chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: No adverse event. After the vaccine requested was administered, it came to my knowledge the patient had not completed her primary series, she had only received her first dose of Pfizer a year ago. As a result, contacted CDC on recommendation, which is to receive a dose of monovalent Moderna in order to be considered up to date, then the booster again at least 2 months after. Made this recommendation to the patient and made patient's primary care doctor aware.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Bed rest, Chest pain, Dizziness, Dyspnoea
Clinical narrative: approximately 8 hours after injection I began to experience pain in my chest and head, arrhythmia, dizziness,  fever, shortness of breath, and loss of consciousness.  no treatment was received  beyond 2 days bedrest at home, due to inability to travel from symptoms. outcomes include continued shortness of breath, hypertension, waning loss of feeling in hands, arms legs and feet after short durations of sitting.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypertension, Loss of consciousness, Loss of personal independence in daily activities, Pyrexia
Clinical narrative: approximately 8 hours after injection I began to experience pain in my chest and head, arrhythmia, dizziness,  fever, shortness of breath, and loss of consciousness.  no treatment was received  beyond 2 days bedrest at home, due to inability to travel from symptoms. outcomes include continued shortness of breath, hypertension, waning loss of feeling in hands, arms legs and feet after short durations of sitting.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Sensory loss
Clinical narrative: approximately 8 hours after injection I began to experience pain in my chest and head, arrhythmia, dizziness,  fever, shortness of breath, and loss of consciousness.  no treatment was received  beyond 2 days bedrest at home, due to inability to travel from symptoms. outcomes include continued shortness of breath, hypertension, waning loss of feeling in hands, arms legs and feet after short durations of sitting.
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Angiogram pulmonary normal, Blood culture negative, Blood gases, Blood lactic acid
Clinical narrative: Clinical Summary Patient is a 38 y.o. female with a history of leukemia in remission and insomnia who presented to outside urgent care with worsening respiratory symptoms and transferred to hospital 12/16/2022 for COVID-19 and respiratory failure. Treated for CAP. Discharged to home 12/18/22.    1. COVID-19 Pneumonia: positive test 12/12/22. CTPA 12/16/22 negative for PE with LLL and RML opacities. Started on decadron for hypoxia. Patient declined remdesivir treatment due to outpatient trial of Paxlovid PTA.   2. CAP: Severe Sepsis POA (WBC 14.97, HR 131 and RR 24, Lactic acid 1.9.) Blood Cultures 12/16/22 NGTD. Urine Ags negative. Given IVF. Given rocephin and azithromycin in ED and transitioned to levaquin on admit. Given 5 day course of antibiotics end date 12/20/22.  3. Acute Hypoxic Respiratory Failure: RR 24 and 2 LPM placed in the ED.  No desaturation documented.  VBG showed O2 45 mmHg and CO2 51.8 mmHg with pH 7.40 on 12/16/2022.  CTPA per above. Resolved.  4. Leukocytosis: Pt clinically improved 12/18/22 although WBCs 22K. On room air and blood cultures remain NGTD. Treated for CAP as above. No other focal s/sx infection. Suspected steroid induced. Repeat CBC in one week
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Blood pH normal, COVID-19, COVID-19 pneumonia, Carbon dioxide increased, Hypoxia
Clinical narrative: Clinical Summary Patient is a 38 y.o. female with a history of leukemia in remission and insomnia who presented to outside urgent care with worsening respiratory symptoms and transferred to hospital 12/16/2022 for COVID-19 and respiratory failure. Treated for CAP. Discharged to home 12/18/22.    1. COVID-19 Pneumonia: positive test 12/12/22. CTPA 12/16/22 negative for PE with LLL and RML opacities. Started on decadron for hypoxia. Patient declined remdesivir treatment due to outpatient trial of Paxlovid PTA.   2. CAP: Severe Sepsis POA (WBC 14.97, HR 131 and RR 24, Lactic acid 1.9.) Blood Cultures 12/16/22 NGTD. Urine Ags negative. Given IVF. Given rocephin and azithromycin in ED and transitioned to levaquin on admit. Given 5 day course of antibiotics end date 12/20/22.  3. Acute Hypoxic Respiratory Failure: RR 24 and 2 LPM placed in the ED.  No desaturation documented.  VBG showed O2 45 mmHg and CO2 51.8 mmHg with pH 7.40 on 12/16/2022.  CTPA per above. Resolved.  4. Leukocytosis: Pt clinically improved 12/18/22 although WBCs 22K. On room air and blood cultures remain NGTD. Treated for CAP as above. No other focal s/sx infection. Suspected steroid induced. Repeat CBC in one week
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Leukocytosis, Pneumonia, Respiratory failure, Sepsis, Urine antigen test
Clinical narrative: Clinical Summary Patient is a 38 y.o. female with a history of leukemia in remission and insomnia who presented to outside urgent care with worsening respiratory symptoms and transferred to hospital 12/16/2022 for COVID-19 and respiratory failure. Treated for CAP. Discharged to home 12/18/22.    1. COVID-19 Pneumonia: positive test 12/12/22. CTPA 12/16/22 negative for PE with LLL and RML opacities. Started on decadron for hypoxia. Patient declined remdesivir treatment due to outpatient trial of Paxlovid PTA.   2. CAP: Severe Sepsis POA (WBC 14.97, HR 131 and RR 24, Lactic acid 1.9.) Blood Cultures 12/16/22 NGTD. Urine Ags negative. Given IVF. Given rocephin and azithromycin in ED and transitioned to levaquin on admit. Given 5 day course of antibiotics end date 12/20/22.  3. Acute Hypoxic Respiratory Failure: RR 24 and 2 LPM placed in the ED.  No desaturation documented.  VBG showed O2 45 mmHg and CO2 51.8 mmHg with pH 7.40 on 12/16/2022.  CTPA per above. Resolved.  4. Leukocytosis: Pt clinically improved 12/18/22 although WBCs 22K. On room air and blood cultures remain NGTD. Treated for CAP as above. No other focal s/sx infection. Suspected steroid induced. Repeat CBC in one week
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: White blood cell count increased
Clinical narrative: Clinical Summary Patient is a 38 y.o. female with a history of leukemia in remission and insomnia who presented to outside urgent care with worsening respiratory symptoms and transferred to hospital 12/16/2022 for COVID-19 and respiratory failure. Treated for CAP. Discharged to home 12/18/22.    1. COVID-19 Pneumonia: positive test 12/12/22. CTPA 12/16/22 negative for PE with LLL and RML opacities. Started on decadron for hypoxia. Patient declined remdesivir treatment due to outpatient trial of Paxlovid PTA.   2. CAP: Severe Sepsis POA (WBC 14.97, HR 131 and RR 24, Lactic acid 1.9.) Blood Cultures 12/16/22 NGTD. Urine Ags negative. Given IVF. Given rocephin and azithromycin in ED and transitioned to levaquin on admit. Given 5 day course of antibiotics end date 12/20/22.  3. Acute Hypoxic Respiratory Failure: RR 24 and 2 LPM placed in the ED.  No desaturation documented.  VBG showed O2 45 mmHg and CO2 51.8 mmHg with pH 7.40 on 12/16/2022.  CTPA per above. Resolved.  4. Leukocytosis: Pt clinically improved 12/18/22 although WBCs 22K. On room air and blood cultures remain NGTD. Treated for CAP as above. No other focal s/sx infection. Suspected steroid induced. Repeat CBC in one week
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Blindness, Blood creatinine normal, Blood glucose increased, Blood thyroid stimulating hormone decreased
Clinical narrative: Assessment and Plan: Patient is a very pleasant  63 y.o. female patient of local DO with history of Afib S/P CV, CKD 3, S/P Renal transplant, CAD, HTN, HLD, DM2, OSA, Hypothyroidism, Retinopathy, Meningioma, Obesity, Glaucoma,who presented with fall and confusion, found to have covid 19 PNA with respiratory failure on 12/23/22. She required NC supplemental oxygen and now is on RA.  ID recommended dexamethasone and remdesivir and she received one dose of tocilizumab. She lost venous access and was a difficult IV placement and given CKD ID was ok with dc remdesivir given her improvement and dc plans.  Her blood glucose levels were elevated secondary to dexamethasone and patient will need to contact her endocrinologist for adjustments to her insulin dose.  She had a ct scan of her orbits that showed retinal detachment and calcifications and were deemed to be chronic findings.  Ophthalmology recommends that she continue her eye drops and follow up with her opthalmologist.  Patient was schedule for discharge yesterday but transportation could not be obtained.  She is scheduled for discharge today with home health.      Acute hypoxic respiratory failure Covid-19 Virus Infection Date of onset of symptoms: chills, nasal congestion Symptoms present on admission: 12/21 Date of covid positive test: 12/23 Vaccination status: vaccinated Imaging: CXR with bilateral congestion Oxygen requirements on admission: 2 L NC Current oxygen requirements: RA Medical therapy: steroids, rocephin, and zithromax, (STARTED 12/23) received vanc, cefepime in ER for sepsis-- >ID input appreciated with recommendations to continue dexamethasone and they added remdesivir (12/23/22) and recommended one dose of tocilizumab if pct <0.5 (given on 12/23/22 for 1 dose)  Asymptomatic/improved SOB ID was ok with stopping remdesivir do to venous access and dc planning Complete 4  mores days of dexamethasone then resume her normal prednisone dose for renal transpant    Acute toxic encephalopathy Resolved At baseline mental status   Hx of renal transplant CKD 3 Cr stable at baseline  Continued home cyclosporine, mycophenolate Giving dexamethasone for above so holding home prednisone which was ok with nephrology. Resume home prednisone dose when dexamethasone is completed   Chronic afib Rate controlled; continued home toprol and xarelto   Essential HTN Controlled presently; continued home toprol and lasix   Yeast Infection/rash Given one dose of diflucan (12/24/22) and nystatin powder  Abnormal CT brain Left eye retinal detachment with loss of vision Appreciate opthalmology evaluation.  Findings are not new.  F/U with patients opthalmology.  Continue eye drops   DM2, with long term insulin use with retinopathy and polyneuropathy Hyperglycemia worsened by steroid use Monitor BG and cover with SSI and basal insulin   Acquired hypothyroidism TSH 0.62
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Chest X-ray abnormal, Chills, Computerised tomogram head abnormal
Clinical narrative: Assessment and Plan: Patient is a very pleasant  63 y.o. female patient of local DO with history of Afib S/P CV, CKD 3, S/P Renal transplant, CAD, HTN, HLD, DM2, OSA, Hypothyroidism, Retinopathy, Meningioma, Obesity, Glaucoma,who presented with fall and confusion, found to have covid 19 PNA with respiratory failure on 12/23/22. She required NC supplemental oxygen and now is on RA.  ID recommended dexamethasone and remdesivir and she received one dose of tocilizumab. She lost venous access and was a difficult IV placement and given CKD ID was ok with dc remdesivir given her improvement and dc plans.  Her blood glucose levels were elevated secondary to dexamethasone and patient will need to contact her endocrinologist for adjustments to her insulin dose.  She had a ct scan of her orbits that showed retinal detachment and calcifications and were deemed to be chronic findings.  Ophthalmology recommends that she continue her eye drops and follow up with her opthalmologist.  Patient was schedule for discharge yesterday but transportation could not be obtained.  She is scheduled for discharge today with home health.      Acute hypoxic respiratory failure Covid-19 Virus Infection Date of onset of symptoms: chills, nasal congestion Symptoms present on admission: 12/21 Date of covid positive test: 12/23 Vaccination status: vaccinated Imaging: CXR with bilateral congestion Oxygen requirements on admission: 2 L NC Current oxygen requirements: RA Medical therapy: steroids, rocephin, and zithromax, (STARTED 12/23) received vanc, cefepime in ER for sepsis-- >ID input appreciated with recommendations to continue dexamethasone and they added remdesivir (12/23/22) and recommended one dose of tocilizumab if pct <0.5 (given on 12/23/22 for 1 dose)  Asymptomatic/improved SOB ID was ok with stopping remdesivir do to venous access and dc planning Complete 4  mores days of dexamethasone then resume her normal prednisone dose for renal transpant    Acute toxic encephalopathy Resolved At baseline mental status   Hx of renal transplant CKD 3 Cr stable at baseline  Continued home cyclosporine, mycophenolate Giving dexamethasone for above so holding home prednisone which was ok with nephrology. Resume home prednisone dose when dexamethasone is completed   Chronic afib Rate controlled; continued home toprol and xarelto   Essential HTN Controlled presently; continued home toprol and lasix   Yeast Infection/rash Given one dose of diflucan (12/24/22) and nystatin powder  Abnormal CT brain Left eye retinal detachment with loss of vision Appreciate opthalmology evaluation.  Findings are not new.  F/U with patients opthalmology.  Continue eye drops   DM2, with long term insulin use with retinopathy and polyneuropathy Hyperglycemia worsened by steroid use Monitor BG and cover with SSI and basal insulin   Acquired hypothyroidism TSH 0.62
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dyspnoea, Fall, Fungal infection, Hyperglycaemia
Clinical narrative: Assessment and Plan: Patient is a very pleasant  63 y.o. female patient of local DO with history of Afib S/P CV, CKD 3, S/P Renal transplant, CAD, HTN, HLD, DM2, OSA, Hypothyroidism, Retinopathy, Meningioma, Obesity, Glaucoma,who presented with fall and confusion, found to have covid 19 PNA with respiratory failure on 12/23/22. She required NC supplemental oxygen and now is on RA.  ID recommended dexamethasone and remdesivir and she received one dose of tocilizumab. She lost venous access and was a difficult IV placement and given CKD ID was ok with dc remdesivir given her improvement and dc plans.  Her blood glucose levels were elevated secondary to dexamethasone and patient will need to contact her endocrinologist for adjustments to her insulin dose.  She had a ct scan of her orbits that showed retinal detachment and calcifications and were deemed to be chronic findings.  Ophthalmology recommends that she continue her eye drops and follow up with her opthalmologist.  Patient was schedule for discharge yesterday but transportation could not be obtained.  She is scheduled for discharge today with home health.      Acute hypoxic respiratory failure Covid-19 Virus Infection Date of onset of symptoms: chills, nasal congestion Symptoms present on admission: 12/21 Date of covid positive test: 12/23 Vaccination status: vaccinated Imaging: CXR with bilateral congestion Oxygen requirements on admission: 2 L NC Current oxygen requirements: RA Medical therapy: steroids, rocephin, and zithromax, (STARTED 12/23) received vanc, cefepime in ER for sepsis-- >ID input appreciated with recommendations to continue dexamethasone and they added remdesivir (12/23/22) and recommended one dose of tocilizumab if pct <0.5 (given on 12/23/22 for 1 dose)  Asymptomatic/improved SOB ID was ok with stopping remdesivir do to venous access and dc planning Complete 4  mores days of dexamethasone then resume her normal prednisone dose for renal transpant    Acute toxic encephalopathy Resolved At baseline mental status   Hx of renal transplant CKD 3 Cr stable at baseline  Continued home cyclosporine, mycophenolate Giving dexamethasone for above so holding home prednisone which was ok with nephrology. Resume home prednisone dose when dexamethasone is completed   Chronic afib Rate controlled; continued home toprol and xarelto   Essential HTN Controlled presently; continued home toprol and lasix   Yeast Infection/rash Given one dose of diflucan (12/24/22) and nystatin powder  Abnormal CT brain Left eye retinal detachment with loss of vision Appreciate opthalmology evaluation.  Findings are not new.  F/U with patients opthalmology.  Continue eye drops   DM2, with long term insulin use with retinopathy and polyneuropathy Hyperglycemia worsened by steroid use Monitor BG and cover with SSI and basal insulin   Acquired hypothyroidism TSH 0.62
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pulmonary congestion, Rash, Respiratory failure, Retinal detachment
Clinical narrative: Assessment and Plan: Patient is a very pleasant  63 y.o. female patient of local DO with history of Afib S/P CV, CKD 3, S/P Renal transplant, CAD, HTN, HLD, DM2, OSA, Hypothyroidism, Retinopathy, Meningioma, Obesity, Glaucoma,who presented with fall and confusion, found to have covid 19 PNA with respiratory failure on 12/23/22. She required NC supplemental oxygen and now is on RA.  ID recommended dexamethasone and remdesivir and she received one dose of tocilizumab. She lost venous access and was a difficult IV placement and given CKD ID was ok with dc remdesivir given her improvement and dc plans.  Her blood glucose levels were elevated secondary to dexamethasone and patient will need to contact her endocrinologist for adjustments to her insulin dose.  She had a ct scan of her orbits that showed retinal detachment and calcifications and were deemed to be chronic findings.  Ophthalmology recommends that she continue her eye drops and follow up with her opthalmologist.  Patient was schedule for discharge yesterday but transportation could not be obtained.  She is scheduled for discharge today with home health.      Acute hypoxic respiratory failure Covid-19 Virus Infection Date of onset of symptoms: chills, nasal congestion Symptoms present on admission: 12/21 Date of covid positive test: 12/23 Vaccination status: vaccinated Imaging: CXR with bilateral congestion Oxygen requirements on admission: 2 L NC Current oxygen requirements: RA Medical therapy: steroids, rocephin, and zithromax, (STARTED 12/23) received vanc, cefepime in ER for sepsis-- >ID input appreciated with recommendations to continue dexamethasone and they added remdesivir (12/23/22) and recommended one dose of tocilizumab if pct <0.5 (given on 12/23/22 for 1 dose)  Asymptomatic/improved SOB ID was ok with stopping remdesivir do to venous access and dc planning Complete 4  mores days of dexamethasone then resume her normal prednisone dose for renal transpant    Acute toxic encephalopathy Resolved At baseline mental status   Hx of renal transplant CKD 3 Cr stable at baseline  Continued home cyclosporine, mycophenolate Giving dexamethasone for above so holding home prednisone which was ok with nephrology. Resume home prednisone dose when dexamethasone is completed   Chronic afib Rate controlled; continued home toprol and xarelto   Essential HTN Controlled presently; continued home toprol and lasix   Yeast Infection/rash Given one dose of diflucan (12/24/22) and nystatin powder  Abnormal CT brain Left eye retinal detachment with loss of vision Appreciate opthalmology evaluation.  Findings are not new.  F/U with patients opthalmology.  Continue eye drops   DM2, with long term insulin use with retinopathy and polyneuropathy Hyperglycemia worsened by steroid use Monitor BG and cover with SSI and basal insulin   Acquired hypothyroidism TSH 0.62
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Retinal disorder, Sepsis, Toxic encephalopathy
Clinical narrative: Assessment and Plan: Patient is a very pleasant  63 y.o. female patient of local DO with history of Afib S/P CV, CKD 3, S/P Renal transplant, CAD, HTN, HLD, DM2, OSA, Hypothyroidism, Retinopathy, Meningioma, Obesity, Glaucoma,who presented with fall and confusion, found to have covid 19 PNA with respiratory failure on 12/23/22. She required NC supplemental oxygen and now is on RA.  ID recommended dexamethasone and remdesivir and she received one dose of tocilizumab. She lost venous access and was a difficult IV placement and given CKD ID was ok with dc remdesivir given her improvement and dc plans.  Her blood glucose levels were elevated secondary to dexamethasone and patient will need to contact her endocrinologist for adjustments to her insulin dose.  She had a ct scan of her orbits that showed retinal detachment and calcifications and were deemed to be chronic findings.  Ophthalmology recommends that she continue her eye drops and follow up with her opthalmologist.  Patient was schedule for discharge yesterday but transportation could not be obtained.  She is scheduled for discharge today with home health.      Acute hypoxic respiratory failure Covid-19 Virus Infection Date of onset of symptoms: chills, nasal congestion Symptoms present on admission: 12/21 Date of covid positive test: 12/23 Vaccination status: vaccinated Imaging: CXR with bilateral congestion Oxygen requirements on admission: 2 L NC Current oxygen requirements: RA Medical therapy: steroids, rocephin, and zithromax, (STARTED 12/23) received vanc, cefepime in ER for sepsis-- >ID input appreciated with recommendations to continue dexamethasone and they added remdesivir (12/23/22) and recommended one dose of tocilizumab if pct <0.5 (given on 12/23/22 for 1 dose)  Asymptomatic/improved SOB ID was ok with stopping remdesivir do to venous access and dc planning Complete 4  mores days of dexamethasone then resume her normal prednisone dose for renal transpant    Acute toxic encephalopathy Resolved At baseline mental status   Hx of renal transplant CKD 3 Cr stable at baseline  Continued home cyclosporine, mycophenolate Giving dexamethasone for above so holding home prednisone which was ok with nephrology. Resume home prednisone dose when dexamethasone is completed   Chronic afib Rate controlled; continued home toprol and xarelto   Essential HTN Controlled presently; continued home toprol and lasix   Yeast Infection/rash Given one dose of diflucan (12/24/22) and nystatin powder  Abnormal CT brain Left eye retinal detachment with loss of vision Appreciate opthalmology evaluation.  Findings are not new.  F/U with patients opthalmology.  Continue eye drops   DM2, with long term insulin use with retinopathy and polyneuropathy Hyperglycemia worsened by steroid use Monitor BG and cover with SSI and basal insulin   Acquired hypothyroidism TSH 0.62
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Infection, Scar, Skin lesion
Clinical narrative: Infected sore on wrist
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: 1st time with Moderns, now have Tinnitus started a few days later.
Age: 46.0
Sex: F
Vaccine: HEPA
Symptoms: Arthralgia, Ear swelling, Eye swelling, Heart rate increased, Lymphadenopathy
Clinical narrative: Swollen face especially eyes, fever 101.1, swollen glands in face. Neck, ears, throat, swollen tonsils, joint pain, sporadic pain in right arm and right leg, fast heart beat when in motion. Can't sleep from all the pain.
Age: 46.0
Sex: F
Vaccine: HEPA
Symptoms: Pain, Pain in extremity, Pharyngeal swelling, Pyrexia, Sleep disorder
Clinical narrative: Swollen face especially eyes, fever 101.1, swollen glands in face. Neck, ears, throat, swollen tonsils, joint pain, sporadic pain in right arm and right leg, fast heart beat when in motion. Can't sleep from all the pain.
Age: 46.0
Sex: F
Vaccine: HEPA
Symptoms: Swelling, Swelling face, Tonsillar hypertrophy
Clinical narrative: Swollen face especially eyes, fever 101.1, swollen glands in face. Neck, ears, throat, swollen tonsils, joint pain, sporadic pain in right arm and right leg, fast heart beat when in motion. Can't sleep from all the pain.
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Gave the monovalent instead of the bivalent for the age.
Age: 45.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Electrocardiogram, Feeling abnormal, Palpitations
Clinical narrative: I have feel racing heartbeat on 1/6/2023 and 1/7/2023, I have developed symptoms of shortness of breath and chest pressure on 1/8/2023, I still feeling bad on 1/9/2023
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Headache, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Flu like symptoms (headache, muscle aches, fever) for 2 days before tested positiv.  Doctor visit to confirm the test result. Prescription medication: Azithromycin 250 mg tablets 6-pak Plus over the counter medication: Melatonin 3 mg, Zinc 30 mg, Vitamin D. I felt better after the first day with treatment.  12/14/2022 I tested negativ.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Flu like symptoms (headache, muscle aches, fever) for 2 days before tested positiv.  Doctor visit to confirm the test result. Prescription medication: Azithromycin 250 mg tablets 6-pak Plus over the counter medication: Melatonin 3 mg, Zinc 30 mg, Vitamin D. I felt better after the first day with treatment.  12/14/2022 I tested negativ.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Electrocardiogram normal, Syncope
Clinical narrative: Syncope happened twice on 1/8/23. Went to hospital emergency where they did all the blood tests and EKG as well. Everything was normal.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (ex. temp./location).
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Axillary mass, Injection site erythema, Injection site induration, Injection site swelling, Pain
Clinical narrative: Severe red swollen hard arm almost to elbow. Also terrible body aches felt like Mac truck hit me. Going on 4th day and arm still very sore, red and swollen. Also baseball size lump under arm and hurts.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity
Clinical narrative: Severe red swollen hard arm almost to elbow. Also terrible body aches felt like Mac truck hit me. Going on 4th day and arm still very sore, red and swollen. Also baseball size lump under arm and hurts.
Age: 50.0
Sex: M
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient was given a bivalent dose instead of a monovalent to finish primary series. No symptoms reported. CDC recommendations were to administer monovalent dose immediately with no minimum interval. Patient declined and would like to wait the 2 months and received the monovalent vaccine at that time.
Age: 8.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Product preparation error
Clinical narrative: NO ADVERSE EVENTS HAVE BEEN REPORTED SINCE 12/31/2022 COVID VACCINE ADMINISTERED WITHOUT BEING DILUTED 0.7ML INJECTED RIGHT ARM IM. TOTAL OF DOSES IN VIAL EQUIVALENT TO 10 AFTER DILUTION OF 1.3 ML OF SODIUM CHLORIDE
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: having COVID; having COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP, Nurse, Physician and Other HCP) from product quality group.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6199) and on 26Mar2021 as dose 2, single (Lot number: ER8732) at the age of 58 years, all intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "having COVID".; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Vaccination failure (LOE) and COVID-19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202101091850 same reporter/patient different vaccine dose/events;
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: 12/12/22 presents to ED for "SOB". PMHx of "HFpEF, CAD s/p CABG, PAF on Eliquis, CKD, and Hypertension"
Age: 43.0
Sex: M
Vaccine: COVID19-2, COVID19-2, COVID19-2
Symptoms: Product storage error
Clinical narrative: Bad case of covid following temperature excursion of booster
Age: 43.0
Sex: M
Vaccine: COVID19-2, COVID19-2, COVID19-2
Symptoms: COVID-19, Product storage error
Clinical narrative: Bad case of covid following temperature excursion of booster
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Chest pain, Pregnancy, SARS-CoV-2 test positive
Clinical narrative: 11/23/22 presents to ed for "chest pain" "COVID" "34 weeks pregnancy". PMHx of "graves disease, anxiety disorder"
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient was late on receiving her second dose, by 2 weeks.; no AE; This spontaneous report was received from a nurse referring to a female patient of unknown age. The patient's concurrent conditions, medical histories, concomitant therapies and drug reaction/allergies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 3 dose series, administered for prophylaxis (strength, dose, lot #, expiry date, route of administration and anatomical site of administration were not provided). On an unknown date, the patient was late on receiving her second dose by 2 weeks (inappropriate schedule of vaccine administered). No additional adverse event was report (no adverse event).
Age: 0.17
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE reported; GARDASIL 9 was administered to a 2-month old patient today 1/5/2023; This spontaneous report was received from a nurse referring to a 2-month-old female patient. The patient's medical history, historical drugs, concurrent conditions, and concomitant drugs were not reported.   On 05-JAN-2023 (also reported as "today"), the patient was administered HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection (lot#: U029033, expiration date: 13-MAR-2024; strength, dose, route of administration, and anatomical location were not reported) for prophylaxis (product administered to patient of inappropriate age). No additional adverse event details available. No additional adverse events reported (no adverse event).
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Patient received a vaccine after 34 days in the fridge; No adverse event; Patient received a vaccine after 34 days in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine after 34 days in the fridge), PRODUCT STORAGE ERROR (Patient received a vaccine after 34 days in the fridge) and NO ADVERSE EVENT (No adverse event) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057A22A) for COVID-19 prophylaxis.     No Allergy No Diseases.     On 03-Jan-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Jan-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine after 34 days in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received a vaccine after 34 days in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine after 34 days in the fridge), PRODUCT STORAGE ERROR (Patient received a vaccine after 34 days in the fridge) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine after 34 days in the fridge) and PRODUCT STORAGE ERROR (Patient received a vaccine after 34 days in the fridge).    Concomitant medication was not provided. Treatment medication information was not provided by the reporter.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; received a dose from a vial that was punctured a week ago; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was punctured a week ago) and NO ADVERSE EVENT (No adverse event) in a 79-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7166B) for COVID-19 prophylaxis.     Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concurrent medical conditions included Drug allergy (Allergy to Codeine), Hypertension and Colon cancer.    On 04-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 04-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was punctured a week ago). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was punctured a week ago) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was punctured a week ago).    No concomitant medications were reported. No treatment details were reported.
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: covid positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid positive) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to Severe ).   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (covid positive). At the time of the report, COVID-19 (covid positive) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.   No concomitant medications were reported. Was reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19, COVID19, FLUX
Symptoms: Vaccination site pain
Clinical narrative: Mild and temporary Injection site pain; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Mild and temporary Injection site pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication and INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    No Medical History information was reported.   In October 2022, the patient received dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Mild and temporary Injection site pain). At the time of the report, VACCINATION SITE PAIN (Mild and temporary Injection site pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.  Patient is a retired registered nurse. Patient received flu shot on October on an unknown date and year and had flu on 26- Dec of an unknown year. Patient's husband and daughters had COVID at different times in 2022, all were vaccinated and recovered with no residual effects.   This case was linked to MODERNATX, INC.-MOD-2023-694623, MODERNATX, INC.-MOD-2023-694625 (E2B Linked Report). This case was linked to MOD-2023-694621 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2023: Live follow-up includes Non-significant information.; Sender's Comments:  MODERNATX, INC.-MOD-2023-694623:Husband's case MODERNATX, INC.-MOD-2023-694625:Case for daughters
Sex: F
Vaccine: COVID19, COVID19-2, FLUX
Symptoms: Influenza, Vaccination site pain
Clinical narrative: Flu; mild and temporary Injection site pain; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA (Flu) and VACCINATION SITE PAIN (mild and temporary Injection site pain) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication and INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.   In October 2022, the patient received dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. In 2022, the patient experienced VACCINATION SITE PAIN (mild and temporary Injection site pain). On 26-Dec-2022, the patient experienced INFLUENZA (Flu). At the time of the report, INFLUENZA (Flu) and VACCINATION SITE PAIN (mild and temporary Injection site pain) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. Patient received 2 moderna vaccines and a moderna booster. No treatment medication details was reported   This case was linked to MODERNATX, INC.-MOD-2023-694625 (E2B Linked Report). This case was linked to MOD-2023-694616, MOD-2023-694623 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2023: Follow up received included non-significant information. Sender's Comments:  MODERNATX, INC.-MOD-2023-694625:Reporter case
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Covid) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.   In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced COVID-19 (Covid). At the time of the report, COVID-19 (Covid) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: Positive.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported. The treatment medication was not reported.   This case was linked to MODERNATX, INC.-MOD-2023-694625 (E2B Linked Report). This case was linked to MOD-2023-694616, MOD-2023-694621 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2023: Live follow-up received contains no new information; Sender's Comments:  MODERNATX, INC.-MOD-2023-694625:Daughters case
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: had COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (had COVID-19) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced COVID-19 (had COVID-19). At the time of the report, COVID-19 (had COVID-19) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Patient had COVID on an unknown date of 2022, but had been vaccinated and recovered with no residual effects. No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-694621, US-MODERNATX, INC.-MOD-2023-694616, US-MODERNATX, INC.-MOD-2023-694623 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jan-2023: Live follow-up included non-significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-694616:Reporter case US-MODERNATX, INC.-MOD-2023-694621:Reporter case US-MODERNATX, INC.-MOD-2023-694623:Husband case
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Muscle spasms, Pain
Clinical narrative: leg cramping and pain issues before receiving the Moderna Bivalent vaccine and symptoms worsening a day after receiving the vaccine; leg cramping and pain issues before receiving the Moderna Bivalent vaccine and symptoms worsening a day after receiving the vaccine; leg cramping and pain issues before receiving the Moderna Bivalent vaccine and symptoms worsening a day after receiving the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of MUSCLE SPASMS (leg cramping and pain issues before receiving the Moderna Bivalent vaccine and symptoms worsening a day after receiving the vaccine), PAIN (leg cramping and pain issues before receiving the Moderna Bivalent vaccine and symptoms worsening a day after receiving the vaccine) and CONDITION AGGRAVATED (leg cramping and pain issues before receiving the Moderna Bivalent vaccine and symptoms worsening a day after receiving the vaccine) in a 56-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Cramps leg and Pain.    On 29-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 30-Dec-2022, the patient experienced MUSCLE SPASMS (leg cramping and pain issues before receiving the Moderna Bivalent vaccine and symptoms worsening a day after receiving the vaccine) and PAIN (leg cramping and pain issues before receiving the Moderna Bivalent vaccine and symptoms worsening a day after receiving the vaccine). On an unknown date, the patient experienced CONDITION AGGRAVATED (leg cramping and pain issues before receiving the Moderna Bivalent vaccine and symptoms worsening a day after receiving the vaccine). At the time of the report, MUSCLE SPASMS (leg cramping and pain issues before receiving the Moderna Bivalent vaccine and symptoms worsening a day after receiving the vaccine) and PAIN (leg cramping and pain issues before receiving the Moderna Bivalent vaccine and symptoms worsening a day after receiving the vaccine) was resolving and CONDITION AGGRAVATED (leg cramping and pain issues before receiving the Moderna Bivalent vaccine and symptoms worsening a day after receiving the vaccine) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. patient reports having leg cramping and pain issues before receiving the Moderna Bivalent vaccine and symptoms worsening a day after receiving the vaccine It was unknown if the patient experienced any additional symptoms or events. Medication Details and reason for taking the medicine. No treatment medications were reported.   Reporter did not allow further contact
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: he started having a lot of itching on her back. The itching then randomly appeared on other places on the body.; 4 Weeks later a rash appeared on her body.; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (he started having a lot of itching on her back. The itching then randomly appeared on other places on the body.) and RASH (4 Weeks later a rash appeared on her body.) in a 98-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (First Dose Lot:012M20A & Exp. Date: unknown) on 18-Feb-2021, Moderna COVID-19 Vaccine (Second dose Lot: 014M20A & Exp. Date: unknown) on 18-Mar-2021 and Moderna COVID-19 Vaccine (First Monovalent Booster dose  Lot: 035121A & Exp. Date unknown) on 22-Nov-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 02-Dec-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced PRURITUS (he started having a lot of itching on her back. The itching then randomly appeared on other places on the body.). In December 2022, the patient experienced RASH (4 Weeks later a rash appeared on her body.). At the time of the report, PRURITUS (he started having a lot of itching on her back. The itching then randomly appeared on other places on the body.) had not resolved and RASH (4 Weeks later a rash appeared on her body.) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   Patient reported that doctor suggested to use a lotion. She stated even Benadryl did not help her.