chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose decreased, Blood glucose fluctuation, Coma, Confusional state
Clinical narrative: Almost Died/I've almost died due to the vaccine; Coma; Severe low blood sugar level; Dizziness; Blood sugar level fluctuations; Confusion; This spontaneous case was reported by a consumer and describes the occurrence of NEAR DEATH EXPERIENCE (Almost Died/I've almost died due to the vaccine), COMA (Coma), BLOOD GLUCOSE DECREASED (Severe low blood sugar level), DIZZINESS (Dizziness) and BLOOD GLUCOSE FLUCTUATION (Blood sugar level fluctuations) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic (Since 12 years).    On 19-Oct-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 NEAR DEATH EXPERIENCE (Almost Died/I've almost died due to the vaccine), COMA (Coma), BLOOD GLUCOSE DECREASED (Severe low blood sugar level), DIZZINESS (Dizziness), BLOOD GLUCOSE FLUCTUATION (Blood sugar level fluctuations) and CONFUSIONAL STATE (Confusion). At the time of the report, NEAR DEATH EXPERIENCE (Almost Died/I've almost died due to the vaccine), COMA (Coma), BLOOD GLUCOSE DECREASED (Severe low blood sugar level), DIZZINESS (Dizziness), BLOOD GLUCOSE FLUCTUATION (Blood sugar level fluctuations) and CONFUSIONAL STATE (Confusion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: 40 (Low) in morning and 126 (High) later.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported. No treatment information was reported.  Patient was diabetic and the day after getting vaccine experienced severe low level of blood sugar level and didn't take insulin per HCP. Patient took 450 gram of sugar and almost died and experienced Coma and dizziness and went to urgent care and no additional medication was administered, insulin level was adjusted and also reports confusion following his incident. patient reports no other condition, medication or allergy and has HCP appointment next month. Patient thinking what happened to him is Moderna Vaccine fault and like escalate his own case and talk to supervisor and like to be contacted by safety team on that day. Medical inquiry process was explained to caller and his case can escalated once HCP calls back and was informed  go to urgent care if he has emergency medical needs.     Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Non significant follow up appended no new information.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Near death experience
Clinical narrative: Almost Died/I've almost died due to the vaccine; Coma; Severe low blood sugar level; Dizziness; Blood sugar level fluctuations; Confusion; This spontaneous case was reported by a consumer and describes the occurrence of NEAR DEATH EXPERIENCE (Almost Died/I've almost died due to the vaccine), COMA (Coma), BLOOD GLUCOSE DECREASED (Severe low blood sugar level), DIZZINESS (Dizziness) and BLOOD GLUCOSE FLUCTUATION (Blood sugar level fluctuations) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic (Since 12 years).    On 19-Oct-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 NEAR DEATH EXPERIENCE (Almost Died/I've almost died due to the vaccine), COMA (Coma), BLOOD GLUCOSE DECREASED (Severe low blood sugar level), DIZZINESS (Dizziness), BLOOD GLUCOSE FLUCTUATION (Blood sugar level fluctuations) and CONFUSIONAL STATE (Confusion). At the time of the report, NEAR DEATH EXPERIENCE (Almost Died/I've almost died due to the vaccine), COMA (Coma), BLOOD GLUCOSE DECREASED (Severe low blood sugar level), DIZZINESS (Dizziness), BLOOD GLUCOSE FLUCTUATION (Blood sugar level fluctuations) and CONFUSIONAL STATE (Confusion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: 40 (Low) in morning and 126 (High) later.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported. No treatment information was reported.  Patient was diabetic and the day after getting vaccine experienced severe low level of blood sugar level and didn't take insulin per HCP. Patient took 450 gram of sugar and almost died and experienced Coma and dizziness and went to urgent care and no additional medication was administered, insulin level was adjusted and also reports confusion following his incident. patient reports no other condition, medication or allergy and has HCP appointment next month. Patient thinking what happened to him is Moderna Vaccine fault and like escalate his own case and talk to supervisor and like to be contacted by safety team on that day. Medical inquiry process was explained to caller and his case can escalated once HCP calls back and was informed  go to urgent care if he has emergency medical needs.     Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Non significant follow up appended no new information.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Received third dose from vial refrigerated for more than 30 days; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received third dose from vial refrigerated for more than 30 days) and PRODUCT STORAGE ERROR (Product storage error) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received third dose from vial refrigerated for more than 30 days) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received third dose from vial refrigerated for more than 30 days) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided. Patient reported- The vaccine was defrosted in 30Aug2021 and it was administered on 01Oct2021.   This case was linked to MOD-2021-358921, MOD-2021-358773 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Vaccination site pain
Clinical narrative: Stiffness; Sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness) and VACCINATION SITE PAIN (Sore arm at the injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness) and VACCINATION SITE PAIN (Sore arm at the injection site). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness) and VACCINATION SITE PAIN (Sore arm at the injection site) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-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 PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-358717, MOD-2021-358845 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Not immunocompromised and received full third dose of 0.5ml; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Not immunocompromised and received full third dose of 0.5ml) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00F421A, 038K20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Not immunocompromised and received full third dose of 0.5ml). On 19-Oct-2021, ACCIDENTAL OVERDOSE (Not immunocompromised and received full third dose of 0.5ml) had resolved.            Concomitant information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-358928 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: This spontaneous case was reported by a physician assistant and describes the occurrence of PRODUCT STORAGE ERROR (received third dose from vial refrigerated for more than 30 days) in an 82-year-old female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced PRODUCT STORAGE ERROR (received third dose from vial refrigerated for more than 30 days). On 01-Oct-2021, PRODUCT STORAGE ERROR (received third dose from vial refrigerated for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported No  treatment Drug was reported   This case was linked to MOD-2021-358921, MOD-2021-358773 (Patient Link).
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received third dose from vial refrigerated for more than 30 days; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-358921, MOD-2021-358773 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle disorder, Muscular weakness
Clinical narrative: Second Vaccine affected all his left Leg muscles; Has to lift up the leg by hand; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE DISORDER (Second Vaccine affected all his left Leg muscles) and MUSCULAR WEAKNESS (Has to lift up the leg by hand) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient spent 10 days in the hospital, he could not move his body and 2 days in the nursing home post COVID Disease.) in 2020.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced MUSCLE DISORDER (Second Vaccine affected all his left Leg muscles) and MUSCULAR WEAKNESS (Has to lift up the leg by hand). At the time of the report, MUSCLE DISORDER (Second Vaccine affected all his left Leg muscles) and MUSCULAR WEAKNESS (Has to lift up the leg by hand) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details was not provided.  Treatment details was not provided by reporter.  He was scared to take a third shot. The second vaccine affected all his left leg muscles. He has to lift up the left leg by hand for example to put shoes on.  Company comment include This case concerns a 69 year-old male patient with no relevant medical history, who experienced the unexpected non-serious events of Muscle disorder and Muscular weakness. The event s occurred on the same day as the second dose of mRNA-1273 vaccine. The seriousness criteria of Medically significant and Disability are removed from this spontaneous case based on medical judgement and review of source document that does not include information supporting progressive or permanent disability requiring treatment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 69 year-old male patient with no relevant medical history, who experienced the unexpected non-serious events of Muscle disorder and Muscular weakness. The event s occurred on the same day as the second dose of mRNA-1273 vaccine. The seriousness criteria of Medically significant and Disability are removed from this spontaneous case based on medical judgement and review of source document that does not include information supporting progressive or permanent disability requiring treatment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Depression, Vaccination complication
Clinical narrative: Severe depression; Vaccine hit them hard; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSION (Severe depression) and VACCINATION COMPLICATION (Vaccine hit them hard) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEPRESSION (Severe depression) and VACCINATION COMPLICATION (Vaccine hit them hard). At the time of the report, DEPRESSION (Severe depression) and VACCINATION COMPLICATION (Vaccine hit them hard) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was not provided. Treatment information was not reported.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received third dose from vial refrigerated for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received third dose from vial refrigerated for more than 30 days) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received third dose from vial refrigerated for more than 30 days). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received third dose from vial refrigerated for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-358735, MOD-2021-358800, MOD-2021-359032, MOD-2021-358753, MOD-2021-358773, MOD-2021-358799, MOD-2021-358841, MOD-2021-358865, MOD-2021-359183, MOD-2021-359764 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chest pain, Chills, Depression, Diarrhoea
Clinical narrative: Damage to her stomach; Heart and chest felling like burning/burning on the left side of her heart; Fogginess in her mind/wanting to disappear; Severe depression; Shingles on the left side 3of her mouth; Not being able to open her mouth; Diarrhea; Falling; Bbig ball in the injection site; Very high fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Damage to her stomach), CHEST PAIN (Heart and chest felling like burning/burning on the left side of her heart), FEELING ABNORMAL (Fogginess in her mind/wanting to disappear), DEPRESSION (Severe depression) and HERPES ZOSTER (Shingles on the left side 3of her mouth) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 063e21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included CARVEDILOL, VIT D [VITAMIN D NOS], VITAMIN C [ASCORBIC ACID] and VITAMIN E NOS for an unknown indication.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced ABDOMINAL DISCOMFORT (Damage to her stomach), CHEST PAIN (Heart and chest felling like burning/burning on the left side of her heart), FEELING ABNORMAL (Fogginess in her mind/wanting to disappear), DEPRESSION (Severe depression), HERPES ZOSTER (Shingles on the left side 3of her mouth), DYSKINESIA (Not being able to open her mouth), DIARRHOEA (Diarrhea), FALL (Falling), VACCINATION SITE SWELLING (Bbig ball in the injection site), PYREXIA (Very high fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Damage to her stomach) had not resolved and CHEST PAIN (Heart and chest felling like burning/burning on the left side of her heart), FEELING ABNORMAL (Fogginess in her mind/wanting to disappear), DEPRESSION (Severe depression), HERPES ZOSTER (Shingles on the left side 3of her mouth), DYSKINESIA (Not being able to open her mouth), DIARRHOEA (Diarrhea), FALL (Falling), VACCINATION SITE SWELLING (Bbig ball in the injection site), PYREXIA (Very high fever) and CHILLS (Chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Other concomitant medications included high blood pressure medicine. Treatment also included tea, ice pack and antibiotics.   This case was linked to MOD-2021-358984.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Fall, Feeling abnormal, Herpes zoster, Pyrexia
Clinical narrative: Damage to her stomach; Heart and chest felling like burning/burning on the left side of her heart; Fogginess in her mind/wanting to disappear; Severe depression; Shingles on the left side 3of her mouth; Not being able to open her mouth; Diarrhea; Falling; Bbig ball in the injection site; Very high fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Damage to her stomach), CHEST PAIN (Heart and chest felling like burning/burning on the left side of her heart), FEELING ABNORMAL (Fogginess in her mind/wanting to disappear), DEPRESSION (Severe depression) and HERPES ZOSTER (Shingles on the left side 3of her mouth) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 063e21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included CARVEDILOL, VIT D [VITAMIN D NOS], VITAMIN C [ASCORBIC ACID] and VITAMIN E NOS for an unknown indication.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced ABDOMINAL DISCOMFORT (Damage to her stomach), CHEST PAIN (Heart and chest felling like burning/burning on the left side of her heart), FEELING ABNORMAL (Fogginess in her mind/wanting to disappear), DEPRESSION (Severe depression), HERPES ZOSTER (Shingles on the left side 3of her mouth), DYSKINESIA (Not being able to open her mouth), DIARRHOEA (Diarrhea), FALL (Falling), VACCINATION SITE SWELLING (Bbig ball in the injection site), PYREXIA (Very high fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Damage to her stomach) had not resolved and CHEST PAIN (Heart and chest felling like burning/burning on the left side of her heart), FEELING ABNORMAL (Fogginess in her mind/wanting to disappear), DEPRESSION (Severe depression), HERPES ZOSTER (Shingles on the left side 3of her mouth), DYSKINESIA (Not being able to open her mouth), DIARRHOEA (Diarrhea), FALL (Falling), VACCINATION SITE SWELLING (Bbig ball in the injection site), PYREXIA (Very high fever) and CHILLS (Chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Other concomitant medications included high blood pressure medicine. Treatment also included tea, ice pack and antibiotics.   This case was linked to MOD-2021-358984.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Damage to her stomach; Heart and chest felling like burning/burning on the left side of her heart; Fogginess in her mind/wanting to disappear; Severe depression; Shingles on the left side 3of her mouth; Not being able to open her mouth; Diarrhea; Falling; Bbig ball in the injection site; Very high fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Damage to her stomach), CHEST PAIN (Heart and chest felling like burning/burning on the left side of her heart), FEELING ABNORMAL (Fogginess in her mind/wanting to disappear), DEPRESSION (Severe depression) and HERPES ZOSTER (Shingles on the left side 3of her mouth) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 063e21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high. Concomitant products included CARVEDILOL, VIT D [VITAMIN D NOS], VITAMIN C [ASCORBIC ACID] and VITAMIN E NOS for an unknown indication.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, the patient experienced ABDOMINAL DISCOMFORT (Damage to her stomach), CHEST PAIN (Heart and chest felling like burning/burning on the left side of her heart), FEELING ABNORMAL (Fogginess in her mind/wanting to disappear), DEPRESSION (Severe depression), HERPES ZOSTER (Shingles on the left side 3of her mouth), DYSKINESIA (Not being able to open her mouth), DIARRHOEA (Diarrhea), FALL (Falling), VACCINATION SITE SWELLING (Bbig ball in the injection site), PYREXIA (Very high fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Damage to her stomach) had not resolved and CHEST PAIN (Heart and chest felling like burning/burning on the left side of her heart), FEELING ABNORMAL (Fogginess in her mind/wanting to disappear), DEPRESSION (Severe depression), HERPES ZOSTER (Shingles on the left side 3of her mouth), DYSKINESIA (Not being able to open her mouth), DIARRHOEA (Diarrhea), FALL (Falling), VACCINATION SITE SWELLING (Bbig ball in the injection site), PYREXIA (Very high fever) and CHILLS (Chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Other concomitant medications included high blood pressure medicine. Treatment also included tea, ice pack and antibiotics.   This case was linked to MOD-2021-358984.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received third dose from vial refrigerated for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided.  It was reported that 12 patients were administered dose. The vial was defrosted from 30-Aug-2021.   This case was linked to MOD-2021-358921 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased, Pain in extremity
Clinical narrative: Soreness in his arm after all three shots; Could not lift shoulder for a day and a half; Soreness in his shoulder; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Soreness in his arm after all three shots), MOBILITY DECREASED (Could not lift shoulder for a day and a half) and ARTHRALGIA (Soreness in his shoulder) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02AL20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CLONAZEPAM (KLONOPIN) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness in his arm after all three shots), MOBILITY DECREASED (Could not lift shoulder for a day and a half) and ARTHRALGIA (Soreness in his shoulder). At the time of the report, PAIN IN EXTREMITY (Soreness in his arm after all three shots), MOBILITY DECREASED (Could not lift shoulder for a day and a half) and ARTHRALGIA (Soreness in his shoulder) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment details were reported.   This case was linked to MOD-2021-359056, MOD-2021-359053.   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Patient date of birth updated and new reporter added.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in arm) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 02AL20A) for COVID-19 vaccination.     No medical history was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-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 received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in arm). At the time of the report, PAIN IN EXTREMITY (soreness in arm) outcome was unknown.            He is not immunocompromised but received a third full dose.  He had soreness in his shoulder and could not lift it for a day and a half.  Concomitant product include Clonipin with unknown indication .  He does not believe his sore arm was an adverse reaction and he is not interested in filling out the follow up form. He wantsto help Moderna by getting his antibody level checked, as a 3 dose recipient of the Moderna COVID-19 vaccine.   This case was linked to MOD-2021-359056, MOD-2021-359050, MOD-2021-359050 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow up received included date of birth and new reporter added
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Dyspnoea, Fatigue, Paraesthesia oral
Clinical narrative: Chest pain; Tingling sensation  in tongue; Extremely fatigue; Wheezing; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (Wheezing), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain), PARAESTHESIA ORAL (Tingling sensation  in tongue) and FATIGUE (Extremely fatigue) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 037B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2021, the patient experienced WHEEZING (Wheezing), DYSPNOEA (Shortness of breath), PARAESTHESIA ORAL (Tingling sensation  in tongue) and FATIGUE (Extremely fatigue). On 19-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHEST PAIN (Chest pain). In October 2021, WHEEZING (Wheezing), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain) and PARAESTHESIA ORAL (Tingling sensation  in tongue) had resolved. At the time of the report, FATIGUE (Extremely fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: normal (normal) Patient has nothing in her lung..         No concomitant medications were provided. No treatment medications were provided.  Patient was going for an echocardiogram and patient was waiting for an appointment.   This case was linked to MOD-2021-358744, MOD-2021-358982, MOD-2021-358738 (Patient Link).
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Chest pain; Tingling sensation  in tongue; Extremely fatigue; Wheezing; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (Wheezing), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain), PARAESTHESIA ORAL (Tingling sensation  in tongue) and FATIGUE (Extremely fatigue) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A and 037B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2021, the patient experienced WHEEZING (Wheezing), DYSPNOEA (Shortness of breath), PARAESTHESIA ORAL (Tingling sensation  in tongue) and FATIGUE (Extremely fatigue). On 19-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHEST PAIN (Chest pain). In October 2021, WHEEZING (Wheezing), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain) and PARAESTHESIA ORAL (Tingling sensation  in tongue) had resolved. At the time of the report, FATIGUE (Extremely fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: normal (normal) Patient has nothing in her lung..         No concomitant medications were provided. No treatment medications were provided.  Patient was going for an echocardiogram and patient was waiting for an appointment.   This case was linked to MOD-2021-358744, MOD-2021-358982, MOD-2021-358738 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (could not lift it for a day and a half), VACCINATION SITE PAIN (soreness in his arm after all three shots) and ARTHRALGIA (soreness in his shoulder) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CLONIDINE for an unknown indication.    On 19-Sep-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 MOBILITY DECREASED (could not lift it for a day and a half), VACCINATION SITE PAIN (soreness in his arm after all three shots) and ARTHRALGIA (soreness in his shoulder). At the time of the report, MOBILITY DECREASED (could not lift it for a day and a half), VACCINATION SITE PAIN (soreness in his arm after all three shots) and ARTHRALGIA (soreness in his shoulder) outcome was unknown.            No treatment medications were reported.  Patient reported that he is not immunocompromised but received a third full dose.   This case was linked to MOD-2021-359050, MOD-2021-359053 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Patient demographics were updated.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 12 patients were administered expired dose; 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 (12 patients were administered expired dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (12 patients were administered expired dose). On 15-Oct-2021, EXPIRED PRODUCT ADMINISTERED (12 patients were administered expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received third dose from vial refrigerated for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vaccine was defrosted in 30Aug2021 and was administered on 01Oct2021.  Reporter stated that patient was fine. No concomitant medication were provided. No treatment information were provided.   This case was linked to MOD-2021-358921, MOD-2021-358773 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received third dose from vial refrigerated for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Administered vaccine to patient which was refrigerated for more than 30 days. Vaccine was defrosted on 30-AUG-2021 and administered on 01-OCT-2021. It was administered as a third dose but unknown if the patient is immunocompromised or not.   Concomitant medications were not provided.  Treatment information was not provided.   This case was linked to MOD-2021-358921, MOD-2021-358773 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The patient was administered with an expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient was administered with an expired vaccine) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient was administered with an expired vaccine). On 16-Oct-2021, EXPIRED PRODUCT ADMINISTERED (The patient was administered with an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The date moved to refrigeration was 15-Oct-2021.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID) 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.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 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 SARS-COV-2 TEST POSITIVE (tested positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID) had resolved.            No concomitant and treatment medications was reported . This case concerns a patient of unknown age and gender, with unknown medical history, who experienced the non-serious unexpected AESI of SARS-CoV-2 TEST POSITIVE. The even occurred on an unknown date after receiving the second dose of Spikevax. The rechallenge is not applicable as causality for COVID 19 is not applicable. The benefit-risk relation of Spikevax is not affected by this report. This is a social media case, hence no further information is available for case assessment.; Sender's Comments: This case concerns a patient of unknown age and gender, with unknown medical history, who experienced the non-serious unexpected AESI of SARS-CoV-2 TEST POSITIVE. The even occurred on an unknown date after receiving the second dose of Spikevax. The rechallenge is not applicable as causality for COVID 19 is not applicable. The benefit-risk relation of Spikevax is not affected by this report. This is a social media case, hence no further information is available for case assessment.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea started around 9 pm; Severe vomiting shortly after until 3am; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the right arm on 06May2021 at 11:30 at the age of 42-years-old as a single dose for COVID-19 immunisation. The patient had no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient previously received ELIQUIS on an unknown date and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the right arm on 15Apr2021 at 11:30 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. On 06May2021 at 21:00, the patient experienced nausea started around 21:00 and then had severe vomiting shortly after until 03:00. The shot was given at 11:30. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events vomiting was resolved on 07May2021 at 03:00 and nausea was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Incontinence, Pain
Clinical narrative: Diarrhea; Incontinence; Light headed; Chills; Body sore; Arm hurts; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 06May2021 at 11:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications included vitamins (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 06May2021 at 17:00, the patient experienced diarrhea, incontinence, light headed, chills, body sore and arm hurt. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events diarrhea, incontinence, light headed, chills, body sore and arm hurt was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Diarrhea; Incontinence; Light headed; Chills; Body sore; Arm hurts; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0182) via an unspecified route of administration in the left arm on 06May2021 at 11:45 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications included vitamins (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 06May2021 at 17:00, the patient experienced diarrhea, incontinence, light headed, chills, body sore and arm hurt. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events diarrhea, incontinence, light headed, chills, body sore and arm hurt was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.