chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Acute respiratory failure, Ammonia normal, Blood gases normal, Blood pressure increased
Clinical narrative: Admission Date: 2/1/2023 Discharge Date: 2/16/23  PRESENTING PROBLEM: Acute respiratory insufficiency  Acute respiratory failure with hypoxia    HOSPITAL COURSE: Patient is a 51-year-old female with PMH significant for hypertension, OSA/CPAP, epilepsy on antiepileptics, type 2 diabetes, history of malignant brain tumor status post excision/VP shunt, thyroid cancer, anoxic brain injury/developmental delay and right hemiplegia with associated dysphagia/feeding tube, nonverbal/non communicative, wheelchair-bound complete care at baseline at home with mom as being primary caregiver, hypothyroidism presents to the hospital on 2/1---with complaints of increased blood pressure at home, facial swelling, abdominal distension and labored breathing. Patient was noted to be hypoxic in ER at 88%, tachypneic, needing supplemental oxygen and chest x-ray showing cardiomegaly and pulmonary congestion.  Patient was admitted with suspicion for pulmonary congestion related to uncontrolled blood pressures, echo without any significant findings, was given diuretics.  Echo showed EF of 70%.  Blood pressure medications were further adjusted resulting in better control. Patient developed fever and 2/6 and with continued hypoxia further workup  with chest x-ray that showed infiltrates, CT thorax/abdomen and pelvis without any acute changes.  Urinalysis was negative.  Patient did not have any meningeal signs.  Ultimately she did test positive for COVID-19 on film array and interestingly her film array was negative at admit with prior COVID infection in Dec 2022.  Patient was started on remdesivir and antibiotics discontinued. Her hypoxia and respiratory status worsened so she was started on dexamethasone with gradual improvement. Patient also developed increased lethargy around 2/5 of unclear etiology.  Further workup with CT head without any acute changes, TSH, VBG, ammonia, B12 were all normal.  Neurology consultation was obtained who recommended MRI brain (no acute changes), EEG (which was abnormal with occasional LR DA and GRDA and interictal epileptiform discharges) her home Keppra and Tegretol doses were increased. She had significant improvement with steroids. She was weaned down to RA and ultimately discharged home is stable conditions with plans to continue increased dose of BP meds and to finish steroids. It was discussed to the mother/caregiver to return if respiratory status worsened after stopping steroids for covid with the possibility of post-covid ILD.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood thyroid stimulating hormone normal, COVID-19, Cardiomegaly, Chest X-ray abnormal, Computerised tomogram abdomen normal
Clinical narrative: Admission Date: 2/1/2023 Discharge Date: 2/16/23  PRESENTING PROBLEM: Acute respiratory insufficiency  Acute respiratory failure with hypoxia    HOSPITAL COURSE: Patient is a 51-year-old female with PMH significant for hypertension, OSA/CPAP, epilepsy on antiepileptics, type 2 diabetes, history of malignant brain tumor status post excision/VP shunt, thyroid cancer, anoxic brain injury/developmental delay and right hemiplegia with associated dysphagia/feeding tube, nonverbal/non communicative, wheelchair-bound complete care at baseline at home with mom as being primary caregiver, hypothyroidism presents to the hospital on 2/1---with complaints of increased blood pressure at home, facial swelling, abdominal distension and labored breathing. Patient was noted to be hypoxic in ER at 88%, tachypneic, needing supplemental oxygen and chest x-ray showing cardiomegaly and pulmonary congestion.  Patient was admitted with suspicion for pulmonary congestion related to uncontrolled blood pressures, echo without any significant findings, was given diuretics.  Echo showed EF of 70%.  Blood pressure medications were further adjusted resulting in better control. Patient developed fever and 2/6 and with continued hypoxia further workup  with chest x-ray that showed infiltrates, CT thorax/abdomen and pelvis without any acute changes.  Urinalysis was negative.  Patient did not have any meningeal signs.  Ultimately she did test positive for COVID-19 on film array and interestingly her film array was negative at admit with prior COVID infection in Dec 2022.  Patient was started on remdesivir and antibiotics discontinued. Her hypoxia and respiratory status worsened so she was started on dexamethasone with gradual improvement. Patient also developed increased lethargy around 2/5 of unclear etiology.  Further workup with CT head without any acute changes, TSH, VBG, ammonia, B12 were all normal.  Neurology consultation was obtained who recommended MRI brain (no acute changes), EEG (which was abnormal with occasional LR DA and GRDA and interictal epileptiform discharges) her home Keppra and Tegretol doses were increased. She had significant improvement with steroids. She was weaned down to RA and ultimately discharged home is stable conditions with plans to continue increased dose of BP meds and to finish steroids. It was discussed to the mother/caregiver to return if respiratory status worsened after stopping steroids for covid with the possibility of post-covid ILD.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram head normal, Computerised tomogram thorax normal, Diuretic therapy, Dyspnoea, Echocardiogram normal
Clinical narrative: Admission Date: 2/1/2023 Discharge Date: 2/16/23  PRESENTING PROBLEM: Acute respiratory insufficiency  Acute respiratory failure with hypoxia    HOSPITAL COURSE: Patient is a 51-year-old female with PMH significant for hypertension, OSA/CPAP, epilepsy on antiepileptics, type 2 diabetes, history of malignant brain tumor status post excision/VP shunt, thyroid cancer, anoxic brain injury/developmental delay and right hemiplegia with associated dysphagia/feeding tube, nonverbal/non communicative, wheelchair-bound complete care at baseline at home with mom as being primary caregiver, hypothyroidism presents to the hospital on 2/1---with complaints of increased blood pressure at home, facial swelling, abdominal distension and labored breathing. Patient was noted to be hypoxic in ER at 88%, tachypneic, needing supplemental oxygen and chest x-ray showing cardiomegaly and pulmonary congestion.  Patient was admitted with suspicion for pulmonary congestion related to uncontrolled blood pressures, echo without any significant findings, was given diuretics.  Echo showed EF of 70%.  Blood pressure medications were further adjusted resulting in better control. Patient developed fever and 2/6 and with continued hypoxia further workup  with chest x-ray that showed infiltrates, CT thorax/abdomen and pelvis without any acute changes.  Urinalysis was negative.  Patient did not have any meningeal signs.  Ultimately she did test positive for COVID-19 on film array and interestingly her film array was negative at admit with prior COVID infection in Dec 2022.  Patient was started on remdesivir and antibiotics discontinued. Her hypoxia and respiratory status worsened so she was started on dexamethasone with gradual improvement. Patient also developed increased lethargy around 2/5 of unclear etiology.  Further workup with CT head without any acute changes, TSH, VBG, ammonia, B12 were all normal.  Neurology consultation was obtained who recommended MRI brain (no acute changes), EEG (which was abnormal with occasional LR DA and GRDA and interictal epileptiform discharges) her home Keppra and Tegretol doses were increased. She had significant improvement with steroids. She was weaned down to RA and ultimately discharged home is stable conditions with plans to continue increased dose of BP meds and to finish steroids. It was discussed to the mother/caregiver to return if respiratory status worsened after stopping steroids for covid with the possibility of post-covid ILD.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ejection fraction normal, Electroencephalogram abnormal, Hypoxia, Lethargy, Lung infiltration
Clinical narrative: Admission Date: 2/1/2023 Discharge Date: 2/16/23  PRESENTING PROBLEM: Acute respiratory insufficiency  Acute respiratory failure with hypoxia    HOSPITAL COURSE: Patient is a 51-year-old female with PMH significant for hypertension, OSA/CPAP, epilepsy on antiepileptics, type 2 diabetes, history of malignant brain tumor status post excision/VP shunt, thyroid cancer, anoxic brain injury/developmental delay and right hemiplegia with associated dysphagia/feeding tube, nonverbal/non communicative, wheelchair-bound complete care at baseline at home with mom as being primary caregiver, hypothyroidism presents to the hospital on 2/1---with complaints of increased blood pressure at home, facial swelling, abdominal distension and labored breathing. Patient was noted to be hypoxic in ER at 88%, tachypneic, needing supplemental oxygen and chest x-ray showing cardiomegaly and pulmonary congestion.  Patient was admitted with suspicion for pulmonary congestion related to uncontrolled blood pressures, echo without any significant findings, was given diuretics.  Echo showed EF of 70%.  Blood pressure medications were further adjusted resulting in better control. Patient developed fever and 2/6 and with continued hypoxia further workup  with chest x-ray that showed infiltrates, CT thorax/abdomen and pelvis without any acute changes.  Urinalysis was negative.  Patient did not have any meningeal signs.  Ultimately she did test positive for COVID-19 on film array and interestingly her film array was negative at admit with prior COVID infection in Dec 2022.  Patient was started on remdesivir and antibiotics discontinued. Her hypoxia and respiratory status worsened so she was started on dexamethasone with gradual improvement. Patient also developed increased lethargy around 2/5 of unclear etiology.  Further workup with CT head without any acute changes, TSH, VBG, ammonia, B12 were all normal.  Neurology consultation was obtained who recommended MRI brain (no acute changes), EEG (which was abnormal with occasional LR DA and GRDA and interictal epileptiform discharges) her home Keppra and Tegretol doses were increased. She had significant improvement with steroids. She was weaned down to RA and ultimately discharged home is stable conditions with plans to continue increased dose of BP meds and to finish steroids. It was discussed to the mother/caregiver to return if respiratory status worsened after stopping steroids for covid with the possibility of post-covid ILD.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head normal, Pulmonary congestion, Pyrexia, SARS-CoV-2 test positive, Swelling face
Clinical narrative: Admission Date: 2/1/2023 Discharge Date: 2/16/23  PRESENTING PROBLEM: Acute respiratory insufficiency  Acute respiratory failure with hypoxia    HOSPITAL COURSE: Patient is a 51-year-old female with PMH significant for hypertension, OSA/CPAP, epilepsy on antiepileptics, type 2 diabetes, history of malignant brain tumor status post excision/VP shunt, thyroid cancer, anoxic brain injury/developmental delay and right hemiplegia with associated dysphagia/feeding tube, nonverbal/non communicative, wheelchair-bound complete care at baseline at home with mom as being primary caregiver, hypothyroidism presents to the hospital on 2/1---with complaints of increased blood pressure at home, facial swelling, abdominal distension and labored breathing. Patient was noted to be hypoxic in ER at 88%, tachypneic, needing supplemental oxygen and chest x-ray showing cardiomegaly and pulmonary congestion.  Patient was admitted with suspicion for pulmonary congestion related to uncontrolled blood pressures, echo without any significant findings, was given diuretics.  Echo showed EF of 70%.  Blood pressure medications were further adjusted resulting in better control. Patient developed fever and 2/6 and with continued hypoxia further workup  with chest x-ray that showed infiltrates, CT thorax/abdomen and pelvis without any acute changes.  Urinalysis was negative.  Patient did not have any meningeal signs.  Ultimately she did test positive for COVID-19 on film array and interestingly her film array was negative at admit with prior COVID infection in Dec 2022.  Patient was started on remdesivir and antibiotics discontinued. Her hypoxia and respiratory status worsened so she was started on dexamethasone with gradual improvement. Patient also developed increased lethargy around 2/5 of unclear etiology.  Further workup with CT head without any acute changes, TSH, VBG, ammonia, B12 were all normal.  Neurology consultation was obtained who recommended MRI brain (no acute changes), EEG (which was abnormal with occasional LR DA and GRDA and interictal epileptiform discharges) her home Keppra and Tegretol doses were increased. She had significant improvement with steroids. She was weaned down to RA and ultimately discharged home is stable conditions with plans to continue increased dose of BP meds and to finish steroids. It was discussed to the mother/caregiver to return if respiratory status worsened after stopping steroids for covid with the possibility of post-covid ILD.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachypnoea, Urine analysis normal, Vitamin B12 normal
Clinical narrative: Admission Date: 2/1/2023 Discharge Date: 2/16/23  PRESENTING PROBLEM: Acute respiratory insufficiency  Acute respiratory failure with hypoxia    HOSPITAL COURSE: Patient is a 51-year-old female with PMH significant for hypertension, OSA/CPAP, epilepsy on antiepileptics, type 2 diabetes, history of malignant brain tumor status post excision/VP shunt, thyroid cancer, anoxic brain injury/developmental delay and right hemiplegia with associated dysphagia/feeding tube, nonverbal/non communicative, wheelchair-bound complete care at baseline at home with mom as being primary caregiver, hypothyroidism presents to the hospital on 2/1---with complaints of increased blood pressure at home, facial swelling, abdominal distension and labored breathing. Patient was noted to be hypoxic in ER at 88%, tachypneic, needing supplemental oxygen and chest x-ray showing cardiomegaly and pulmonary congestion.  Patient was admitted with suspicion for pulmonary congestion related to uncontrolled blood pressures, echo without any significant findings, was given diuretics.  Echo showed EF of 70%.  Blood pressure medications were further adjusted resulting in better control. Patient developed fever and 2/6 and with continued hypoxia further workup  with chest x-ray that showed infiltrates, CT thorax/abdomen and pelvis without any acute changes.  Urinalysis was negative.  Patient did not have any meningeal signs.  Ultimately she did test positive for COVID-19 on film array and interestingly her film array was negative at admit with prior COVID infection in Dec 2022.  Patient was started on remdesivir and antibiotics discontinued. Her hypoxia and respiratory status worsened so she was started on dexamethasone with gradual improvement. Patient also developed increased lethargy around 2/5 of unclear etiology.  Further workup with CT head without any acute changes, TSH, VBG, ammonia, B12 were all normal.  Neurology consultation was obtained who recommended MRI brain (no acute changes), EEG (which was abnormal with occasional LR DA and GRDA and interictal epileptiform discharges) her home Keppra and Tegretol doses were increased. She had significant improvement with steroids. She was weaned down to RA and ultimately discharged home is stable conditions with plans to continue increased dose of BP meds and to finish steroids. It was discussed to the mother/caregiver to return if respiratory status worsened after stopping steroids for covid with the possibility of post-covid ILD.
Age: 66.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Back pain, Bursitis, C-reactive protein increased, Chondromalacia, Inflammatory marker test
Clinical narrative: Pt had an aching sensation in her left arm after receiving the vaccination on 6/2/22. As time went on, she developed worsening difficulty in lifting her arm above 90 degrees and pain radiated into the middle of her back. Pt presented to clinic on 6/23/22 for these symptoms and an MRI of her shoulder was ordered which showed a large joint effusion and synovitis/debris. Labs showed normal white count and normal markers of inflammation. She was given tramadol for the pain, but that made her dizzy. She was referred to orthopedics who managed her care going forward. She received a corticosteroid injection on 7/19/22 and was referred to physical therapy. She subsequently attended one session of PT.  Pt returned to orthopedics on 1/9/23 with concerns about ongoing pain.
Age: 66.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injected limb mobility decreased, Joint effusion, Magnetic resonance imaging abnormal, Osteoarthritis, Pain
Clinical narrative: Pt had an aching sensation in her left arm after receiving the vaccination on 6/2/22. As time went on, she developed worsening difficulty in lifting her arm above 90 degrees and pain radiated into the middle of her back. Pt presented to clinic on 6/23/22 for these symptoms and an MRI of her shoulder was ordered which showed a large joint effusion and synovitis/debris. Labs showed normal white count and normal markers of inflammation. She was given tramadol for the pain, but that made her dizzy. She was referred to orthopedics who managed her care going forward. She received a corticosteroid injection on 7/19/22 and was referred to physical therapy. She subsequently attended one session of PT.  Pt returned to orthopedics on 1/9/23 with concerns about ongoing pain.
Age: 66.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain in extremity, Red blood cell sedimentation rate normal, Synovitis, Tendon disorder, White blood cell count decreased
Clinical narrative: Pt had an aching sensation in her left arm after receiving the vaccination on 6/2/22. As time went on, she developed worsening difficulty in lifting her arm above 90 degrees and pain radiated into the middle of her back. Pt presented to clinic on 6/23/22 for these symptoms and an MRI of her shoulder was ordered which showed a large joint effusion and synovitis/debris. Labs showed normal white count and normal markers of inflammation. She was given tramadol for the pain, but that made her dizzy. She was referred to orthopedics who managed her care going forward. She received a corticosteroid injection on 7/19/22 and was referred to physical therapy. She subsequently attended one session of PT.  Pt returned to orthopedics on 1/9/23 with concerns about ongoing pain.
Age: 66.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Joint range of motion decreased, Loss of personal independence in daily activities, Magnetic resonance imaging abnormal
Clinical narrative: Pt had an aching sensation in her left arm after receiving the vaccination on 6/2/22. As time went on, she developed worsening difficulty in lifting her arm above 90 degrees and pain radiated into the middle of her back. Pt presented to clinic on 6/23/22 for these symptoms and an MRI of her shoulder was ordered which showed a large joint effusion and synovitis/debris. Labs showed normal white count and normal markers of inflammation. She was given tramadol for the pain, but that made her dizzy. She was referred to orthopedics who managed her care going forward. She received a corticosteroid injection on 7/19/22 and was referred to physical therapy. She subsequently attended one session of PT.  Pt returned to orthopedics on 1/9/23 with concerns about ongoing pain.
Age: 66.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Pain, Pain in extremity, X-ray
Clinical narrative: Pt had an aching sensation in her left arm after receiving the vaccination on 6/2/22. As time went on, she developed worsening difficulty in lifting her arm above 90 degrees and pain radiated into the middle of her back. Pt presented to clinic on 6/23/22 for these symptoms and an MRI of her shoulder was ordered which showed a large joint effusion and synovitis/debris. Labs showed normal white count and normal markers of inflammation. She was given tramadol for the pain, but that made her dizzy. She was referred to orthopedics who managed her care going forward. She received a corticosteroid injection on 7/19/22 and was referred to physical therapy. She subsequently attended one session of PT.  Pt returned to orthopedics on 1/9/23 with concerns about ongoing pain.
Age: 1.0
Sex: U
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: Product administration error
Clinical narrative: No additional AEs were reported; both MMR II and VARIVAX which were reconstituted with a diluent (w026848 5/21/2025) and then put in one syringe and administered to the patient; MMR II and VARIVAX which were reconstituted with a diluent (w026848 5/21/2025) and then put in one syringe and administered to the patient; This spontaneous report was received from a physician assitant and refers to a 12-month-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 09-FEB-2023 (reported as yesterday), the patient was vaccinted with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant human albumin) (M-M-R II) subcutaneous injection, lot number W007040 was verified to be a valid number with an expiration date reported and established as 29-FEB-2024; and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot number W022825 was verified to be a valid number with an expiration date reported and established as 18-JUL-2024, administered for prophylaxis (doses, strengths, anatomical injection sites, vaccination schemes and routes of administration were not provided were not provided); both vaccines were reconstituted with a sterile diluent (manufacturer unknown) solution for injection/infusion, lot number W026848 was verified to be a valid number with an expiration date reported and established as 21-MAY-2025, and then put in one syringe and administered to the patient (product preparation issue and wrong technique in product usage process). No additional adverse event was reported.
Age: 1.0
Sex: U
Vaccine: MMR, VARCEL, MMR, VARCEL
Symptoms: No adverse event, Product preparation issue, Wrong technique in product usage process
Clinical narrative: No additional AEs were reported; both MMR II and VARIVAX which were reconstituted with a diluent (w026848 5/21/2025) and then put in one syringe and administered to the patient; MMR II and VARIVAX which were reconstituted with a diluent (w026848 5/21/2025) and then put in one syringe and administered to the patient; This spontaneous report was received from a physician assitant and refers to a 12-month-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 09-FEB-2023 (reported as yesterday), the patient was vaccinted with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant human albumin) (M-M-R II) subcutaneous injection, lot number W007040 was verified to be a valid number with an expiration date reported and established as 29-FEB-2024; and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot number W022825 was verified to be a valid number with an expiration date reported and established as 18-JUL-2024, administered for prophylaxis (doses, strengths, anatomical injection sites, vaccination schemes and routes of administration were not provided were not provided); both vaccines were reconstituted with a sterile diluent (manufacturer unknown) solution for injection/infusion, lot number W026848 was verified to be a valid number with an expiration date reported and established as 21-MAY-2025, and then put in one syringe and administered to the patient (product preparation issue and wrong technique in product usage process). No additional adverse event was reported.
Age: 37.0
Sex: M
Vaccine: COVID19-2, FLU4, COVID19-2
Symptoms: Cyanosis, Dizziness, Hypotension, Loss of consciousness, Syncope
Clinical narrative: Fainting/Blurry vision/Lightheadedness; Started feeling tinnitus; Blue lips; This spontaneous case was reported by an other health care professional and describes the occurrence of SYNCOPE (Fainting/Blurry vision/Lightheadedness) in a 37-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concomitant products included INFLUENZA VACCINE (INFLUENZA) for an unknown indication.    On 15-Feb-2023 at 10:00 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 15-Feb-2023, the patient experienced SYNCOPE (Fainting/Blurry vision/Lightheadedness) (seriousness criterion medically significant), TINNITUS (Started feeling tinnitus) and CYANOSIS (Blue lips). The patient was treated with VITAMIN B12 NOS at an unspecified dose and frequency and ADEMETIONINE at an unspecified dose and frequency. On 15-Feb-2023, SYNCOPE (Fainting/Blurry vision/Lightheadedness), TINNITUS (Started feeling tinnitus) and CYANOSIS (Blue lips) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2023, Blood pressure measurement: Blood pressure remained low for about an hour after incident.     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.   Patient experienced events on 15-Feb-2023 at 6:45 PM. It was reported that all the events occurred in less than 5 minutes. The patient gained consciousness in less than a minute. Blood pressure and oxygenation were monitored after fainting spell.   The patient did not have an adverse event following any previous vaccine.  Company comment:This is a spontaneous case concerning 37 years old male patient, with no medical history, who experienced unexpected serious (medically significant) event of syncope, which occurred on same day after fourth dose of mRNA-1273 bivalent BA.1 Vaccination. After 5 minutes of vaccination patient experienced tinnitus, lightheadedness, blue lips, blurry vision, fainting, in less than a minute patient gained consciousness. Blood pressure was low for one hour after the fainting, oxygen saturation is also monitored. At the time of reporting event is recovered. The benefit-risk relationship of mRNA-1273 bivalent BA.1 vaccination is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2023: Live Non-significant follow-up appended (Reporter given follow-up consent)
Age: 37.0
Sex: M
Vaccine: COVID19-2, FLU4, COVID19-2
Symptoms: Tinnitus, Vision blurred
Clinical narrative: Fainting/Blurry vision/Lightheadedness; Started feeling tinnitus; Blue lips; This spontaneous case was reported by an other health care professional and describes the occurrence of SYNCOPE (Fainting/Blurry vision/Lightheadedness) in a 37-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concomitant products included INFLUENZA VACCINE (INFLUENZA) for an unknown indication.    On 15-Feb-2023 at 10:00 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 15-Feb-2023, the patient experienced SYNCOPE (Fainting/Blurry vision/Lightheadedness) (seriousness criterion medically significant), TINNITUS (Started feeling tinnitus) and CYANOSIS (Blue lips). The patient was treated with VITAMIN B12 NOS at an unspecified dose and frequency and ADEMETIONINE at an unspecified dose and frequency. On 15-Feb-2023, SYNCOPE (Fainting/Blurry vision/Lightheadedness), TINNITUS (Started feeling tinnitus) and CYANOSIS (Blue lips) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2023, Blood pressure measurement: Blood pressure remained low for about an hour after incident.     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.   Patient experienced events on 15-Feb-2023 at 6:45 PM. It was reported that all the events occurred in less than 5 minutes. The patient gained consciousness in less than a minute. Blood pressure and oxygenation were monitored after fainting spell.   The patient did not have an adverse event following any previous vaccine.  Company comment:This is a spontaneous case concerning 37 years old male patient, with no medical history, who experienced unexpected serious (medically significant) event of syncope, which occurred on same day after fourth dose of mRNA-1273 bivalent BA.1 Vaccination. After 5 minutes of vaccination patient experienced tinnitus, lightheadedness, blue lips, blurry vision, fainting, in less than a minute patient gained consciousness. Blood pressure was low for one hour after the fainting, oxygen saturation is also monitored. At the time of reporting event is recovered. The benefit-risk relationship of mRNA-1273 bivalent BA.1 vaccination is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2023: Live Non-significant follow-up appended (Reporter given follow-up consent)
Age: 37.0
Sex: M
Vaccine: COVID19-2, FLU4, COVID19-2
Symptoms: Blood pressure measurement, Cyanosis, Syncope, Tinnitus
Clinical narrative: Fainting/Blurry vision/Lightheadedness; Started feeling tinnitus; Blue lips; This spontaneous case was reported by an other health care professional and describes the occurrence of SYNCOPE (Fainting/Blurry vision/Lightheadedness) in a 37-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concomitant products included INFLUENZA VACCINE (INFLUENZA) for an unknown indication.    On 15-Feb-2023 at 10:00 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 15-Feb-2023, the patient experienced SYNCOPE (Fainting/Blurry vision/Lightheadedness) (seriousness criterion medically significant), TINNITUS (Started feeling tinnitus) and CYANOSIS (Blue lips). The patient was treated with VITAMIN B12 NOS at an unspecified dose and frequency and ADEMETIONINE at an unspecified dose and frequency. On 15-Feb-2023, SYNCOPE (Fainting/Blurry vision/Lightheadedness), TINNITUS (Started feeling tinnitus) and CYANOSIS (Blue lips) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Feb-2023, Blood pressure measurement: Blood pressure remained low for about an hour after incident.     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.   Patient experienced events on 15-Feb-2023 at 6:45 PM. It was reported that all the events occurred in less than 5 minutes. The patient gained consciousness in less than a minute. Blood pressure and oxygenation were monitored after fainting spell.   The patient did not have an adverse event following any previous vaccine.  Company comment:This is a spontaneous case concerning 37 years old male patient, with no medical history, who experienced unexpected serious (medically significant) event of syncope, which occurred on same day after fourth dose of mRNA-1273 bivalent BA.1 Vaccination. After 5 minutes of vaccination patient experienced tinnitus, lightheadedness, blue lips, blurry vision, fainting, in less than a minute patient gained consciousness. Blood pressure was low for one hour after the fainting, oxygen saturation is also monitored. At the time of reporting event is recovered. The benefit-risk relationship of mRNA-1273 bivalent BA.1 vaccination is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 16-Feb-2023: Live Non-significant follow-up appended (Reporter given follow-up consent)
Age: 70.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Injected limb mobility decreased, Injection site nerve damage
Clinical narrative: nerve damage on her left deltoid where the injection site was; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Nov2022 at 11:45 as dose 4 (booster), single (Lot number: GJ3275) at the age of 70 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing); "pain" (unspecified if ongoing); "bone disease" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose: 1; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose: 2; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose: 3; unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION SITE NERVE DAMAGE (non-serious) with onset 24Nov2022, outcome "not recovered", described as "nerve damage on her left deltoid where the injection site was". The event "nerve damage on her left deltoid where the injection site was" required physician office visit. It was unknown if therapeutic measures were taken as a result of vaccination site nerve damage. Additional information: The patient had no other vaccine in four weeks. The patient had no known allergy. She's stating been going to several doctors for treatment of her nerve damage.   No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Vaccination site nerve damage
Clinical narrative: nerve damage on her left deltoid where the injection site was; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 70-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Nov2022 at 11:45 as dose 4 (booster), single (Lot number: GJ3275) at the age of 70 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Hyperlipidemia" (unspecified if ongoing); "pain" (unspecified if ongoing); "bone disease" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose: 1; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose: 2; unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose: 3; unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION SITE NERVE DAMAGE (non-serious) with onset 24Nov2022, outcome "not recovered", described as "nerve damage on her left deltoid where the injection site was". The event "nerve damage on her left deltoid where the injection site was" required physician office visit. It was unknown if therapeutic measures were taken as a result of vaccination site nerve damage. Additional information: The patient had no other vaccine in four weeks. The patient had no known allergy. She's stating been going to several doctors for treatment of her nerve damage.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported / no reported side effects; administered a dose of PNEUMOVAX 23 that was 5 days after the expiration date; This spontaneous report has been received from a health care professional and a pharmacist referring to a patient of unknown age and gender, whose medical history, concurrent conditions, previous adverse drug reaction, or family adverse drug reactions were not provided.  On 19-JAN-2023, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, for prophylaxis (strength, dose, anatomical location, lot number, route of administration, and vaccine scheme were not reported; the expiration date was reported as: 14-JAN-2023). There were no adverse side effects reported (no adverse event).
Sex: F
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; Temperature excursion of 47.9°C for 47 min; This spontaneous report was received from an other health care professional and referred to a 4-month-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 15-DEC-2022, the patient was vaccinated with the third dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, lot #1892784, expiration date: 03-DEC-2023, administered orally for prophylaxis (dose, strength was not provided).   The administered dose of the vaccine experienced a temperature excursion (product storage error) on 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Digital data logger was involved. No adverse event was reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA009088:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles following  Vx administration/ suspected vaccination failure; Cases of shingles; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-FEB-2023 Reporter's Comment: The physician and his registered nurse mentioned that the patient had break through cases of shingles following administration of Shingrix. The reporter consent to follow up. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Age: 26.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: infanrix given  instead of Boostrix; Adult received Infanrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 26-year-old male patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th February 2023, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 10th February 2023, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 13-Feb-2023. Reporter's Comment: Reporter stated that they inadvertently administered Infanrix to an adult patient instead of Boostrix. Nurse inquired what to look for. The reporter did not consent to follow-up. Additional Supportive Information: An adult patient received Infanrix instead of Boostrix inadvertently, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired Engerixadministered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number 74EM4, expiry date 31st December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th February 2023, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 15th February 2023, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-Feb-2023 Reporter's comment: The health care professional reported that a patient received an expired dose of Engerix B. Reporter consented to follow up. Additional supportive information: As patient received expired Engerix B vaccine which led to expired vaccine used.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain
Clinical narrative: felt slightly fatigued; they had sore injection site arms; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INJECTION SITE PAIN (they had sore injection site arms) and FATIGUE (felt slightly fatigued) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 001B21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE and INFLUENZA VACCINE. Past adverse reactions to the above products included Fatigue with INFLUENZA VACCINE; and Vaccination site pain with INFLUENZA VACCINE.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form, third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form, fourth dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form and fifth dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (they had sore injection site arms) and FATIGUE (felt slightly fatigued). At the time of the report, INJECTION SITE PAIN (they had sore injection site arms) and FATIGUE (felt slightly fatigued) had resolved.        mRNA-1273 (Spikevax) (Intramuscular) and mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.   For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.   It was reported that, the patient received 5 Moderna vaccinations and had no side effects to the Moderna vaccine except they had sore injection site arms and felt slightly fatigued. "Just like with a Flu shot". Arm was sore for a day.   No treatment details were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-710518, US-MODERNATX, INC.-MOD-2023-710735, US-MODERNATX, INC.-MOD-2023-710736, US-MODERNATX, INC.-MOD-2023-710737, US-MODERNATX, INC.-MOD-2023-710738 ( Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2023: Follow-up information included patient age group updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-710518:Master case US-MODERNATX, INC.-MOD-2023-710738:5 out of 5 siblings US-MODERNATX, INC.-MOD-2023-710736:3 out of 5 siblings US-MODERNATX, INC.-MOD-2023-710735:2 out of 5 siblings US-MODERNATX, INC.-MOD-2023-710737:4 out of 5 siblings
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Poor quality product administered, Product storage error
Clinical narrative: patient was administered the product post temperature excursion with no reported adverse event; lowest temperature it reached was 30.9F for a total duration out of range of 4 hours and 30 minutes with no reported adverse event; Initial and live follow-up information received on 15-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 years old male patient who was administered the Diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel] post temperature excursion with no reported adverse event and lowest temperature it reached was 30.9f for a total duration out of range of 4 hours and 30 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Feb-2023, the patient received suspect Diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection (strength were not reported) (lot C6003BA and expiry date- 01-Jun-2024) via intramuscular route in the left deltoid for Immunization post temperature excursion with no reported adverse event  (poor quality product administered).  On 13-Feb-2023 vaccine has lowest temperature it reached was 30.9f for a total duration out of range of 4 hours and 30 minutes with no reported adverse event (Product storage error ).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  01493845: 01493759:
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Abnormal loss of weight, Bladder diverticulum, COVID-19
Clinical narrative: In September 2021, I received my second dose of Pfizer covid 19 vaccine. 12/2021 I had an episode of acute pancreatitis where I experienced severe abdominal pain 10/10 2-3 days in a row for less than an hour. At ER, my lipase levels were in 599. CT of abdomen and pelvis was negative except for a hutch diverticuli on bladder which was found incidentally.   01/2022 I tested positive for Covid 19 with symptoms for the second time (the first time 12/2022). After the episode of acute pancreatitis, I continued to have abdominal discomfort, diarrhea, nausea, chills, and abnormal weight loss (190lbs December 2022 down to 165 August 2022). August 2022, diagnosed with exocrine pancreatic insufficiency. I've been eating healthy, exercising, and maintaining a healthy lifestyle up until this episode of pancreatitis. I had regular blood work done with my PCP and am a registered nurse myself.