chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Ocular hyperaemia, Pyrexia
Clinical narrative: nauseous; joint aches; temperature 102 degrees Farenheight; headache which lasted for several hours; eyes blood shot; face red; Chills/shaking; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (eyes blood shot), ERYTHEMA (face red), CHILLS (Chills/shaking), NAUSEA (nauseous) and ARTHRALGIA (joint aches) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included PARACETAMOL (ACETAMINOPHEN) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (Chills/shaking). On an unknown date, the patient experienced OCULAR HYPERAEMIA (eyes blood shot), ERYTHEMA (face red), NAUSEA (nauseous), ARTHRALGIA (joint aches), PYREXIA (temperature 102 degrees Farenheight) and HEADACHE (headache which lasted for several hours). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, OCULAR HYPERAEMIA (eyes blood shot), ERYTHEMA (face red), CHILLS (Chills/shaking), NAUSEA (nauseous), ARTHRALGIA (joint aches) and PYREXIA (temperature 102 degrees Farenheight) outcome was unknown and HEADACHE (headache which lasted for several hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 degrees farenheight (High) 102 degrees farenheight.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Lethargy
Clinical narrative: felt lethargic; felt bloated; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (felt lethargic) and ABDOMINAL DISTENSION (felt bloated) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, the patient experienced LETHARGY (felt lethargic) and ABDOMINAL DISTENSION (felt bloated). At the time of the report, LETHARGY (felt lethargic) and ABDOMINAL DISTENSION (felt bloated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-355582 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Nausea, Vaccination site erythema, Vaccination site induration
Clinical narrative: feel a little sick, and horrible.; huge red circle in her left arm, and is hard and swollen like a golf ball; huge red circle in her left arm, and is hard and swollen like a golf ball; huge red circle in her left arm, and is hard and swollen like a golf ball; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (feel a little sick, and horrible.), VACCINATION SITE ERYTHEMA (huge red circle in her left arm, and is hard and swollen like a golf ball), VACCINATION SITE INDURATION (huge red circle in her left arm, and is hard and swollen like a golf ball), VACCINATION SITE SWELLING (huge red circle in her left arm, and is hard and swollen like a golf ball) and NAUSEA (nausea) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011f21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Immunocompromised. Concomitant products included TRAMADOL, LEVOTHYROXINE SODIUM (SYNTHROID), ATORVASTATIN CALCIUM (LIPITROL [ATORVASTATIN CALCIUM]), VITAMIN D [VITAMIN D NOS], MIRABEGRON (MYRBETRIQ) and SALBUTAMOL (ALBUTEROL HFA) for an unknown indication.    On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Oct-2021, the patient experienced ILLNESS (feel a little sick, and horrible.), VACCINATION SITE ERYTHEMA (huge red circle in her left arm, and is hard and swollen like a golf ball), VACCINATION SITE INDURATION (huge red circle in her left arm, and is hard and swollen like a golf ball), VACCINATION SITE SWELLING (huge red circle in her left arm, and is hard and swollen like a golf ball), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, ILLNESS (feel a little sick, and horrible.), VACCINATION SITE ERYTHEMA (huge red circle in her left arm, and is hard and swollen like a golf ball), VACCINATION SITE INDURATION (huge red circle in her left arm, and is hard and swollen like a golf ball), VACCINATION SITE SWELLING (huge red circle in her left arm, and is hard and swollen like a golf ball), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no treatment medication were reported.  patient got the first dose of moderna vaccine on 15March202 with batch number 002b21a and received second dose on 12April2021 with lot number 031a21a both on her left arm.  She mention that on the 13April2021 felt tired, and didn't take anything and that symptom went away on the 14April2021.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: feel a little sick, and horrible.; huge red circle in her left arm, and is hard and swollen like a golf ball; huge red circle in her left arm, and is hard and swollen like a golf ball; huge red circle in her left arm, and is hard and swollen like a golf ball; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (feel a little sick, and horrible.), VACCINATION SITE ERYTHEMA (huge red circle in her left arm, and is hard and swollen like a golf ball), VACCINATION SITE INDURATION (huge red circle in her left arm, and is hard and swollen like a golf ball), VACCINATION SITE SWELLING (huge red circle in her left arm, and is hard and swollen like a golf ball) and NAUSEA (nausea) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011f21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Immunocompromised. Concomitant products included TRAMADOL, LEVOTHYROXINE SODIUM (SYNTHROID), ATORVASTATIN CALCIUM (LIPITROL [ATORVASTATIN CALCIUM]), VITAMIN D [VITAMIN D NOS], MIRABEGRON (MYRBETRIQ) and SALBUTAMOL (ALBUTEROL HFA) for an unknown indication.    On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Oct-2021, the patient experienced ILLNESS (feel a little sick, and horrible.), VACCINATION SITE ERYTHEMA (huge red circle in her left arm, and is hard and swollen like a golf ball), VACCINATION SITE INDURATION (huge red circle in her left arm, and is hard and swollen like a golf ball), VACCINATION SITE SWELLING (huge red circle in her left arm, and is hard and swollen like a golf ball), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, ILLNESS (feel a little sick, and horrible.), VACCINATION SITE ERYTHEMA (huge red circle in her left arm, and is hard and swollen like a golf ball), VACCINATION SITE INDURATION (huge red circle in her left arm, and is hard and swollen like a golf ball), VACCINATION SITE SWELLING (huge red circle in her left arm, and is hard and swollen like a golf ball), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no treatment medication were reported.  patient got the first dose of moderna vaccine on 15March202 with batch number 002b21a and received second dose on 12April2021 with lot number 031a21a both on her left arm.  She mention that on the 13April2021 felt tired, and didn't take anything and that symptom went away on the 14April2021.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Face oedema, Heart rate increased, Lethargy, Localised oedema
Clinical narrative: continued to feel lethargic; continued to feel bloated; retaining fluid in his face; retaining fluid in his neck; heart beats fast after second vaccine dose; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (continued to feel lethargic), ABDOMINAL DISTENSION (continued to feel bloated), FACE OEDEMA (retaining fluid in his face), LOCALISED OEDEMA (retaining fluid in his neck) and HEART RATE INCREASED (heart beats fast after second vaccine dose) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jul-2021, the patient experienced LETHARGY (continued to feel lethargic), ABDOMINAL DISTENSION (continued to feel bloated), FACE OEDEMA (retaining fluid in his face), LOCALISED OEDEMA (retaining fluid in his neck) and HEART RATE INCREASED (heart beats fast after second vaccine dose). At the time of the report, LETHARGY (continued to feel lethargic), ABDOMINAL DISTENSION (continued to feel bloated), FACE OEDEMA (retaining fluid in his face), LOCALISED OEDEMA (retaining fluid in his neck) and HEART RATE INCREASED (heart beats fast after second vaccine dose) outcome was unknown.            Concomitant medications were not reported. No treatment information was reported.   This case was linked to MOD-2021-355568 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Fatigue, Headache, Influenza like illness
Clinical narrative: Diarrhea; Flu like symptoms; Neck stiffness; Neck pain; Sleepy; Cloggy; Temperature of 99°; Headache; Tired; This spontaneous case was reported by a nurse and describes the occurrence of DIARRHOEA (Diarrhea), INFLUENZA LIKE ILLNESS (Flu like symptoms), MUSCULOSKELETAL STIFFNESS (Neck stiffness), NECK PAIN (Neck pain) and SOMNOLENCE (Sleepy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included West Nile viral infection (She already had antibodies).    On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021, the patient experienced DIARRHOEA (Diarrhea), INFLUENZA LIKE ILLNESS (Flu like symptoms), MUSCULOSKELETAL STIFFNESS (Neck stiffness), NECK PAIN (Neck pain), SOMNOLENCE (Sleepy), VACCINATION COMPLICATION (Cloggy), PYREXIA (Temperature of 99°), HEADACHE (Headache) and FATIGUE (Tired). At the time of the report, DIARRHOEA (Diarrhea), INFLUENZA LIKE ILLNESS (Flu like symptoms), MUSCULOSKELETAL STIFFNESS (Neck stiffness), NECK PAIN (Neck pain), SOMNOLENCE (Sleepy), VACCINATION COMPLICATION (Cloggy), PYREXIA (Temperature of 99°), HEADACHE (Headache) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 °f (High) 99 °F. On an unknown date, West Nile virus test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Neck pain, Pyrexia, Somnolence, Vaccination complication
Clinical narrative: Diarrhea; Flu like symptoms; Neck stiffness; Neck pain; Sleepy; Cloggy; Temperature of 99°; Headache; Tired; This spontaneous case was reported by a nurse and describes the occurrence of DIARRHOEA (Diarrhea), INFLUENZA LIKE ILLNESS (Flu like symptoms), MUSCULOSKELETAL STIFFNESS (Neck stiffness), NECK PAIN (Neck pain) and SOMNOLENCE (Sleepy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included West Nile viral infection (She already had antibodies).    On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021, the patient experienced DIARRHOEA (Diarrhea), INFLUENZA LIKE ILLNESS (Flu like symptoms), MUSCULOSKELETAL STIFFNESS (Neck stiffness), NECK PAIN (Neck pain), SOMNOLENCE (Sleepy), VACCINATION COMPLICATION (Cloggy), PYREXIA (Temperature of 99°), HEADACHE (Headache) and FATIGUE (Tired). At the time of the report, DIARRHOEA (Diarrhea), INFLUENZA LIKE ILLNESS (Flu like symptoms), MUSCULOSKELETAL STIFFNESS (Neck stiffness), NECK PAIN (Neck pain), SOMNOLENCE (Sleepy), VACCINATION COMPLICATION (Cloggy), PYREXIA (Temperature of 99°), HEADACHE (Headache) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 °f (High) 99 °F. On an unknown date, West Nile virus test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: West Nile virus test
Clinical narrative: Diarrhea; Flu like symptoms; Neck stiffness; Neck pain; Sleepy; Cloggy; Temperature of 99°; Headache; Tired; This spontaneous case was reported by a nurse and describes the occurrence of DIARRHOEA (Diarrhea), INFLUENZA LIKE ILLNESS (Flu like symptoms), MUSCULOSKELETAL STIFFNESS (Neck stiffness), NECK PAIN (Neck pain) and SOMNOLENCE (Sleepy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included West Nile viral infection (She already had antibodies).    On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021, the patient experienced DIARRHOEA (Diarrhea), INFLUENZA LIKE ILLNESS (Flu like symptoms), MUSCULOSKELETAL STIFFNESS (Neck stiffness), NECK PAIN (Neck pain), SOMNOLENCE (Sleepy), VACCINATION COMPLICATION (Cloggy), PYREXIA (Temperature of 99°), HEADACHE (Headache) and FATIGUE (Tired). At the time of the report, DIARRHOEA (Diarrhea), INFLUENZA LIKE ILLNESS (Flu like symptoms), MUSCULOSKELETAL STIFFNESS (Neck stiffness), NECK PAIN (Neck pain), SOMNOLENCE (Sleepy), VACCINATION COMPLICATION (Cloggy), PYREXIA (Temperature of 99°), HEADACHE (Headache) and FATIGUE (Tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 °f (High) 99 °F. On an unknown date, West Nile virus test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 5 doses were administered expired yesterday 14Oct2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses were administered expired yesterday 14Oct2021) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses were administered expired yesterday 14Oct2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 doses were administered expired yesterday 14Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Migraine, Myalgia, Neck pain
Clinical narrative: sore arm; Migraine type pain; Neck Pain; Shooting pain into her head and down her back; body aches; Shooting pain into her head and down her back; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), MIGRAINE (Migraine type pain), NECK PAIN (Neck Pain), BACK PAIN (Shooting pain into her head and down her back) and MYALGIA (body aches) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091021A, 040A21A and 02FB21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concurrent medical conditions included Diabetes.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Oct-2021, the patient experienced PAIN IN EXTREMITY (sore arm), MIGRAINE (Migraine type pain), NECK PAIN (Neck Pain), BACK PAIN (Shooting pain into her head and down her back), MYALGIA (body aches) and HEADACHE (Shooting pain into her head and down her back). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency and ACETYLSALICYLIC ACID, CHLORPHENAMINE MALEATE, PHENYLEPHRINE BITARTRATE (ALKA SELTZER PLUS COLD [ACETYLSALICYLIC ACID;CHLORPHENAMINE MALEATE;PHENYLEPHRINE BITARTRATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), MIGRAINE (Migraine type pain), NECK PAIN (Neck Pain), BACK PAIN (Shooting pain into her head and down her back) and HEADACHE (Shooting pain into her head and down her back) had not resolved and MYALGIA (body aches) was resolving.            Concomitant medications were not reported.   This case was linked to MOD-2021-355604 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; Migraine type pain; Neck Pain; Shooting pain into her head and down her back; body aches; Shooting pain into her head and down her back; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), MIGRAINE (Migraine type pain), NECK PAIN (Neck Pain), BACK PAIN (Shooting pain into her head and down her back) and MYALGIA (body aches) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091021A, 040A21A and 02FB21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concurrent medical conditions included Diabetes.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Oct-2021, the patient experienced PAIN IN EXTREMITY (sore arm), MIGRAINE (Migraine type pain), NECK PAIN (Neck Pain), BACK PAIN (Shooting pain into her head and down her back), MYALGIA (body aches) and HEADACHE (Shooting pain into her head and down her back). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency and ACETYLSALICYLIC ACID, CHLORPHENAMINE MALEATE, PHENYLEPHRINE BITARTRATE (ALKA SELTZER PLUS COLD [ACETYLSALICYLIC ACID;CHLORPHENAMINE MALEATE;PHENYLEPHRINE BITARTRATE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), MIGRAINE (Migraine type pain), NECK PAIN (Neck Pain), BACK PAIN (Shooting pain into her head and down her back) and HEADACHE (Shooting pain into her head and down her back) had not resolved and MYALGIA (body aches) was resolving.            Concomitant medications were not reported.   This case was linked to MOD-2021-355604 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chest pain, Myalgia, Pain
Clinical narrative: Can't use the arm; pain went across the shoulder and then to chest and back; pain went across the shoulder and then to chest and back; Feel a lighting bolt hit my arm/When the needle went in, AU lighting bolt; Pain; Overall aching feeling; pain went across the shoulder and then to chest and back; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Can't use the arm), CHEST PAIN (pain went across the shoulder and then to chest and back), BACK PAIN (pain went across the shoulder and then to chest and back), VACCINATION SITE DISCOMFORT (Feel a lighting bolt hit my arm/When the needle went in, AU lighting bolt) and PAIN (Pain) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A and 040CZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Oct-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Can't use the arm), CHEST PAIN (pain went across the shoulder and then to chest and back), BACK PAIN (pain went across the shoulder and then to chest and back), VACCINATION SITE DISCOMFORT (Feel a lighting bolt hit my arm/When the needle went in, AU lighting bolt), PAIN (Pain), MYALGIA (Overall aching feeling) and ARTHRALGIA (pain went across the shoulder and then to chest and back). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Can't use the arm), CHEST PAIN (pain went across the shoulder and then to chest and back), BACK PAIN (pain went across the shoulder and then to chest and back), VACCINATION SITE DISCOMFORT (Feel a lighting bolt hit my arm/When the needle went in, AU lighting bolt), PAIN (Pain), MYALGIA (Overall aching feeling) and ARTHRALGIA (pain went across the shoulder and then to chest and back) outcome was unknown.            Concomitant medications were not provided by reporter.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort, Vaccination site movement impairment
Clinical narrative: Can't use the arm; pain went across the shoulder and then to chest and back; pain went across the shoulder and then to chest and back; Feel a lighting bolt hit my arm/When the needle went in, AU lighting bolt; Pain; Overall aching feeling; pain went across the shoulder and then to chest and back; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Can't use the arm), CHEST PAIN (pain went across the shoulder and then to chest and back), BACK PAIN (pain went across the shoulder and then to chest and back), VACCINATION SITE DISCOMFORT (Feel a lighting bolt hit my arm/When the needle went in, AU lighting bolt) and PAIN (Pain) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A and 040CZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Oct-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Can't use the arm), CHEST PAIN (pain went across the shoulder and then to chest and back), BACK PAIN (pain went across the shoulder and then to chest and back), VACCINATION SITE DISCOMFORT (Feel a lighting bolt hit my arm/When the needle went in, AU lighting bolt), PAIN (Pain), MYALGIA (Overall aching feeling) and ARTHRALGIA (pain went across the shoulder and then to chest and back). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Can't use the arm), CHEST PAIN (pain went across the shoulder and then to chest and back), BACK PAIN (pain went across the shoulder and then to chest and back), VACCINATION SITE DISCOMFORT (Feel a lighting bolt hit my arm/When the needle went in, AU lighting bolt), PAIN (Pain), MYALGIA (Overall aching feeling) and ARTHRALGIA (pain went across the shoulder and then to chest and back) outcome was unknown.            Concomitant medications were not provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Pruritus, Urticaria
Clinical narrative: itch; The booster dose, was not a half dose but a full dose; she got an acute urticaria; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itch), URTICARIA (she got an acute urticaria) and ACCIDENTAL OVERDOSE (The booster dose, was not a half dose but a full dose) 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-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 26-Aug-2021, the patient experienced ACCIDENTAL OVERDOSE (The booster dose, was not a half dose but a full dose). On an unknown date, the patient experienced PRURITUS (itch) and URTICARIA (she got an acute urticaria). On 26-Aug-2021, ACCIDENTAL OVERDOSE (The booster dose, was not a half dose but a full dose) had resolved. At the time of the report, PRURITUS (itch) and URTICARIA (she got an acute urticaria) outcome was unknown.            No concomitant medications were reported.  Patient was taking an antihistaminic and a cream for the itch.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: received an expired second dose; second dose >35 days after first dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose >35 days after first dose) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 007C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose >35 days after first dose). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received an expired second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose >35 days after first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: She developed a blood clot in her leg and hand two weeks after her first shot, five blood clots in total; This spontaneous case was reported by a patient and describes the occurrence of THROMBOSIS (She developed a blood clot in her leg and hand two weeks after her first shot, five blood clots in total) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced THROMBOSIS (She developed a blood clot in her leg and hand two weeks after her first shot, five blood clots in total) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (She developed a blood clot in her leg and hand two weeks after her first shot, five blood clots in total) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-356679 (Patient Link).; Sender's Comments: This case concerns a 53-year-old, female patient with no relevant medical history, who experienced the unexpected event of Thrombosis. The event occurred approximately 2 weeks after the first dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Vaccination complication
Clinical narrative: Feel weak; Severe reaction; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Feel weak) and VACCINATION COMPLICATION (Severe reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Feel weak) and VACCINATION COMPLICATION (Severe reaction). At the time of the report, ASTHENIA (Feel weak) and VACCINATION COMPLICATION (Severe reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided Treatment medications were not provided   Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Translation received on 19 Oct 2021 contains translation  of social media post
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: There are 5 blood clots in total; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (There are 5 blood clots in total) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026021A and 020B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, 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 experienced THROMBOSIS (There are 5 blood clots in total) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (There are 5 blood clots in total) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.    This case was linked to MOD-2021-356470 (Patient Link).; Sender's Comments: This case concerns a 53-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected event of thrombosis. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. further information was requested.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: it was just sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (it was just sore) 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 02-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced VACCINATION SITE PAIN (it was just sore). At the time of the report, VACCINATION SITE PAIN (it was just sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-352100 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site mass
Clinical narrative: Dose 1: Start Date/Time: [Pfizer] 18Jan2021 09:00 AM/ Dose 2: Start Date/Time: [Pfizer] 4Feb2021 09:00 AM; a lump at the injection site that a magnet will stick to; This is a spontaneous report from a contactable consumer or other non-HCP (patient reported for self). A 67-years-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3249), via an unspecified route of administration, administered in left arm on 04Feb2021 09:00 as dose 2, single (at the age of 67-years-old) for COVID-19 immunization. Medical history included atrial fibrillation (Afib), high cholesterol (blood cholesterol increased), high blood pressure (hypertension), mitral valve replacement in Mar1999 (taking anticoagulants for mitral valve replacement), Known allergies includes penicillin, vancomyacin, any pain medication. Concomitant medication(s) included warfarin; sotalol; famotidine; amlodipine; cetirizine. No other vaccine administered in four weeks. The patient had not diagnosed with covid prior vaccination. Patient is non-pregnant. The patient previously took vancomycin and experienced drug hypersensitivity. Patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL1685 via an unspecified route of administration, administered in Left Arm on 18Jan2021 09:00 as dose 1, single for COVID-19 immunization. On 04Feb2021 at 04:00 the patient experienced a lump at the injection site that a magnet will stick to. Patient received dose 1: start date/time: [pfizer] 18Jan2021 09:00 am/ dose 2: start date/time: [pfizer] 04Feb2021 09:00 am (Inappropriate schedule of vaccine administered). Post vaccination, patient had not tested with COVID. No treatment received for the reported events. The outcome of reported event (Vaccination site lump) was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site mass, Unevaluable event
Clinical narrative: Dose 1: Start Date/Time: [Pfizer] 18Jan2021 09:00 AM/ Dose 2: Start Date/Time: [Pfizer] 4Feb2021 09:00 AM; a lump at the injection site that a magnet will stick to; This is a spontaneous report from a contactable consumer or other non-HCP (patient reported for self). A 67-years-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL3249), via an unspecified route of administration, administered in left arm on 04Feb2021 09:00 as dose 2, single (at the age of 67-years-old) for COVID-19 immunization. Medical history included atrial fibrillation (Afib), high cholesterol (blood cholesterol increased), high blood pressure (hypertension), mitral valve replacement in Mar1999 (taking anticoagulants for mitral valve replacement), Known allergies includes penicillin, vancomyacin, any pain medication. Concomitant medication(s) included warfarin; sotalol; famotidine; amlodipine; cetirizine. No other vaccine administered in four weeks. The patient had not diagnosed with covid prior vaccination. Patient is non-pregnant. The patient previously took vancomycin and experienced drug hypersensitivity. Patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL1685 via an unspecified route of administration, administered in Left Arm on 18Jan2021 09:00 as dose 1, single for COVID-19 immunization. On 04Feb2021 at 04:00 the patient experienced a lump at the injection site that a magnet will stick to. Patient received dose 1: start date/time: [pfizer] 18Jan2021 09:00 am/ dose 2: start date/time: [pfizer] 04Feb2021 09:00 am (Inappropriate schedule of vaccine administered). Post vaccination, patient had not tested with COVID. No treatment received for the reported events. The outcome of reported event (Vaccination site lump) was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest discomfort, Headache, Migraine, Nausea
Clinical narrative: Nausea; body aches; heat sensation on chest; mouth blisters; fever; sore throat; headaches/migraines; headaches/migraines; This is a spontaneous report from a contactable other hcp (Nurse) for herself. A 44-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 09Jul2021 (age at vaccination: 44-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included migraine, asthma and vitamin D deficiency (recently vitamin D deficiency) all from an unknown date and unknown if ongoing. Concomitant medication(s) included ibuprofen taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfa (sulfanilamide) and experienced drug hypersensitivity. The patient was not pregnant at the time of vaccination. She received the vaccine at pharmacy or drug store. On 09Jul2021 the patient experienced nausea, body aches, heat sensation on chest, mouth blisters, fever, sore throat, headaches/migraines (headache, migraine). AE resulted in Doctor or other healthcare professional office/clinic visit. On 20Jul2021, the patient underwent lab tests and procedures which included negative COVID-19 with nasal swab. The patient had not received any other vaccine within 4 weeks. No covid prior vaccination. Therapeutic measures were taken as a result of events which included oxycodone, toradol, muscle relaxer and otc ibuprop. The outcome of events was recovered/resolved with sequel (on an unspecified date in 2021).  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (07Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Oral mucosal blistering, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Nausea; body aches; heat sensation on chest; mouth blisters; fever; sore throat; headaches/migraines; headaches/migraines; This is a spontaneous report from a contactable other hcp (Nurse) for herself. A 44-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 09Jul2021 (age at vaccination: 44-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included migraine, asthma and vitamin D deficiency (recently vitamin D deficiency) all from an unknown date and unknown if ongoing. Concomitant medication(s) included ibuprofen taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfa (sulfanilamide) and experienced drug hypersensitivity. The patient was not pregnant at the time of vaccination. She received the vaccine at pharmacy or drug store. On 09Jul2021 the patient experienced nausea, body aches, heat sensation on chest, mouth blisters, fever, sore throat, headaches/migraines (headache, migraine). AE resulted in Doctor or other healthcare professional office/clinic visit. On 20Jul2021, the patient underwent lab tests and procedures which included negative COVID-19 with nasal swab. The patient had not received any other vaccine within 4 weeks. No covid prior vaccination. Therapeutic measures were taken as a result of events which included oxycodone, toradol, muscle relaxer and otc ibuprop. The outcome of events was recovered/resolved with sequel (on an unspecified date in 2021).  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (07Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo; This is a spontaneous report from a contactable consumer (patient's mother-in-law). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: not reported, expiration date: not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced vertigo. Clinical outcome of the event was reported as unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.  Follow-up activities closed. Batch/lot number not available for [Vaccine BNT162B2].
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration, Lip discolouration, Pyrexia, Vaccination site pain
Clinical narrative: Patient received second dose 8 days, after the first dose.; Sore arm, after second vaccine; White, pale, lips, after second vaccine; fever; headache; This is a spontaneous report from a contactable pharmacist. A 13-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: not reported), via an unspecified route of administration in left arm on 15Sep2021 (probably in the evening), (at the age of 13-years-old) as dose 2, single for COVID-19 immunization at pharmacy. Medical history and concomitant medications were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: not reported), via an unspecified route of administration in left arm, on 07Sep2021 as dose 1, single for COVID-19 immunization. It was unknown if patient received any vaccine within four weeks prior to the first administration date of the vaccine. The patient received second dose 8 days, after the first dose on 15Sep2021 (Inappropriate schedule of vaccine administered). The patient experienced fever, headache, sore arm, after second vaccine and white, pale, lips, after second vaccine on an unspecified date in 2021. The caller (pharmacist) who administered the Pfizer Biontech COVID19 vaccine two weeks earlier than the recommended scheduled interval to a 13-year-old female patient. Reporter mentioned that the mother of the patient was freaking out and thinks that her daughter will die and heard that the second shot is more intense in terms of side effects. They were told originally to watch side effects for fever and headache if it stays that way. Reporter was asking for recommendations on what should they and what to expect with the event. Reporter added that it was not life threatening, and she was told that the patient treated herself with Tylenol for sore arm because it was reported to her, second hand, she does not know if the patient got relief from the Tylenol. It was unknown if the AE required to visit emergency room or physician office. Outcome of the events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Myalgia, Pyrexia
Clinical narrative: fever; chills; muscle aches; scratchy throat; can't taste or smell; can't taste or smell; sinus infection/sinus infection off and on; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on 15Sep2021 (Batch/Lot number was not reported) as dose 2, single (age at vaccination 39-year-old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on an unknown date in 2021 for COVID-immunization for no events reported. The patient experienced fever, chills, muscle aches, scratchy throat, can't taste or smell on Sep2021 and sinus infection/sinus infection off and on an unknown date 2021. Caller reports she had her second Pfizer Covid 19 dose on Wednesday. Wants to know if someone can tell her some of the side effects and how long they last. Has had a sinus infection off and on and on Wednesday was fine when she got the shot, now since then she has had a scratchy throat. She told the pharmacist this and was told to go ahead and get the vaccine and she called her doctor. She has had fever, chills, and muscles aches and saw that they were common, but now she could not taste or smell right. Therapeutic measures were taken as a result of events. The outcome for event fever and chills was recovered on an 16Sep2021 while muscle aches and scratchy throat was unknown and rest was not recovered.   The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.