chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pyrexia
Clinical narrative: No energy since the 2nd dose/weak; Tired since the 2nd dose; Bigger knot on side of neck after 2nd dose; ache and pain; headache; a pain in the left side of the neck; temperature is 99.3 degrees; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (No energy since the 2nd dose/weak), FATIGUE (Tired since the 2nd dose), NECK MASS (Bigger knot on side of neck after 2nd dose), MYALGIA (ache and pain) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not provided) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced NECK MASS (Bigger knot on side of neck after 2nd dose), MYALGIA (ache and pain), HEADACHE (headache), NECK PAIN (a pain in the left side of the neck) and PYREXIA (temperature is 99.3 degrees). On an unknown date, the patient experienced ASTHENIA (No energy since the 2nd dose/weak) and FATIGUE (Tired since the 2nd dose). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form. At the time of the report, ASTHENIA (No energy since the 2nd dose/weak), FATIGUE (Tired since the 2nd dose), NECK MASS (Bigger knot on side of neck after 2nd dose), MYALGIA (ache and pain), HEADACHE (headache), NECK PAIN (a pain in the left side of the neck) and PYREXIA (temperature is 99.3 degrees) outcome was unknown.            Concomitant medications were not reported.   This case was linked to MOD-2021-049400 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Due to system limitation IRD captured as latest present in system 02-JUN-21 instead of backdated IRD of 17-APR-21.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Diarrhea; Vomiting; 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) and VOMITING (Vomiting) 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, 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) and VOMITING (Vomiting). At the time of the report, DIARRHOEA (Diarrhea) and VOMITING (Vomiting) outcome was unknown.            No concomitant medications were reported. Treatment details were not provided.   This case was linked to MOD-2021-206890 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site dysaesthesia
Clinical narrative: Magnets stick to her vaccination site; Fever exceeding 102; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE DYSAESTHESIA (Magnets stick to her vaccination site) and PYREXIA (Fever exceeding 102) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. 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 SITE DYSAESTHESIA (Magnets stick to her vaccination site) and PYREXIA (Fever exceeding 102). At the time of the report, VACCINATION SITE DYSAESTHESIA (Magnets stick to her vaccination site) and PYREXIA (Fever exceeding 102) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (Inconclusive) 102.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: hand in pain on the same arm as injection; 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 MYALGIA (hand in pain on the same arm as injection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by the reporter.     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 MYALGIA (hand in pain on the same arm as injection). At the time of the report, MYALGIA (hand in pain on the same arm as injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided by the reporter. No  concomitant medications  provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: usual side effects; 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 (usual side effects) 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 (usual side effects). At the time of the report, VACCINATION COMPLICATION (usual side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: terrible muscle spasms after first dose; 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 (terrible muscle spasms after first dose) 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 MUSCLE SPASMS (terrible muscle spasms after first dose). At the time of the report, MUSCLE SPASMS (terrible muscle spasms after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Somnolence
Clinical narrative: have been sleeping both afternoon and night; pain in arm; After the second dose also i have extreme fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (have been sleeping both afternoon and night), PAIN IN EXTREMITY (pain in arm) and FATIGUE (After the second dose also i have extreme fatigue) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 049C21A) for COVID-19 vaccination.     Concomitant products included LOSARTAN for Blood pressure, METFORMIN for Diabetes, HYDROCHLOROTHIAZIDE, BUPROPION HYDROCHLORIDE (WELLBUTRIN), CLONAZEPAM (KLONOPIN), ROSUVASTATIN CALCIUM (CRESTOR) and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.   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 SOMNOLENCE (have been sleeping both afternoon and night), PAIN IN EXTREMITY (pain in arm) and FATIGUE (After the second dose also i have extreme fatigue). On 29-May-2021, PAIN IN EXTREMITY (pain in arm) had resolved. At the time of the report, SOMNOLENCE (have been sleeping both afternoon and night) and FATIGUE (After the second dose also i have extreme fatigue) outcome was unknown.            No treatment medications were provided.   Patient felt full day sleeping only got up for dinner.   This case was linked to MOD-2021-117012 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Condition aggravated
Clinical narrative: autoimmune disease flareups; Condition aggravated; 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 AUTOIMMUNE DISORDER (autoimmune disease flareups) and CONDITION AGGRAVATED (Condition aggravated) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (autoimmune disease flareups) and CONDITION AGGRAVATED (Condition aggravated). At the time of the report, AUTOIMMUNE DISORDER (autoimmune disease flareups) and CONDITION AGGRAVATED (Condition aggravated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.   No treatment medication was reported.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  further information has been requested; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  further information has been requested
Sex: U
Vaccine: COVID19
Symptoms: Chromaturia
Clinical narrative: Urine is a very strange color; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of CHROMATURIA (Urine is a very strange color) 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, 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 CHROMATURIA (Urine is a very strange color). At the time of the report, CHROMATURIA (Urine is a very strange color) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was reported   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: past by 2 weeks for the second shot - second dose not administered within 35 days interval; 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 (past by 2 weeks for the second shot - second dose not administered within 35 days interval) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (past by 2 weeks for the second shot - second dose not administered within 35 days interval). At the time of the report, PRODUCT DOSE OMISSION ISSUE (past by 2 weeks for the second shot - second dose not administered within 35 days interval) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever over 100; 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 over 100) 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 (Fever over 100). At the time of the report, PYREXIA (Fever over 100) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient took medication for fever.  Concomitant medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Feeling cold, Feeling hot, Myalgia
Clinical narrative: feeling Hot; feeling cold; feeling 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 FEELING HOT (feeling Hot), FEELING COLD (feeling cold) and MYALGIA (feeling 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (feeling Hot), FEELING COLD (feeling cold) and MYALGIA (feeling pain). At the time of the report, FEELING HOT (feeling Hot), FEELING COLD (feeling cold) and MYALGIA (feeling pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported No treatment medication was reported
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Axillary pain, Breast mass, Breast pain, Swelling
Clinical narrative: ball in breast doesn't hurt unless it is pressed; felt a ball in right breast; ball hurt; a little ball in left armpit; After two days ball was bigger and after two more days it was gone; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (a little ball in left armpit), SWELLING (After two days ball was bigger and after two more days it was gone), BREAST MASS (felt a ball in right breast), BREAST PAIN (ball in breast doesn't hurt unless it is pressed) and AXILLARY PAIN (ball hurt) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) 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) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced AXILLARY MASS (a little ball in left armpit), SWELLING (After two days ball was bigger and after two more days it was gone) and AXILLARY PAIN (ball hurt). On 16-May-2021, the patient experienced BREAST MASS (felt a ball in right breast). On an unknown date, the patient experienced BREAST PAIN (ball in breast doesn't hurt unless it is pressed). On 14-May-2021, AXILLARY MASS (a little ball in left armpit), SWELLING (After two days ball was bigger and after two more days it was gone) and AXILLARY PAIN (ball hurt) had resolved. At the time of the report, BREAST MASS (felt a ball in right breast) and BREAST PAIN (ball in breast doesn't hurt unless it is pressed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by reporter. Treatment information not reported.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore right arm), PYREXIA (low grade fevers), HYPERHIDROSIS (sweats, with his tee shirt getting wet from sweat), HEADACHE (headache) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for an unreported indication: FLU. 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 MYALGIA (sore right arm), PYREXIA (low grade fevers), HYPERHIDROSIS (sweats, with his tee shirt getting wet from sweat), HEADACHE (headache), CHILLS (chills), ARTHRALGIA (severe pain in his joints, sustained joint pain) and FATIGUE (fatigue). The patient was treated with MONTELUKAST SODIUM (SINGULAIR) at an unspecified dose and frequency and GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE (MUCINEX D) at an unspecified dose and frequency. At the time of the report, MYALGIA (sore right arm), PYREXIA (low grade fevers), HYPERHIDROSIS (sweats, with his tee shirt getting wet from sweat), HEADACHE (headache), CHILLS (chills), ARTHRALGIA (severe pain in his joints, sustained joint pain) and FATIGUE (fatigue) 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.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore right arm), PYREXIA (low grade fevers), HYPERHIDROSIS (sweats, with his tee shirt getting wet from sweat), HEADACHE (headache) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for an unreported indication: FLU. 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 MYALGIA (sore right arm), PYREXIA (low grade fevers), HYPERHIDROSIS (sweats, with his tee shirt getting wet from sweat), HEADACHE (headache), CHILLS (chills), ARTHRALGIA (severe pain in his joints, sustained joint pain) and FATIGUE (fatigue). The patient was treated with MONTELUKAST SODIUM (SINGULAIR) at an unspecified dose and frequency and GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE (MUCINEX D) at an unspecified dose and frequency. At the time of the report, MYALGIA (sore right arm), PYREXIA (low grade fevers), HYPERHIDROSIS (sweats, with his tee shirt getting wet from sweat), HEADACHE (headache), CHILLS (chills), ARTHRALGIA (severe pain in his joints, sustained joint pain) and FATIGUE (fatigue) 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination error
Clinical narrative: Vaccine administered to patient right away before defrosting; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION ERROR (Vaccine administered to patient right away before defrosting) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced VACCINATION ERROR (Vaccine administered to patient right away before defrosting). At the time of the report, VACCINATION ERROR (Vaccine administered to patient right away before defrosting) 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 relevant concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever went over 100; 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 went over 100) 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 (Fever went over 100). At the time of the report, PYREXIA (Fever went over 100) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication were not provided.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Feeling hot, Headache, Myalgia
Clinical narrative: Hotness; Pain in the lower back; Body aches; chills; headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Jun-2021 and was forwarded to Moderna on 02-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Hotness), BACK PAIN (Pain in the lower back), MYALGIA (Body aches), CHILLS (chills) and HEADACHE (headache) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Hotness), BACK PAIN (Pain in the lower back), MYALGIA (Body aches), CHILLS (chills) and HEADACHE (headache). At the time of the report, FEELING HOT (Hotness), BACK PAIN (Pain in the lower back), MYALGIA (Body aches), CHILLS (chills) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient thinks that pain is due to effort  made in lifting chair.  No Treatment and concomitant medicines were reported
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site reaction
Clinical narrative: Magnetic clip sticking on injection site; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Magnetic clip sticking on injection site) and PYREXIA (Fever) in a 38-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) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced VACCINATION SITE REACTION (Magnetic clip sticking on injection site) and PYREXIA (Fever). At the time of the report, VACCINATION SITE REACTION (Magnetic clip sticking on injection site) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) high.         Patient has allergies with poison .  No concomitant medications were reported. No treatment medication medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Red rash on the injected arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Red rash on the injected 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 22-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced VACCINATION SITE RASH (Red rash on the injected arm). At the time of the report, VACCINATION SITE RASH (Red rash on the injected arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported.   No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; 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 CHILLS (Chills) 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 CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications was not given.  Concomitant medication were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pains; 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 ARTHRALGIA (Joint pains) 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 ARTHRALGIA (Joint pains). At the time of the report, ARTHRALGIA (Joint pains) outcome was unknown.            Concomitant medications were not reported.  No treatment details were provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Movement disorder, Myalgia, Pain in extremity, Peripheral swelling, Vitamin D
Clinical narrative: difficult in climbling chair, squatting and getting up from the chair; swollen hands; Increased pain in shoulders,hands.; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Increased pain in shoulders,hands.), PERIPHERAL SWELLING (swollen hands), MOVEMENT DISORDER (difficult in climbling chair, squatting and getting up from the chair) and MYALGIA (Muscle pain) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Medical history was not provided.  Concomitant products included VITAMIN D3 from 16-Mar-2021 to an unknown date for Vitamin D deficiency.    On 29-Mar-2021 at 1:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (Increased pain in shoulders,hands.) and MYALGIA (Muscle pain). On 12-Apr-2021, the patient experienced PERIPHERAL SWELLING (swollen hands). On an unknown date, the patient experienced MOVEMENT DISORDER (difficult in climbling chair, squatting and getting up from the chair). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Increased pain in shoulders,hands.), PERIPHERAL SWELLING (swollen hands) and MYALGIA (Muscle pain) had not resolved and MOVEMENT DISORDER (difficult in climbling chair, squatting and getting up from the chair) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vitamin D: 29 (Low) low.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA 1273 with the events was considered as not applicable.  Patient reported that he had his appointment with PA on 18 June to repeat the blood work.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jun-2021: Follow-up document received. Added reporter information, patient demographics(age, height, weight, race and ethnic group),laboratory details, concomitant medication, new events( peripheral swelling and moment disorder).
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient has not received the second dose of Moderna vaccine within the appropriate window of time between two doses; 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 (Patient has not received the second dose of Moderna vaccine within the appropriate window of time between two doses) 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 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose of Moderna vaccine within the appropriate window of time between two doses). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose of Moderna vaccine within the appropriate window of time between two doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that Patient was getting close to day 42 after the first dose was received at the time of report.  No relevant concomitant medications reported.  No treatment information was provided.    Reporter did not allow further contact
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, Polymerase chain reaction
Clinical narrative: Second shot is greater than day 35; COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second shot is greater than day 35) and COVID-19 (COVID-19) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L208 and 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Codeine) and Osteoarthritis.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced COVID-19 (COVID-19). On 02-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second shot is greater than day 35). The patient was treated with HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE/ACETAMINOPHEN) (oral) on 29-Jun-2021 for Pain, at a dose of UNK mg, prn. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second shot is greater than day 35) had resolved and COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Polymerase chain reaction: positive (Positive) Tested positive for COVID-19.         No concomitant medication was reported. The reporter stated that the patient was given second dose greater than 35 days after the first dose due to patient tested positive for COVID-19 on 10-Feb-2021 and patient did not exhibit adverse reactions due to timing of vaccine dose.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow-up contains significant information. The medical history added. The lab data information was added. The dose 1 and dose 2 details were added. The treatment medication were added. The event occurred after dose 1 was added.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Influenza like illness, Pruritus, Sluggishness, Urticaria
Clinical narrative: dizzy/ light heady; Sluggish; began to itch; Hives all over/ broke out in hives from head to toe; flu like symptoms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives all over/ broke out in hives from head to toe), INFLUENZA LIKE ILLNESS (flu like symptoms), DIZZINESS (dizzy/ light heady), SLUGGISHNESS (Sluggish) and PRURITUS (began to itch) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 013M20A) for COVID-19 vaccination.     The patient's past medical history included Back disorder NOS (Improved after surgery) in September 1988, Prostatic disorder NOS (Improved after surgery) on 20-Feb-2018 and Mitral valve prolapse (Improved after surgery) in December 2018. Concurrent medical conditions included Drug allergy (Allergy to codeine), Drug allergy (Allergy to vancomycin), Drug allergy (Allergy to tetracycline), Drug allergy (Allergy to doxycycline) and Barrett's esophagus (Taking medication) in December 1991. Concomitant products included MELOXICAM for Arthritis, OMEPRAZOLE for Barrett's esophagus, ROSUVASTATIN for Cholesterol, LATANOPROST for Glaucoma, PROPRANOLOL for Migraine and Heart disorder, DUTASTERIDE for Prostatic disorder NOS.   On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). On 22-Mar-2021, the patient experienced URTICARIA (Hives all over/ broke out in hives from head to toe). On an unknown date, the patient experienced DIZZINESS (dizzy/ light heady), SLUGGISHNESS (Sluggish) and PRURITUS (began to itch). The patient was treated with HYDROXYZINE EMBONATE (VISTARIL [HYDROXYZINE EMBONATE]) for Adverse event, at a dose of 25 milligram every six hours and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itch, at a dose of UNK dosage form, q4h. On 21-Mar-2021, INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved. On 01-Apr-2021, URTICARIA (Hives all over/ broke out in hives from head to toe) had resolved. At the time of the report, DIZZINESS (dizzy/ light heady) and SLUGGISHNESS (Sluggish) outcome was unknown and PRURITUS (began to itch) had resolved. Not Provided          The patient reported that he visited the primary care physician for the hives and was given a prescription for Vistaril. He reported that he discontinued the medication and took Benadryl for the itch.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: low grade 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 (low grade 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 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 (low grade fever). At the time of the report, PYREXIA (low grade fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blepharospasm
Clinical narrative: eyelid twitching; 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 BLEPHAROSPASM (eyelid twitching) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by the reporter. .     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On an unknown date, the patient experienced BLEPHAROSPASM (eyelid twitching). At the time of the report, BLEPHAROSPASM (eyelid twitching) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided by the reporter. No  concomitant medical  provided by the reporter.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Vomiting; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting) and DIARRHOEA (Diarrhea) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced VOMITING (Vomiting) and DIARRHOEA (Diarrhea). At the time of the report, VOMITING (Vomiting) and DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included Diabetes medications.  Treatment medications was not given.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever (98.1 degrees fahrenheit); 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 (98.1 degrees fahrenheit)) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concomitant products included COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.   On 01-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced PYREXIA (Fever (98.1 degrees fahrenheit)). The patient was treated with IBUPROFEN at a dose of 1 DF. At the time of the report, PYREXIA (Fever (98.1 degrees fahrenheit)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jun-2021, Body temperature: 98.1 (High) fever (98.1 degrees Fahrenheit)..         The patient took Ibuprofen as a treatment of the symptom.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-201926 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain
Clinical narrative: My ribs hurt after getting the shot yesterday; 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 MUSCULOSKELETAL CHEST PAIN (My ribs hurt after getting the shot yesterday) 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 MUSCULOSKELETAL CHEST PAIN (My ribs hurt after getting the shot yesterday). At the time of the report, MUSCULOSKELETAL CHEST PAIN (My ribs hurt after getting the shot yesterday) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were given  No treatment information was provided
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dandruff, Dry skin, Headache, Influenza like illness
Clinical narrative: Flu like symptoms; late period; dandruff; dry scalp; fever; increased heart rate; Chills; Headache; Leg ached; Arm ached; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache), PAIN IN EXTREMITY (Leg ached), MYALGIA (Arm ached) and INFLUENZA LIKE ILLNESS (Flu like symptoms   ) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache), PAIN IN EXTREMITY (Leg ached) and MYALGIA (Arm ached). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms   ), MENSTRUATION DELAYED (late period   ), DANDRUFF (dandruff   ), DRY SKIN (dry scalp   ), PYREXIA (fever   ) and TACHYCARDIA (increased heart rate). At the time of the report, CHILLS (Chills), HEADACHE (Headache), MYALGIA (Arm ached), INFLUENZA LIKE ILLNESS (Flu like symptoms   ), MENSTRUATION DELAYED (late period   ), DRY SKIN (dry scalp   ), PYREXIA (fever   ) and TACHYCARDIA (increased heart rate) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-202148.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Myalgia, Pain in extremity, Pyrexia, Tachycardia
Clinical narrative: Flu like symptoms; late period; dandruff; dry scalp; fever; increased heart rate; Chills; Headache; Leg ached; Arm ached; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache), PAIN IN EXTREMITY (Leg ached), MYALGIA (Arm ached) and INFLUENZA LIKE ILLNESS (Flu like symptoms   ) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache), PAIN IN EXTREMITY (Leg ached) and MYALGIA (Arm ached). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms   ), MENSTRUATION DELAYED (late period   ), DANDRUFF (dandruff   ), DRY SKIN (dry scalp   ), PYREXIA (fever   ) and TACHYCARDIA (increased heart rate). At the time of the report, CHILLS (Chills), HEADACHE (Headache), MYALGIA (Arm ached), INFLUENZA LIKE ILLNESS (Flu like symptoms   ), MENSTRUATION DELAYED (late period   ), DRY SKIN (dry scalp   ), PYREXIA (fever   ) and TACHYCARDIA (increased heart rate) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-202148.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: little itchy rash where she had the vaccine; little itchy rash where she had the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (little itchy rash where she had the vaccine) and VACCINATION SITE RASH (little itchy rash where she had the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (little itchy rash where she had the vaccine) and VACCINATION SITE RASH (little itchy rash where she had the vaccine). At the time of the report, VACCINATION SITE PRURITUS (little itchy rash where she had the vaccine) and VACCINATION SITE RASH (little itchy rash where she had the vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant or treatment medication has been reported.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: Has all the symptoms of covid; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (Has all the symptoms of covid) 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 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 01-Jun-2021, the patient experienced SUSPECTED COVID-19 (Has all the symptoms of covid). At the time of the report, SUSPECTED COVID-19 (Has all the symptoms of covid) outcome was unknown.            No relevant concomitant medications reported.  No treatment information was provided.