chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Decreased appetite, Dizziness, Feeling abnormal, Flatulence
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of DECREASED APPETITE (was eating and had to leave the food in the middle,), ABDOMINAL DISCOMFORT (upset stomach), DIZZINESS (dizziness , that lasted for 2 or 3 days), FLATULENCE (has foul-smelling flatulence even though she is eating her regular food, ¨had never experienced this before.) and FEELING ABNORMAL (Since she got the vaccine, her ¨body is different , it is not the same one', some days she is fine and others that she fells horrible, it has been 2 weeks and i am feeling uncomfortable) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Surgery (Patient had surgery "for not getting pregnant") in 2016. On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach) and FEELING ABNORMAL (Since she got the vaccine, her ¨body is different , it is not the same one', some days she is fine and others that she fells horrible, it has been 2 weeks and i am feeling uncomfortable). On 07-May-2021, the patient experienced DIZZINESS (dizziness , that lasted for 2 or 3 days), NAUSEA (nauseas that lasted for 2 or 3 days, has nauseas, everything she smells make her felt with nauseas), PYREXIA (fever, that lasted for 2 or 3 days) and HEADACHE (headache, that lasted for 2 or 3 days). In May 2021, the patient experienced FLATULENCE (has foul-smelling flatulence even though she is eating her regular food, ¨had never experienced this before.). On 23-May-2021, the patient experienced DECREASED APPETITE (was eating and had to leave the food in the middle,). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever, at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (was eating and had to leave the food in the middle,), ABDOMINAL DISCOMFORT (upset stomach), DIZZINESS (dizziness , that lasted for 2 or 3 days), FLATULENCE (has foul-smelling flatulence even though she is eating her regular food, ¨had never experienced this before.), FEELING ABNORMAL (Since she got the vaccine, her ¨body is different , it is not the same one', some days she is fine and others that she fells horrible, it has been 2 weeks and i am feeling uncomfortable), NAUSEA (nauseas that lasted for 2 or 3 days, has nauseas, everything she smells make her felt with nauseas), PYREXIA (fever, that lasted for 2 or 3 days) and HEADACHE (headache, that lasted for 2 or 3 days) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of DECREASED APPETITE (was eating and had to leave the food in the middle,), ABDOMINAL DISCOMFORT (upset stomach), DIZZINESS (dizziness , that lasted for 2 or 3 days), FLATULENCE (has foul-smelling flatulence even though she is eating her regular food, ¨had never experienced this before.) and FEELING ABNORMAL (Since she got the vaccine, her ¨body is different , it is not the same one', some days she is fine and others that she fells horrible, it has been 2 weeks and i am feeling uncomfortable) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Surgery (Patient had surgery "for not getting pregnant") in 2016. On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach) and FEELING ABNORMAL (Since she got the vaccine, her ¨body is different , it is not the same one', some days she is fine and others that she fells horrible, it has been 2 weeks and i am feeling uncomfortable). On 07-May-2021, the patient experienced DIZZINESS (dizziness , that lasted for 2 or 3 days), NAUSEA (nauseas that lasted for 2 or 3 days, has nauseas, everything she smells make her felt with nauseas), PYREXIA (fever, that lasted for 2 or 3 days) and HEADACHE (headache, that lasted for 2 or 3 days). In May 2021, the patient experienced FLATULENCE (has foul-smelling flatulence even though she is eating her regular food, ¨had never experienced this before.). On 23-May-2021, the patient experienced DECREASED APPETITE (was eating and had to leave the food in the middle,). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever, at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (was eating and had to leave the food in the middle,), ABDOMINAL DISCOMFORT (upset stomach), DIZZINESS (dizziness , that lasted for 2 or 3 days), FLATULENCE (has foul-smelling flatulence even though she is eating her regular food, ¨had never experienced this before.), FEELING ABNORMAL (Since she got the vaccine, her ¨body is different , it is not the same one', some days she is fine and others that she fells horrible, it has been 2 weeks and i am feeling uncomfortable), NAUSEA (nauseas that lasted for 2 or 3 days, has nauseas, everything she smells make her felt with nauseas), PYREXIA (fever, that lasted for 2 or 3 days) and HEADACHE (headache, that lasted for 2 or 3 days) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Limb discomfort, Lip swelling, Muscle spasms, Myalgia
Clinical narrative: Pain in legs; leg cramps/cramping in right leg; Face swelling; Lips swollen; Felt weird and strange; Really heavy legs legs; Vomiting; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in legs), MUSCLE SPASMS (leg cramps/cramping in right leg), SWELLING FACE (Face swelling), LIP SWELLING (Lips swollen) and FEELING ABNORMAL (Felt weird and strange) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine. Concomitant products included BOTULINUM TOXIN TYPE A (BOTOX) and TOPIRAMATE (TOPAMAX) for Migraine.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced PAIN IN EXTREMITY (Pain in legs), MUSCLE SPASMS (leg cramps/cramping in right leg), SWELLING FACE (Face swelling), LIP SWELLING (Lips swollen), FEELING ABNORMAL (Felt weird and strange), LIMB DISCOMFORT (Really heavy legs legs), VOMITING (Vomiting) and MYALGIA (Muscle pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 20-May-2021, VOMITING (Vomiting) had resolved. On 21-May-2021, SWELLING FACE (Face swelling) and LIP SWELLING (Lips swollen) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in legs), MUSCLE SPASMS (leg cramps/cramping in right leg), FEELING ABNORMAL (Felt weird and strange), LIMB DISCOMFORT (Really heavy legs legs) and MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.; 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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling face, Vomiting
Clinical narrative: Pain in legs; leg cramps/cramping in right leg; Face swelling; Lips swollen; Felt weird and strange; Really heavy legs legs; Vomiting; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in legs), MUSCLE SPASMS (leg cramps/cramping in right leg), SWELLING FACE (Face swelling), LIP SWELLING (Lips swollen) and FEELING ABNORMAL (Felt weird and strange) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Migraine. Concomitant products included BOTULINUM TOXIN TYPE A (BOTOX) and TOPIRAMATE (TOPAMAX) for Migraine.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced PAIN IN EXTREMITY (Pain in legs), MUSCLE SPASMS (leg cramps/cramping in right leg), SWELLING FACE (Face swelling), LIP SWELLING (Lips swollen), FEELING ABNORMAL (Felt weird and strange), LIMB DISCOMFORT (Really heavy legs legs), VOMITING (Vomiting) and MYALGIA (Muscle pain). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 20-May-2021, VOMITING (Vomiting) had resolved. On 21-May-2021, SWELLING FACE (Face swelling) and LIP SWELLING (Lips swollen) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in legs), MUSCLE SPASMS (leg cramps/cramping in right leg), FEELING ABNORMAL (Felt weird and strange), LIMB DISCOMFORT (Really heavy legs legs) and MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.; 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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Insomnia, Nausea
Clinical narrative: trouble sleeping; dizziness; big red ball that hurts on right arm; big red ball that hurts on right arm; big red ball that hurts on right arm; headache; wants to throw up; fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (trouble sleeping), DIZZINESS (dizziness), VACCINATION SITE INDURATION (big red ball that hurts on right arm), VACCINATION SITE ERYTHEMA (big red ball that hurts on right arm) and VACCINATION SITE PAIN (big red ball that hurts on right arm) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INSOMNIA (trouble sleeping), DIZZINESS (dizziness), VACCINATION SITE INDURATION (big red ball that hurts on right arm), VACCINATION SITE ERYTHEMA (big red ball that hurts on right arm), VACCINATION SITE PAIN (big red ball that hurts on right arm), HEADACHE (headache), NAUSEA (wants to throw up), PYREXIA (fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, INSOMNIA (trouble sleeping), DIZZINESS (dizziness), VACCINATION SITE INDURATION (big red ball that hurts on right arm), VACCINATION SITE ERYTHEMA (big red ball that hurts on right arm), VACCINATION SITE PAIN (big red ball that hurts on right arm), HEADACHE (headache), NAUSEA (wants to throw up), PYREXIA (fever) and CHILLS (Chills) outcome was unknown.            This case was linked to MOD-2021-163692 (Patient Link).
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: trouble sleeping; dizziness; big red ball that hurts on right arm; big red ball that hurts on right arm; big red ball that hurts on right arm; headache; wants to throw up; fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (trouble sleeping), DIZZINESS (dizziness), VACCINATION SITE INDURATION (big red ball that hurts on right arm), VACCINATION SITE ERYTHEMA (big red ball that hurts on right arm) and VACCINATION SITE PAIN (big red ball that hurts on right arm) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D) for an unknown indication.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INSOMNIA (trouble sleeping), DIZZINESS (dizziness), VACCINATION SITE INDURATION (big red ball that hurts on right arm), VACCINATION SITE ERYTHEMA (big red ball that hurts on right arm), VACCINATION SITE PAIN (big red ball that hurts on right arm), HEADACHE (headache), NAUSEA (wants to throw up), PYREXIA (fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, INSOMNIA (trouble sleeping), DIZZINESS (dizziness), VACCINATION SITE INDURATION (big red ball that hurts on right arm), VACCINATION SITE ERYTHEMA (big red ball that hurts on right arm), VACCINATION SITE PAIN (big red ball that hurts on right arm), HEADACHE (headache), NAUSEA (wants to throw up), PYREXIA (fever) and CHILLS (Chills) outcome was unknown.            This case was linked to MOD-2021-163692 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Out of nowhere my arm is killing me; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Out of nowhere my arm is killing me) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Out of nowhere my arm is killing me). At the time of the report, VACCINATION SITE PAIN (Out of nowhere my arm is killing me) outcome was unknown.            Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain
Clinical narrative: Aches and Pains; Dizziness; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HEADACHE (Headaches) and PAIN (Aches and Pains) in a male 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced DIZZINESS (Dizziness), HEADACHE (Headaches) and PAIN (Aches and Pains). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.            Med Info Agent:  AE submitted via chatbot Patient stated that he received the second dose Moderna shot on 19May2021. Patient is still experiencing dizziness, headaches and aches and pains. Patient stated that these side effects would last only 2 to 3 days.  Patient wanted to know what he should do   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia
Clinical narrative: cramping in upper arms; muscle pain in forearms; 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 MUSCLE SPASMS (cramping in upper arms) and MYALGIA (muscle pain in forearms) 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 MUSCLE SPASMS (cramping in upper arms) and MYALGIA (muscle pain in forearms). At the time of the report, MUSCLE SPASMS (cramping in upper arms) and MYALGIA (muscle pain in forearms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment  medications were reported.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia, Myalgia, Vaccination site pain
Clinical narrative: Slept all day Saturday; Fatigued and tired; Body aches; Left arm where I got the shot was sore; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept all day Saturday), FATIGUE (Fatigued and tired), MYALGIA (Body aches) and VACCINATION SITE PAIN (Left arm where I got the shot was sore) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced FATIGUE (Fatigued and tired), MYALGIA (Body aches) and VACCINATION SITE PAIN (Left arm where I got the shot was sore). On 24-Apr-2021, the patient experienced HYPERSOMNIA (Slept all day Saturday). The patient was treated with PARACETAMOL (ACETAMINOPHEN) at a dose of UNK dosage form. On 25-Apr-2021, HYPERSOMNIA (Slept all day Saturday) had resolved. On 27-Apr-2021, FATIGUE (Fatigued and tired), MYALGIA (Body aches) and VACCINATION SITE PAIN (Left arm where I got the shot was sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: outcome of events updated.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test positive
Clinical narrative: After the First vacine i take the COVID; 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 SARS-COV-2 ANTIBODY TEST POSITIVE (After the First vacine i take the COVID) 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 SARS-COV-2 ANTIBODY TEST POSITIVE (After the First vacine i take the COVID). At the time of the report, SARS-COV-2 ANTIBODY TEST POSITIVE (After the First vacine i take the COVID) 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: U
Vaccine: COVID19
Symptoms: Pruritus, Swelling
Clinical narrative: swollen; itchy; 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 SWELLING (swollen) and PRURITUS (itchy) 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 SWELLING (swollen) and PRURITUS (itchy). At the time of the report, SWELLING (swollen) and PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment drugs were reported
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inflammation, Malaise, Musculoskeletal discomfort, Myalgia
Clinical narrative: Malaise; Neck pain; Inflammation; Patient states feeling heat around the injection site; after receiving the second dose of the Moderna Covid-19 Vaccine she states that has difficulties to move her arm; this days feels like a ball on the shoulder; lot of arm pain; tiredness; she states feeling lot of pain in the injected arm; redness around the injection site 2 dose; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Malaise), NECK PAIN (Neck pain), INFLAMMATION (Inflammation), VACCINATION SITE WARMTH (Patient states feeling heat around the injection site) and VACCINATION SITE MOVEMENT IMPAIRMENT (after receiving the second dose of the Moderna Covid-19 Vaccine she states that has difficulties to move her arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (Malaise), NECK PAIN (Neck pain), INFLAMMATION (Inflammation), VACCINATION SITE WARMTH (Patient states feeling heat around the injection site), VACCINATION SITE MOVEMENT IMPAIRMENT (after receiving the second dose of the Moderna Covid-19 Vaccine she states that has difficulties to move her arm), MUSCULOSKELETAL DISCOMFORT (this days feels like a ball on the shoulder), VACCINATION SITE PAIN (lot of arm pain), FATIGUE (tiredness), MYALGIA (she states feeling lot of pain in the injected arm) and VACCINATION SITE ERYTHEMA (redness around the injection site 2 dose). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency. At the time of the report, MALAISE (Malaise), NECK PAIN (Neck pain), INFLAMMATION (Inflammation), VACCINATION SITE WARMTH (Patient states feeling heat around the injection site), VACCINATION SITE MOVEMENT IMPAIRMENT (after receiving the second dose of the Moderna Covid-19 Vaccine she states that has difficulties to move her arm), MUSCULOSKELETAL DISCOMFORT (this days feels like a ball on the shoulder), VACCINATION SITE PAIN (lot of arm pain), FATIGUE (tiredness), MYALGIA (she states feeling lot of pain in the injected arm) and VACCINATION SITE ERYTHEMA (redness around the injection site 2 dose) outcome was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Vaccination site erythema, Vaccination site movement impairment, Vaccination site pain, Vaccination site warmth
Clinical narrative: Malaise; Neck pain; Inflammation; Patient states feeling heat around the injection site; after receiving the second dose of the Moderna Covid-19 Vaccine she states that has difficulties to move her arm; this days feels like a ball on the shoulder; lot of arm pain; tiredness; she states feeling lot of pain in the injected arm; redness around the injection site 2 dose; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Malaise), NECK PAIN (Neck pain), INFLAMMATION (Inflammation), VACCINATION SITE WARMTH (Patient states feeling heat around the injection site) and VACCINATION SITE MOVEMENT IMPAIRMENT (after receiving the second dose of the Moderna Covid-19 Vaccine she states that has difficulties to move her arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (Malaise), NECK PAIN (Neck pain), INFLAMMATION (Inflammation), VACCINATION SITE WARMTH (Patient states feeling heat around the injection site), VACCINATION SITE MOVEMENT IMPAIRMENT (after receiving the second dose of the Moderna Covid-19 Vaccine she states that has difficulties to move her arm), MUSCULOSKELETAL DISCOMFORT (this days feels like a ball on the shoulder), VACCINATION SITE PAIN (lot of arm pain), FATIGUE (tiredness), MYALGIA (she states feeling lot of pain in the injected arm) and VACCINATION SITE ERYTHEMA (redness around the injection site 2 dose). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency. At the time of the report, MALAISE (Malaise), NECK PAIN (Neck pain), INFLAMMATION (Inflammation), VACCINATION SITE WARMTH (Patient states feeling heat around the injection site), VACCINATION SITE MOVEMENT IMPAIRMENT (after receiving the second dose of the Moderna Covid-19 Vaccine she states that has difficulties to move her arm), MUSCULOSKELETAL DISCOMFORT (this days feels like a ball on the shoulder), VACCINATION SITE PAIN (lot of arm pain), FATIGUE (tiredness), MYALGIA (she states feeling lot of pain in the injected arm) and VACCINATION SITE ERYTHEMA (redness around the injection site 2 dose) outcome was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Cyst
Clinical narrative: Breast pain; Cyst; This spontaneous case was reported by a pharmacist and describes the occurrence of BREAST PAIN (Breast pain) and CYST (Cyst) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BREAST PAIN (Breast pain) and CYST (Cyst). At the time of the report, BREAST PAIN (Breast pain) and CYST (Cyst) 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.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: report a side effect; 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 ADVERSE EVENT (report a side effect) 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.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (report a side effect). At the time of the report, ADVERSE EVENT (report a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: Urinary tract infection; 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 URINARY TRACT INFECTION (Urinary tract infection) 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 URINARY TRACT INFECTION (Urinary tract infection). At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: I received my first dose but was then told that it may have been improperly stored.; 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 STORAGE ERROR (I received my first dose but was then told that it may have been improperly stored.) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (I received my first dose but was then told that it may have been improperly stored.). At the time of the report, PRODUCT STORAGE ERROR (I received my first dose but was then told that it may have been improperly stored.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that patient was informed after receiving the first dose that the clinic was suspended for improper storage and that the patient could have 2 more shots.Patient enquired if patient should have one more or 2 more doses. AE Submitted  No treatment medication was reported. No concomitant medication was provided.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) 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 22-May-2021, the patient experienced PYREXIA (Fever). On 22-May-2021, PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Eye infection
Clinical narrative: horrible case of eye infection; This spontaneous case was reported by a patient and describes the occurrence of EYE INFECTION (horrible case of eye infection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2. On an unknown date, the patient experienced EYE INFECTION (horrible case of eye infection). At the time of the report, EYE INFECTION (horrible case of eye infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  No treatment details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea shortly after second moderna 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 DIARRHOEA (diarrhea shortly after second 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 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 DIARRHOEA (diarrhea shortly after second moderna vaccine). At the time of the report, DIARRHOEA (diarrhea shortly after second moderna vaccine) outcome was unknown.            The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. no concomitant and treatment product was reported
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I gave a rash on my arm; 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 RASH (I gave a rash on my arm) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (I gave a rash on my arm). At the time of the report, RASH (I gave a rash on my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs and treatment medications were reported.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pyrexia
Clinical narrative: sick; high fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick) and PYREXIA (high fever) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-May-2021, the patient experienced PYREXIA (high fever). On an unknown date, the patient experienced ILLNESS (sick). At the time of the report, ILLNESS (sick) and PYREXIA (high fever) 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.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore left injection site arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B212A) for COVID-19 vaccination.     Concomitant products included DIPHENHYDRAMINE for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm). On 17-Apr-2021, VACCINATION SITE PAIN (Sore left injection site arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: chest pain; 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 CHEST PAIN (chest pain) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pain). At the time of the report, CHEST PAIN (chest pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment and concomitant medication information reported.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: feel sick; 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 MALAISE (feel sick) and PYREXIA (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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (feel sick) and PYREXIA (fever). At the time of the report, MALAISE (feel sick) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity, Vaccination site pain
Clinical narrative: could not raise the right arm and currently still can not/not being able to lift his arm as normal; when moving the arm out from his body it still hurts; arm is sore around the injection area; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (could not raise the right arm and currently still can not/not being able to lift his arm as normal), PAIN IN EXTREMITY (when moving the arm out from his body it still hurts) and VACCINATION SITE PAIN (arm is sore around the injection area) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018C21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, CALCIUM, METOPROLOL, OXYBUTYNIN HYDROCHLORIDE (OXIBUTIN), RIFAMPICIN (RIFAMPIN), MINOCYCLINE, AMLODIPINE BESILATE (AMLODIPINE BESYLATE), APIXABAN (ELIQUIS), MULTIVITAMIN [VITAMINS NOS], VITAMIN C [ASCORBIC ACID], ACETYLSALICYLIC ACID (ASAPRIN) and MELATONIN for an unknown indication.    On 24-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, the patient experienced LIMB DISCOMFORT (could not raise the right arm and currently still can not/not being able to lift his arm as normal), PAIN IN EXTREMITY (when moving the arm out from his body it still hurts) and VACCINATION SITE PAIN (arm is sore around the injection area). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (could not raise the right arm and currently still can not/not being able to lift his arm as normal), PAIN IN EXTREMITY (when moving the arm out from his body it still hurts) and VACCINATION SITE PAIN (arm is sore around the injection area) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (pharmacist got worse with second shot) 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 ADVERSE EVENT (pharmacist got worse with second shot). At the time of the report, ADVERSE EVENT (pharmacist got worse with second shot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Getting a some itching on my arm; 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 PRURITUS (Getting a some itching on my arm) 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 PRURITUS (Getting a some itching on my arm). At the time of the report, PRURITUS (Getting a some itching on my arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: strong menstrual cramps; bleeding bright red/Bright red spotting; hadn't had a period for over 9; This spontaneous case was reported by a consumer and describes the occurrence of DYSMENORRHOEA (strong menstrual cramps), HEAVY MENSTRUAL BLEEDING (bleeding bright red/Bright red spotting) and MENSTRUAL DISORDER (hadn't had a period for over 9) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 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 DYSMENORRHOEA (strong menstrual cramps), HEAVY MENSTRUAL BLEEDING (bleeding bright red/Bright red spotting) and MENSTRUAL DISORDER (hadn't had a period for over 9). At the time of the report, DYSMENORRHOEA (strong menstrual cramps), HEAVY MENSTRUAL BLEEDING (bleeding bright red/Bright red spotting) and MENSTRUAL DISORDER (hadn't had a period for over 9) outcome was unknown.            No concomitant and treatment medications were reported
Sex: U
Vaccine: COVID19
Symptoms: Mobility decreased, Vaccination site pain
Clinical narrative: can't raise that arm; extreme pain at the injection site weeks after 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 MOBILITY DECREASED (can't raise that arm) and VACCINATION SITE PAIN (extreme pain at the injection site weeks after 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) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (can't raise that arm) and VACCINATION SITE PAIN (extreme pain at the injection site weeks after the second vaccine). At the time of the report, MOBILITY DECREASED (can't raise that arm) and VACCINATION SITE PAIN (extreme pain at the injection site weeks after the second vaccine) outcome was unknown.            No concomitant medications were provided. No treatment information provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Arthritis, Spinal stenosis
Clinical narrative: spinal stenosis was worse; arthritis was worse; 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 SPINAL STENOSIS (spinal stenosis was worse) and ARTHRITIS (arthritis was worse) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Heart disorder, Spinal stenosis and Arthritis.    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 SPINAL STENOSIS (spinal stenosis was worse) and ARTHRITIS (arthritis was worse). At the time of the report, SPINAL STENOSIS (spinal stenosis was worse) and ARTHRITIS (arthritis was worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Joint range of motion decreased, Nasopharyngitis, Sinusitis, Vaccination site pain
Clinical narrative: cold symptoms; slept and her arm hurt terribly; was tired, described as real fatigue; arm felt heavy and sore, and could not lift it; sinus infection; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SINUSITIS (sinus infection), JOINT RANGE OF MOTION DECREASED (arm felt heavy and sore, and could not lift it), NASOPHARYNGITIS (cold symptoms), VACCINATION SITE PAIN (slept and her arm hurt terribly) and FATIGUE (was tired, described as real fatigue) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced JOINT RANGE OF MOTION DECREASED (arm felt heavy and sore, and could not lift it), VACCINATION SITE PAIN (slept and her arm hurt terribly) and FATIGUE (was tired, described as real fatigue). In May 2021, the patient experienced SINUSITIS (sinus infection). On 20-May-2021, the patient experienced NASOPHARYNGITIS (cold symptoms). On 17-May-2021, JOINT RANGE OF MOTION DECREASED (arm felt heavy and sore, and could not lift it), VACCINATION SITE PAIN (slept and her arm hurt terribly) and FATIGUE (was tired, described as real fatigue) had resolved. At the time of the report, SINUSITIS (sinus infection) and NASOPHARYNGITIS (cold symptoms) 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.