chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Neck mass
Clinical narrative: Small balls in neck; This spontaneous case was reported by a patient and describes the occurrence of NECK MASS (Small balls in neck) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NECK MASS (Small balls in neck). At the time of the report, NECK MASS (Small balls in neck) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Hypersensitivity, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: cannot swallow; her throat is killing her; allergic reaction; swollen glands; This spontaneous case was reported by a consumer and describes the occurrence of DYSPHAGIA (cannot swallow), OROPHARYNGEAL PAIN (her throat is killing her), HYPERSENSITIVITY (allergic reaction) and LYMPHADENOPATHY (swollen glands) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced DYSPHAGIA (cannot swallow), OROPHARYNGEAL PAIN (her throat is killing her), HYPERSENSITIVITY (allergic reaction) and LYMPHADENOPATHY (swollen glands). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 UNK. At the time of the report, DYSPHAGIA (cannot swallow), OROPHARYNGEAL PAIN (her throat is killing her), HYPERSENSITIVITY (allergic reaction) and LYMPHADENOPATHY (swollen glands) outcome was unknown.            Concomitant medication was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: came down with nausea; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (came down with nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (came down with nausea). At the time of the report, NAUSEA (came down with nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment was reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Just passed 6 weeks from 1st dose and hasn't yet received 2nd dose; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Just passed 6 weeks from 1st dose and hasn't yet received 2nd dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-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 PRODUCT DOSE OMISSION ISSUE (Just passed 6 weeks from 1st dose and hasn't yet received 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Just passed 6 weeks from 1st dose and hasn't yet received 2nd dose) outcome was unknown.        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.   Healthcare professional is calling from family practice with a question regarding the timing of the 2nd dose of the Moderna COVID-19 vaccine. She says she has a patient who received the 1st No concomitant medication were reported No treatment medication were reported.  dose on 19Apr2021. She says it just passed 6 weeks from the 1st dose and she is asking if she should still get the 2nd dose.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache
Clinical narrative: Light headed/ still feel dizzy; Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed/ still feel dizzy), FATIGUE (Fatigue) and HEADACHE (Headache) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Light headed/ still feel dizzy), FATIGUE (Fatigue) and HEADACHE (Headache). At the time of the report, DIZZINESS (Light headed/ still feel dizzy), FATIGUE (Fatigue) and HEADACHE (Headache) had not resolved.            No concomitant medications were reported. No treatment details were reported. Patient reported that it has been 2 weeks since she had received her second shot and the adverse events are still ongoing.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: tried to get his second dose after recovery but was denied at the site; Patient got COVID infection after first dose of Moderna vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (Patient got COVID infection after first dose of Moderna vaccine) and PRODUCT DOSE OMISSION ISSUE (tried to get his second dose after recovery but was denied at the site) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced COVID-19 (Patient got COVID infection after first dose of Moderna vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (tried to get his second dose after recovery but was denied at the site). At the time of the report, COVID-19 (Patient got COVID infection after first dose of Moderna vaccine) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (tried to get his second dose after recovery but was denied at the site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.     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 relevant concomitant medications reported. No treatment information was provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Hypoaesthesia, Lip swelling, Pharyngeal swelling, Pruritus
Clinical narrative: Swollen throat; Swollen lips; Swollen tongue; Swollen ears; Everything was itchy; Facial numbness; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Swollen throat), LIP SWELLING (Swollen lips), SWOLLEN TONGUE (Swollen tongue), EAR SWELLING (Swollen ears) and PRURITUS (Everything was itchy) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VALPROIC ACID, LEVOTHYROXINE SODIUM (SYNTHROID), OMEPRAZOLE and LORAZEPAM for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PHARYNGEAL SWELLING (Swollen throat), LIP SWELLING (Swollen lips), SWOLLEN TONGUE (Swollen tongue), EAR SWELLING (Swollen ears), PRURITUS (Everything was itchy) and HYPOAESTHESIA (Facial numbness). The patient was treated with EPINEPHRINE (intravenous) ongoing since an unknown date at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PHARYNGEAL SWELLING (Swollen throat), LIP SWELLING (Swollen lips), SWOLLEN TONGUE (Swollen tongue), EAR SWELLING (Swollen ears), PRURITUS (Everything was itchy) and HYPOAESTHESIA (Facial numbness) had not resolved.            She had facial fillers on 8April 2021 at 10:30am. Four hours after the facial filler procedure, her throat, lips,tongue, and ears were all swollen. Everything was itchy and she had facial numbness. She went to the Emergency room two times in a day.   Treatment medications included steroid given at the emergency room, along with above mentioned medications.  She was feeling better right now but the problem was still ongoing
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Swollen throat; Swollen lips; Swollen tongue; Swollen ears; Everything was itchy; Facial numbness; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Swollen throat), LIP SWELLING (Swollen lips), SWOLLEN TONGUE (Swollen tongue), EAR SWELLING (Swollen ears) and PRURITUS (Everything was itchy) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VALPROIC ACID, LEVOTHYROXINE SODIUM (SYNTHROID), OMEPRAZOLE and LORAZEPAM for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced PHARYNGEAL SWELLING (Swollen throat), LIP SWELLING (Swollen lips), SWOLLEN TONGUE (Swollen tongue), EAR SWELLING (Swollen ears), PRURITUS (Everything was itchy) and HYPOAESTHESIA (Facial numbness). The patient was treated with EPINEPHRINE (intravenous) ongoing since an unknown date at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PHARYNGEAL SWELLING (Swollen throat), LIP SWELLING (Swollen lips), SWOLLEN TONGUE (Swollen tongue), EAR SWELLING (Swollen ears), PRURITUS (Everything was itchy) and HYPOAESTHESIA (Facial numbness) had not resolved.            She had facial fillers on 8April 2021 at 10:30am. Four hours after the facial filler procedure, her throat, lips,tongue, and ears were all swollen. Everything was itchy and she had facial numbness. She went to the Emergency room two times in a day.   Treatment medications included steroid given at the emergency room, along with above mentioned medications.  She was feeling better right now but the problem was still ongoing
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: high fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (high fever). At the time of the report, PYREXIA (high fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment medication was not provided.   This case was linked to MOD-2021-201725 (Patient Link).   Reporter did not allow further contact
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Headache; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PAIN IN EXTREMITY (Arm pain) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced HEADACHE (Headache) and PAIN IN EXTREMITY (Arm pain). At the time of the report, HEADACHE (Headache) and PAIN IN EXTREMITY (Arm pain) outcome was unknown.            Concomitant medications were not reported.  No treatment details were provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects due to Vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects due to Vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects due to Vaccine). At the time of the report, VACCINATION COMPLICATION (side effects due to Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.            No concomitant medication was reported. The treatment information was not given.  Action taken with m-RNA-1273 in response to the event was not applicable.   Reporter did not allow further contact
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Chills; Headache; Sore arm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache), MYALGIA (Sore arm) and PYREXIA (Fever) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 01DA2ZA) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache), MYALGIA (Sore arm) and PYREXIA (Fever). At the time of the report, CHILLS (Chills), HEADACHE (Headache), MYALGIA (Sore arm) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was provided. No laboratory data was provided. No Treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.       Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: No new information
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Nausea
Clinical narrative: body weakness; nausea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (body weakness) and NAUSEA (nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was provided by the reporter.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (body weakness) and NAUSEA (nausea). At the time of the report, ASTHENIA (body weakness) and NAUSEA (nausea) outcome was unknown.            No information about the concomitants was provided.  No information about treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: shot mess with my period keep me frrom having it/shot mess up my menstrual cycle; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (shot mess with my period keep me frrom having it/shot mess up my menstrual cycle) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (shot mess with my period keep me frrom having it/shot mess up my menstrual cycle). At the time of the report, MENSTRUAL DISORDER (shot mess with my period keep me frrom having it/shot mess up my menstrual cycle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. The treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: really fast heart rate; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (really fast heart rate) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (really fast heart rate). At the time of the report, HEART RATE INCREASED (really fast heart rate) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) Fast heart rate.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: After 1st dose, patient only experienced small pain in the arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (After 1st dose, patient only experienced small pain in the arm of injection) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01DA2ZA) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE PAIN (After 1st dose, patient only experienced small pain in the arm of injection). At the time of the report, VACCINATION SITE PAIN (After 1st dose, patient only experienced small pain in the arm of injection) 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.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of product dose omission issue (has not gotten second dose yet) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Feb 15, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced product dose omission issue (has not gotten second dose yet). At the time of the report, product dose omission issue (has not gotten second dose yet) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No relevant concomitant medications or treatment information reported.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose given less than 21 days after 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given less than 21 days after 1st dose) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given less than 21 days after 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given less than 21 days after 1st dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   MD told patient to get 3rd dose  Concomitant product use was not provided by the reporter.   ? No treatment information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia
Clinical narrative: Severe shoulder pain/ joint pain in both shoulders; Hard for her to sleep; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Severe shoulder pain/ joint pain in both shoulders) and INSOMNIA (Hard for her to sleep) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Severe shoulder pain/ joint pain in both shoulders) and INSOMNIA (Hard for her to sleep). At the time of the report, ARTHRALGIA (Severe shoulder pain/ joint pain in both shoulders) and INSOMNIA (Hard for her to sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Reported symptoms after the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reported symptoms after the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reported symptoms after the vaccine). At the time of the report, VACCINATION COMPLICATION (Reported symptoms after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medication were provided.  No concomitant medication were reported.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: I have missed one menstrual cycle completely and think I am going to miss a second after receiving the Moderna vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (I have missed one menstrual cycle completely and think I am going to miss a second after receiving the Moderna 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (I have missed one menstrual cycle completely and think I am going to miss a second after receiving the Moderna vaccine.). At the time of the report, MENSTRUAL DISORDER (I have missed one menstrual cycle completely and think I am going to miss a second after receiving the Moderna vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication were provided. No concomitant medication information was provided.   Reporter did not allow further contact
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: Possible exposure to covid; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPOSURE TO SARS-COV-2 (Possible exposure to covid) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced EXPOSURE TO SARS-COV-2 (Possible exposure to covid). At the time of the report, EXPOSURE TO SARS-COV-2 (Possible exposure to covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Guttate psoriasis
Clinical narrative: flare of guttate psoriasis; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of GUTTATE PSORIASIS (flare of guttate psoriasis) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GUTTATE PSORIASIS (flare of guttate psoriasis). At the time of the report, GUTTATE PSORIASIS (flare of guttate psoriasis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Illness, Product dose omission issue, Pyrexia
Clinical narrative: very sick; did not get 2 dose; fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick), PRODUCT DOSE OMISSION ISSUE (did not get 2 dose) and PYREXIA (fever) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (very sick), PRODUCT DOSE OMISSION ISSUE (did not get 2 dose) and PYREXIA (fever). At the time of the report, ILLNESS (very sick) and PYREXIA (fever) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not get 2 dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: 99 abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: I was wondering i went past my 2nd vaccine date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I was wondering i went past my 2nd vaccine date) in a  patient of an unknown age and gender 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I was wondering i went past my 2nd vaccine date). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I was wondering i went past my 2nd vaccine date) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pain in extremity, Pyrexia
Clinical narrative: I feel like I have a pinched nerve all the way down my arm/ cant even hold a cup/ pain also runs through her elbow and down to her thumb area; Arm sore/ pain in her arm that feels different then the soreness/Hand pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (I feel like I have a pinched nerve all the way down my arm/ cant even hold a cup/ pain also runs through her elbow and down to her thumb area), PAIN IN EXTREMITY (Arm sore/ pain in her arm that feels different then the soreness/Hand pain) and PYREXIA (Fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced NEURALGIA (I feel like I have a pinched nerve all the way down my arm/ cant even hold a cup/ pain also runs through her elbow and down to her thumb area), PAIN IN EXTREMITY (Arm sore/ pain in her arm that feels different then the soreness/Hand pain) and PYREXIA (Fever). At the time of the report, NEURALGIA (I feel like I have a pinched nerve all the way down my arm/ cant even hold a cup/ pain also runs through her elbow and down to her thumb area), PAIN IN EXTREMITY (Arm sore/ pain in her arm that feels different then the soreness/Hand pain) and PYREXIA (Fever) outcome was unknown. Not Provided          Patient  takes tramadol for back pain. Treatment medicines were not reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine)  was Not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: follow up received on 03-JUN-2021 .Added new events arm  sore, pyrexia, hand pain
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Myalgia, Nausea
Clinical narrative: experienced flu-like symptoms; left arm was in excruciating pain; nauseous; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA (experienced flu-like symptoms), MYALGIA (left arm was in excruciating pain) and NAUSEA (nauseous) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Declined) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 02-Jun-2021, the patient experienced INFLUENZA (experienced flu-like symptoms), MYALGIA (left arm was in excruciating pain) and NAUSEA (nauseous). At the time of the report, INFLUENZA (experienced flu-like symptoms), MYALGIA (left arm was in excruciating pain) and NAUSEA (nauseous) 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.   Consent for follow-up with Safety was declined, as the patient refused to provide additional information and disconnected the call.  No concomitant medications are provided .  No treatment medications are provided .
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headaches since vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches since vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headaches since vaccine). At the time of the report, HEADACHE (headaches since vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided  No Treatment medications were provided
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects worse with the second vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects worse with the second vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects worse with the second vaccine). At the time of the report, VACCINATION COMPLICATION (side effects worse with the second vaccine) outcome was unknown.            No concomitant medication was provided.  No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Long lasting fatigue after the 2nd  dose of Moderna vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Jun-2021 and was forwarded to Moderna on 03-Jun-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Long lasting fatigue after the 2nd  dose of Moderna vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Long lasting fatigue after the 2nd  dose of Moderna vaccine). At the time of the report, FATIGUE (Long lasting fatigue after the 2nd  dose of Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment medication was provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chest pain, Dizziness, Dyspnoea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness / still dizzy), ASTHENIA (weakness / still weak), SKIN WARM (skin is hot), PRURITUS (itchy really bad) and PERIPHERAL SWELLING (feet are swollen really bad,  swollen leg) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 002CZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced DIZZINESS (dizziness / still dizzy), ASTHENIA (weakness / still weak), RASH (couple of days later rash spread over his arm and to body), MYALGIA (body aches / muscle aches), ARTHRALGIA (joint aches), HEADACHE (Headache) and NAUSEA (nausea / still having nausea). On an unknown date, the patient experienced SKIN WARM (skin is hot), PRURITUS (itchy really bad), PERIPHERAL SWELLING (feet are swollen really bad,  swollen leg), DYSPNOEA (short of breath), CHEST PAIN (chest pain), JOINT SWELLING (Swollen ankle), VACCINATION COMPLICATION (Not feeling well), PYREXIA (fever that lasted about a week and half) and VACCINATION SITE RASH (rash on left shoulder where they administer the vaccine). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness / still dizzy), ASTHENIA (weakness / still weak), SKIN WARM (skin is hot), PRURITUS (itchy really bad), PERIPHERAL SWELLING (feet are swollen really bad,  swollen leg), DYSPNOEA (short of breath) and NAUSEA (nausea / still having nausea) had not resolved and CHEST PAIN (chest pain), JOINT SWELLING (Swollen ankle), VACCINATION COMPLICATION (Not feeling well), RASH (couple of days later rash spread over his arm and to body), PYREXIA (fever that lasted about a week and half), MYALGIA (body aches / muscle aches), ARTHRALGIA (joint aches), HEADACHE (Headache) and VACCINATION SITE RASH (rash on left shoulder where they administer the vaccine) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was provided. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Followup received contains  added new events chest pain. On 06-Aug-2021: Follow-up received on 06-Aug-2021 included no new information.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Joint swelling, Myalgia, Nausea, Peripheral swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness / still dizzy), ASTHENIA (weakness / still weak), SKIN WARM (skin is hot), PRURITUS (itchy really bad) and PERIPHERAL SWELLING (feet are swollen really bad,  swollen leg) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 002CZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced DIZZINESS (dizziness / still dizzy), ASTHENIA (weakness / still weak), RASH (couple of days later rash spread over his arm and to body), MYALGIA (body aches / muscle aches), ARTHRALGIA (joint aches), HEADACHE (Headache) and NAUSEA (nausea / still having nausea). On an unknown date, the patient experienced SKIN WARM (skin is hot), PRURITUS (itchy really bad), PERIPHERAL SWELLING (feet are swollen really bad,  swollen leg), DYSPNOEA (short of breath), CHEST PAIN (chest pain), JOINT SWELLING (Swollen ankle), VACCINATION COMPLICATION (Not feeling well), PYREXIA (fever that lasted about a week and half) and VACCINATION SITE RASH (rash on left shoulder where they administer the vaccine). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness / still dizzy), ASTHENIA (weakness / still weak), SKIN WARM (skin is hot), PRURITUS (itchy really bad), PERIPHERAL SWELLING (feet are swollen really bad,  swollen leg), DYSPNOEA (short of breath) and NAUSEA (nausea / still having nausea) had not resolved and CHEST PAIN (chest pain), JOINT SWELLING (Swollen ankle), VACCINATION COMPLICATION (Not feeling well), RASH (couple of days later rash spread over his arm and to body), PYREXIA (fever that lasted about a week and half), MYALGIA (body aches / muscle aches), ARTHRALGIA (joint aches), HEADACHE (Headache) and VACCINATION SITE RASH (rash on left shoulder where they administer the vaccine) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was provided. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Followup received contains  added new events chest pain. On 06-Aug-2021: Follow-up received on 06-Aug-2021 included no new information.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash, Skin warm, Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness / still dizzy), ASTHENIA (weakness / still weak), SKIN WARM (skin is hot), PRURITUS (itchy really bad) and PERIPHERAL SWELLING (feet are swollen really bad,  swollen leg) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 002CZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced DIZZINESS (dizziness / still dizzy), ASTHENIA (weakness / still weak), RASH (couple of days later rash spread over his arm and to body), MYALGIA (body aches / muscle aches), ARTHRALGIA (joint aches), HEADACHE (Headache) and NAUSEA (nausea / still having nausea). On an unknown date, the patient experienced SKIN WARM (skin is hot), PRURITUS (itchy really bad), PERIPHERAL SWELLING (feet are swollen really bad,  swollen leg), DYSPNOEA (short of breath), CHEST PAIN (chest pain), JOINT SWELLING (Swollen ankle), VACCINATION COMPLICATION (Not feeling well), PYREXIA (fever that lasted about a week and half) and VACCINATION SITE RASH (rash on left shoulder where they administer the vaccine). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness / still dizzy), ASTHENIA (weakness / still weak), SKIN WARM (skin is hot), PRURITUS (itchy really bad), PERIPHERAL SWELLING (feet are swollen really bad,  swollen leg), DYSPNOEA (short of breath) and NAUSEA (nausea / still having nausea) had not resolved and CHEST PAIN (chest pain), JOINT SWELLING (Swollen ankle), VACCINATION COMPLICATION (Not feeling well), RASH (couple of days later rash spread over his arm and to body), PYREXIA (fever that lasted about a week and half), MYALGIA (body aches / muscle aches), ARTHRALGIA (joint aches), HEADACHE (Headache) and VACCINATION SITE RASH (rash on left shoulder where they administer the vaccine) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was provided. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Followup received contains  added new events chest pain. On 06-Aug-2021: Follow-up received on 06-Aug-2021 included no new information.