chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired 2nd dose given; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose given) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     The patient's past medical history included Lipid metabolism disorder NOS. Concurrent medical conditions included Essential hypertension. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) for Hypertension.    On 29-Nov-2021 at 9:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose given). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose given) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication use was reported.   This case was linked to MOD-2021-399961, MOD-2021-399945 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Significant information received: Secondary reporter (Physician) added. Patient demographics (height, weight and race) added. Medical history added. Concomitant medication added. Dosing details updated.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Nausea
Clinical narrative: Very unsteady when the patient looked down to the point of falling; feeling very dizzy/lightheaded; nauseous; This spontaneous case was reported by an other health care professional and describes the occurrence of GAIT DISTURBANCE (Very unsteady when the patient looked down to the point of falling), DIZZINESS (feeling very dizzy/lightheaded) and NAUSEA (nauseous) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Nov-2021, the patient experienced GAIT DISTURBANCE (Very unsteady when the patient looked down to the point of falling), DIZZINESS (feeling very dizzy/lightheaded) and NAUSEA (nauseous). At the time of the report, GAIT DISTURBANCE (Very unsteady when the patient looked down to the point of falling), DIZZINESS (feeling very dizzy/lightheaded) and NAUSEA (nauseous) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.   Reporter did not allow further contact
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired 2nd dose given; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose given) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 019F21A) for COVID-19 vaccination.     Concurrent medical conditions included Cervical dysplasia. Concomitant products included ESTRADIOL for Birth control.   On 29-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose given). On 29-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose given) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.  The vial was moved to refrigerator on 29-Nov-2021. No previous temperature excursions.   This case was linked to MOD-2021-399872 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2021: Significant follow up received contains medical history, race,  route of administration,,Anatomical Location,  concomitant medication,
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Body aches; Temperature for a couple of days after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) and PYREXIA (Temperature for a couple of days after the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body aches) and PYREXIA (Temperature for a couple of days after the vaccine). At the time of the report, MYALGIA (Body aches) and PYREXIA (Temperature for a couple of days after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2021: Non Significant follow up added-Contact info and snapshot document added.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Periorbital swelling, Rash, Swelling face, Urticaria
Clinical narrative: Face was puffy/ face has continued to be puffy; Eyes are puffed; Severe hives all over her body/hives shifting around her body; Rash is on her stomach, arms, and back.; Allergic reaction/with welts on the back of her head; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face was puffy/ face has continued to be puffy), PERIORBITAL SWELLING (Eyes are puffed), URTICARIA (Severe hives all over her body/hives shifting around her body), RASH (Rash is on her stomach, arms, and back.) and HYPERSENSITIVITY (Allergic reaction/with welts on the back of her head) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939909, 041B21A and 027B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Nov-2021, the patient experienced SWELLING FACE (Face was puffy/ face has continued to be puffy), PERIORBITAL SWELLING (Eyes are puffed), URTICARIA (Severe hives all over her body/hives shifting around her body), RASH (Rash is on her stomach, arms, and back.) and HYPERSENSITIVITY (Allergic reaction/with welts on the back of her head). The patient was treated with EPINEPHRINE for Adverse event, at a dose of 1 dosage form; PREDNISONE for Adverse event, at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, SWELLING FACE (Face was puffy/ face has continued to be puffy), PERIORBITAL SWELLING (Eyes are puffed), URTICARIA (Severe hives all over her body/hives shifting around her body) and RASH (Rash is on her stomach, arms, and back.) had not resolved and HYPERSENSITIVITY (Allergic reaction/with welts on the back of her head) was resolving.            No concomitant information were reported by the reporter
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: experienced same thing; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experienced same thing) 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 VACCINATION COMPLICATION (experienced same thing). At the time of the report, VACCINATION COMPLICATION (experienced same thing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were reported. No treatment information were given.   This case was linked to MOD21-167887 (E2B Linked Report). This case was linked to MOD-2021-400476 (Patient Link).; Sender's Comments:  MOD21-167887:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lethargy, Myalgia, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargy), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (muscle ache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. CC1BZIA) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Ovarian cancer ((20 years ago)), Glaucoma and Deep vein thrombosis leg. Concomitant products included METFORMIN, PRASUGREL HYDROCHLORIDE (EFFIENT), GLIPIZIDE, FENOFIBRATE, LOSARTAN, TRAZODONE, ATORVASTATIN, LINAGLIPTIN (TRADJENTA), EICOSAPENTAENOIC ACID ETHYL ESTER (VASCEPA), MECLIZINE HCL, ACETYLSALICYLIC ACID (BABY ASPIRIN), FERROUS SULFATE (SULFATE DE FERROUS), VITAMIN C [ASCORBIC ACID], FOLIC ACID, ZINC, CALCIUM and MAGNESIUM for an unknown indication.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced LETHARGY (lethargy), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (muscle ache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date at a dose of UNK dosage form. On 13-Mar-2021, LETHARGY (lethargy), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (muscle ache) had resolved.            Concomitant Medications also include i.e., eyedrops for glaucoma   This case was linked to MOD21-167887 (E2B Linked Report). This case was linked to MOD-2021-400304, MOD-2021-400464 (Patient Link).; Sender's Comments:  MOD21-167887:
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Breast pain, Feeling abnormal
Clinical narrative: Breast pain on left side; Feels like ink is being injected into my body; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (Breast pain on left side) and FEELING ABNORMAL (Feels like ink is being injected into my body) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BREAST PAIN (Breast pain on left side) and FEELING ABNORMAL (Feels like ink is being injected into my body). At the time of the report, BREAST PAIN (Breast pain on left side) and FEELING ABNORMAL (Feels like ink is being injected into my body) outcome was unknown.      Concomitant medication was not provided.  Treatment information was not provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Computerised tomogram, Dizziness, Dyspnoea, Fatigue
Clinical narrative: sick; chest pains; cold; shortness of breath; light headed; still just tired; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), CHEST PAIN (chest pains), NASOPHARYNGITIS (cold), DYSPNOEA (shortness of breath) and DIZZINESS (light headed) in a 57-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.     Previously administered products included for Product used for unknown indication: Flu shot (Patient got the shot I got a flu shot in January or February.). Past adverse reactions to the above products included No adverse event with Flu shot.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced ILLNESS (sick), CHEST PAIN (chest pains), NASOPHARYNGITIS (cold), DYSPNOEA (shortness of breath), DIZZINESS (light headed) and FATIGUE (still just tired). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, ILLNESS (sick), CHEST PAIN (chest pains), NASOPHARYNGITIS (cold), DYSPNOEA (shortness of breath) and DIZZINESS (light headed) was resolving and FATIGUE (still just tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) Patient had cat scan and that was it. Was normal.. On an unknown date, SARS-CoV-2 test: negative (Negative) Patient tested with COVID and she didn't have it.."felt like I did"..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  One was in left one was in right. First dose OK 2nd shot got it on Wednesday and Thursday got sick (at work). Patient ended up in hospital with chest pains. Was there for around 3 hours.Symptoms lasted about 24 hours. Friday morning feeling a whole lot better, still just tired.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: sick; chest pains; cold; shortness of breath; light headed; still just tired; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), CHEST PAIN (chest pains), NASOPHARYNGITIS (cold), DYSPNOEA (shortness of breath) and DIZZINESS (light headed) in a 57-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.     Previously administered products included for Product used for unknown indication: Flu shot (Patient got the shot I got a flu shot in January or February.). Past adverse reactions to the above products included No adverse event with Flu shot.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced ILLNESS (sick), CHEST PAIN (chest pains), NASOPHARYNGITIS (cold), DYSPNOEA (shortness of breath), DIZZINESS (light headed) and FATIGUE (still just tired). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, ILLNESS (sick), CHEST PAIN (chest pains), NASOPHARYNGITIS (cold), DYSPNOEA (shortness of breath) and DIZZINESS (light headed) was resolving and FATIGUE (still just tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) Patient had cat scan and that was it. Was normal.. On an unknown date, SARS-CoV-2 test: negative (Negative) Patient tested with COVID and she didn't have it.."felt like I did"..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  One was in left one was in right. First dose OK 2nd shot got it on Wednesday and Thursday got sick (at work). Patient ended up in hospital with chest pains. Was there for around 3 hours.Symptoms lasted about 24 hours. Friday morning feeling a whole lot better, still just tired.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis, Rhinorrhoea, Sneezing
Clinical narrative: sneezing; Sniffles; cold; congestion; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (sneezing), RHINORRHOEA (Sniffles), NASOPHARYNGITIS (cold) and NASAL CONGESTION (congestion) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 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 SNEEZING (sneezing), RHINORRHOEA (Sniffles), NASOPHARYNGITIS (cold) and NASAL CONGESTION (congestion). The patient was treated with LORATADINE (CLARITINE) for Congestion nasal, at an unspecified dose and frequency. At the time of the report, SNEEZING (sneezing), RHINORRHOEA (Sniffles), NASOPHARYNGITIS (cold) and NASAL CONGESTION (congestion) outcome was unknown. Not Provided          No concomitant medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Myalgia, Pyrexia
Clinical narrative: got a booster dose from a vaccine after Use by date 30; fever; body sores and body aches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (got a booster dose from a vaccine after Use by date 30), PYREXIA (fever) and MYALGIA (body sores and body aches) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (got a booster dose from a vaccine after Use by date 30), PYREXIA (fever) and MYALGIA (body sores and body aches). At the time of the report, EXPIRED PRODUCT ADMINISTERED (got a booster dose from a vaccine after Use by date 30) had resolved and PYREXIA (fever) and MYALGIA (body sores and body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-402678 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: 3 of her coworkers also experienced hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (3 of her coworkers also experienced hives) 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 URTICARIA (3 of her coworkers also experienced hives). At the time of the report, URTICARIA (3 of her coworkers also experienced hives) 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.
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: blurry vision; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (blurry vision) 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 29-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced VISION BLURRED (blurry vision). At the time of the report, VISION BLURRED (blurry vision) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: chills; body aches; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2021, the patient experienced CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache). At the time of the report, CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache) outcome was unknown.            No concomitant drug details were reported. No treatment details were reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migraines; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraines) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Fibromyalgia and Arthritis.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (migraines). At the time of the report, MIGRAINE (migraines) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not reported. Treatment medications were not reported.   This case was linked to MOD-2021-402744 (Patient Link).   Reporter did not allow further contact
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Ocular discomfort, Visual impairment
Clinical narrative: Left eye seemed to be off a little bit/Felt like he wore somebody's eye glass on his left eye and the glass was too strong or too; Something was off; Weird effect on his vision; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (Left eye seemed to be off a little bit/Felt like he wore somebody's eye glass on his left eye and the glass was too strong or too), FEELING ABNORMAL (Something was off) and VISUAL IMPAIRMENT (Weird effect on his vision) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Johnson and Johnson COVID 19 vaccine (Arm of injection: Not sure but guess right arm Lot #: 002A21A) on 11-Apr-2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson COVID 19 vaccine.    On 29-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Nov-2021, the patient experienced OCULAR DISCOMFORT (Left eye seemed to be off a little bit/Felt like he wore somebody's eye glass on his left eye and the glass was too strong or too), FEELING ABNORMAL (Something was off) and VISUAL IMPAIRMENT (Weird effect on his vision). At the time of the report, OCULAR DISCOMFORT (Left eye seemed to be off a little bit/Felt like he wore somebody's eye glass on his left eye and the glass was too strong or too), FEELING ABNORMAL (Something was off) and VISUAL IMPAIRMENT (Weird effect on his vision) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drug details were reported. No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Only sore arm after the first two doses of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Only sore arm after the first two doses of Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Only sore arm after the first two doses of Moderna vaccine). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, MYALGIA (Only sore arm after the first two doses of Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant informations were reported.   This case was linked to MOD-2021-402682, MOD-2021-402739 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Only sore arm after the first two doses of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Only sore arm after the first two doses of Moderna vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Only sore arm after the first two doses of Moderna vaccine). At the time of the report, PAIN IN EXTREMITY (Only sore arm after the first two doses of Moderna vaccine) outcome was unknown.            No concomitant medications provided. No treatment medications provided.   This case was linked to MOD-2021-402738, MOD-2021-402682 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: pain in both thighs/occurs in the mornings and kind of fades away as he gets active during the day/kind of painful/Comes back everyday in the morning; strangest feeling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in both thighs/occurs in the mornings and kind of fades away as he gets active during the day/kind of painful/Comes back everyday in the morning) and FEELING ABNORMAL (strangest feeling) in a 70-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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in both thighs/occurs in the mornings and kind of fades away as he gets active during the day/kind of painful/Comes back everyday in the morning) and FEELING ABNORMAL (strangest feeling). At the time of the report, PAIN IN EXTREMITY (pain in both thighs/occurs in the mornings and kind of fades away as he gets active during the day/kind of painful/Comes back everyday in the morning) and FEELING ABNORMAL (strangest feeling) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: administered a Booster Dose to a patient who last received their Second; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered a Booster Dose to a patient who last received their Second) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered a Booster Dose to a patient who last received their Second). On 30-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (administered a Booster Dose to a patient who last received their Second) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient complained of no additional events  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Cystitis
Clinical narrative: Taking antibiotics because of a bladder infection; This spontaneous case was reported by a pharmacist and describes the occurrence of CYSTITIS (Taking antibiotics because of a bladder infection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-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 CYSTITIS (Taking antibiotics because of a bladder infection). At the time of the report, CYSTITIS (Taking antibiotics because of a bladder infection) 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.   Concomitant medication and treatment information was  not reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: received a steroid injection 2 weeks ago/unknown condition; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (received a steroid injection 2 weeks ago/unknown condition) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (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 VACCINATION COMPLICATION (received a steroid injection 2 weeks ago/unknown condition). At the time of the report, VACCINATION COMPLICATION (received a steroid injection 2 weeks ago/unknown condition) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication were reported.  It was reported that patient was requested to receive booster dose  patient received a steroid injection two weeks ago for unknown condition
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Gait disturbance, Loss of personal independence in daily activities, Mobility decreased, Vaccination complication
Clinical narrative: couldn't walk; couldn't do anything for 2 or 3 days; crippled; "The Moderna vaccine totally put her on a position of not being able to move"; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (couldn't walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't do anything for 2 or 3 days), VACCINATION COMPLICATION (crippled) and MOBILITY DECREASED ("The Moderna vaccine totally put her on a position of not being able to move") in a 39-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (couldn't walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't do anything for 2 or 3 days), VACCINATION COMPLICATION (crippled) and MOBILITY DECREASED ("The Moderna vaccine totally put her on a position of not being able to move"). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (couldn't walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (couldn't do anything for 2 or 3 days), VACCINATION COMPLICATION (crippled) and MOBILITY DECREASED ("The Moderna vaccine totally put her on a position of not being able to move") outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable  No concomitant medications reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Erythema, Fatigue, Pain
Clinical narrative: low energy; red on his skin, raised up; soreness; joint soreness; rash; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (low energy), ERYTHEMA (red on his skin, raised up), PAIN (soreness), ARTHRALGIA (joint soreness) and RASH (rash) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A, 014M20A and 027B21A) for COVID-19 vaccination.   The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced ASTHENIA (low energy), ERYTHEMA (red on his skin, raised up), PAIN (soreness), ARTHRALGIA (joint soreness), RASH (rash) and FATIGUE (fatigue). At the time of the report, ASTHENIA (low energy), ERYTHEMA (red on his skin, raised up), PAIN (soreness), ARTHRALGIA (joint soreness), RASH (rash) and FATIGUE (fatigue) had resolved.      Patient stated that started something that is not necessarily a rash, it looks like poison ivy but it is not poison ivy, most of it is more like a straight line, like a saw machine. It is red on his skin, raised up, and it itches, like poison ivy.  He had a real big one on his right inner upper thigh, with a smaller one next to that, and then had a couple very small spots on his lower abdomen. He also stated that on his upper inner right thigh he had a large rash by the lines that are there. he stated that the information about urticaria was pretty close to what he was experiencing, he is not certain if it is a side effect, it could be the hives, not really spreading much but not really going away.  Concomitant medications was not reported.  Treatment medications was not reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: low energy; red on his skin, raised up; soreness; joint soreness; rash; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (low energy), ERYTHEMA (red on his skin, raised up), PAIN (soreness), ARTHRALGIA (joint soreness) and RASH (rash) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A, 014M20A and 027B21A) for COVID-19 vaccination.   The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced ASTHENIA (low energy), ERYTHEMA (red on his skin, raised up), PAIN (soreness), ARTHRALGIA (joint soreness), RASH (rash) and FATIGUE (fatigue). At the time of the report, ASTHENIA (low energy), ERYTHEMA (red on his skin, raised up), PAIN (soreness), ARTHRALGIA (joint soreness), RASH (rash) and FATIGUE (fatigue) had resolved.      Patient stated that started something that is not necessarily a rash, it looks like poison ivy but it is not poison ivy, most of it is more like a straight line, like a saw machine. It is red on his skin, raised up, and it itches, like poison ivy.  He had a real big one on his right inner upper thigh, with a smaller one next to that, and then had a couple very small spots on his lower abdomen. He also stated that on his upper inner right thigh he had a large rash by the lines that are there. he stated that the information about urticaria was pretty close to what he was experiencing, he is not certain if it is a side effect, it could be the hives, not really spreading much but not really going away.  Concomitant medications was not reported.  Treatment medications was not reported.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: past the expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (past the expiration date) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (past the expiration date). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (past the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information provided by the reporter No treatment information provided by the reporter
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: sore injection site arm after each vaccine; greater than 36 days between doses of Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 36 days between doses of Moderna Covid-19 vaccine) and VACCINATION SITE PAIN (sore injection site arm after each vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 36 days between doses of Moderna Covid-19 vaccine). On an unknown date, the patient experienced VACCINATION SITE PAIN (sore injection site arm after each vaccine). On 28-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 36 days between doses of Moderna Covid-19 vaccine) had resolved. At the time of the report, VACCINATION SITE PAIN (sore injection site arm after each vaccine) outcome was unknown.            No concomitants medications was reported.  No treatments medications was reported.   This case was linked to MOD-2021-402855 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: Received booster from a vial that was punctured 21 times; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Received booster from a vial that was punctured 21 times) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Received booster from a vial that was punctured 21 times). On 29-Nov-2021, PRODUCT ADMINISTRATION ERROR (Received booster from a vial that was punctured 21 times) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications and no treatment medications were reported.  Reporter stated that trying to identify which patient received the 21st booster dose. On 29 Nov 2021, 21 patients received the booster vaccine from 1 vial. On 22 Nov 2021 11:40AM vial moved from freezer to refrigerator. Vaccine state change: Liquid vaccine looked normal, No particulate matter in the syringe was reported. Vial was punctured too many times (21 times) and never had previous excursion   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2021: Follow-up Information received.Updated Reporter fax number and Email id.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Myalgia, Pain in extremity
Clinical narrative: Her arm is also really sore; chills; headache; low grade fever of 99.6-100.2; achy from head to toe/ generally achy all over; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm is also really sore), CHILLS (chills), HEADACHE (headache), PYREXIA (low grade fever of 99.6-100.2) and MYALGIA (achy from head to toe/ generally achy all over) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (Patient had breast cancer years ago on her left side, so she cannot have anything in her left arm). Concurrent medical conditions included Thyroid disorder NOS and Anxiety. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Her arm is also really sore), CHILLS (chills), HEADACHE (headache), PYREXIA (low grade fever of 99.6-100.2) and MYALGIA (achy from head to toe/ generally achy all over). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of 2 tablets and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Her arm is also really sore) had not resolved and CHILLS (chills), HEADACHE (headache), PYREXIA (low grade fever of 99.6-100.2) and MYALGIA (achy from head to toe/ generally achy all over) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.6-100.2 (High) low grade fever of 99.6-100.2.         Patient took 2 tablets of Advil, that helped her kind off a little to take the edge off, and she waited a few hours to take Tylenol, but that did not help. She mentioned experiencing similar reactions with the 2nd dose
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Her arm is also really sore; chills; headache; low grade fever of 99.6-100.2; achy from head to toe/ generally achy all over; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Her arm is also really sore), CHILLS (chills), HEADACHE (headache), PYREXIA (low grade fever of 99.6-100.2) and MYALGIA (achy from head to toe/ generally achy all over) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (Patient had breast cancer years ago on her left side, so she cannot have anything in her left arm). Concurrent medical conditions included Thyroid disorder NOS and Anxiety. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Her arm is also really sore), CHILLS (chills), HEADACHE (headache), PYREXIA (low grade fever of 99.6-100.2) and MYALGIA (achy from head to toe/ generally achy all over). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of 2 tablets and PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Her arm is also really sore) had not resolved and CHILLS (chills), HEADACHE (headache), PYREXIA (low grade fever of 99.6-100.2) and MYALGIA (achy from head to toe/ generally achy all over) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.6-100.2 (High) low grade fever of 99.6-100.2.         Patient took 2 tablets of Advil, that helped her kind off a little to take the edge off, and she waited a few hours to take Tylenol, but that did not help. She mentioned experiencing similar reactions with the 2nd dose
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort
Clinical narrative: rush in the brain after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (rush in the brain after the first dose) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-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 HEAD DISCOMFORT (rush in the brain after the first dose). At the time of the report, HEAD DISCOMFORT (rush in the brain after the first dose) 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  Symptoms: It was reported that the patient was not immunocompromised.   This case was linked to MOD-2021-402795 (Patient Link).