chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Energy increased, Therapeutic response unexpected
Clinical narrative: improvement in her ability to breath/ increase in energy level; Reports an increase in energy level; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (improvement in her ability to breath/ increase in energy level) and ENERGY INCREASED (Reports an increase in energy level) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     Concurrent medical conditions included Congestive heart failure.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (improvement in her ability to breath/ increase in energy level) and ENERGY INCREASED (Reports an increase in energy level). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (improvement in her ability to breath/ increase in energy level) and ENERGY INCREASED (Reports an increase in energy level) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Medical history also included a "TENS unit for my heart" in her left arm.   Concomitant product use was not reported.  Patient reported that she has a history of congestive heart failure and used to have trouble with her breathing and would pass out. After her first dose of the vaccine, she reported that her breathing was better and her whole body seemed to have more energy.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Blister, Rash
Clinical narrative: Bumps with liquid in them within one week after first shot,Sores on my head within one week after first shot; Very bad rash within one week after first shot; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Bumps with liquid in them within one week after first shot,Sores on my head within one week after first shot) and RASH (Very bad rash within one week after first shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced BLISTER (Bumps with liquid in them within one week after first shot,Sores on my head within one week after first shot) and RASH (Very bad rash within one week after first shot). At the time of the report, BLISTER (Bumps with liquid in them within one week after first shot,Sores on my head within one week after first shot) had not resolved and RASH (Very bad rash within one week after first shot) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not reported  Treatment information was not reported
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) 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 RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  Treatment information was not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: second dose was administered more than 42 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was administered more than 42 days after first dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was administered more than 42 days after first dose). On 02-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose was administered more than 42 days after first dose) had resolved.            Other concomitant medications include supplements and vitamins.  No treatment medications were provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was given a dose from an expired vial; 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 (Patient was given a dose from an expired vial) 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 EXPIRED PRODUCT ADMINISTERED (Patient was given a dose from an expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was given a dose from an expired vial) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medication was provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysphonia, Nasal congestion
Clinical narrative: chest congestion; hoarse cough; hoarse voice; This spontaneous case was reported by a nurse and describes the occurrence of NASAL CONGESTION (chest congestion), COUGH (hoarse cough) and DYSPHONIA (hoarse voice) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASAL CONGESTION (chest congestion), COUGH (hoarse cough) and DYSPHONIA (hoarse voice). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, NASAL CONGESTION (chest congestion), COUGH (hoarse cough) and DYSPHONIA (hoarse voice) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No medical history reported. patient was not on regular medications. patient vaccinated with second dose on 03Aug2021.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Injection site swelling, Pyrexia, Vaccination site erythema, Vaccination site pain
Clinical narrative: Left arm hurts on movement and when rolls over at nights, long after second shot/Painful to raise the left arm  long after second shot; Swelling on the injection site came back long after second shot; Swelling on the injection site (Softball Size) after second shot; Red injection site after second shot; Fever 102.3 F after second shot; Warm to the touch injection site after second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch injection site after second shot), VACCINATION SITE PAIN (Left arm hurts on movement and when rolls over at nights, long after second shot/Painful to raise the left arm  long after second shot), INJECTION SITE SWELLING (Swelling on the injection site came back long after second shot), VACCINATION SITE SWELLING (Swelling on the injection site (Softball Size) after second shot) and VACCINATION SITE ERYTHEMA (Red injection site after second shot) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch injection site after second shot), VACCINATION SITE SWELLING (Swelling on the injection site (Softball Size) after second shot), VACCINATION SITE ERYTHEMA (Red injection site after second shot) and PYREXIA (Fever 102.3 F after second shot). On 20-Jul-2021, the patient experienced VACCINATION SITE PAIN (Left arm hurts on movement and when rolls over at nights, long after second shot/Painful to raise the left arm  long after second shot) and INJECTION SITE SWELLING (Swelling on the injection site came back long after second shot). On 30-Apr-2021, VACCINATION SITE WARMTH (Warm to the touch injection site after second shot), VACCINATION SITE SWELLING (Swelling on the injection site (Softball Size) after second shot), VACCINATION SITE ERYTHEMA (Red injection site after second shot) and PYREXIA (Fever 102.3 F after second shot) had resolved. At the time of the report, VACCINATION SITE PAIN (Left arm hurts on movement and when rolls over at nights, long after second shot/Painful to raise the left arm  long after second shot) and INJECTION SITE SWELLING (Swelling on the injection site came back long after second shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.3 (High) High.         No concomitant medication was reported  No treatment medication was reported
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Left arm hurts on movement and when rolls over at nights, long after second shot/Painful to raise the left arm  long after second shot; Swelling on the injection site came back long after second shot; Swelling on the injection site (Softball Size) after second shot; Red injection site after second shot; Fever 102.3 F after second shot; Warm to the touch injection site after second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch injection site after second shot), VACCINATION SITE PAIN (Left arm hurts on movement and when rolls over at nights, long after second shot/Painful to raise the left arm  long after second shot), INJECTION SITE SWELLING (Swelling on the injection site came back long after second shot), VACCINATION SITE SWELLING (Swelling on the injection site (Softball Size) after second shot) and VACCINATION SITE ERYTHEMA (Red injection site after second shot) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch injection site after second shot), VACCINATION SITE SWELLING (Swelling on the injection site (Softball Size) after second shot), VACCINATION SITE ERYTHEMA (Red injection site after second shot) and PYREXIA (Fever 102.3 F after second shot). On 20-Jul-2021, the patient experienced VACCINATION SITE PAIN (Left arm hurts on movement and when rolls over at nights, long after second shot/Painful to raise the left arm  long after second shot) and INJECTION SITE SWELLING (Swelling on the injection site came back long after second shot). On 30-Apr-2021, VACCINATION SITE WARMTH (Warm to the touch injection site after second shot), VACCINATION SITE SWELLING (Swelling on the injection site (Softball Size) after second shot), VACCINATION SITE ERYTHEMA (Red injection site after second shot) and PYREXIA (Fever 102.3 F after second shot) had resolved. At the time of the report, VACCINATION SITE PAIN (Left arm hurts on movement and when rolls over at nights, long after second shot/Painful to raise the left arm  long after second shot) and INJECTION SITE SWELLING (Swelling on the injection site came back long after second shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.3 (High) High.         No concomitant medication was reported  No treatment medication was reported
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient did not receive second dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose of the Moderna COVID-19 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 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose of the Moderna COVID-19 vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not receive second dose of the Moderna COVID-19 vaccine) had resolved.            No Concomitant medications were reported.   Reporter did not allow further contact
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Off label use
Clinical narrative: 1st dose Pfizer; 2nd dose Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (1st dose Pfizer; 2nd dose Moderna) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE MRNA (BNT162B2) for COVID-19 vaccination.    No Medical History information was reported.   On 10-Jul-2021, the patient received first dose of COVID-19 VACCINE MRNA (BNT162B2) (Intramuscular) 1 dosage form. On 02-Aug-2021 at 4:21 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 02-Aug-2021, the patient experienced OFF LABEL USE (1st dose Pfizer; 2nd dose Moderna). On 02-Aug-2021, OFF LABEL USE (1st dose Pfizer; 2nd dose Moderna) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter.  No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Non significant information received.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Urticaria
Clinical narrative: Certain parts of body will get really itchy and red and then goes away; Certain parts of body will get really itchy and red and then goes away; all over hives/rash; all over hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (all over hives), ERYTHEMA (Certain parts of body will get really itchy and red and then goes away), PRURITUS (Certain parts of body will get really itchy and red and then goes away) and RASH (all over hives/rash) 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 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced URTICARIA (all over hives) and RASH (all over hives/rash). On an unknown date, the patient experienced ERYTHEMA (Certain parts of body will get really itchy and red and then goes away) and PRURITUS (Certain parts of body will get really itchy and red and then goes away). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL N) for Hives, at a dose of 1 dosage form and METHYLPREDNISOLONE for Hives, at a dose of 1 dosage form. At the time of the report, URTICARIA (all over hives) and RASH (all over hives/rash) had resolved and ERYTHEMA (Certain parts of body will get really itchy and red and then goes away) and PRURITUS (Certain parts of body will get really itchy and red and then goes away) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient did not use any concomitant medications
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: administered a vaccine on a patient where the vaccine had been pre-drawn for just under 36 hours; administered a vaccine on a patient where the vaccine had been pre-drawn for just under 36 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (administered a vaccine on a patient where the vaccine had been pre-drawn for just under 36 hours) and EXPIRED PRODUCT ADMINISTERED (administered a vaccine on a patient where the vaccine had been pre-drawn for just under 36 hours) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (administered a vaccine on a patient where the vaccine had been pre-drawn for just under 36 hours) and EXPIRED PRODUCT ADMINISTERED (administered a vaccine on a patient where the vaccine had been pre-drawn for just under 36 hours). On 03-Aug-2021, PRODUCT STORAGE ERROR (administered a vaccine on a patient where the vaccine had been pre-drawn for just under 36 hours) and EXPIRED PRODUCT ADMINISTERED (administered a vaccine on a patient where the vaccine had been pre-drawn for just under 36 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No treatment information was provided.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: More than 36 days after the first dose without receiving the second dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cold sweat, Fatigue, Gait disturbance, Hyperhidrosis
Clinical narrative: not being well; difficulty walking; eyesight blurry; Hot/cold sweats; extreme fatigue/bed ridden; Joint pain/ joint aches; lowgrade fever/ fever; body aches/ muscle pain/ muscle aches; migraine/severe all day migraine/ horrible migrane; "during the administation of the vaccine,blood trickled down her arm"; cold sweat; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine/severe all day migraine/ horrible migrane), VACCINATION SITE HAEMORRHAGE (blood trickled down arm), NASOPHARYNGITIS (cold), MALAISE (not being well) and GAIT DISTURBANCE (difficulty walking) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by Reporter.  Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced MIGRAINE (migraine/severe all day migraine/ horrible migrane), VACCINATION SITE HAEMORRHAGE (blood trickled down arm), NASOPHARYNGITIS (cold), GAIT DISTURBANCE (difficulty walking), VISION BLURRED (eyesight blurry), HYPERHIDROSIS (Hot/cold sweats), FATIGUE (extreme fatigue/bed ridden), ARTHRALGIA (Joint pain/ joint aches), PYREXIA (lowgrade fever/ fever) and MYALGIA (body aches/ muscle pain/ muscle aches). On an unknown date, the patient experienced MALAISE (not being well). At the time of the report, MIGRAINE (migraine/severe all day migraine/ horrible migrane) and FATIGUE (extreme fatigue/bed ridden) had not resolved, VACCINATION SITE HAEMORRHAGE (blood trickled down arm), NASOPHARYNGITIS (cold), MALAISE (not being well), GAIT DISTURBANCE (difficulty walking), VISION BLURRED (eyesight blurry) and ARTHRALGIA (Joint pain/ joint aches) outcome was unknown and HYPERHIDROSIS (Hot/cold sweats), PYREXIA (lowgrade fever/ fever) and MYALGIA (body aches/ muscle pain/ muscle aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Event start date for feeling unwell reported as unknown day of AUG 2021.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Additional information included patient demographic data, suspect drug batch number, new events blurry vision, walking difficulty, blood trickled down arm  and event outcome updated for fever, body aches, hot/cold sweats.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Migraine, Myalgia, Pyrexia, Vaccination site haemorrhage
Clinical narrative: not being well; difficulty walking; eyesight blurry; Hot/cold sweats; extreme fatigue/bed ridden; Joint pain/ joint aches; lowgrade fever/ fever; body aches/ muscle pain/ muscle aches; migraine/severe all day migraine/ horrible migrane; "during the administation of the vaccine,blood trickled down her arm"; cold sweat; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine/severe all day migraine/ horrible migrane), VACCINATION SITE HAEMORRHAGE (blood trickled down arm), NASOPHARYNGITIS (cold), MALAISE (not being well) and GAIT DISTURBANCE (difficulty walking) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by Reporter.  Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced MIGRAINE (migraine/severe all day migraine/ horrible migrane), VACCINATION SITE HAEMORRHAGE (blood trickled down arm), NASOPHARYNGITIS (cold), GAIT DISTURBANCE (difficulty walking), VISION BLURRED (eyesight blurry), HYPERHIDROSIS (Hot/cold sweats), FATIGUE (extreme fatigue/bed ridden), ARTHRALGIA (Joint pain/ joint aches), PYREXIA (lowgrade fever/ fever) and MYALGIA (body aches/ muscle pain/ muscle aches). On an unknown date, the patient experienced MALAISE (not being well). At the time of the report, MIGRAINE (migraine/severe all day migraine/ horrible migrane) and FATIGUE (extreme fatigue/bed ridden) had not resolved, VACCINATION SITE HAEMORRHAGE (blood trickled down arm), NASOPHARYNGITIS (cold), MALAISE (not being well), GAIT DISTURBANCE (difficulty walking), VISION BLURRED (eyesight blurry) and ARTHRALGIA (Joint pain/ joint aches) outcome was unknown and HYPERHIDROSIS (Hot/cold sweats), PYREXIA (lowgrade fever/ fever) and MYALGIA (body aches/ muscle pain/ muscle aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Event start date for feeling unwell reported as unknown day of AUG 2021.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Additional information included patient demographic data, suspect drug batch number, new events blurry vision, walking difficulty, blood trickled down arm  and event outcome updated for fever, body aches, hot/cold sweats.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: not being well; difficulty walking; eyesight blurry; Hot/cold sweats; extreme fatigue/bed ridden; Joint pain/ joint aches; lowgrade fever/ fever; body aches/ muscle pain/ muscle aches; migraine/severe all day migraine/ horrible migrane; "during the administation of the vaccine,blood trickled down her arm"; cold sweat; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine/severe all day migraine/ horrible migrane), VACCINATION SITE HAEMORRHAGE (blood trickled down arm), NASOPHARYNGITIS (cold), MALAISE (not being well) and GAIT DISTURBANCE (difficulty walking) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history provided by Reporter.  Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced MIGRAINE (migraine/severe all day migraine/ horrible migrane), VACCINATION SITE HAEMORRHAGE (blood trickled down arm), NASOPHARYNGITIS (cold), GAIT DISTURBANCE (difficulty walking), VISION BLURRED (eyesight blurry), HYPERHIDROSIS (Hot/cold sweats), FATIGUE (extreme fatigue/bed ridden), ARTHRALGIA (Joint pain/ joint aches), PYREXIA (lowgrade fever/ fever) and MYALGIA (body aches/ muscle pain/ muscle aches). On an unknown date, the patient experienced MALAISE (not being well). At the time of the report, MIGRAINE (migraine/severe all day migraine/ horrible migrane) and FATIGUE (extreme fatigue/bed ridden) had not resolved, VACCINATION SITE HAEMORRHAGE (blood trickled down arm), NASOPHARYNGITIS (cold), MALAISE (not being well), GAIT DISTURBANCE (difficulty walking), VISION BLURRED (eyesight blurry) and ARTHRALGIA (Joint pain/ joint aches) outcome was unknown and HYPERHIDROSIS (Hot/cold sweats), PYREXIA (lowgrade fever/ fever) and MYALGIA (body aches/ muscle pain/ muscle aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Event start date for feeling unwell reported as unknown day of AUG 2021.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Additional information included patient demographic data, suspect drug batch number, new events blurry vision, walking difficulty, blood trickled down arm  and event outcome updated for fever, body aches, hot/cold sweats.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blister, Dizziness, Dyspnoea, Headache
Clinical narrative: a sinus infection even now; blowing her nose; short of breath; her right upper back and shoulder were sore; lymph nodes in the right side of her neck and in her throat were swollen; having headaches; got a fever; sore left arm; getting dizzy; blisters; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm), DIZZINESS (getting dizzy), BLISTER (blisters), SINUSITIS (a sinus infection even now) and RHINORRHOEA (blowing her nose) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2021, the patient experienced PAIN IN EXTREMITY (sore left arm), DIZZINESS (getting dizzy), BLISTER (blisters), DYSPNOEA (short of breath), ARTHRALGIA (her right upper back and shoulder were sore), LYMPHADENOPATHY (lymph nodes in the right side of her neck and in her throat were swollen), HEADACHE (having headaches) and PYREXIA (got a fever). On an unknown date, the patient experienced SINUSITIS (a sinus infection even now) and RHINORRHOEA (blowing her nose). At the time of the report, PAIN IN EXTREMITY (sore left arm), DIZZINESS (getting dizzy), BLISTER (blisters), DYSPNOEA (short of breath), ARTHRALGIA (her right upper back and shoulder were sore), LYMPHADENOPATHY (lymph nodes in the right side of her neck and in her throat were swollen), HEADACHE (having headaches) and PYREXIA (got a fever) had resolved and SINUSITIS (a sinus infection even now) and RHINORRHOEA (blowing her nose) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication include vitamins   No Treatment information was reported.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Pyrexia, Rhinorrhoea, Sinusitis
Clinical narrative: a sinus infection even now; blowing her nose; short of breath; her right upper back and shoulder were sore; lymph nodes in the right side of her neck and in her throat were swollen; having headaches; got a fever; sore left arm; getting dizzy; blisters; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left arm), DIZZINESS (getting dizzy), BLISTER (blisters), SINUSITIS (a sinus infection even now) and RHINORRHOEA (blowing her nose) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2021, the patient experienced PAIN IN EXTREMITY (sore left arm), DIZZINESS (getting dizzy), BLISTER (blisters), DYSPNOEA (short of breath), ARTHRALGIA (her right upper back and shoulder were sore), LYMPHADENOPATHY (lymph nodes in the right side of her neck and in her throat were swollen), HEADACHE (having headaches) and PYREXIA (got a fever). On an unknown date, the patient experienced SINUSITIS (a sinus infection even now) and RHINORRHOEA (blowing her nose). At the time of the report, PAIN IN EXTREMITY (sore left arm), DIZZINESS (getting dizzy), BLISTER (blisters), DYSPNOEA (short of breath), ARTHRALGIA (her right upper back and shoulder were sore), LYMPHADENOPATHY (lymph nodes in the right side of her neck and in her throat were swollen), HEADACHE (having headaches) and PYREXIA (got a fever) had resolved and SINUSITIS (a sinus infection even now) and RHINORRHOEA (blowing her nose) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication include vitamins   No Treatment information was reported.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 10 patients received doses from an expire vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 patients received doses from an expire vial) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 054C214) for COVID-19 vaccination.     No Medical History information was reported.   On 27-May-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021 at 2:49 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (10 patients received doses from an expire vial). On 24-Jun-2021, EXPIRED PRODUCT ADMINISTERED (10 patients received doses from an expire vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not reported.  Treatment information was not provided.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received dose from expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 054C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperglycemia since 29-Sep-2019 and Pure hypercholesterolemia since 26-Aug-2008. Concomitant products included HYDROCHLOROTHIAZIDE from 17-Sep-2019 to an unknown date for an unknown indication.   On 17-May-2021 at 1:38 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021 at 9:26 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial). On 24-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received doses from an expire vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received doses from an expire vial) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 054C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperlipidemia since 02-Apr-2019. Concomitant products included PRAVASTATIN for Blood cholesterol abnormal.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received doses from an expire vial). On 24-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received doses from an expire vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication provided.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine from expire vial) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 054C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypercholesterolemia since 26-Dec-2018 and Hyperlipidemia since 03-Jun-2018. Concomitant products included ATORVASTATIN from 26-Dec-2018 to an unknown date for an unknown indication.   On 27-May-2021 at 8:51 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021 at 9:02 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine from expire vial). On 24-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Received vaccine from expire vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received doses from an expire vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received doses from an expire vial) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 054C21A) for COVID-19 vaccination.     Concurrent medical conditions included Anemia since 18-Mar-2021, Amenorrhea, Benign essential hypertension and Allergy to nuts (Walnut). Concomitant products included AMLODIPINE from 17-Jul-2020 to an unknown date and ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) from 12-Mar-2021 to an unknown date for an unknown indication.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received doses from an expire vial). On 24-Jun-2021, EXPIRED PRODUCT ADMINISTERED (received doses from an expire vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   the patient race was given as Black.  No concomitant medication information was provided.  No treatment medication information was given.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patients received doses from an expire vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received doses from an expire vial) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 054C21A) for COVID-19 vaccination.     The patient's past medical history included Lumbar radiculopathy. Concomitant products included SERTRALINE from 09-Jun-2021 to an unknown date and OXAPROZIN from 27-Jan-2020 to an unknown date for an unknown indication.   On 27-May-2021 at 3:06 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021 at 1:01 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received doses from an expire vial). On 24-Jun-2021, EXPIRED PRODUCT ADMINISTERED (patients received doses from an expire vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patients received doses from an expire vial; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021.    This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received doses from an expire vial) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation since 02-Aug-2017 and Blood pressure increased since 28-Nov-2017. Concomitant products included ATORVASTATIN from 15-Mar-2021 to an unknown date and ACETYLSALICYLIC ACID (ASPRIN) from 28-Nov-2017 to an unknown date for an unknown indication.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received doses from an expire vial). On 24-Jun-2021, EXPIRED PRODUCT ADMINISTERED (patients received doses from an expire vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   No corrective treatment was provided.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested Covid positive after getting Moderna's vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested Covid positive after getting Moderna's 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 SARS-COV-2 TEST POSITIVE (Tested Covid positive after getting Moderna's vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested Covid positive after getting Moderna's vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.   Reporter did not allow further contact
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site pain
Clinical narrative: still has a strong pain at the injection site; 3 weeks ago it started to swell his right leg from his knee to his foot thumb; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (still has a strong pain at the injection site) and PERIPHERAL SWELLING (3 weeks ago it started to swell his right leg from his knee to his foot thumb) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (still has a strong pain at the injection site) and PERIPHERAL SWELLING (3 weeks ago it started to swell his right leg from his knee to his foot thumb). At the time of the report, VACCINATION SITE PAIN (still has a strong pain at the injection site) and PERIPHERAL SWELLING (3 weeks ago it started to swell his right leg from his knee to his foot thumb) outcome was unknown.            No concomitant medication was provided by the reporter.  No treatment medication was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: felt tension at the base of my neck; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (felt tension at the base of my neck) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (felt tension at the base of my neck). At the time of the report, MUSCULOSKELETAL DISCOMFORT (felt tension at the base of my neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: The backs of my knees hurt really bad when I try to straighten my legs out; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (The backs of my knees hurt really bad when I try to straighten my legs out) 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 ARTHRALGIA (The backs of my knees hurt really bad when I try to straighten my legs out). At the time of the report, ARTHRALGIA (The backs of my knees hurt really bad when I try to straighten my legs out) 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.