACCINATION SITE PAIN (soreness at the right arm , which was the injection site , 10 days after receiving the first dose of Moderna COVID-19 vaccine/pain at the right arm , which was the injection site , 10 days after receiving the first dose of Moderna COVID-19 vaccine) and VACCINATION SITE PRURITUS (itches at the right arm , which was the injection site , 10 days after receiving the first dose of Moderna COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced MYALGIA (Body aches). At the time of the report, MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Pyrexia: 104 (Inconclusive) 104.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       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 events, a causal relationship cannot be excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Eye discharge, Headache, Rhinorrhoea
Clinical narrative: Coughs; Runny Eyes; Runny Nose; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughs), EYE DISCHARGE (Runny Eyes), RHINORRHOEA (Runny Nose) and HEADACHE (Headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 307K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-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 COUGH (Coughs), EYE DISCHARGE (Runny Eyes), RHINORRHOEA (Runny Nose) and HEADACHE (Headache). At the time of the report, COUGH (Coughs), EYE DISCHARGE (Runny Eyes), RHINORRHOEA (Runny Nose) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided. The reporter enquired whether these symptoms are related to Moderna vaccine.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Dizziness, Nausea, Pyrexia
Clinical narrative: Fever; Chills; Nausea; Dizziness; Stomach Pain; This spontaneous case was reported by a health care professional and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), DIZZINESS (Dizziness) and ABDOMINAL PAIN UPPER (Stomach Pain) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), DIZZINESS (Dizziness) and ABDOMINAL PAIN UPPER (Stomach Pain). At the time of the report, PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), DIZZINESS (Dizziness) and ABDOMINAL PAIN UPPER (Stomach Pain) 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 details included Celebrex. No relevant concomitant medications were reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Ended up in the emergency room; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ADVERSE EVENT (Ended up in the emergency room) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Ended up in the emergency room). At the time of the report, ADVERSE EVENT (Ended up in the emergency room) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Headache, Nasal congestion
Clinical narrative: Stuffiness; Loss of taste; Loss of smell; couple of headaches that were really bad; Pt tested positive after receiving the 1st dose; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (Pt tested positive after receiving the 1st dose), NASAL CONGESTION (Stuffiness), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell) and HEADACHE (couple of headaches that were really bad) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 14-Jan-2021, the patient experienced COVID-19 (Pt tested positive after receiving the 1st dose). On an unknown date, the patient experienced NASAL CONGESTION (Stuffiness), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell) and HEADACHE (couple of headaches that were really bad). At the time of the report, COVID-19 (Pt tested positive after receiving the 1st dose), NASAL CONGESTION (Stuffiness), AGEUSIA (Loss of taste), ANOSMIA (Loss of smell) and HEADACHE (couple of headaches that were really bad) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. Patient received Tylenol and Ibuprofen treatment for the symptoms. Patient received 1st dose of vaccine at the health center.   Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2021: No specific follow-up information recorded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: tingling on  lips; This spontaneous case was reported by an other health care professional and describes the occurrence of PARAESTHESIA ORAL (tingling on  lips) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PARAESTHESIA ORAL (tingling on  lips). At the time of the report, PARAESTHESIA ORAL (tingling on  lips) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid thickening
Clinical narrative: Weird, small, raised bumps on one of her eyelids, next day on both eye lids; This spontaneous case was reported by a consumer and describes the occurrence of EYELID THICKENING (Weird, small, raised bumps on one of her eyelids, next day on both eye lids) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced EYELID THICKENING (Weird, small, raised bumps on one of her eyelids, next day on both eye lids). At the time of the report, EYELID THICKENING (Weird, small, raised bumps on one of her eyelids, next day on both eye lids) 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 start date of the events, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site infection, Vaccination site lymphadenopathy, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Noticed lymph node under my arm; Arm below the injection site is red; Hot; swollen; Infected; Sore; Started itching belowthe injection site; A spontaneous report (United States) was received from a consumer concerning a 54-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events - itching below the injection site/vaccination site pruritus , noticed lymph node under arm/ vaccination site lymphadenopathy, red/vaccination site erythema , hot/vaccination site warmth, sore/vaccination site pain, swollen/vaccination site swelling, infected/vaccination site infection.  The patient's medical history was not provided. Concomitant medications reported were Lisinopril , Estradiol, Medroxyprogesterone and Clonazepam (for unknown indication).  On 06 Feb 2021, prior to the onset of the events the patient received their first dose of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 6 Feb 2021, the patient experienced itching below the injection site.On 7 Feb 2021, the patient developed lymph node under her arm that was sore and swollen.Arm below the injection site was red, hot and swollen. The patient went to urgent care and told it was infected.  Treatment details included-  Prescribed antibiotics Cephalexin 500mg, Atarax 10mg , Diflucan (Fluconazole)150mg (but did not take any of these yet).  Action taken with mRNA-1273 in response to the events was unknown   The outcome of events- started itching below the injection site, noticed lymph node under arm, red, hot, sore, swollen, infected  -was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Noticed lymph node under my arm; Arm below the injection site is red; Hot; swollen; Infected; Sore; Started itching belowthe injection site; A spontaneous report (United States) was received from a consumer concerning a 54-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events - itching below the injection site/vaccination site pruritus , noticed lymph node under arm/ vaccination site lymphadenopathy, red/vaccination site erythema , hot/vaccination site warmth, sore/vaccination site pain, swollen/vaccination site swelling, infected/vaccination site infection.  The patient's medical history was not provided. Concomitant medications reported were Lisinopril , Estradiol, Medroxyprogesterone and Clonazepam (for unknown indication).  On 06 Feb 2021, prior to the onset of the events the patient received their first dose of two planned doses of mRNA-1273 (lot/batch: 007M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 6 Feb 2021, the patient experienced itching below the injection site.On 7 Feb 2021, the patient developed lymph node under her arm that was sore and swollen.Arm below the injection site was red, hot and swollen. The patient went to urgent care and told it was infected.  Treatment details included-  Prescribed antibiotics Cephalexin 500mg, Atarax 10mg , Diflucan (Fluconazole)150mg (but did not take any of these yet).  Action taken with mRNA-1273 in response to the events was unknown   The outcome of events- started itching below the injection site, noticed lymph node under arm, red, hot, sore, swollen, infected  -was unknown.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Nausea
Clinical narrative: very sour stomach; feels like vomiting; A spontaneous report was received from a consumer concerning a 85-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events very sour stomach and feels like vomiting.  The patient's medical history include, she is a diabetic and had a pacemaker.   No relevant concomitant medications were reported. patient and her daughter called to report that,on 29 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On 1 Feb 2021, the patient experienced the events,very sour stomach and still ongoing and she feels like vomiting but is holding it back vaccine sour stomach. she did not receive card with information at vaccination site  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, very sour stomach and feels like vomiting were unknown.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Pruritus, Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: Itching in the arm; Has a lump on the arm, Injection site is hard; injection site warmth; Injection site is hard; Injection site red; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching in the arm), INDURATION (Has a lump on the arm, Injection site is hard), VACCINATION SITE WARMTH (injection site warmth), VACCINATION SITE INDURATION (Injection site is hard) and VACCINATION SITE ERYTHEMA (Injection site red) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included Heart attack, Stent placement and Shoulder replacement. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO), CARVEDILOL, CABERGOLINE and CALCIUM GLUCONATE, CALCIUM PHOSPHATE DIBASIC, ERGOCALCIFEROL, RIBOFLAVIN (VITAMINS, CALCIUM HYDROGEN PHOSPHATE AND CALCIUM GLUCONATE) for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PRURITUS (Itching in the arm), INDURATION (Has a lump on the arm, Injection site is hard), VACCINATION SITE WARMTH (injection site warmth), VACCINATION SITE INDURATION (Injection site is hard) and VACCINATION SITE ERYTHEMA (Injection site red). At the time of the report, PRURITUS (Itching in the arm), INDURATION (Has a lump on the arm, Injection site is hard), VACCINATION SITE WARMTH (injection site warmth), VACCINATION SITE INDURATION (Injection site is hard) and VACCINATION SITE ERYTHEMA (Injection site red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment include applying ice on injection site.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: soreness, swelling and fever on her arm; soreness, swelling and fever on her arm; fever; A spontaneous report was received from a consumer concerning an 80 year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed sore arm/pain in extremity, swollen arm/peripheral swelling, and fever/pyrexia.  The patient's medical history was not provided. Concomitant medications reported were potassium, vit B12, furosemide, calcium, gabapentin, high blood pressure medication and lisinopril.  On 05 Jan 2021 the patient received their first of two planned doses of mRNA-1273 (batch number not provided) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 01 Feb 2021, approximately two days prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   The patient experienced a fever and arm soreness and swelling on 03 Feb 2021.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events sore arm, swollen arm, and fever were not reported.  Reporter causality for the events was not provided.; Reporter's Comments: This case concerns an 80-year-old female who experienced nonserious unexpected events of pain in extremity and peripheral swelling and nonserious expected event of fever. The events occurred 2 days after the second dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Illness, Myalgia, Pyrexia, Respiratory disorder
Clinical narrative: Became much sicker than when they had Covid-19; Respiratory symptoms; Fever of 101°F; Muscle pain; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ILLNESS (Became much sicker than when they had Covid-19), RESPIRATORY DISORDER (Respiratory symptoms), PYREXIA (Fever of 101°F) and MYALGIA (Muscle pain) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included SARS-CoV-2 acute respiratory disease (Mild symptoms, including a slight fever) on 17-Feb-2021.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced ILLNESS (Became much sicker than when they had Covid-19), RESPIRATORY DISORDER (Respiratory symptoms), PYREXIA (Fever of 101°F) and MYALGIA (Muscle pain). At the time of the report, ILLNESS (Became much sicker than when they had Covid-19), RESPIRATORY DISORDER (Respiratory symptoms), PYREXIA (Fever of 101°F) and MYALGIA (Muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive. On 27-Jan-2021, Body temperature: 101 f (High) High.     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.   Treatment information was not provided.  HCP reported that after the first dose the patient became much sicker than when they had Covid-19. HCP states it was like a strong acquire immune response, not an allergic one.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Became much sicker than when they had Covid-19; Respiratory symptoms; Fever of 101°F; Muscle pain; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ILLNESS (Became much sicker than when they had Covid-19), RESPIRATORY DISORDER (Respiratory symptoms), PYREXIA (Fever of 101°F) and MYALGIA (Muscle pain) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included SARS-CoV-2 acute respiratory disease (Mild symptoms, including a slight fever) on 17-Feb-2021.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced ILLNESS (Became much sicker than when they had Covid-19), RESPIRATORY DISORDER (Respiratory symptoms), PYREXIA (Fever of 101°F) and MYALGIA (Muscle pain). At the time of the report, ILLNESS (Became much sicker than when they had Covid-19), RESPIRATORY DISORDER (Respiratory symptoms), PYREXIA (Fever of 101°F) and MYALGIA (Muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive. On 27-Jan-2021, Body temperature: 101 f (High) High.     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.   Treatment information was not provided.  HCP reported that after the first dose the patient became much sicker than when they had Covid-19. HCP states it was like a strong acquire immune response, not an allergic one.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Dizziness, Flushing, Head discomfort
Clinical narrative: dizzy; I am walking, and my cheeks are flushed; temperature is around; chills; pressure on top of the head; Her body was hurting a little; Not feeling well; very slight headache and a little dizzy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Not feeling well), HEADACHE (very slight headache and a little dizzy), DIZZINESS (dizzy), MYALGIA (Her body was hurting a little) and FLUSHING (I am walking, and my cheeks are flushed) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 COMPLICATION (Not feeling well), HEADACHE (very slight headache and a little dizzy) and MYALGIA (Her body was hurting a little). On 03-Feb-2021, the patient experienced HEAD DISCOMFORT (pressure on top of the head). On 04-Feb-2021, the patient experienced DIZZINESS (dizzy), FLUSHING (I am walking, and my cheeks are flushed), BODY TEMPERATURE INCREASED (temperature is around) and CHILLS (chills). At the time of the report, VACCINATION COMPLICATION (Not feeling well), HEADACHE (very slight headache and a little dizzy), DIZZINESS (dizzy), MYALGIA (Her body was hurting a little), FLUSHING (I am walking, and my cheeks are flushed), BODY TEMPERATURE INCREASED (temperature is around), CHILLS (chills) and HEAD DISCOMFORT (pressure on top of the head) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Vaccination complication
Clinical narrative: dizzy; I am walking, and my cheeks are flushed; temperature is around; chills; pressure on top of the head; Her body was hurting a little; Not feeling well; very slight headache and a little dizzy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Not feeling well), HEADACHE (very slight headache and a little dizzy), DIZZINESS (dizzy), MYALGIA (Her body was hurting a little) and FLUSHING (I am walking, and my cheeks are flushed) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 COMPLICATION (Not feeling well), HEADACHE (very slight headache and a little dizzy) and MYALGIA (Her body was hurting a little). On 03-Feb-2021, the patient experienced HEAD DISCOMFORT (pressure on top of the head). On 04-Feb-2021, the patient experienced DIZZINESS (dizzy), FLUSHING (I am walking, and my cheeks are flushed), BODY TEMPERATURE INCREASED (temperature is around) and CHILLS (chills). At the time of the report, VACCINATION COMPLICATION (Not feeling well), HEADACHE (very slight headache and a little dizzy), DIZZINESS (dizzy), MYALGIA (Her body was hurting a little), FLUSHING (I am walking, and my cheeks are flushed), BODY TEMPERATURE INCREASED (temperature is around), CHILLS (chills) and HEAD DISCOMFORT (pressure on top of the head) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.