chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Skin burning sensation, Vaccination site erythema
Clinical narrative: Burns like a sunburn; Aches; Redness at the injection site; Pain at the injection site that is increasing; Swelling at the injection site; Fever; Headaches; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SKIN BURNING SENSATION (Burns like a sunburn), PAIN (Aches), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE PAIN (Pain at the injection site that is increasing) and VACCINATION SITE SWELLING (Swelling at the injection site) in a 45-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.     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 SKIN BURNING SENSATION (Burns like a sunburn), PAIN (Aches), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE PAIN (Pain at the injection site that is increasing), VACCINATION SITE SWELLING (Swelling at the injection site), PYREXIA (Fever) and HEADACHE (Headaches). At the time of the report, SKIN BURNING SENSATION (Burns like a sunburn), PAIN (Aches), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE PAIN (Pain at the injection site that is increasing), VACCINATION SITE SWELLING (Swelling at the injection site), PYREXIA (Fever) and HEADACHE (Headaches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator o No treatment medications provided by the reporter
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Burns like a sunburn; Aches; Redness at the injection site; Pain at the injection site that is increasing; Swelling at the injection site; Fever; Headaches; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SKIN BURNING SENSATION (Burns like a sunburn), PAIN (Aches), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE PAIN (Pain at the injection site that is increasing) and VACCINATION SITE SWELLING (Swelling at the injection site) in a 45-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.     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 SKIN BURNING SENSATION (Burns like a sunburn), PAIN (Aches), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE PAIN (Pain at the injection site that is increasing), VACCINATION SITE SWELLING (Swelling at the injection site), PYREXIA (Fever) and HEADACHE (Headaches). At the time of the report, SKIN BURNING SENSATION (Burns like a sunburn), PAIN (Aches), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE PAIN (Pain at the injection site that is increasing), VACCINATION SITE SWELLING (Swelling at the injection site), PYREXIA (Fever) and HEADACHE (Headaches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator o No treatment medications provided by the reporter
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia
Clinical narrative: Fever; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and PYREXIA (Fever) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced FATIGUE (Fatigue). On 21-Feb-2021, the patient experienced PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FATIGUE (Fatigue) and PYREXIA (Fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site swelling
Clinical narrative: Itchiness; Rash; Swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness), RASH (Rash) and VACCINATION SITE SWELLING (Swelling at injection site) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PRURITUS (Itchiness), RASH (Rash) and VACCINATION SITE SWELLING (Swelling at injection site). At the time of the report, PRURITUS (Itchiness), RASH (Rash) and VACCINATION SITE SWELLING (Swelling at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow-up received on 20-APR-2021 updated contact details.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Felt dizzy again; Dizziness walking around the house; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizziness walking around the house) and DIZZINESS (Felt dizzy again) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 06-Feb-2021, the patient experienced DIZZINESS (Dizziness walking around the house). On 22-Feb-2021, the patient experienced DIZZINESS (Felt dizzy again). On 30-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. On 08-Feb-2021, DIZZINESS (Dizziness walking around the house) had resolved. At the time of the report, DIZZINESS (Felt dizzy again) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment drugs were reported.   This case was linked to MOD-2021-026385, MOD-2021-026385 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin swelling
Clinical narrative: Redness; quite a bit of puffiness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness) and SKIN SWELLING (quite a bit of puffiness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Redness) and SKIN SWELLING (quite a bit of puffiness). At the time of the report, ERYTHEMA (Redness) and SKIN SWELLING (quite a bit of puffiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: A rash that I've got all over my body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (A rash that I've got all over my body) 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 25-Feb-2021, the patient experienced RASH (A rash that I've got all over my body). On 25-Feb-2021, RASH (A rash that I've got all over my body) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Endodontic procedure
Clinical narrative: have root cannel (surgery on a tooth); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ENDODONTIC PROCEDURE (have root cannel (surgery on a tooth)) 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 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 25-Feb-2021, the patient experienced ENDODONTIC PROCEDURE (have root cannel (surgery on a tooth)). On 25-Feb-2021, ENDODONTIC PROCEDURE (have root cannel (surgery on a tooth)) outcome was unknown.            The patient take antibiotics previously and after the procedure .
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN (soreness). At the time of the report, PAIN (soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Inappropriate schedule of product administration
Clinical narrative: got sick; can receive the vaccine at this time or not since it been more than 42 days; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ILLNESS (got sick) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (can receive the vaccine at this time or not since it been more than 42 days) 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 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (got sick) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (can receive the vaccine at this time or not since it been more than 42 days). At the time of the report, ILLNESS (got sick) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (can receive the vaccine at this time or not since it been more than 42 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Vaccination site dermatitis
Clinical narrative: Injection site was black and crusty broken skin (dime sized); Felt sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt sick) and VACCINATION SITE DERMATITIS (Injection site was black and crusty broken skin (dime sized)) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jan-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-Feb-2021, the patient experienced MALAISE (Felt sick). On 07-Feb-2021, the patient experienced VACCINATION SITE DERMATITIS (Injection site was black and crusty broken skin (dime sized)). At the time of the report, MALAISE (Felt sick) and VACCINATION SITE DERMATITIS (Injection site was black and crusty broken skin (dime sized)) had not resolved. Not Provided          No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Coronavirus test
Clinical narrative: Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Coronavirus test: (Positive) tested  positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Nasal dryness, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included SERTRALINE HYDROCHLORIDE (SERTAC) for an unknown indication. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medications provided by the reporter.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: experienced a redness all over his body; his left arm became itchy and swollen; his left arm became itchy and swollen; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (experienced a redness all over his body), VACCINATION SITE SWELLING (his left arm became itchy and swollen) and VACCINATION SITE PRURITUS (his left arm became itchy and swollen) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced ERYTHEMA (experienced a redness all over his body), VACCINATION SITE SWELLING (his left arm became itchy and swollen) and VACCINATION SITE PRURITUS (his left arm became itchy and swollen). On 25-Feb-2021, ERYTHEMA (experienced a redness all over his body), VACCINATION SITE SWELLING (his left arm became itchy and swollen) and VACCINATION SITE PRURITUS (his left arm became itchy and swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient take "pills for itchiness" and "pills for something else" patient was unsure about the medicines that were prescribed to him
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash, Injection site warmth, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (warm), PAIN IN EXTREMITY (sore), INJECTION SITE PAIN (got real hard when needle went it, still tender when she rub at injection site) and INJECTION SITE RASH (red rash around injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Medical history not provided. The patient's past medical history included No adverse event (no medical records). Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]), LISINOPRIL and PRAVASTATIN for an unknown indication, INSULIN GLARGINE (LANTUS), DULAGLUTIDE (TRULICITY), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), FERROUS SULFATE, VITAMINS NOS (MULTIVITAMINS PLUS IRON) and PARACETAMOL (TYLENOL). On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE WARMTH (warm), PAIN IN EXTREMITY (sore), INJECTION SITE PAIN (got real hard when needle went it, still tender when she rub at injection site) and INJECTION SITE RASH (red rash around injection site). At the time of the report, INJECTION SITE WARMTH (warm), PAIN IN EXTREMITY (sore), INJECTION SITE PAIN (got real hard when needle went it, still tender when she rub at injection site) and INJECTION SITE RASH (red rash around injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Movement disorder, Nausea, Taste disorder
Clinical narrative: nauseated; vomiting for 4 hours; strong metal taste in my mouth; got very weak; couldn't move; no appetite; This spontaneous case was reported by a physical therapist and describes the occurrence of TASTE DISORDER (strong metal taste in my mouth), ASTHENIA (got very weak), MOVEMENT DISORDER (couldn't move), DECREASED APPETITE (no appetite) and NAUSEA (nauseated) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history not provided.  The patient's past medical history included No adverse event. Concomitant products included lisnopril for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced TASTE DISORDER (strong metal taste in my mouth), ASTHENIA (got very weak), MOVEMENT DISORDER (couldn't move), DECREASED APPETITE (no appetite) and VOMITING (vomiting for 4 hours). On 25-Feb-2021, the patient experienced NAUSEA (nauseated). At the time of the report, TASTE DISORDER (strong metal taste in my mouth), ASTHENIA (got very weak), MOVEMENT DISORDER (couldn't move), DECREASED APPETITE (no appetite) and NAUSEA (nauseated) 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's Comments: Concomitant products included LISINOPRIL and CARVEDILOL (coreg) for unknown indication.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: nauseated; vomiting for 4 hours; strong metal taste in my mouth; got very weak; couldn't move; no appetite; This spontaneous case was reported by a physical therapist and describes the occurrence of TASTE DISORDER (strong metal taste in my mouth), ASTHENIA (got very weak), MOVEMENT DISORDER (couldn't move), DECREASED APPETITE (no appetite) and NAUSEA (nauseated) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history not provided.  The patient's past medical history included No adverse event. Concomitant products included lisnopril for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced TASTE DISORDER (strong metal taste in my mouth), ASTHENIA (got very weak), MOVEMENT DISORDER (couldn't move), DECREASED APPETITE (no appetite) and VOMITING (vomiting for 4 hours). On 25-Feb-2021, the patient experienced NAUSEA (nauseated). At the time of the report, TASTE DISORDER (strong metal taste in my mouth), ASTHENIA (got very weak), MOVEMENT DISORDER (couldn't move), DECREASED APPETITE (no appetite) and NAUSEA (nauseated) 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's Comments: Concomitant products included LISINOPRIL and CARVEDILOL (coreg) for unknown indication.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lymphadenopathy, Mass, Pruritus, Rash
Clinical narrative: it was red and itching; there was a lump there; it was red and itching; developed this terrible rash; the lymph nodes under my arm were swollen; left arm was very sore; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (it was red and itching), MASS (there was a lump there), ERYTHEMA (it was red and itching), VACCINATION SITE PAIN (left arm was very sore) and RASH (developed this terrible rash) in a 76-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.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (left arm was very sore). On 19-Feb-2021, the patient experienced PRURITUS (it was red and itching), MASS (there was a lump there), ERYTHEMA (it was red and itching), RASH (developed this terrible rash) and LYMPHADENOPATHY (the lymph nodes under my arm were swollen). On 11-Feb-2021, VACCINATION SITE PAIN (left arm was very sore) had resolved. On 21-Feb-2021, PRURITUS (it was red and itching), MASS (there was a lump there), ERYTHEMA (it was red and itching), RASH (developed this terrible rash) and LYMPHADENOPATHY (the lymph nodes under my arm were swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: it was red and itching; there was a lump there; it was red and itching; developed this terrible rash; the lymph nodes under my arm were swollen; left arm was very sore; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (it was red and itching), MASS (there was a lump there), ERYTHEMA (it was red and itching), VACCINATION SITE PAIN (left arm was very sore) and RASH (developed this terrible rash) in a 76-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.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (left arm was very sore). On 19-Feb-2021, the patient experienced PRURITUS (it was red and itching), MASS (there was a lump there), ERYTHEMA (it was red and itching), RASH (developed this terrible rash) and LYMPHADENOPATHY (the lymph nodes under my arm were swollen). On 11-Feb-2021, VACCINATION SITE PAIN (left arm was very sore) had resolved. On 21-Feb-2021, PRURITUS (it was red and itching), MASS (there was a lump there), ERYTHEMA (it was red and itching), RASH (developed this terrible rash) and LYMPHADENOPATHY (the lymph nodes under my arm were swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: Received second dose outside doisng interval; Pain at injection site (right) arm; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose outside doisng interval) and VACCINATION SITE PAIN (Pain at injection site (right) arm) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose outside doisng interval). 24-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site (right) arm). On 24-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose outside doisng interval) had resolved. At the time of the report, VACCINATION SITE PAIN (Pain at injection site (right) arm) outcome was unknown.            No concomitant medication information was provided. No treatment medication were provided.    This case was linked to MOD-2021-021891, MOD-2021-021891 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: email added.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot # 012A21A) with AE reported of vaccination site pain.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: occasionally itches  injection site; mild soreness around injection site; swollen injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (occasionally itches  injection site), INJECTION SITE PAIN (mild soreness around injection site) and INJECTION SITE SWELLING (swollen injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Wheelchair user.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. In February 2021, the patient experienced INJECTION SITE PRURITUS (occasionally itches  injection site), INJECTION SITE PAIN (mild soreness around injection site) and INJECTION SITE SWELLING (swollen injection site). At the time of the report, INJECTION SITE PRURITUS (occasionally itches  injection site), INJECTION SITE PAIN (mild soreness around injection site) and INJECTION SITE SWELLING (swollen injection site) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided. Action taken with mRNA-123 is not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pruritus, Rash
Clinical narrative: itchiness; warmness; rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness), FEELING HOT (warmness) and RASH (rash) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PRURITUS (itchiness), FEELING HOT (warmness) and RASH (rash). On 16-Feb-2021, PRURITUS (itchiness), FEELING HOT (warmness) and RASH (rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Delayed Arm soreness; Arm warm to the touch; Delayed Arm redness; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Delayed Arm soreness), VACCINATION SITE WARMTH (Arm warm to the touch), VACCINATION SITE PAIN (injection site pain) and VACCINATION SITE ERYTHEMA (Delayed Arm redness) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced VACCINATION SITE PAIN (injection site pain). On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (Delayed Arm soreness), VACCINATION SITE WARMTH (Arm warm to the touch) and VACCINATION SITE ERYTHEMA (Delayed Arm redness). At the time of the report, PAIN IN EXTREMITY (Delayed Arm soreness), VACCINATION SITE WARMTH (Arm warm to the touch), VACCINATION SITE PAIN (injection site pain) and VACCINATION SITE ERYTHEMA (Delayed Arm redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little sore arm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included OMEPRAZOLE and MULTIVITAMINS & MINERALS PLUS LUTEIN for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (little sore arm). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (little sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Vaccination site pain
Clinical narrative: left arm is still very sore; still doesn't have full range of motion without a lot of pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (still doesn't have full range of motion without a lot of pain) and VACCINATION SITE PAIN (left arm is still very sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical records).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (still doesn't have full range of motion without a lot of pain). On an unknown date, the patient experienced VACCINATION SITE PAIN (left arm is still very sore). At the time of the report, ABDOMINAL DISCOMFORT (still doesn't have full range of motion without a lot of pain) and VACCINATION SITE PAIN (left arm is still very sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Eye infection
Clinical narrative: eye infection; This spontaneous case was reported by a consumer and describes the occurrence of EYE INFECTION (eye infection) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced EYE INFECTION (eye infection). At the time of the report, EYE INFECTION (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.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy, Vaccination site rash
Clinical narrative: rash(injection site); Inflamed lymph node a week after receiving the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE RASH (rash(injection site)) and VACCINATION SITE LYMPHADENOPATHY (Inflamed lymph node a week after receiving the first dose) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 RASH (rash(injection site)) and VACCINATION SITE LYMPHADENOPATHY (Inflamed lymph node a week after receiving the first dose). At the time of the report, VACCINATION SITE RASH (rash(injection site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment details were not provided.   Reporter did not allow further contact
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 31-Jan-2021, PAIN IN EXTREMITY (sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.   Treatment information include 'rubbed hand with alcohol'.   Reporter did not allow further contact
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Raynaud's phenomenon
Clinical narrative: injection site swelling; Ryanoid phenomenon (cold hands); This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (injection site swelling) and RAYNAUD'S PHENOMENON (Ryanoid phenomenon (cold hands)) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Raynaud's disease.   On 23-Feb-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) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced INJECTION SITE SWELLING (injection site swelling) and RAYNAUD'S PHENOMENON (Ryanoid phenomenon (cold hands)). At the time of the report, INJECTION SITE SWELLING (injection site swelling) and RAYNAUD'S PHENOMENON (Ryanoid phenomenon (cold hands)) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea
Clinical narrative: really nauseous; do not feel good; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (really nauseous) and MALAISE (do not feel good) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.     On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced NAUSEA (really nauseous) and MALAISE (do not feel good). The patient was treated with ONDANSETRON at a dose of UNK dosage form. At the time of the report, NAUSEA (really nauseous) and MALAISE (do not feel good) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site erythema, Oral pain, Oropharyngeal pain, Pain in extremity
Clinical narrative: sore throat; running nose; Headache; cold sore of mouth; sore arm; injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (running nose), ORAL PAIN (cold sore of mouth), PAIN IN EXTREMITY (sore arm) and INJECTION SITE ERYTHEMA (injection site redness) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and INJECTION SITE ERYTHEMA (injection site redness). On 12-Jan-2021, the patient experienced ORAL PAIN (cold sore of mouth). On 14-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (running nose) and HEADACHE (Headache). At the time of the report, OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (running nose), ORAL PAIN (cold sore of mouth), PAIN IN EXTREMITY (sore arm), INJECTION SITE ERYTHEMA (injection site redness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: sore throat; running nose; Headache; cold sore of mouth; sore arm; injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (running nose), ORAL PAIN (cold sore of mouth), PAIN IN EXTREMITY (sore arm) and INJECTION SITE ERYTHEMA (injection site redness) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and INJECTION SITE ERYTHEMA (injection site redness). On 12-Jan-2021, the patient experienced ORAL PAIN (cold sore of mouth). On 14-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (running nose) and HEADACHE (Headache). At the time of the report, OROPHARYNGEAL PAIN (sore throat), RHINORRHOEA (running nose), ORAL PAIN (cold sore of mouth), PAIN IN EXTREMITY (sore arm), INJECTION SITE ERYTHEMA (injection site redness) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Vaccination site pain
Clinical narrative: arm soreness; excessive fatigue; flu-like symptoms; chills; A spontaneous report was received from a consumer concerning a 87-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, flu-like symptoms, arm soreness, excessive fatigue, had to lay down yesterday.  The patient's medical history was not provided. Concomitant medications reported were Lipitor for an unknown indication and eye drops for glaucoma.  On 22 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 029L20A) intramuscularly for prophylaxis of COVID-19 infection. On 16 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient experienced the event(s) chills, flu-like symptoms. On 16 Feb 2021, the patient experienced the event(s) arm soreness, excessive fatigue. On 24 Feb 2021, the patient experienced the event(s) had to lay down yesterday.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of event(s), chills, flu-like symptoms, arm soreness, excessive fatigue, had to lay down yesterday was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Administration site warmth, Erythema, Injection site pain, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection site soreness), PAIN IN EXTREMITY (arm pain), ERYTHEMA (redness) and ADMINISTRATION SITE WARMTH (arm Warm to touch) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (no medical records). On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced INJECTION SITE PAIN (injection site soreness). On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm pain), ERYTHEMA (redness) and ADMINISTRATION SITE WARMTH (arm Warm to touch). At the time of the report, INJECTION SITE PAIN (injection site soreness), PAIN IN EXTREMITY (arm pain), ERYTHEMA (redness) and ADMINISTRATION SITE WARMTH (arm Warm to touch) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (my arm was bad) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 001A21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (my arm was bad). At the time of the report, PAIN IN EXTREMITY (my arm was bad) had resolved. Concomitant products and treatment information were not provided. Action taken with mRNA-1273 in response to the events was not applicable. This case was linked to MOD21-038530.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Insomnia, Nausea
Clinical narrative: lack of appetite; body shaking; I could not go back to sleep; just really debilitating; Fever at 100.5; chills; Pretty bad nausea; Teeth chattering; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (lack of appetite), TREMOR (body shaking), INSOMNIA (I could not go back to sleep), ASTHENIA (just really debilitating) and PYREXIA (Fever at 100.5) in a female patient of an unknown age 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.     The patient's past medical history included No adverse event (No medical history provided.).    On 23-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced DECREASED APPETITE (lack of appetite), TREMOR (body shaking), INSOMNIA (I could not go back to sleep), ASTHENIA (just really debilitating), PYREXIA (Fever at 100.5), CHILLS (chills), NAUSEA (Pretty bad nausea) and CHILLS (Teeth chattering). At the time of the report, DECREASED APPETITE (lack of appetite), TREMOR (body shaking), INSOMNIA (I could not go back to sleep), ASTHENIA (just really debilitating), PYREXIA (Fever at 100.5), CHILLS (chills), NAUSEA (Pretty bad nausea) and CHILLS (Teeth chattering) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment information included Tylenol all day throughout the day on 23 Feb 2021.   Reporter did not allow further contact