chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: worst fatigue; feels having a cold; nasal congestion; pain in the injection site; mild headache; tiredness; mild nausea; A spontaneous report was received from a Consumer concerning a 73-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events injection site pain , headache, fatigue, nausea, nasopharyngitis, nasal congestion.  The patient's medical history was not provided. Concomitant medications reported were Simvastatin for cholesterone, Buspirone for anxiety, Trazodone for anxiety, Zyrtec for allergy, Venlafaxine for depression, Preservision for macular degreneration, Calcium for Osteoporosis, Vitamin D for Osteoporosis for drug use for unknown indication.  On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 27 Jan 2021, the patient experienced the events nausea, nasopharyngitis, nasal congestion.  On 30 Jan 2021, the patient experienced the events  headache, fatigue.  Treatment details included Tylenol yesterday  Action taken with mRNA-1273 in response to the events was not reported.  On 28 Jan 2021 the outcome of events injection site pain  was resolved.On 31 Jan 2021 the outcome of events  headache was resolved.On 28 Jan 2021 the outcome of events fatigue was resolved.On 28 Jan 2021 the outcome of events  nausea was resolved.On 29 Jan 2021 the outcome of events feels having a cold was resolved.On 29 Jan 2021 the outcome of events nasal congestion was resolved.On 30 Jan 2021 the outcome of events  headache was resolved.On 30 Jan 2021 the outcome of events  fatigue was resolved.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Haematoma, Ocular hyperaemia, Pain in extremity
Clinical narrative: In the right hand, the point finger with hematoma; Red eye; Arm pain; Pain in the front chest; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), CHEST PAIN (Pain in the front chest), OCULAR HYPERAEMIA (Red eye) and HAEMATOMA (In the right hand, the point finger with hematoma) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm pain) and CHEST PAIN (Pain in the front chest). On 01-Feb-2021, the patient experienced OCULAR HYPERAEMIA (Red eye). On 03-Feb-2021, the patient experienced HAEMATOMA (In the right hand, the point finger with hematoma). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency and HYDROXYZINE at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm pain), CHEST PAIN (Pain in the front chest), OCULAR HYPERAEMIA (Red eye) and HAEMATOMA (In the right hand, the point finger with hematoma) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported by the reporter.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth, Vaccination site swelling
Clinical narrative: Reaction was bigger; Swollen area at the injection site; Red are at the injection site; Injection site hot to the touch; Little pain at the injection site; A spontaneous report was received from a Consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events little pain at the injection site, swollen area at the injection site, red are at the injection site, injection site hot to the touch, reaction was bigger.  The patient's medical history was not provided. Concomitant medications reported were Virica 75, Axelonol 50 mg, Clonazepam, for unknown indication.  On 22 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 032120A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient experienced the events little pain at the injection site . On 30 Jan 2021, the patient experienced the events swollen area at the injection site. red are at the injection site, injection site hot to the touch. On 31 Jan 2021, the patient experienced the events reaction was bigger.  Treatment details included Applied Ice  Action taken with mRNA-1273 in response to the events was not reported.  On 22 Jan 2021 the outcome of events little pain at the injection site was resolved. On an unknown date the outcome of events, swollen area at the injection site, On an unknown date the outcome of events, red are at the injection site, On an unknown date the outcome of events, injection site hot to the touch, On an unknown date the outcome of events, reaction was bigger was not reported.  Based on comment,  Listedness is incorrect and should be unknown (Injection site reaction)
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: Small Red Circle on the Injection Site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE ERYTHEMA (Small Red Circle on the Injection Site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 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 INJECTION SITE ERYTHEMA (Small Red Circle on the Injection Site). At the time of the report, INJECTION SITE ERYTHEMA (Small Red Circle on the Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product were not provided/unknown. Treatment medication were not reported/unknown.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Swelling; Redness; Itching at the injection site; Rash in arm at the injection site; Big circle around it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE RASH (Rash in arm at the injection site) and VACCINATION SITE REACTION (Big circle around it) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), METOPROLOL and CALCIUM for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swelling), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE RASH (Rash in arm at the injection site) and VACCINATION SITE REACTION (Big circle around it). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (Swelling), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE RASH (Rash in arm at the injection site) and VACCINATION SITE REACTION (Big circle around it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and 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 these events, a causal relationship cannot be excluded.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Photosensitivity reaction, Rash, Rash papular, SARS-CoV-2 antibody test, Vaccination site pain
Clinical narrative: Raised on the skin/ covid arm; Warm to touch/ covid arm; Pinkish/ covid arm; The injection site arm was sore/ Little bit painful/ covid arm; big round rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (Raised on the skin/ covid arm), VACCINATION SITE WARMTH (Warm to touch/ covid arm), PHOTOSENSITIVITY REACTION (Pinkish/ covid arm), VACCINATION SITE PAIN (The injection site arm was sore/ Little bit painful/ covid arm) and RASH (big round rash) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced RASH (big round rash). On 30-Jan-2021, the patient experienced RASH PAPULAR (Raised on the skin/ covid arm), VACCINATION SITE WARMTH (Warm to touch/ covid arm), PHOTOSENSITIVITY REACTION (Pinkish/ covid arm) and VACCINATION SITE PAIN (The injection site arm was sore/ Little bit painful/ covid arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH PAPULAR (Raised on the skin/ covid arm), VACCINATION SITE WARMTH (Warm to touch/ covid arm), PHOTOSENSITIVITY REACTION (Pinkish/ covid arm), VACCINATION SITE PAIN (The injection site arm was sore/ Little bit painful/ covid arm) and RASH (big round rash) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.   This case was linked to MOD-2021-243493, MOD-2021-243281 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up received updated first dose events outcome, route of administration and batch number.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Raised on the skin/ covid arm; Warm to touch/ covid arm; Pinkish/ covid arm; The injection site arm was sore/ Little bit painful/ covid arm; big round rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (Raised on the skin/ covid arm), VACCINATION SITE WARMTH (Warm to touch/ covid arm), PHOTOSENSITIVITY REACTION (Pinkish/ covid arm), VACCINATION SITE PAIN (The injection site arm was sore/ Little bit painful/ covid arm) and RASH (big round rash) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced RASH (big round rash). On 30-Jan-2021, the patient experienced RASH PAPULAR (Raised on the skin/ covid arm), VACCINATION SITE WARMTH (Warm to touch/ covid arm), PHOTOSENSITIVITY REACTION (Pinkish/ covid arm) and VACCINATION SITE PAIN (The injection site arm was sore/ Little bit painful/ covid arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, RASH PAPULAR (Raised on the skin/ covid arm), VACCINATION SITE WARMTH (Warm to touch/ covid arm), PHOTOSENSITIVITY REACTION (Pinkish/ covid arm), VACCINATION SITE PAIN (The injection site arm was sore/ Little bit painful/ covid arm) and RASH (big round rash) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.   This case was linked to MOD-2021-243493, MOD-2021-243281 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up received updated first dose events outcome, route of administration and batch number.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site swelling
Clinical narrative: Red rash on the injection site; Rash got bigger and was pink in the center and bright red on the borders; baseball ball; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Red rash on the injection site), VACCINATION SITE ERYTHEMA (Rash got bigger and was pink in the center and bright red on the borders) and VACCINATION SITE SWELLING (baseball ball) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-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 VACCINATION SITE RASH (Red rash on the injection site), VACCINATION SITE ERYTHEMA (Rash got bigger and was pink in the center and bright red on the borders) and VACCINATION SITE SWELLING (baseball ball). At the time of the report, VACCINATION SITE RASH (Red rash on the injection site), VACCINATION SITE ERYTHEMA (Rash got bigger and was pink in the center and bright red on the borders) and VACCINATION SITE SWELLING (baseball ball) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other relevant concomitant medications included Blood pressure medication, Thyroids medication, Sleeping pill, Stomach medication and Intestine problems medication.  Treatment information included Ice on the injection site.; 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. Further information has been requested
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Arm was sore at the injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) 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 07-Jan-2021, the patient experienced INJECTION SITE PAIN (Arm was sore at the injection site). At the time of the report, INJECTION SITE PAIN (Arm was sore at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. No treatment drugs were reported.   Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rush on the body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rush on the body) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced RASH (Rush on the body). At the time of the report, RASH (Rush on the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.; Reporter's Comments: .; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Positive for covid between the first and the second dose; A spontaneous report was received from a consumer concerning a 60-year old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced positive for COVID between first and second.  The patient's medical history was not provided. Concomitant medications were listed as meloxicam, allopurinol, rosuvastatin calcium, acetylsalicylic acid and vitamins nos.  On 05 Jan 2021, approximately 10 days prior to the onset of the events, the patient received their first of the two planned doses of mRNA-1273 (Batch number: 027L20A) for prophylaxis of COVID-19 infection.   On 14 Jan 2021, patient tested positive for COVID-19.  Treatment information was not provided. Lab tests mention a positive COVID-19 test.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, tested positive between the first and second, was considered resolved on 14 Jan 2021.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Haematuria, Headache, Myalgia, Pyrexia
Clinical narrative: hematuria; rash on both upper arms; headache; body aches; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATURIA (hematuria), RASH (rash on both upper arms), PYREXIA (fever), HEADACHE (headache) and CHILLS (chills) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypothyroidism since an unknown date. Concurrent medical conditions included Shellfish allergy. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 02-Jan-2010 to an unknown date for Hypothyroidism.   On 30-Dec-2020 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). On 28-Jan-2021, the patient experienced HEADACHE (headache). 28-Jan-2021, the patient experienced MYALGIA (body aches). On 29-Jan-2021, the patient experienced HAEMATURIA (hematuria). 29-Jan-2021, the patient experienced RASH (rash on both upper arms). On 29-Jan-2021, PYREXIA (fever) had resolved. On 30-Jan-2021, HAEMATURIA (hematuria) had resolved. On 12-Feb-2021, RASH (rash on both upper arms) had resolved. At the time of the report, HEADACHE (headache) and CHILLS (chills) outcome was unknown and MYALGIA (body aches) had resolved.            No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Events added,  event outcome updated, Product, reporter and patient info updated.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: hematuria; rash on both upper arms; headache; body aches; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATURIA (hematuria), RASH (rash on both upper arms), PYREXIA (fever), HEADACHE (headache) and CHILLS (chills) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypothyroidism since an unknown date. Concurrent medical conditions included Shellfish allergy. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 02-Jan-2010 to an unknown date for Hypothyroidism.   On 30-Dec-2020 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). On 28-Jan-2021, the patient experienced HEADACHE (headache). 28-Jan-2021, the patient experienced MYALGIA (body aches). On 29-Jan-2021, the patient experienced HAEMATURIA (hematuria). 29-Jan-2021, the patient experienced RASH (rash on both upper arms). On 29-Jan-2021, PYREXIA (fever) had resolved. On 30-Jan-2021, HAEMATURIA (hematuria) had resolved. On 12-Feb-2021, RASH (rash on both upper arms) had resolved. At the time of the report, HEADACHE (headache) and CHILLS (chills) outcome was unknown and MYALGIA (body aches) had resolved.            No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Events added,  event outcome updated, Product, reporter and patient info updated.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: swelling at the site of injection; redness which is 6 inches long and 3 inches wide; A spontaneous report was received from a consumer concerning a 65 year old female patients who received  Moderna's  Covid 19 vaccine(mRNA1273) experienced swelling and redness at injection site.  The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.    On 12-FEB-2021,approximately 1 week prior to the onset of symptoms the patient received first of two planned dose of mRNA-1273 (Batch Number 024M20A)  for prophylaxis of Covid 19 infection.  Patients felt swelling at the site of injection after 1 week of vaccine administration. Patient had redness at the site of injection which is 6 inches long and 3 inches wide .The treatment information was not provided.  Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the events, swelling and redness at the site of injection were unknown.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: little soreness in shoulder and arm; little soreness in shoulder and arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little soreness in shoulder and arm) and ARTHRALGIA (little soreness in shoulder and arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (little soreness in shoulder and arm) and ARTHRALGIA (little soreness in shoulder and arm). At the time of the report, PAIN IN EXTREMITY (little soreness in shoulder and arm) and ARTHRALGIA (little soreness in shoulder and arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication provided No concomitant medication provided
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Decreased appetite, Fatigue, Feeling abnormal
Clinical narrative: tested positive for COVID-19; chills; fever; lost of appetite; tiredness; feel bad; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever), DECREASED APPETITE (lost of appetite), FATIGUE (tiredness) and FEELING ABNORMAL (feel bad) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced CHILLS (chills), PYREXIA (fever), DECREASED APPETITE (lost of appetite), FATIGUE (tiredness) and FEELING ABNORMAL (feel bad). On 23-Jan-2021, the patient experienced COVID-19 (tested positive for COVID-19). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and ACETYLSALICYLIC ACID (ALKA SELTZER [ACETYLSALICYLIC ACID]) at a dose of 1 dosage form. At the time of the report, CHILLS (chills), PYREXIA (fever), DECREASED APPETITE (lost of appetite), FATIGUE (tiredness), FEELING ABNORMAL (feel bad) and COVID-19 (tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, SARS-CoV-2 test: (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; chills; fever; lost of appetite; tiredness; feel bad; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever), DECREASED APPETITE (lost of appetite), FATIGUE (tiredness) and FEELING ABNORMAL (feel bad) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced CHILLS (chills), PYREXIA (fever), DECREASED APPETITE (lost of appetite), FATIGUE (tiredness) and FEELING ABNORMAL (feel bad). On 23-Jan-2021, the patient experienced COVID-19 (tested positive for COVID-19). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and ACETYLSALICYLIC ACID (ALKA SELTZER [ACETYLSALICYLIC ACID]) at a dose of 1 dosage form. At the time of the report, CHILLS (chills), PYREXIA (fever), DECREASED APPETITE (lost of appetite), FATIGUE (tiredness), FEELING ABNORMAL (feel bad) and COVID-19 (tested positive for COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, SARS-CoV-2 test: (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Disoriented feeling; Pretty hot at injection site; Red rash at injection site; Red rash at injection site; Very itchy at injection site; Arm was swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen), INJECTION SITE ERYTHEMA (Red rash at injection site), INJECTION SITE RASH (Red rash at injection site), INJECTION SITE PRURITUS (Very itchy at injection site) and INJECTION SITE WARMTH (Pretty hot at injection site) in a 63-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.     The patient's past medical history included No adverse event (No medical reported history). Concomitant products included METOPROLOL TARTRATE for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen). On 28-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Red rash at injection site), INJECTION SITE RASH (Red rash at injection site), INJECTION SITE PRURITUS (Very itchy at injection site), INJECTION SITE WARMTH (Pretty hot at injection site) and DISORIENTATION (Disoriented feeling). The patient was treated with LORATADINE (CLARITINE) ongoing since an unknown date at a dose of 1 dosage form; IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form and BACITRACIN ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (Arm was swollen) had resolved and INJECTION SITE ERYTHEMA (Red rash at injection site), INJECTION SITE RASH (Red rash at injection site), INJECTION SITE PRURITUS (Very itchy at injection site), INJECTION SITE WARMTH (Pretty hot at injection site) and DISORIENTATION (Disoriented feeling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This case concerns a female of unknown age with NS unexpected injection site warmth, peripheral swelling, disorientation, and NS expected injection site rash, injection site pruritus, injection site erythema.  Event onset the same day as first dose mRNA-1273, with rash on Day 14. Treated with Claritin, ibuprofen, bacitracin. Based on the current available information and temporal association between use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Disoriented feeling; Pretty hot at injection site; Red rash at injection site; Red rash at injection site; Very itchy at injection site; Arm was swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen), INJECTION SITE ERYTHEMA (Red rash at injection site), INJECTION SITE RASH (Red rash at injection site), INJECTION SITE PRURITUS (Very itchy at injection site) and INJECTION SITE WARMTH (Pretty hot at injection site) in a 63-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.     The patient's past medical history included No adverse event (No medical reported history). Concomitant products included METOPROLOL TARTRATE for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen). On 28-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Red rash at injection site), INJECTION SITE RASH (Red rash at injection site), INJECTION SITE PRURITUS (Very itchy at injection site), INJECTION SITE WARMTH (Pretty hot at injection site) and DISORIENTATION (Disoriented feeling). The patient was treated with LORATADINE (CLARITINE) ongoing since an unknown date at a dose of 1 dosage form; IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form and BACITRACIN ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (Arm was swollen) had resolved and INJECTION SITE ERYTHEMA (Red rash at injection site), INJECTION SITE RASH (Red rash at injection site), INJECTION SITE PRURITUS (Very itchy at injection site), INJECTION SITE WARMTH (Pretty hot at injection site) and DISORIENTATION (Disoriented feeling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This case concerns a female of unknown age with NS unexpected injection site warmth, peripheral swelling, disorientation, and NS expected injection site rash, injection site pruritus, injection site erythema.  Event onset the same day as first dose mRNA-1273, with rash on Day 14. Treated with Claritin, ibuprofen, bacitracin. Based on the current available information and temporal association between use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Vaccination complication
Clinical narrative: had a circle appear even after 14 days later; had a similar reaction to what they have; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (had a circle appear even after 14 days later) and VACCINATION COMPLICATION (had a similar reaction to what they have) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (had a circle appear even after 14 days later) and VACCINATION COMPLICATION (had a similar reaction to what they have). At the time of the report, ERYTHEMA (had a circle appear even after 14 days later) and VACCINATION COMPLICATION (had a similar reaction to what they have) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Diarrhoea, Fatigue, Nausea
Clinical narrative: fever; body aches; nausea; diarrhea; fatigue; canker sores in mouth; canker sores on roof of mouth; eft side of face puffy; This spontaneous case was reported by a health care professional and describes the occurrence of PYREXIA (fever), PAIN (body aches), NAUSEA (nausea), DIARRHOEA (diarrhea) and FATIGUE (fatigue) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 28-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 PYREXIA (fever), PAIN (body aches), NAUSEA (nausea), DIARRHOEA (diarrhea), FATIGUE (fatigue), ORAL PAIN (canker sores in mouth), STOMATITIS (canker sores on roof of mouth) and SWELLING FACE (eft side of face puffy). At the time of the report, PYREXIA (fever), PAIN (body aches), NAUSEA (nausea), DIARRHOEA (diarrhea), FATIGUE (fatigue), ORAL PAIN (canker sores in mouth), STOMATITIS (canker sores on roof of mouth) and SWELLING FACE (eft side of face puffy) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.2 °f 102.2 °F and 101. On an unknown date, COVID-19: (Negative) Negative.     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 reported. Treatment included steroid and magic mouthwash
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Oral pain, Pain, Pyrexia, Stomatitis, Swelling face
Clinical narrative: fever; body aches; nausea; diarrhea; fatigue; canker sores in mouth; canker sores on roof of mouth; eft side of face puffy; This spontaneous case was reported by a health care professional and describes the occurrence of PYREXIA (fever), PAIN (body aches), NAUSEA (nausea), DIARRHOEA (diarrhea) and FATIGUE (fatigue) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 28-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 PYREXIA (fever), PAIN (body aches), NAUSEA (nausea), DIARRHOEA (diarrhea), FATIGUE (fatigue), ORAL PAIN (canker sores in mouth), STOMATITIS (canker sores on roof of mouth) and SWELLING FACE (eft side of face puffy). At the time of the report, PYREXIA (fever), PAIN (body aches), NAUSEA (nausea), DIARRHOEA (diarrhea), FATIGUE (fatigue), ORAL PAIN (canker sores in mouth), STOMATITIS (canker sores on roof of mouth) and SWELLING FACE (eft side of face puffy) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.2 °f 102.2 °F and 101. On an unknown date, COVID-19: (Negative) Negative.     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 reported. Treatment included steroid and magic mouthwash
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination site erythema
Clinical narrative: tching in her arm; d spot 6 inches and long 4 inches wide at the injection site; large spot 6 inches and long 4 inches wide at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (tching in her arm), VACCINATION SITE ERYTHEMA (d spot 6 inches and long 4 inches wide at the injection site) and ERYTHEMA (large spot 6 inches and long 4 inches wide at the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), METOPROLOL, HYDROCHLOROTHIAZIDE and statin for an unknown indication.    On 14-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 PRURITUS (tching in her arm), VACCINATION SITE ERYTHEMA (d spot 6 inches and long 4 inches wide at the injection site) and ERYTHEMA (large spot 6 inches and long 4 inches wide at the injection site). At the time of the report, PRURITUS (tching in her arm), VACCINATION SITE ERYTHEMA (d spot 6 inches and long 4 inches wide at the injection site) and ERYTHEMA (large spot 6 inches and long 4 inches wide at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included 1 2 Benadryl. Cortisone cream.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site pruritus
Clinical narrative: a little redness; a little hard induration; a little eruption; itchy; a little pain; it burned a little bit; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (it burned a little bit), VACCINATION SITE ERYTHEMA (a little redness), VACCINATION SITE INDURATION (a little hard induration), INJECTION SITE RASH (a little eruption) and VACCINATION SITE PRURITUS (itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical reported history).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE PAIN (it burned a little bit). On 31-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (a little redness), VACCINATION SITE INDURATION (a little hard induration), INJECTION SITE RASH (a little eruption), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE PAIN (a little pain). On 29-Jan-2021, VACCINATION SITE PAIN (it burned a little bit) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (a little redness), VACCINATION SITE INDURATION (a little hard induration), INJECTION SITE RASH (a little eruption), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE PAIN (a little pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Sex: M
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 an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical reported history).    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Blood creatine phosphokinase, Fatigue, Pain in extremity
Clinical narrative: Tired; Inflammation in her joint particularly in her hand; Swollen arm; Joints were really painful; Arm was a tad sore; A spontaneous report was received from a Consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tired, inflammation in her joint particularly in her hand, swollen arm, joints were really painful and arm was a tad sore.  The patient's medical history was not provided. Concomitant medications reported were B12, rosuvastatin and omeprazole, drug used for unknown indication.  On 11 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 00053740) in the left arm for prophylaxis of COVID-19 infection.  On 15 Jan 2021, the patient experienced the events tired, inflammation in her joint particularly in her hand, swollen arm, joints were really painful and arm was a tad sore.  Treatment details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, tired, inflammation in her joint particularly in her hand, swollen arm, joints were really painful and arm was a tad sore was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Tired; Inflammation in her joint particularly in her hand; Swollen arm; Joints were really painful; Arm was a tad sore; A spontaneous report was received from a Consumer concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tired, inflammation in her joint particularly in her hand, swollen arm, joints were really painful and arm was a tad sore.  The patient's medical history was not provided. Concomitant medications reported were B12, rosuvastatin and omeprazole, drug used for unknown indication.  On 11 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 00053740) in the left arm for prophylaxis of COVID-19 infection.  On 15 Jan 2021, the patient experienced the events tired, inflammation in her joint particularly in her hand, swollen arm, joints were really painful and arm was a tad sore.  Treatment details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, tired, inflammation in her joint particularly in her hand, swollen arm, joints were really painful and arm was a tad sore was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Testicular mass, Testicular pain
Clinical narrative: Pain in the left testicle; Nodule in the left testicle; This spontaneous case was reported by a consumer and describes the occurrence of   in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included Prostate cancer and Testicular disorder (testicular nodules).    On 14-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.       Patient started on Antibiotics as treatment. No relevant concomitant medications were reported.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Itchiness; Rash; Swelling; redness 3-6inches; was warm to touch; Tenderiness; Small pink redness; This spontaneous case was reported by a consumer and describes the occurrence of   in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-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.       Treatment included Cortisone and Advil
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Itchiness; Rash; Swelling; redness 3-6inches; was warm to touch; Tenderiness; Small pink redness; This spontaneous case was reported by a consumer and describes the occurrence of   in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 23-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.       Treatment included Cortisone and Advil