chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: reaction to the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (reaction to the Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced ADVERSE DRUG REACTION (reaction to the Moderna vaccine). At the time of the report, ADVERSE DRUG REACTION (reaction to the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jan-2021 and was forwarded to Moderna on 24-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (reaction to the Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced ADVERSE DRUG REACTION (reaction to the Moderna vaccine). At the time of the report, ADVERSE DRUG REACTION (reaction to the Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment details were reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Injection site induration, Injection site warmth
Clinical narrative: it was warm; It went and then came back from a very small red lump to about 6 CM in diameter; Large red lump; Large red lump; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Large red lump), INJECTION SITE INDURATION (Large red lump), INJECTION SITE WARMTH (it was warm) and ERYTHEMA (It went and then came back from a very small red lump to about 6 CM in diameter) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 immunisation.     No Medical History Information was reported.     On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced ERYTHEMA (Large red lump) and INJECTION SITE INDURATION (Large red lump). On an unknown date, the patient experienced INJECTION SITE WARMTH (it was warm) and ERYTHEMA (It went and then came back from a very small red lump to about 6 CM in diameter). On 05-Jan-2021, ERYTHEMA (Large red lump) and INJECTION SITE INDURATION (Large red lump) outcome was unknown. At the time of the report, INJECTION SITE WARMTH (it was warm) and ERYTHEMA (It went and then came back from a very small red lump to about 6 CM in diameter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jan-2021 and was forwarded to Moderna on 23-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Large red lump), INJECTION SITE INDURATION (Large red lump), INJECTION SITE WARMTH (it was warm) and ERYTHEMA (It went and then came back from a very small red lump to about 6 CM in diameter) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 immunisation.     No Medical History Information was reported.     On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced ERYTHEMA (Large red lump) and INJECTION SITE INDURATION (Large red lump). On an unknown date, the patient experienced INJECTION SITE WARMTH (it was warm) and ERYTHEMA (It went and then came back from a very small red lump to about 6 CM in diameter). On 05-Jan-2021, ERYTHEMA (Large red lump) and INJECTION SITE INDURATION (Large red lump) outcome was unknown. At the time of the report, INJECTION SITE WARMTH (it was warm) and ERYTHEMA (It went and then came back from a very small red lump to about 6 CM in diameter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Red Injection Site; Itchy Injection Site; Rash Baseball Size on the Inje ction Site; Sore Left Arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Red Injection Site), INJECTION SITE PRURITUS (Itchy Injection Site), INJECTION SITE RASH (Rash Baseball Size on the Inje ction Site) and INJECTION SITE PAIN (Sore Left Arm) in a 66-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 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced INJECTION SITE PAIN (Sore Left Arm). On 23-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Red Injection Site), INJECTION SITE PRURITUS (Itchy Injection Site) and INJECTION SITE RASH (Rash Baseball Size on the Inje ction Site). On 17-Jan-2021, INJECTION SITE PAIN (Sore Left Arm) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (Red Injection Site), INJECTION SITE PRURITUS (Itchy Injection Site) and INJECTION SITE RASH (Rash Baseball Size on the Inje ction Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received on 24-Jan-2021 and was forwarded to Moderna on 24-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Red Injection Site), INJECTION SITE PRURITUS (Itchy Injection Site), INJECTION SITE RASH (Rash Baseball Size on the Inje ction Site) and INJECTION SITE PAIN (Sore Left Arm) in a 66-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 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced INJECTION SITE PAIN (Sore Left Arm). On 23-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Red Injection Site), INJECTION SITE PRURITUS (Itchy Injection Site) and INJECTION SITE RASH (Rash Baseball Size on the Inje ction Site). On 17-Jan-2021, INJECTION SITE PAIN (Sore Left Arm) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (Red Injection Site), INJECTION SITE PRURITUS (Itchy Injection Site) and INJECTION SITE RASH (Rash Baseball Size on the Inje ction Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle pain in arms, legs, cheeks; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (muscle pain in arms, legs, cheeks) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Fibromyalgia.    On 20-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced MYALGIA (muscle pain in arms, legs, cheeks). At the time of the report, MYALGIA (muscle pain in arms, legs, cheeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the event included the patient's fibromyalgia pain medication.  Concomitant product use was not provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jan-2021 and was forwarded to Moderna on 23-Jan-2021.    This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (muscle pain in arms, legs, cheeks) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Fibromyalgia.    On 20-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced MYALGIA (muscle pain in arms, legs, cheeks). At the time of the report, MYALGIA (muscle pain in arms, legs, cheeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the event included the patient's fibromyalgia pain medication.  Concomitant product use was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Tenderness, Vaccination site rash
Clinical narrative: Rash on my arm where the vaccine was given; Slight tenderness, upper arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (Rash on my arm where the vaccine was given) and TENDERNESS (Slight tenderness, upper arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.     On 05-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Rash on my arm where the vaccine was given) and TENDERNESS (Slight tenderness, upper arm). At the time of the report, VACCINATION SITE RASH (Rash on my arm where the vaccine was given) and TENDERNESS (Slight tenderness, upper arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient visited his local doctor. Patient was told to put some heat on it and take some Tylenol.   No Concomitant medication was reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jan-2021 and was forwarded to Moderna on 23-Jan-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (Rash on my arm where the vaccine was given) and TENDERNESS (Slight tenderness, upper arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.     On 05-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Rash on my arm where the vaccine was given) and TENDERNESS (Slight tenderness, upper arm). At the time of the report, VACCINATION SITE RASH (Rash on my arm where the vaccine was given) and TENDERNESS (Slight tenderness, upper arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient visited his local doctor. Patient was told to put some heat on it and take some Tylenol.   No Concomitant medication was reported.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Got vaccine while Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine while Pregnant) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M2LA and 011L208A) for COVID-19 vaccination.     The patient's past medical history included Migraine in 2013 and Pregnancy (Live, full-term birth.) on 18-Jan-2019. Concurrent medical conditions included Allergy to antibiotic, Allergy to antibiotic (Cipros) and GERD since 2013. Concomitant products included FAMOTIDINE (PEPCID [FAMOTIDINE]) for GERD, SUMATRIPTAN (IMITREX [SUMATRIPTAN]) and MAGNESIUM for Migraine, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, RIBOFLAVIN for an unknown indication.   On 12-Jan-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021 at 12:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 28-Jun-2020 and the estimated date of delivery was 04-Apr-2021. On 12-Jan-2021 at 3:30 PM, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine while Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-second week of the pregnancy.  On 12-Jan-2021 at 3:30 PM, MATERNAL EXPOSURE DURING PREGNANCY (Got vaccine while Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jul-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Blood glucose: normal (normal) Normal. On an unknown date, Ultrasound scan: normal (normal) Normal.         The conception date of patient was on 12-Jul-2020 and date of positive pregnancy test was 22-Jul-2020. The patient has an established prenatal care. Number of fetus was found to be one. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: Injections site is red; looks like rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injections site is red) and VACCINATION SITE RASH (looks like rash at injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No reported medical history.     On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injections site is red) and VACCINATION SITE RASH (looks like rash at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Injections site is red) and VACCINATION SITE RASH (looks like rash at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported.   No treatment information was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Jan-2021 and was forwarded to Moderna on 01-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injections site is red) and VACCINATION SITE RASH (looks like rash at injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No reported medical history.     On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injections site is red) and VACCINATION SITE RASH (looks like rash at injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Injections site is red) and VACCINATION SITE RASH (looks like rash at injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication were not reported.   No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Fatigue, Malaise, Pain in extremity, Vaccination site pruritus
Clinical narrative: Sore arm; Tired; Intense itching at injection site; red spot (on my arm); Malaise; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired), VACCINATION SITE PRURITUS (Intense itching at injection site), ERYTHEMA (red spot (on my arm)) and MALAISE (Malaise) in a 64-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 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired), VACCINATION SITE PRURITUS (Intense itching at injection site), ERYTHEMA (red spot (on my arm)) and MALAISE (Malaise). At the time of the report, PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired), VACCINATION SITE PRURITUS (Intense itching at injection site), ERYTHEMA (red spot (on my arm)) and MALAISE (Malaise) 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 product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jan-2021 and was forwarded to Moderna on 23-Jan-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired), VACCINATION SITE PRURITUS (Intense itching at injection site), ERYTHEMA (red spot (on my arm)) and MALAISE (Malaise) in a 64-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 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired), VACCINATION SITE PRURITUS (Intense itching at injection site), ERYTHEMA (red spot (on my arm)) and MALAISE (Malaise). At the time of the report, PAIN IN EXTREMITY (Sore arm), FATIGUE (Tired), VACCINATION SITE PRURITUS (Intense itching at injection site), ERYTHEMA (red spot (on my arm)) and MALAISE (Malaise) 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 product use was not provided.  No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Somnolence
Clinical narrative: Headache; Sleepiness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and SOMNOLENCE (Sleepiness) in an 85-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 21-Jan-2021, the patient experienced HEADACHE (Headache) and SOMNOLENCE (Sleepiness). At the time of the report, HEADACHE (Headache) and SOMNOLENCE (Sleepiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Patient received treatment including Tylenol 250 mg. Patient stated patient "took 1 pill to relief headache." This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jan-2021 and was forwarded to Moderna on 28-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and SOMNOLENCE (Sleepiness) in an 85-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 21-Jan-2021, the patient experienced HEADACHE (Headache) and SOMNOLENCE (Sleepiness). At the time of the report, HEADACHE (Headache) and SOMNOLENCE (Sleepiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Patient received treatment including Tylenol 250 mg. Patient stated patient "took 1 pill to relief headache."
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm  really hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm  really hurts) 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 21-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  really hurts). At the time of the report, PAIN IN EXTREMITY (arm  really hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jan-2021 and was forwarded to Moderna on 23-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm  really hurts) 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 21-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  really hurts). At the time of the report, PAIN IN EXTREMITY (arm  really hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Peripheral swelling, Pruritus, Rash papular
Clinical narrative: red bumps on her fingers; itching; swelling; strong chills; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (strong chills), HEADACHE (headache), RASH PAPULAR (red bumps on her fingers), PRURITUS (itching) and PERIPHERAL SWELLING (swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026220A) for COVID-19 vaccination.     No Medical History information was reported.     On 08-Jan-2021 at 2:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced CHILLS (strong chills) and HEADACHE (headache). On 11-Jan-2021, the patient experienced RASH PAPULAR (red bumps on her fingers), PRURITUS (itching) and PERIPHERAL SWELLING (swelling). At the time of the report, CHILLS (strong chills), HEADACHE (headache), RASH PAPULAR (red bumps on her fingers), PRURITUS (itching) and PERIPHERAL SWELLING (swelling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient saw a Dermatologist, but no treatment for symptoms were reported.   No concomitant medications are were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jan-2021 and was forwarded to Moderna on 23-Jan-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (strong chills), HEADACHE (headache), RASH PAPULAR (red bumps on her fingers), PRURITUS (itching) and PERIPHERAL SWELLING (swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026220A) for COVID-19 vaccination.     No Medical History information was reported.     On 08-Jan-2021 at 2:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced CHILLS (strong chills) and HEADACHE (headache). On 11-Jan-2021, the patient experienced RASH PAPULAR (red bumps on her fingers), PRURITUS (itching) and PERIPHERAL SWELLING (swelling). At the time of the report, CHILLS (strong chills), HEADACHE (headache), RASH PAPULAR (red bumps on her fingers), PRURITUS (itching) and PERIPHERAL SWELLING (swelling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient saw a Dermatologist, but no treatment for symptoms were reported.   No concomitant medications are were reported.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Limb discomfort, Nausea, Pain
Clinical narrative: Arm hurting, Trouble lifting Arm; Nausea; Headache; Soreness; Lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm hurting, Trouble lifting Arm), NAUSEA (Nausea), HEADACHE (Headache), PAIN (Soreness) and DIZZINESS (Lightheadedness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     NO medical history information was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced LIMB DISCOMFORT (Arm hurting, Trouble lifting Arm), NAUSEA (Nausea), HEADACHE (Headache), PAIN (Soreness) and DIZZINESS (Lightheadedness). At the time of the report, LIMB DISCOMFORT (Arm hurting, Trouble lifting Arm), NAUSEA (Nausea), HEADACHE (Headache), PAIN (Soreness) and DIZZINESS (Lightheadedness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jan-2021 and was forwarded to Moderna on 29-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Arm hurting, Trouble lifting Arm), NAUSEA (Nausea), HEADACHE (Headache), PAIN (Soreness) and DIZZINESS (Lightheadedness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     NO medical history information was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced LIMB DISCOMFORT (Arm hurting, Trouble lifting Arm), NAUSEA (Nausea), HEADACHE (Headache), PAIN (Soreness) and DIZZINESS (Lightheadedness). At the time of the report, LIMB DISCOMFORT (Arm hurting, Trouble lifting Arm), NAUSEA (Nausea), HEADACHE (Headache), PAIN (Soreness) and DIZZINESS (Lightheadedness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  No treatment details were reported.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore right arm the night after the 1st shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore right arm the night after the 1st shot) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025TA20A) for COVID-19 vaccination.     NO Medical history information was reported.     On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore right arm the night after the 1st shot). On 22-Jan-2021, PAIN IN EXTREMITY (Sore right arm the night after the 1st shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jan-2021 and was forwarded to Moderna on 25-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore right arm the night after the 1st shot) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025TA20A) for COVID-19 vaccination.     NO Medical history information was reported.     On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore right arm the night after the 1st shot). On 22-Jan-2021, PAIN IN EXTREMITY (Sore right arm the night after the 1st shot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin A, Blood immunoglobulin G, Blood immunoglobulin M, Polymerase chain reaction, Vaccination site rash
Clinical narrative: Rash at the injection site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (Rash at the injection site) 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 11-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 VACCINATION SITE RASH (Rash at the injection site). At the time of the report, VACCINATION SITE RASH (Rash at the injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood immunoglobulin A: Negative. On an unknown date, Blood immunoglobulin G: Positive. On an unknown date, Blood immunoglobulin M: Positive. On an unknown date, Polymerase chain reaction: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: Not specified This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Jan-2021. The most recent information was received on 25-Jan-2021 and was forwarded to Moderna on an unknown date.    This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (Rash at the injection site) 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 11-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 VACCINATION SITE RASH (Rash at the injection site). At the time of the report, VACCINATION SITE RASH (Rash at the injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood immunoglobulin A: Negative. On an unknown date, Blood immunoglobulin G: Positive. On an unknown date, Blood immunoglobulin M: Positive. On an unknown date, Polymerase chain reaction: Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: Not specified
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Vaccination site rash
Clinical narrative: headache; a slight rash; flu like soreness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), VACCINATION SITE RASH (a slight rash) and INFLUENZA LIKE ILLNESS (flu like soreness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.    The patient's past medical history included Multiple myeloma. Concurrent medical conditions included Allergy (Neupogen allergy), Allergy (Biaxin allergy), Allergy (Celebrex allergy), Drug allergy (Most opioids allergy reported), Sulfonamide allergy (sulfur based drugs allergy), Allergy (Morphine allergy), Allergy (Detrol allergy), Allergy (Hydrocodone allergy) and Amoxicillin (Amoxicillin allergy).   On 20-Jan-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 21-Jan-2021, the patient experienced HEADACHE (headache), VACCINATION SITE RASH (a slight rash) and INFLUENZA LIKE ILLNESS (flu like soreness). At the time of the report, HEADACHE (headache), VACCINATION SITE RASH (a slight rash) and INFLUENZA LIKE ILLNESS (flu like soreness) 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. No treatment information was provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: itchiness below the injection site; redness below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness below the injection site) and VACCINATION SITE ERYTHEMA (redness below the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 07-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness below the injection site) and VACCINATION SITE ERYTHEMA (redness below the injection site).   At the time of the report, VACCINATION SITE PRURITUS (itchiness below the injection site) and VACCINATION SITE ERYTHEMA (redness below the injection site) was resolving. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy, Vaccination site pain
Clinical narrative: Left supraclavicular lymph node was swollen; In general there is a slight feeling of pressure at the site and some tenderness if prodded; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE LYMPHADENOPATHY (Left supraclavicular lymph node was swollen) and VACCINATION SITE PAIN (In general there is a slight feeling of pressure at the site and some tenderness if prodded) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.  On 11-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 VACCINATION SITE LYMPHADENOPATHY (Left supraclavicular lymph node was swollen) and VACCINATION SITE PAIN (In general there is a slight feeling of pressure at the site and some tenderness if prodded).   At the time of the report, VACCINATION SITE LYMPHADENOPATHY (Left supraclavicular lymph node was swollen) and VACCINATION SITE PAIN (In general there is a slight feeling of pressure at the site and some tenderness if prodded) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate increased, Pyrexia
Clinical narrative: Heart beats increase up to 128 bpm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Heart beats increase up to 128 bpm) and PYREXIA (Fever) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 22-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 HEART RATE INCREASED (Heart beats increase up to 128 bpm) and PYREXIA (Fever). At the time of the report, HEART RATE INCREASED (Heart beats increase up to 128 bpm) and PYREXIA (Fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Blood pressure measurement: 128 bpm (High) Heartbeat increased upto 128 bpm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling
Clinical narrative: swelling; pruritus; This spontaneous case was reported by a consumer and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 14 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Malaise, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Very weak), PAIN (Achy), HEADACHE (Headaches) and MALAISE (Not feeling well) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced ASTHENIA (Very weak), PAIN (Achy) and HEADACHE (Headaches). On 22-Jan-2021, the patient experienced MALAISE (Not feeling well). At the time of the report, ASTHENIA (Very weak), PAIN (Achy), HEADACHE (Headaches) and MALAISE (Not feeling well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Sore arm; Injection site swelling; redness at injection site; injection site itching,delayed; Injection site hard bump,delayed; Injection site swelling,delayed; Injection site redness,delayed; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE PRURITUS (injection site itching,delayed) and VACCINATION SITE INDURATION (Injection site hard bump,delayed) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 14-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 VACCINATION SITE PRURITUS (injection site itching,delayed), VACCINATION SITE INDURATION (Injection site hard bump,delayed), VACCINATION SITE SWELLING (Injection site swelling,delayed) and VACCINATION SITE ERYTHEMA (Injection site redness,delayed). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), VACCINATION SITE SWELLING (Injection site swelling) and VACCINATION SITE ERYTHEMA (redness at injection site). At the time of the report, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE SWELLING (Injection site swelling), VACCINATION SITE ERYTHEMA (redness at injection site), VACCINATION SITE PRURITUS (injection site itching,delayed), VACCINATION SITE INDURATION (Injection site hard bump,delayed), VACCINATION SITE SWELLING (Injection site swelling,delayed) and VACCINATION SITE ERYTHEMA (Injection site redness,delayed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Injection site swollen; Injection site started to itch; 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) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 12-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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itching on the shot site; Red splotches around the shot site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching on the shot site) and VACCINATION SITE ERYTHEMA (Red splotches around the shot site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-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 VACCINATION SITE PRURITUS (Itching on the shot site) and VACCINATION SITE ERYTHEMA (Red splotches around the shot site). At the time of the report, VACCINATION SITE PRURITUS (Itching on the shot site) and VACCINATION SITE ERYTHEMA (Red splotches around the shot site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: had a reaction to the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had a reaction to the Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 VACCINATION COMPLICATION (had a reaction to the Moderna vaccine). At the time of the report, VACCINATION COMPLICATION (had a reaction to the Moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Vaccination site mass, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: big lump forming at the injection site; It's itchy; injection site reaction; little bit of sniffles; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (little bit of sniffles), VACCINATION SITE MASS (big lump forming at the injection site), VACCINATION SITE PRURITUS (It's itchy) and VACCINATION SITE REACTION (injection site reaction) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     No medical history was provided by the reporter.     On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced NASOPHARYNGITIS (little bit of sniffles). On 21-Jan-2021, the patient experienced VACCINATION SITE MASS (big lump forming at the injection site), VACCINATION SITE PRURITUS (It's itchy) and VACCINATION SITE REACTION (injection site reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (little bit of sniffles), VACCINATION SITE MASS (big lump forming at the injection site), VACCINATION SITE PRURITUS (It's itchy) and VACCINATION SITE REACTION (injection site reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details also included Wonder Balm on the area.   Reporter did not allow further contact