chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Liquid product physical issue
Clinical narrative: the vaccination liquid in the syringe was not clear, and it was probably a little more than yellow; A spontaneous report was received from a consumer concerning a female patient who experienced the vaccination liquid in the syringe not being clear, and it was probably a little more yellow.   The patient's medical history was not provided.  Concomitant product use was not provided/unknown by the reporter.    The patients received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   The patients recently got their first COVID vaccination and they were trying to contact the manufacturer using the lot number on their card, and they got to the place where it said  "enter the lot number" but when they entered the number  it said that it was not a good number and that the number does not exist. They were disappointed that the vaccination liquid in the syringe was not clear, and it was probably a little more than yellow and they were concerned about that.  Treatment information was not provided.    Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the event was unknown.; Reporter's Comments: This report refers to a case of vaccination liquid in the syringe not being clear, and it was probably a little more yellow (Product appearance cloudy) for mRNA-1273, lot # unknown). There was no associated AEs with the event of product appearance cloudy.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site rash
Clinical narrative: Hard, red rash about 3-4 inches in diameter; Hard, red rash about 3-4 inches in diameter; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Hard, red rash about 3-4 inches in diameter) and VACCINATION SITE INDURATION (Hard, red rash about 3-4 inches in diameter) in a 68-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 (No medical history reported).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE RASH (Hard, red rash about 3-4 inches in diameter) and VACCINATION SITE INDURATION (Hard, red rash about 3-4 inches in diameter). At the time of the report, VACCINATION SITE RASH (Hard, red rash about 3-4 inches in diameter) and VACCINATION SITE INDURATION (Hard, red rash about 3-4 inches in diameter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included Paracetamol. No concomitant medications were provided by reporter.   Reporter did not allow further contact
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Night sweats, Vaccination site pain
Clinical narrative: Extremely sore arm; chills; night sweats; headaches; tiredness; This spontaneous case was reported by an other and describes the occurrence of   in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Reported data: 5 Months ago. Calculated date: ??-Aug-2020.) and Pneumonia (Reported data: Double pneumonia,5 months ago. Calculated date: ??-Aug-2020.).    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.        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 and concomitant medications were not provided by reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Solid red at injection site; Slightly swollen at injection site; Slightly itchy at injection site; Rash 0.5-2 inches in diameter; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash 0.5-2 inches in diameter), VACCINATION SITE ERYTHEMA (Solid red at injection site), VACCINATION SITE SWELLING (Slightly swollen at injection site) and VACCINATION SITE PRURITUS (Slightly itchy at injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash 0.5-2 inches in diameter). On 17-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Solid red at injection site), VACCINATION SITE SWELLING (Slightly swollen at injection site) and VACCINATION SITE PRURITUS (Slightly itchy at injection site). At the time of the report, VACCINATION SITE RASH (Rash 0.5-2 inches in diameter), VACCINATION SITE ERYTHEMA (Solid red at injection site), VACCINATION SITE SWELLING (Slightly swollen at injection site) and VACCINATION SITE PRURITUS (Slightly itchy at injection site) 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 medication included hydrocortisone. No concomitant medications were provided by reporter.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis contact, Joint swelling, Swollen tongue
Clinical narrative: half of his tongue was swollen; swollen; contact dermatitis wrist; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (swollen), DERMATITIS CONTACT (contact dermatitis wrist) and SWOLLEN TONGUE (half of his tongue was swollen) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Contact dermatitis. Concomitant products included ATORVASTATIN and MULTIVITAMIN [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 14-Jan-2021, the patient experienced JOINT SWELLING (swollen) and DERMATITIS CONTACT (contact dermatitis wrist). On 20-Jan-2021, the patient experienced SWOLLEN TONGUE (half of his tongue was swollen). At the time of the report, JOINT SWELLING (swollen) and DERMATITIS CONTACT (contact dermatitis wrist) outcome was unknown and SWOLLEN TONGUE (half of his tongue was swollen) had worsened. Contact dermatitis on one of his wrists was swollen.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included Benadryl.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Discomfort, Headache, Lethargy
Clinical narrative: was in so much pain; chills; headache; his body felt like 100-year-old man's with arthritis; felt discomfort; stinging/hurts to move arm; swelling; felt lethargic; scratchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (stinging/hurts to move arm), VACCINATION SITE SWELLING (swelling), LETHARGY (felt lethargic), MYALGIA (was in so much pain) and CHILLS (chills) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Enlarged prostate and Acute arthritis.    On 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (stinging/hurts to move arm), VACCINATION SITE SWELLING (swelling), LETHARGY (felt lethargic), VACCINATION SITE PRURITUS (scratchy) and DISCOMFORT (felt discomfort). On 21-Jan-2021, the patient experienced MYALGIA (was in so much pain), CHILLS (chills), HEADACHE (headache) and ARTHRALGIA (his body felt like 100-year-old man's with arthritis). At the time of the report, VACCINATION SITE PAIN (stinging/hurts to move arm), VACCINATION SITE SWELLING (swelling), LETHARGY (felt lethargic), MYALGIA (was in so much pain), CHILLS (chills), HEADACHE (headache), VACCINATION SITE PRURITUS (scratchy), ARTHRALGIA (his body felt like 100-year-old man's with arthritis) and DISCOMFORT (felt discomfort) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications included ibuprofen and icing at injection site. No concomitant medications were provided by reporter.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: was in so much pain; chills; headache; his body felt like 100-year-old man's with arthritis; felt discomfort; stinging/hurts to move arm; swelling; felt lethargic; scratchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (stinging/hurts to move arm), VACCINATION SITE SWELLING (swelling), LETHARGY (felt lethargic), MYALGIA (was in so much pain) and CHILLS (chills) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Enlarged prostate and Acute arthritis.    On 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (stinging/hurts to move arm), VACCINATION SITE SWELLING (swelling), LETHARGY (felt lethargic), VACCINATION SITE PRURITUS (scratchy) and DISCOMFORT (felt discomfort). On 21-Jan-2021, the patient experienced MYALGIA (was in so much pain), CHILLS (chills), HEADACHE (headache) and ARTHRALGIA (his body felt like 100-year-old man's with arthritis). At the time of the report, VACCINATION SITE PAIN (stinging/hurts to move arm), VACCINATION SITE SWELLING (swelling), LETHARGY (felt lethargic), MYALGIA (was in so much pain), CHILLS (chills), HEADACHE (headache), VACCINATION SITE PRURITUS (scratchy), ARTHRALGIA (his body felt like 100-year-old man's with arthritis) and DISCOMFORT (felt discomfort) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications included ibuprofen and icing at injection site. No concomitant medications were provided by reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Injection site reaction, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: injection site is round; hard; warm to touch; itchy; injection site reaction lastin more than a week; sweet taste in mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (sweet taste in mouth), VACCINATION SITE SWELLING (injection site is round), VACCINATION SITE INDURATION (hard), VACCINATION SITE WARMTH (warm to touch) and VACCINATION SITE PRURITUS (itchy) in a 64-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.     Concurrent medical conditions included Penicillin allergy.    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 DYSGEUSIA (sweet taste in mouth). On an unknown date, the patient experienced VACCINATION SITE SWELLING (injection site is round), VACCINATION SITE INDURATION (hard), VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (itchy) and INJECTION SITE REACTION (injection site reaction lastin more than a week). On 12-Jan-2021, DYSGEUSIA (sweet taste in mouth) had resolved. At the time of the report, VACCINATION SITE SWELLING (injection site is round), VACCINATION SITE INDURATION (hard), VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (itchy) and INJECTION SITE REACTION (injection site reaction lastin more than a week) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: injection site is round; hard; warm to touch; itchy; injection site reaction lastin more than a week; sweet taste in mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (sweet taste in mouth), VACCINATION SITE SWELLING (injection site is round), VACCINATION SITE INDURATION (hard), VACCINATION SITE WARMTH (warm to touch) and VACCINATION SITE PRURITUS (itchy) in a 64-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.     Concurrent medical conditions included Penicillin allergy.    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 DYSGEUSIA (sweet taste in mouth). On an unknown date, the patient experienced VACCINATION SITE SWELLING (injection site is round), VACCINATION SITE INDURATION (hard), VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (itchy) and INJECTION SITE REACTION (injection site reaction lastin more than a week). On 12-Jan-2021, DYSGEUSIA (sweet taste in mouth) had resolved. At the time of the report, VACCINATION SITE SWELLING (injection site is round), VACCINATION SITE INDURATION (hard), VACCINATION SITE WARMTH (warm to touch), VACCINATION SITE PRURITUS (itchy) and INJECTION SITE REACTION (injection site reaction lastin more than a week) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH (have rash on their bodyave rash on their arm, from shoulder to elbow.) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported.). On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced RASH (have rash on their bodyave rash on their arm, from shoulder to elbow.). At the time of the report, RASH (have rash on their bodyave rash on their arm, from shoulder to elbow.) had not resolved. Reported data: Rash on their arm since the night of 20Jan2021, from their shoulder to their elbow. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment and concomitant medications were not provided by reporter. Reporter did not allow further contact.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site urticaria, Vaccination site warmth
Clinical narrative: Redness of arm raised; Warm to touch; Swelling; redness raised; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness of arm raised), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE URTICARIA (redness raised) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no adverse event).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness of arm raised), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE URTICARIA (redness raised). At the time of the report, VACCINATION SITE ERYTHEMA (Redness of arm raised), VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE SWELLING (Swelling) and VACCINATION SITE URTICARIA (redness raised) 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 medications included Benadryl and prednisone. No concomitant medications were provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Pain in extremity, Pyrexia
Clinical narrative: Arm hurts really bad; Aches in the body; High fever; feeling like getting sick; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced such as running a high fever all the night and morning, fever over 102f, arm hurts really bad, aches in the body, feeling like getting sick.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 19/01/2021, 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 19/01/2021, The patient experienced the events such as running a high fever all the night and morning, fever over 102f, arm hurts really bad, aches in the body, feeling like getting sick.  Laboratory details are not provided.   No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events are not provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Gait disturbance, Influenza like illness, Myalgia
Clinical narrative: could barely move her arm; could barely stand and walk; feels like she has the flu; throat was irritated; nose was stuffed; feeling freezing cold; Body aches; fever (99.8-101.4F); Fatigue; Arm was swollen; A spontaneous report  was received from a reporter concerning a 54-year-old, female patient, participating in the who received Moderna's COVID-19 vaccine (mRNA-1273) Emergency Use Program  who and experienced  events arm was swollen,could barely move her arm,could barely stand,weak, body aches, fatigue, fever, feels like she has the flu, throat is irritated, nose is stuffed, feeling freezing cold.  The patient's medical history, as provided by the reporter, included she is a diabetic.Concomitant medications were not reported.  The patient received their first of two planned dose of mRNA-1273 on 19jan2021.On 19jan2021 around 4:00pm, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 in the left arm for prophylaxis of COVID-19 infection.     The next day after receiving mRNA-1273, the patient experienced  events arm was swollen,could barely move her arm,could barely stand,weak, body aches, fatigue, fever, feels like she has the flu, throat is irritated, nose is stuffed, feeling freezing cold.    Treatment for the events included Tylenol and ibuprofen.     Action taken with mRNA-1273 in response to the events was not reported.     The outcome of events arm  was swollen, could barely move her arm, could barely stand,weak, body aches, fatigue, fever, feels like she has the flu, throat is irritated, nose is stuffed, feeling freezing cold.  were considered unknoown at the time of report.    The reporter did not provide an assessment for the events, experienced  events arm was swollen,could barely move her arm,could barely stand,weak, body aches, fatigue, fever, feels like she has the flu, throat is irritated, nose is stuffed, feeling freezing cold.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pyrexia, Throat irritation, Vaccination site movement impairment, Vaccination site swelling
Clinical narrative: could barely move her arm; could barely stand and walk; feels like she has the flu; throat was irritated; nose was stuffed; feeling freezing cold; Body aches; fever (99.8-101.4F); Fatigue; Arm was swollen; A spontaneous report  was received from a reporter concerning a 54-year-old, female patient, participating in the who received Moderna's COVID-19 vaccine (mRNA-1273) Emergency Use Program  who and experienced  events arm was swollen,could barely move her arm,could barely stand,weak, body aches, fatigue, fever, feels like she has the flu, throat is irritated, nose is stuffed, feeling freezing cold.  The patient's medical history, as provided by the reporter, included she is a diabetic.Concomitant medications were not reported.  The patient received their first of two planned dose of mRNA-1273 on 19jan2021.On 19jan2021 around 4:00pm, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 in the left arm for prophylaxis of COVID-19 infection.     The next day after receiving mRNA-1273, the patient experienced  events arm was swollen,could barely move her arm,could barely stand,weak, body aches, fatigue, fever, feels like she has the flu, throat is irritated, nose is stuffed, feeling freezing cold.    Treatment for the events included Tylenol and ibuprofen.     Action taken with mRNA-1273 in response to the events was not reported.     The outcome of events arm  was swollen, could barely move her arm, could barely stand,weak, body aches, fatigue, fever, feels like she has the flu, throat is irritated, nose is stuffed, feeling freezing cold.  were considered unknoown at the time of report.    The reporter did not provide an assessment for the events, experienced  events arm was swollen,could barely move her arm,could barely stand,weak, body aches, fatigue, fever, feels like she has the flu, throat is irritated, nose is stuffed, feeling freezing cold.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: redness near injection site; swelling near injection site; itchy sensation near the injection site; A regulatory authority report was received from a non-health care professional concerning 66-year-old, female patient who received Moderna's COVID-19 Vaccine (m-RNA-1273) and experienced redness, swelling, itchy sensation at injection site.   The patient medical history was not reported. Concomitant medication was not reported. Laboratory data were not provided.  On 13-Jan-2021, prior to the onset events, the patient received their first dose of mRNA-1273 [lot/batch: 026L20A] intramuscular in left upper arm for prophylaxis of Covid-19 infection.  On 19-Jan-2021 The patient experienced redness, swelling, itchy sensation near injection site. The patient reported that these symptoms have seemed to lessen on 22-JAN-2021. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the experienced events redness, swelling, itchy sensation near injection site was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Nasopharyngitis, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: Tested positive for Covid-19; Onset of Cold Symptoms; Sore Throat; Runny Nose; Slight Fever; A spontaneous report was received from a 69 years old male patient of who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tested positive for Covid-19, onset of cold symptoms, sore throat, runny nose and slight fever.  Medical history was not reported.  Concomitant medication was not reported.  On 14-Jan-2021, prior to the onset of the events tested positive for Covid-19, onset of cold symptoms, sore throat, runny nose and slight fever, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) via intramuscular route in left arm shoulder deltoid condition for prophylaxis of COVID-19 infection.  On 17-Jan-2021, the patient experienced onset of cold symptoms, sore throat, runny nose and slight fever and on 18-Jan-2021 experienced tested positive for Covid-19.  Laboratory details was not provided.  Treatment medication was not provided.  Action taken with mRNA-1273 in response to the events tested positive for Covid-19, onset of cold symptoms, sore throat, runny nose and slight fever was not provided.  The outcome of the events tested positive for Covid-19, onset of cold symptoms, sore throat, runny nose and slight fever was not recovered.  The reporter did not provide the assessment of the events tested positive for Covid-19, onset of cold symptoms, sore throat, runny nose and slight fever to study drug.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Peripheral swelling, Tenderness
Clinical narrative: Scratchy throat; Left hand begun to swell; Left hand tender; A spontaneous report was received from a consumer, concerning a 70 years female who was administered Moderna's COVID -19 vaccine has experienced scratchy throat, left hand swollen, tender and tight. The patient's medical history was unknown. Concomitant medications  description includes blood pressure medication and  rheumatoid arthritis medication, but specific medications were not provided. On 21 Jan 2021, prior to the onset of events, the  patient received  their first of two planned dose of mRNA-1273( Batch no.- 032L20A) in the right arm for prophylaxis of COVID-19 infection. The patient has experienced scratchy throat, left hand swollen, tender and  tight. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The event outcome was not resolved.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule
Clinical narrative: Lump on the left side of her neck; A spontaneous report was received from a consumer concerning a 23-year-old, female patient,  who received Moderna's COVID-19 vaccine (mRNA-1273) and developed a lump on the left side of her neck.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 18 Dec 2021,  approximately 3 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273  intramuscularly in the left arm shoulder deltoid for prophylaxis of COVID-19 infection.     She noticed a lump a day or 2 after she received vaccine on 18 Jan 2021 on the left side of her neck. Treatment for the events were not included.     Action taken with mRNA-1273 in response to the events was not reported.     The outcome for the event  lump on the left side of her neck was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pruritus, Vaccination site rash
Clinical narrative: sore arm; little rash around the injection site; the area became itchy; A spontaneous report was received from a (consumer) concerning a 78yr old female patient who received Moderna's COVID-19 vaccine (Mrna-1273) and experienced events like arm was sore and a little rash started to appear around the injection site. The area became itchy The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:  unknown) intramuscularly in the Anatomical location for prophylaxis of COVID-19 infection. On unknown date, the patient experienced the events list sore arm, little rash around the injection site, itchy.   No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Injection site haemorrhage
Clinical narrative: blood on the band aide and on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE HAEMORRHAGE (blood on the band aide and on the injection site) 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 (No reported medical history.).    On 10-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 INJECTION SITE HAEMORRHAGE (blood on the band aide and on the injection site). At the time of the report, INJECTION SITE HAEMORRHAGE (blood on the band aide and on the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain in extremity
Clinical narrative: Bad arm pain; Chills; Myalgias; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Bad arm pain), CHILLS (Chills) and MYALGIA (Myalgias) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Bad arm pain), CHILLS (Chills) and MYALGIA (Myalgias). At the time of the report, PAIN IN EXTREMITY (Bad arm pain), CHILLS (Chills) and MYALGIA (Myalgias) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Paraesthesia
Clinical narrative: burning in arms and legs; tingling in arms and legs; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning in arms and legs) and PARAESTHESIA (tingling in arms and legs) in a 36-year-old male 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (burning in arms and legs) and PARAESTHESIA (tingling in arms and legs). At the time of the report, BURNING SENSATION (burning in arms and legs) and PARAESTHESIA (tingling in arms and legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Heart rate increased, Malaise
Clinical narrative: Dizziness; Not feeling well; Heart started to pound; anxiety; This spontaneous case was reported by an other and describes the occurrence of DIZZINESS (Dizziness), MALAISE (Not feeling well), HEART RATE INCREASED (Heart started to pound) and ANXIETY (anxiety) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) 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 DIZZINESS (Dizziness), MALAISE (Not feeling well), HEART RATE INCREASED (Heart started to pound) and ANXIETY (anxiety). At the time of the report, DIZZINESS (Dizziness), MALAISE (Not feeling well), HEART RATE INCREASED (Heart started to pound) and ANXIETY (anxiety) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash at the injection site). At the time of the report, VACCINATION SITE RASH (rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Feeling cold, Headache, Limb discomfort
Clinical narrative: feeling freezing cold; weakness; headache; neck pain; hurting all over, body aches; 100 degree fever; chills; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2020.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 21-Jan-2021, CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pyrexia
Clinical narrative: feeling freezing cold; weakness; headache; neck pain; hurting all over, body aches; 100 degree fever; chills; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in September 2020.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 21-Jan-2021, CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: became covid positive; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (became covid positive) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced COVID-19 (became covid positive). At the time of the report, COVID-19 (became covid positive) 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 treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fatigue, Headache, Heart rate increased, Nausea
Clinical narrative: rapid heart rate; Bruise; Pain at the injection site; Fatigue; Nausea; Headache; This spontaneous case was reported by a physician and describes the occurrence of HEART RATE INCREASED (rapid heart rate), CONTUSION (Bruise), VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced HEART RATE INCREASED (rapid heart rate), CONTUSION (Bruise), VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Fatigue), NAUSEA (Nausea) and HEADACHE (Headache). On 29-Dec-2020, HEART RATE INCREASED (rapid heart rate) outcome was unknown. On 30-Dec-2020, VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Fatigue), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown. At the time of the report, CONTUSION (Bruise) 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.   No treatment information was provided.  No concomitant medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: rapid heart rate; Bruise; Pain at the injection site; Fatigue; Nausea; Headache; This spontaneous case was reported by a physician and describes the occurrence of HEART RATE INCREASED (rapid heart rate), CONTUSION (Bruise), VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced HEART RATE INCREASED (rapid heart rate), CONTUSION (Bruise), VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Fatigue), NAUSEA (Nausea) and HEADACHE (Headache). On 29-Dec-2020, HEART RATE INCREASED (rapid heart rate) outcome was unknown. On 30-Dec-2020, VACCINATION SITE PAIN (Pain at the injection site), FATIGUE (Fatigue), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown. At the time of the report, CONTUSION (Bruise) 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.   No treatment information was provided.  No concomitant medication was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sluggishness, Vaccination site reaction
Clinical narrative: arm has a ring around it; feels sluggish; fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (arm has a ring around it), SLUGGISHNESS (feels sluggish) and PYREXIA (fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021 at 1:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE REACTION (arm has a ring around it), SLUGGISHNESS (feels sluggish) and PYREXIA (fever). At the time of the report, VACCINATION SITE REACTION (arm has a ring around it), SLUGGISHNESS (feels sluggish) and PYREXIA (fever) outcome was unknown.        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 case is under data review.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Limb discomfort
Clinical narrative: Mild Fatigue; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of   in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Myalgia, Pain in extremity
Clinical narrative: arm started to get sore; Like the flu; Tired/feels ran down; Body aches especially in his back; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm started to get sore), INFLUENZA LIKE ILLNESS (Like the flu), FATIGUE (Tired/feels ran down), MYALGIA (Body aches especially in his back) and CHILLS (Chills) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Like the flu), FATIGUE (Tired/feels ran down), MYALGIA (Body aches especially in his back) and CHILLS (Chills). On 21-Jan-2021 at 10:00 AM, the patient experienced PAIN IN EXTREMITY (arm started to get sore). At the time of the report, PAIN IN EXTREMITY (arm started to get sore), INFLUENZA LIKE ILLNESS (Like the flu), FATIGUE (Tired/feels ran down) and MYALGIA (Body aches especially in his back) outcome was unknown and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Warm to touch at the injection site; A little black and blue; Itching; Arm was sore; Large area that's hot pink; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm was sore), VACCINATION SITE BRUISING (A little black and blue), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Large area that's hot pink) and VACCINATION SITE WARMTH (Warm to touch at the injection site) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm was sore), VACCINATION SITE BRUISING (A little black and blue), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Large area that's hot pink) and VACCINATION SITE WARMTH (Warm to touch at the injection site). At the time of the report, VACCINATION SITE PAIN (Arm was sore), VACCINATION SITE BRUISING (A little black and blue), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Large area that's hot pink) and VACCINATION SITE WARMTH (Warm to touch at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Headache, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: dryness in throat; nausea; temperature of 99.6; headache; sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DRY THROAT (dryness in throat), NAUSEA (nausea), PYREXIA (temperature of 99.6), HEADACHE (headache) and VACCINATION SITE PAIN (sore arm) in a 68-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 COVID-19 on 01-Dec-2020. Concomitant products included GLIMEPIRIDE (GLIMITAL), ROSUVASTATIN CALCIUM (CRESTOR) and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 20-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 DRY THROAT (dryness in throat), NAUSEA (nausea), PYREXIA (temperature of 99.6), HEADACHE (headache) and VACCINATION SITE PAIN (sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK, q4h. At the time of the report, DRY THROAT (dryness in throat), PYREXIA (temperature of 99.6), HEADACHE (headache) and VACCINATION SITE PAIN (sore arm) outcome was unknown and NAUSEA (nausea) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Flatulence
Clinical narrative: altered taste; diarrhea; bad smelling farts; extremely tired; chills; joint pain; This spontaneous case was reported by an other health care professional and describes the occurrence of DIARRHOEA (diarrhea), FLATULENCE (bad smelling farts), TASTE DISORDER (altered taste), FATIGUE (extremely tired) and CHILLS (chills) in a 43-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 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 13-Jan-2021, the patient experienced ARTHRALGIA (joint pain). On 14-Jan-2021, the patient experienced FATIGUE (extremely tired) and CHILLS (chills). On 15-Jan-2021, the patient experienced DIARRHOEA (diarrhea) and FLATULENCE (bad smelling farts). On 17-Jan-2021, the patient experienced TASTE DISORDER (altered taste). At the time of the report, DIARRHOEA (diarrhea), FLATULENCE (bad smelling farts) and TASTE DISORDER (altered taste) outcome was unknown and FATIGUE (extremely tired), CHILLS (chills) and ARTHRALGIA (joint pain) had not 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.   No treatment information was provided.  No concomitant medication was provided.