chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Heart rate, Heart rate increased, Nausea
Clinical narrative: heart speeded up to about 84-94 bpm; felt a little dizzy; sick to her stomach; headache; arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart speeded up to about 84-94 bpm), DIZZINESS (felt a little dizzy), NAUSEA (sick to her stomach), HEADACHE (headache) and VACCINATION SITE PAIN (arm was sore at the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M2(orZ)20A) for COVID-19 vaccination.     The patient's past medical history included Degenerative disc disease and Heart disease, unspecified. Concurrent medical conditions included Penicillin allergy. Concomitant products included HYDROCODONE, METOPROLOL SUCCINATE (TOPROL) and COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced HEART RATE INCREASED (heart speeded up to about 84-94 bpm), DIZZINESS (felt a little dizzy), NAUSEA (sick to her stomach), HEADACHE (headache) and VACCINATION SITE PAIN (arm was sore at the injection site). At the time of the report, HEART RATE INCREASED (heart speeded up to about 84-94 bpm), DIZZINESS (felt a little dizzy), NAUSEA (sick to her stomach), HEADACHE (headache) and VACCINATION SITE PAIN (arm was sore at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, Heart rate: 84-94 her heart speeded up to about 84-94 bpm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not reported. On 01-Feb-2021, the patient took vaccination at01:30 PM.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: heart speeded up to about 84-94 bpm; felt a little dizzy; sick to her stomach; headache; arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (heart speeded up to about 84-94 bpm), DIZZINESS (felt a little dizzy), NAUSEA (sick to her stomach), HEADACHE (headache) and VACCINATION SITE PAIN (arm was sore at the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M2(orZ)20A) for COVID-19 vaccination.     The patient's past medical history included Degenerative disc disease and Heart disease, unspecified. Concurrent medical conditions included Penicillin allergy. Concomitant products included HYDROCODONE, METOPROLOL SUCCINATE (TOPROL) and COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced HEART RATE INCREASED (heart speeded up to about 84-94 bpm), DIZZINESS (felt a little dizzy), NAUSEA (sick to her stomach), HEADACHE (headache) and VACCINATION SITE PAIN (arm was sore at the injection site). At the time of the report, HEART RATE INCREASED (heart speeded up to about 84-94 bpm), DIZZINESS (felt a little dizzy), NAUSEA (sick to her stomach), HEADACHE (headache) and VACCINATION SITE PAIN (arm was sore at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, Heart rate: 84-94 her heart speeded up to about 84-94 bpm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not reported. On 01-Feb-2021, the patient took vaccination at01:30 PM.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itchiness; Soreness/a little tender; Red rash approximately the size of a tennis ball; Red rash approximately the size of a tennis ball; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE PAIN (Soreness/a little tender), VACCINATION SITE RASH (Red rash approximately the size of a tennis ball) and VACCINATION SITE ERYTHEMA (Red rash approximately the size of a tennis ball) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) 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) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE PAIN (Soreness/a little tender), VACCINATION SITE RASH (Red rash approximately the size of a tennis ball) and VACCINATION SITE ERYTHEMA (Red rash approximately the size of a tennis ball). At the time of the report, VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE PAIN (Soreness/a little tender), VACCINATION SITE RASH (Red rash approximately the size of a tennis ball) and VACCINATION SITE ERYTHEMA (Red rash approximately the size of a tennis ball) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Outcome of events, reported no events after 2nd dose of vaccination
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Itchiness  in the arm that received the injection; Pain in the arm that received the injection; Swelling  in the arm that received the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness  in the arm that received the injection), VACCINATION SITE PAIN (Pain in the arm that received the injection) and VACCINATION SITE SWELLING (Swelling  in the arm that received the injection) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O32L2OA) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness  in the arm that received the injection), VACCINATION SITE PAIN (Pain in the arm that received the injection) and VACCINATION SITE SWELLING (Swelling  in the arm that received the injection). At the time of the report, VACCINATION SITE PRURITUS (Itchiness  in the arm that received the injection), VACCINATION SITE PAIN (Pain in the arm that received the injection) and VACCINATION SITE SWELLING (Swelling  in the arm that received the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.  Initially the patient did not experience any side effects. On 03-Feb-2021, the patient began to experience pain, swelling and itchiness in the arm that received the injection. At this point (time of report) the side effect have not subsided.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced DIARRHOEA (diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) for Diarrhea, at an unspecified dose and frequency. On 28-Jan-2021, DIARRHOEA (diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided.  It was reported that the patient had the second dose without any issues.  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.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up received updated event stop date and suspect dosage details.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: diarrhea; fever; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and PYREXIA (fever) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) 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) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PYREXIA (fever). On 31-Jan-2021, the patient experienced DIARRHOEA (diarrhea). On 31-Jan-2021, PYREXIA (fever) had resolved. At the time of the report, DIARRHOEA (diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment medication included acetaminophen.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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. Last menstrual period and estimated date of delivery were not provided. On 21-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 21-Jan-2021, EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.            Concomitant medication was not reported. Treatment medication was not reported. The patient had the first dose of the Moderna vaccine on 21-Jan-2021 with no adverse side effects and will be getting their second dose on 18-Feb-2021.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itchy today is worse is up and down arm; rash in both arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itchy today is worse is up and down arm) and RASH (rash in both arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced RASH (rash in both arm). On an unknown date, the patient experienced PRURITUS (itchy today is worse is up and down arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash over arms and Itching, at a dose of UNK dosage form. At the time of the report, PRURITUS (itchy today is worse is up and down arm) and RASH (rash in both arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  10/12 hours later the vaccination, started a rash in both arm, mentioned it was itchy; today was worse up and down arm.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: sore throat; Chills; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), CHILLS (Chills) and MYALGIA (Body Aches) in a 50-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 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), CHILLS (Chills) and MYALGIA (Body Aches). At the time of the report, OROPHARYNGEAL PAIN (sore throat), CHILLS (Chills) and MYALGIA (Body Aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, SARS-CoV-2 test: negative negative. On 29-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. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chills, Dizziness, Dyspnoea, Headache
Clinical narrative: lightheaded; a little bit of trouble breathing; blood pressure went really high and came down last; chills; headache; nausea; arm hurt; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DIZZINESS (lightheaded), DYSPNOEA (a little bit of trouble breathing), BLOOD PRESSURE INCREASED (blood pressure went really high and came down last), VACCINATION SITE PAIN (arm hurt) and CHILLS (chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02762UA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included PANTOPRAZOLE, ROSUVASTATIN and LISINOPRIL for an unknown indication.    On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm hurt). On 03-Feb-2021, the patient experienced DIZZINESS (lightheaded), DYSPNOEA (a little bit of trouble breathing), BLOOD PRESSURE INCREASED (blood pressure went really high and came down last), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea). On 28-Jan-2021, VACCINATION SITE PAIN (arm hurt) had resolved. At the time of the report, DIZZINESS (lightheaded), DYSPNOEA (a little bit of trouble breathing), BLOOD PRESSURE INCREASED (blood pressure went really high and came down last), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea) 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.   Other concomitant medication includes 7 in 1 immune support. Treatment medication included acetaminophen.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: lightheaded; a little bit of trouble breathing; blood pressure went really high and came down last; chills; headache; nausea; arm hurt; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DIZZINESS (lightheaded), DYSPNOEA (a little bit of trouble breathing), BLOOD PRESSURE INCREASED (blood pressure went really high and came down last), VACCINATION SITE PAIN (arm hurt) and CHILLS (chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02762UA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included PANTOPRAZOLE, ROSUVASTATIN and LISINOPRIL for an unknown indication.    On 25-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm hurt). On 03-Feb-2021, the patient experienced DIZZINESS (lightheaded), DYSPNOEA (a little bit of trouble breathing), BLOOD PRESSURE INCREASED (blood pressure went really high and came down last), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea). On 28-Jan-2021, VACCINATION SITE PAIN (arm hurt) had resolved. At the time of the report, DIZZINESS (lightheaded), DYSPNOEA (a little bit of trouble breathing), BLOOD PRESSURE INCREASED (blood pressure went really high and came down last), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea) 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.   Other concomitant medication includes 7 in 1 immune support. Treatment medication included acetaminophen.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: still have a red spot; Little sore on my arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (still have a red spot) and VACCINATION SITE PAIN (Little sore on my arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DENOSUMAB (PROLIA) for Osteoporosis.    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 ERYTHEMA (still have a red spot) and VACCINATION SITE PAIN (Little sore on my arm). At the time of the report, VACCINATION SITE ERYTHEMA (still have a red spot) had not resolved and VACCINATION SITE PAIN (Little sore on my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site pain, Vaccination site warmth
Clinical narrative: injection site hot; injection site hard; tenderness at the injection site; injection site red; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (injection site hot), VACCINATION SITE INDURATION (injection site hard), VACCINATION SITE PAIN (tenderness at the injection site) and VACCINATION SITE ERYTHEMA (injection site red) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Cholesterol. Concomitant products included CITALOPRAM.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 02-Jan-2021, the patient experienced VACCINATION SITE WARMTH (injection site hot), VACCINATION SITE INDURATION (injection site hard), VACCINATION SITE PAIN (tenderness at the injection site) and VACCINATION SITE ERYTHEMA (injection site red). At the time of the report, VACCINATION SITE WARMTH (injection site hot), VACCINATION SITE INDURATION (injection site hard), VACCINATION SITE PAIN (tenderness at the injection site) and VACCINATION SITE ERYTHEMA (injection site red) 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.   Patient medicine includes blood pressure, cholesterol and bone density. Also citalopram for her anxiety. Treatment information was not provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm was sore) and VACCINATION SITE ERYTHEMA (circular red area on her arm at the injection site) in a 59-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 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (circular red area on her arm at the injection site). On an unknown date, the patient experienced VACCINATION SITE PAIN (arm was sore). At the time of the report, VACCINATION SITE PAIN (arm was sore) had resolved and VACCINATION SITE ERYTHEMA (circular red area on her arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reporter that the area of injection site is about 2 inches in diameter. It was red, but did not hurt and not rashy. Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itchiness was happening arm, leg, face, all over; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness was happening arm, leg, face, all over) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 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 PRURITUS (Itchiness was happening arm, leg, face, all over). At the time of the report, PRURITUS (Itchiness was happening arm, leg, face, all over) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included diphenhydramine.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site inflammation, Vaccination site pruritus
Clinical narrative: Itching at the injections site; erythema at injection site; induration at the injection site spreading over the proximal arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE INFLAMMATION (nflammation at injection site), VACCINATION SITE INDURATION (induration at the injection site spreading over the proximal arm), VACCINATION SITE PRURITUS (Itching at the injections site) and VACCINATION SITE ERYTHEMA (erythema at injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 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 INFLAMMATION (nflammation at injection site), VACCINATION SITE INDURATION (induration at the injection site spreading over the proximal arm), VACCINATION SITE PRURITUS (Itching at the injections site) and VACCINATION SITE ERYTHEMA (erythema at injection site). At the time of the report, VACCINATION SITE INFLAMMATION (nflammation at injection site), VACCINATION SITE INDURATION (induration at the injection site spreading over the proximal arm) and VACCINATION SITE ERYTHEMA (erythema at injection site) had resolved and VACCINATION SITE PRURITUS (Itching at the injections 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.   Concomitant medications were not provided. The patient did not receive any treatment medications.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-1 test positive, SARS-CoV-2 test
Clinical narrative: Only symptoms are fatigue for that last 2 days; patient got Covid-19 test- it showed positive; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SARS-COV-1 TEST POSITIVE (patient got Covid-19 test- it showed positive) and FATIGUE (Only symptoms are fatigue for that last 2 days) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MELATONIN for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced SARS-COV-1 TEST POSITIVE (patient got Covid-19 test- it showed positive). On an unknown date, the patient experienced FATIGUE (Only symptoms are fatigue for that last 2 days). At the time of the report, SARS-COV-1 TEST POSITIVE (patient got Covid-19 test- it showed positive) had not resolved and FATIGUE (Only symptoms are fatigue for that last 2 days) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, SARS-CoV-2 test: (Positive) On 22Jan2021patient got Covid-19 test- it showed positive on 24Jan2021. On 25-Jan-2021, SARS-CoV-2 test: (Negative) On Monday 25JAN2021 she was re tested and it came back negative on the 26JAN2021..     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 medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Body ache; chills; nausea; A little bit of a fever; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body ache), CHILLS (chills), NAUSEA (nausea), PYREXIA (A little bit of a fever) and VOMITING (vomiting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN (Body ache), CHILLS (chills), NAUSEA (nausea), PYREXIA (A little bit of a fever) and VOMITING (vomiting). At the time of the report, PAIN (Body ache), CHILLS (chills), NAUSEA (nausea), PYREXIA (A little bit of a fever) and VOMITING (vomiting) 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.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm after receiving the first dose of Moderna COVID-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm after receiving the first dose of Moderna COVID-19 vaccine). At the time of the report, PAIN IN EXTREMITY (Sore arm after receiving the first dose of Moderna COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site nodule, Vaccination site pain, Vaccination site rash
Clinical narrative: soreness on injection site; Rash (Injection Site); nodule on injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness on injection site), VACCINATION SITE RASH (Rash (Injection Site)) and VACCINATION SITE NODULE (nodule on injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for an unknown indication.     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 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness on injection site), VACCINATION SITE RASH (Rash (Injection Site)) and VACCINATION SITE NODULE (nodule on injection site). At the time of the report, VACCINATION SITE PAIN (soreness on injection site), VACCINATION SITE RASH (Rash (Injection Site)) and VACCINATION SITE NODULE (nodule on injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: could still see an outline of the arm rash; a giant red welt like rash at the injection site that looked like a burn; left arm was "really itchy"; a hive or two at the injection site; arm itched in general but not in a specific location; left arm started to hurt; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (left arm was "really itchy"), RASH (could still see an outline of the arm rash), VACCINATION SITE URTICARIA (a hive or two at the injection site), VACCINATION SITE PRURITUS (arm itched in general but not in a specific location) and VACCINATION SITE RASH (a giant red welt like rash at the injection site that looked like a burn) in a 34-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 Drug allergy (sulfa drugs, Augmentin.) and Drug allergy (amoxicillin-clavulanate).    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 VACCINATION SITE PAIN (left arm started to hurt). On 28-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (a hive or two at the injection site) and VACCINATION SITE PRURITUS (arm itched in general but not in a specific location). On 29-Jan-2021, the patient experienced PRURITUS (left arm was "really itchy") and VACCINATION SITE RASH (a giant red welt like rash at the injection site that looked like a burn). On 01-Feb-2021, the patient experienced RASH (could still see an outline of the arm rash). The patient was treated with ACRIVASTINE (BENADRYL OTC) at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) at an unspecified dose and frequency. On 01-Feb-2021, PRURITUS (left arm was "really itchy"), RASH (could still see an outline of the arm rash), VACCINATION SITE URTICARIA (a hive or two at the injection site), VACCINATION SITE PRURITUS (arm itched in general but not in a specific location), VACCINATION SITE RASH (a giant red welt like rash at the injection site that looked like a burn) and VACCINATION SITE PAIN (left arm started to hurt) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Her HCP advised her to treat with OTC diphenhydramine and OTC famotidine. Unknown it the patient received second planned vaccine dose.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria
Clinical narrative: could still see an outline of the arm rash; a giant red welt like rash at the injection site that looked like a burn; left arm was "really itchy"; a hive or two at the injection site; arm itched in general but not in a specific location; left arm started to hurt; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (left arm was "really itchy"), RASH (could still see an outline of the arm rash), VACCINATION SITE URTICARIA (a hive or two at the injection site), VACCINATION SITE PRURITUS (arm itched in general but not in a specific location) and VACCINATION SITE RASH (a giant red welt like rash at the injection site that looked like a burn) in a 34-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 Drug allergy (sulfa drugs, Augmentin.) and Drug allergy (amoxicillin-clavulanate).    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 VACCINATION SITE PAIN (left arm started to hurt). On 28-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (a hive or two at the injection site) and VACCINATION SITE PRURITUS (arm itched in general but not in a specific location). On 29-Jan-2021, the patient experienced PRURITUS (left arm was "really itchy") and VACCINATION SITE RASH (a giant red welt like rash at the injection site that looked like a burn). On 01-Feb-2021, the patient experienced RASH (could still see an outline of the arm rash). The patient was treated with ACRIVASTINE (BENADRYL OTC) at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) at an unspecified dose and frequency. On 01-Feb-2021, PRURITUS (left arm was "really itchy"), RASH (could still see an outline of the arm rash), VACCINATION SITE URTICARIA (a hive or two at the injection site), VACCINATION SITE PRURITUS (arm itched in general but not in a specific location), VACCINATION SITE RASH (a giant red welt like rash at the injection site that looked like a burn) and VACCINATION SITE PAIN (left arm started to hurt) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Her HCP advised her to treat with OTC diphenhydramine and OTC famotidine. Unknown it the patient received second planned vaccine dose.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Red Swollen Dot; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red Swollen Dot) and VACCINATION SITE PAIN (Sore Arm) in a 34-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 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 VACCINATION SITE ERYTHEMA (Red Swollen Dot) and VACCINATION SITE PAIN (Sore Arm). At the time of the report, VACCINATION SITE ERYTHEMA (Red Swollen Dot) and VACCINATION SITE PAIN (Sore Arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: My wife's arm is starting to get red where the injection site was; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (My wife's arm is starting to get red where the injection site was) 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 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (My wife's arm is starting to get red where the injection site was). At the time of the report, VACCINATION SITE ERYTHEMA (My wife's arm is starting to get red where the injection site was) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site erythema
Clinical narrative: that's when the itch came; light rash, a small area; red mark on where the needle went in; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red mark on where the needle went in), RASH (light rash, a small area) and PRURITUS (that's when the itch came) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Biceps tenodesis (Patient has bicep tendonitis in both arms;). Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), ESOMEPRAZOLE, FAMOTIDINE, LEVOTHYROXINE and AMLODIPINE for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (red mark on where the needle went in). On 30-Jan-2021, the patient experienced RASH (light rash, a small area). On an unknown date, the patient experienced PRURITUS (that's when the itch came). At the time of the report, VACCINATION SITE ERYTHEMA (red mark on where the needle went in) and RASH (light rash, a small area) had not resolved and PRURITUS (that's when the itch came) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Petechiae, Pruritus, Skin haemorrhage
Clinical narrative: extremely red; would scratch and they would bleed; noticed a little petechiae; very itchy on his lower legs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ERYTHEMA (extremely red), SKIN HAEMORRHAGE (would scratch and they would bleed), PETECHIAE (noticed a little petechiae) and PRURITUS (very itchy on his lower legs) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF), CLONAZEPAM, CLONAZEPAM and CLONAZEPAM for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced ERYTHEMA (extremely red), SKIN HAEMORRHAGE (would scratch and they would bleed), PETECHIAE (noticed a little petechiae) and PRURITUS (very itchy on his lower legs). At the time of the report, ERYTHEMA (extremely red) outcome was unknown and SKIN HAEMORRHAGE (would scratch and they would bleed), PETECHIAE (noticed a little petechiae) and PRURITUS (very itchy on his lower legs) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: Arm was red and burning; Arm was red and burning; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Arm was red and burning) and PAIN IN EXTREMITY (Arm was red and burning) 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 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 ERYTHEMA (Arm was red and burning) and PAIN IN EXTREMITY (Arm was red and burning). At the time of the report, ERYTHEMA (Arm was red and burning) and PAIN IN EXTREMITY (Arm was red and burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Headache, Injection site pruritus, Malaise
Clinical narrative: arm got extremely swollen; also felt really sick; (arm) red; (arm) hot; (arm) painful; headache; fatigued; (arm) itchy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm got extremely swollen), MALAISE (also felt really sick), ERYTHEMA ((arm) red), SKIN BURNING SENSATION ((arm) hot) and VACCINATION SITE PAIN ((arm) painful) in a 60-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 COVID-19 in March 2020.    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 PERIPHERAL SWELLING (arm got extremely swollen), MALAISE (also felt really sick), ERYTHEMA ((arm) red), SKIN BURNING SENSATION ((arm) hot), VACCINATION SITE PAIN ((arm) painful), HEADACHE (headache), FATIGUE (fatigued) and INJECTION SITE PRURITUS ((arm) itchy). At the time of the report, PERIPHERAL SWELLING (arm got extremely swollen), MALAISE (also felt really sick), ERYTHEMA ((arm) red), SKIN BURNING SENSATION ((arm) hot), VACCINATION SITE PAIN ((arm) painful), HEADACHE (headache), FATIGUE (fatigued) and INJECTION SITE PRURITUS ((arm) itchy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: ??-mar-2021 Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, SARS-CoV-2 test, Skin burning sensation, Vaccination site pain
Clinical narrative: arm got extremely swollen; also felt really sick; (arm) red; (arm) hot; (arm) painful; headache; fatigued; (arm) itchy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm got extremely swollen), MALAISE (also felt really sick), ERYTHEMA ((arm) red), SKIN BURNING SENSATION ((arm) hot) and VACCINATION SITE PAIN ((arm) painful) in a 60-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 COVID-19 in March 2020.    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 PERIPHERAL SWELLING (arm got extremely swollen), MALAISE (also felt really sick), ERYTHEMA ((arm) red), SKIN BURNING SENSATION ((arm) hot), VACCINATION SITE PAIN ((arm) painful), HEADACHE (headache), FATIGUE (fatigued) and INJECTION SITE PRURITUS ((arm) itchy). At the time of the report, PERIPHERAL SWELLING (arm got extremely swollen), MALAISE (also felt really sick), ERYTHEMA ((arm) red), SKIN BURNING SENSATION ((arm) hot), VACCINATION SITE PAIN ((arm) painful), HEADACHE (headache), FATIGUE (fatigued) and INJECTION SITE PRURITUS ((arm) itchy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: ??-mar-2021 Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Rash
Clinical narrative: bump on neck; rash on neck; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLISTER (bump on neck) and RASH (rash on neck) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced BLISTER (bump on neck) and RASH (rash on neck). At the time of the report, BLISTER (bump on neck) and RASH (rash on neck) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Supraclavicular lymph node swelling; A spontaneous report was received from an other healthcare professional concerning a female patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced supraclavicular lymph node swelling.  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received their first of two planned doses of mRNA-1273 (batch number: Unknown) on an unknown date. On an unknown date, the patient received their second of two planned doses of mRNA-1273 (batch number: Unknown) for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced supraclavicular lymph node swelling. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event supraclavicular lymph node swelling was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm was really sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was really sore) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was really sore). The patient was treated with NAPROXEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm was really sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.