chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) in a 38-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown if the patient was ever diagnosed with/ tested positive for COVID-19.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023).    No concomitant medication details was reported.  Vial size was reported as 10 dose vial. The vial was initially stored in the refrigerator on 14-MAR-2023  The vial did not undergo any temperature excursions. It was reported that HCP states that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 patients on 15-MAR-2023. There was potentially a second lot number that was expired and was administered to patients on 3-MAR-2023, but HCP did not had any details on that event at the time of report. HCP wanted to know if the vaccine administered on 15-MAR-2023 would be considered valid for the patients.  No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) in a 34-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown if the patient had tested positive or diagnosed with COVID-19 previously.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023).    No concomitant medication was reported.  Vial size was reported as 10 dose vials. The vial was initially stored in the refrigerator on 14-MAR-2023. The vial did not undergo any temperature excursions.  It was reported that HCP states that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 patients on 15-MAR-2023. There was potentially a second lot number that was expired and was administered to patients on 3-MAR-2023, but HCP did not have any details on this event at the time of report. The second potential lot was confirmed to not be used.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023; No adverse event; She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event) in a 46-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown if patient had ever been diagnosed with/ tested positive for COVID-19.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated) and PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023).    Concomitant medication was not reported. Vial size was reported as 10 dose vial. The vial was initially stored in the refrigerator on 14-MAR-2023. The vial did not undergo any temperature excursions. It was reported that HCP stated that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 patients on 15-MAR-2023. There was potentially a second lot number that was expired and was administered to patients on 3-MAR-2023, but HCP did not had any details on that event at the time of report.  Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master Case
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event) in a 23-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023).    No relevant concomitant medications were reported.  It was also reported that there was potentially a second lot number that was expired on 28 Feb 2023 and was administered to patients on 3 Mar 2023, but HCP did not had any details on that event at that time. The vial size was reported as 10 dose vial.  The vial had not  undergone any temperature excursions. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Matster case
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023; No adverse event; She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event) in a 35-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown if patient had ever been diagnosed with/ tested positive for COVID-19.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated) and PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023).    No relevant concomitant medications were reported. It was also reported that there was potentially a second lot number that was expired on 28 Feb 2023 and was administered to patients on 3 Mar 2023, but HCP did not have any details on this event at this time.  Vial size was reported as 10 dose vial. The vial haven't undergone any temperature excursions.  No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine expired on 26Feb2023, vial moved to refrigerator on 14 Mar2023 and administered on 15 Mar2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, vial moved to refrigerator on 14 Mar2023 and administered on 15 Mar2023) and NO ADVERSE EVENT (No adverse event) in a 38-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown that patient had ever been diagnosed with/ tested positive for COVID-19.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, vial moved to refrigerator on 14 Mar2023 and administered on 15 Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, vial moved to refrigerator on 14 Mar2023 and administered on 15 Mar2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, vial moved to refrigerator on 14 Mar2023 and administered on 15 Mar2023).    No concomitant medication details was reported. Vial size was reported as 10 dose vial. The vial was initially stored in the refrigerator on 14-MAR-2023  The vial did not undergo any temperature excursions. It was reported that HCP states that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 patients on 15-MAR-2023. There was potentially a second lot number that was expired and was administered to patients on 3-MAR-2023, but HCP did not have any details on this event at this time. The second potential lot was confirmed to not be used. There are a total of 82 patients involved. HCP wants to know if the vaccine administered on 15-MAR-2023 would be considered valid for the patients. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Coagulopathy, Death, Embolism
Clinical narrative: He received the last COVID Moderna vaccine on 04/26/2022.  He was very healthy, active individual with no signs of illness found dead at home.  His cause of death is surmised to be a thromboembolic event due to coagulopathy.  He has no known history of coagulopathy, nor any known in his family.  Of note, his family is characterized by longevity.   The coagulopathy is suspect to be secondary to the COVID vaccines.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Coagulopathy, Death, Embolism, Respiratory distress, Respiratory failure
Clinical narrative: She had sudden onset respiratory distress/tachycardia on two occasions:  05/05/2023 and 05/07/2023.  She expired on 05/09/2023.  Her death certificate was completed as respiratory failure, but it was told by the mortician and that had marked, excessive blood clots within her vascular system at the time of embalming.  It is now highly suspected that death was due to thromboembolism secondary to blood coagulopathy - due to the COVID vaccines.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tachycardia, Thrombosis
Clinical narrative: She had sudden onset respiratory distress/tachycardia on two occasions:  05/05/2023 and 05/07/2023.  She expired on 05/09/2023.  Her death certificate was completed as respiratory failure, but it was told by the mortician and that had marked, excessive blood clots within her vascular system at the time of embalming.  It is now highly suspected that death was due to thromboembolism secondary to blood coagulopathy - due to the COVID vaccines.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient stated that she's still experiencing arm pain and soreness and it's been a month since her vaccination.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anticoagulant therapy, Blood test abnormal, Erythema, Factor V Leiden mutation, Pain in extremity
Clinical narrative: On 12/3/2022, in my right leg, I had pain and a large, red spot on my upper thigh. The spot was swollen and hot to the touch. I went to the ER, where I underwent an ultrasound of my leg. I was diagnosed with a superficial blood clot that ran from my right ankle to my groin. I was prescribed a blood thinner whose name I forget, and I was told to follow up with a vascular doctor. I saw a vascular doctor within a few days afterwards. While I was at the vascular doctor's office, I underwent another ultrasound of my leg and bloodwork. It was determined at that time that the blood clot extending from the ankle to the groin was still present. The vascular doctor prescribed me XARELTO, which I am currently still taking. She told me that I should see a hematologist, which I did. At the hematologist's office, I underwent blood tests. It was through the blood tests that it was discovered that I have Factor V Leiden mutation; it was mentioned that I had one such gene rather than two. The vascular doctor advised me to come back to her office for a follow-up either four or six weeks later. When I came back for the follow-up, I underwent another ultrasound of my leg. At that point, the blood clot was still present. She told me to just continue taking the medication and that she would check my progress during follow-ups. The last time I saw my vascular doctor, the clot had shrunk, but it still extended from the ankle to the groin. The doctor said that she wasn't sure that the blood clot would go away, but she wasn't very concerned, since improvement had been made. She did not arrange for me to come back for another follow-up, and she has just advised me to continue taking the XARELTO. The vascular doctor told me to come back for a check-up in a year. Of course, if I experience symptoms like the ones that brought me to the ER, I should come back sooner.
Age: 56.0
Sex: F
Vaccine: COVID19-2
Symptoms: Peripheral swelling, Skin warm, Superficial vein thrombosis, Ultrasound Doppler abnormal
Clinical narrative: On 12/3/2022, in my right leg, I had pain and a large, red spot on my upper thigh. The spot was swollen and hot to the touch. I went to the ER, where I underwent an ultrasound of my leg. I was diagnosed with a superficial blood clot that ran from my right ankle to my groin. I was prescribed a blood thinner whose name I forget, and I was told to follow up with a vascular doctor. I saw a vascular doctor within a few days afterwards. While I was at the vascular doctor's office, I underwent another ultrasound of my leg and bloodwork. It was determined at that time that the blood clot extending from the ankle to the groin was still present. The vascular doctor prescribed me XARELTO, which I am currently still taking. She told me that I should see a hematologist, which I did. At the hematologist's office, I underwent blood tests. It was through the blood tests that it was discovered that I have Factor V Leiden mutation; it was mentioned that I had one such gene rather than two. The vascular doctor advised me to come back to her office for a follow-up either four or six weeks later. When I came back for the follow-up, I underwent another ultrasound of my leg. At that point, the blood clot was still present. She told me to just continue taking the medication and that she would check my progress during follow-ups. The last time I saw my vascular doctor, the clot had shrunk, but it still extended from the ankle to the groin. The doctor said that she wasn't sure that the blood clot would go away, but she wasn't very concerned, since improvement had been made. She did not arrange for me to come back for another follow-up, and she has just advised me to continue taking the XARELTO. The vascular doctor told me to come back for a check-up in a year. Of course, if I experience symptoms like the ones that brought me to the ER, I should come back sooner.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Coagulation time prolonged, Coagulopathy, Death
Clinical narrative: She had sudden onset of respiratory distress and chest pain/pressure.  She had been fine just right up to this point.  She had witnessed fall that resulted in laceration injury with blood loss.  It was noted by the coroner and law enforcement that her blood on the floor from the laceration had significant coagulation markedly sooner than normal from a blood loss event.  She collapsed/died.  Based on the findings of the coroner and law enforcement, it is surmised she had thromboembolic event that would have been caused by coagulopathy.  She had no history of such, nor in her family.  Such is surmised from the COVID vaccines.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Embolism, Fall, Haemorrhage, Respiratory distress, Skin laceration
Clinical narrative: She had sudden onset of respiratory distress and chest pain/pressure.  She had been fine just right up to this point.  She had witnessed fall that resulted in laceration injury with blood loss.  It was noted by the coroner and law enforcement that her blood on the floor from the laceration had significant coagulation markedly sooner than normal from a blood loss event.  She collapsed/died.  Based on the findings of the coroner and law enforcement, it is surmised she had thromboembolic event that would have been caused by coagulopathy.  She had no history of such, nor in her family.  Such is surmised from the COVID vaccines.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Syncope
Clinical narrative: She had sudden onset of respiratory distress and chest pain/pressure.  She had been fine just right up to this point.  She had witnessed fall that resulted in laceration injury with blood loss.  It was noted by the coroner and law enforcement that her blood on the floor from the laceration had significant coagulation markedly sooner than normal from a blood loss event.  She collapsed/died.  Based on the findings of the coroner and law enforcement, it is surmised she had thromboembolic event that would have been caused by coagulopathy.  She had no history of such, nor in her family.  Such is surmised from the COVID vaccines.
Age: 58.0
Sex: F
Vaccine: COVID19-2
Symptoms: Loss of personal independence in daily activities, Musculoskeletal stiffness, Pain in extremity, Peripheral swelling
Clinical narrative: Inject was given in left arm. Approximately 6 hours after receiving, patient started to have swelling in opposite arm, swelling of the hand and fingers specifically between the middle and 2nd finger. Patient is experiencing a lot of pain along with swelling and stiffness of fingers to the point where she cannot complete daily functions like openning doors or lighting a glass with affected hand. Patient did apply ice to the affected area, as well as took bendryl. Pharmacist also recommended patient contact primary care regarding reaction. Primary care told patient to continue benadryl and ice. At last time of speaking with patient, patient symptoms had not resolved, but have not heard back from patient this evening.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Really sore arm and shoulder per patient . No fever.
Age: 17.0
Sex: M
Vaccine: HEP, MENB
Symptoms: Wrong product administered
Clinical narrative: Youth was ordered to receive Bexsero series and Hep B vaccination was administered. PCP Dr. contacted and updated with current info. No new orders received. No ASE noted upon assessment. VSS/WNL. Patient condition remains stable will continue to monitor.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Inflammatory marker test, Ligament pain, Muscular weakness
Clinical narrative: The patient received his Shingrix vaccine on -1/30/23.  There was no initial reaction.  However, the patient said that 3 weeks after getting his vaccine he began to have ankle weakness/pain in ligaments.  It peaked 1-1.5 months later with general muscle weakness.  It spread to his shoulders, hips, knees tendons locking up/snapping.  He felt arthritis pain and general muscle weakness.  He went to his PCP in April 2023.  They told him not to get the booster of Shingrix.  He stated that he did have a prior reaction to the flu vaccine with ligament/muscle weakness many years ago.  The Dr is taking blood and testing him for inflammatory markers.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose, Wrong product administered
Clinical narrative: Patient was administered 6months-5 year old vaccine instead of the adult vaccine. Patient was called and she is doing fine.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abscess drainage, Ataxia, Carotid artery stenosis, Cerebral disorder, Cerebral ischaemia
Clinical narrative: She had reported 3-4 weeks of dizziness and ataxia following her bivalent booster injection and she was having difficulty functioning and concerned she may lose her job.  She presented to ED finally on Jan 26, 2023 with refractory neurologic symptoms and was found to have subacute stroke on MRI imaging.  Subsequent in May 2023, she has now been admitted with refractory severe MSSA sepsis with endocarditis, meningitis, epidural abscess and persistently positive blood cx with new multifocal strokes.  She has required epidural abscess drainage, long term antibiotics, vasopressor support, ventilatory support and will require heart valve replacement.  Her long term prognosis is grimm.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cerebral small vessel ischaemic disease, Cerebrovascular accident, Cognitive disorder, Dizziness, Echocardiogram abnormal
Clinical narrative: She had reported 3-4 weeks of dizziness and ataxia following her bivalent booster injection and she was having difficulty functioning and concerned she may lose her job.  She presented to ED finally on Jan 26, 2023 with refractory neurologic symptoms and was found to have subacute stroke on MRI imaging.  Subsequent in May 2023, she has now been admitted with refractory severe MSSA sepsis with endocarditis, meningitis, epidural abscess and persistently positive blood cx with new multifocal strokes.  She has required epidural abscess drainage, long term antibiotics, vasopressor support, ventilatory support and will require heart valve replacement.  Her long term prognosis is grimm.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Ejection fraction decreased, Endocarditis, Extradural abscess, Impaired work ability, Left atrial dilatation
Clinical narrative: She had reported 3-4 weeks of dizziness and ataxia following her bivalent booster injection and she was having difficulty functioning and concerned she may lose her job.  She presented to ED finally on Jan 26, 2023 with refractory neurologic symptoms and was found to have subacute stroke on MRI imaging.  Subsequent in May 2023, she has now been admitted with refractory severe MSSA sepsis with endocarditis, meningitis, epidural abscess and persistently positive blood cx with new multifocal strokes.  She has required epidural abscess drainage, long term antibiotics, vasopressor support, ventilatory support and will require heart valve replacement.  Her long term prognosis is grimm.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Left ventricular hypertrophy, Loss of personal independence in daily activities, Magnetic resonance imaging, Magnetic resonance imaging head abnormal, Mechanical ventilation
Clinical narrative: She had reported 3-4 weeks of dizziness and ataxia following her bivalent booster injection and she was having difficulty functioning and concerned she may lose her job.  She presented to ED finally on Jan 26, 2023 with refractory neurologic symptoms and was found to have subacute stroke on MRI imaging.  Subsequent in May 2023, she has now been admitted with refractory severe MSSA sepsis with endocarditis, meningitis, epidural abscess and persistently positive blood cx with new multifocal strokes.  She has required epidural abscess drainage, long term antibiotics, vasopressor support, ventilatory support and will require heart valve replacement.  Her long term prognosis is grimm.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Meningitis, Mitral valve calcification, Mitral valve incompetence, Neurological symptom, Right atrial dilatation
Clinical narrative: She had reported 3-4 weeks of dizziness and ataxia following her bivalent booster injection and she was having difficulty functioning and concerned she may lose her job.  She presented to ED finally on Jan 26, 2023 with refractory neurologic symptoms and was found to have subacute stroke on MRI imaging.  Subsequent in May 2023, she has now been admitted with refractory severe MSSA sepsis with endocarditis, meningitis, epidural abscess and persistently positive blood cx with new multifocal strokes.  She has required epidural abscess drainage, long term antibiotics, vasopressor support, ventilatory support and will require heart valve replacement.  Her long term prognosis is grimm.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Right ventricular dilatation, Right ventricular systolic pressure decreased, Staphylococcal sepsis, Tricuspid valve calcification, Tricuspid valve stenosis
Clinical narrative: She had reported 3-4 weeks of dizziness and ataxia following her bivalent booster injection and she was having difficulty functioning and concerned she may lose her job.  She presented to ED finally on Jan 26, 2023 with refractory neurologic symptoms and was found to have subacute stroke on MRI imaging.  Subsequent in May 2023, she has now been admitted with refractory severe MSSA sepsis with endocarditis, meningitis, epidural abscess and persistently positive blood cx with new multifocal strokes.  She has required epidural abscess drainage, long term antibiotics, vasopressor support, ventilatory support and will require heart valve replacement.  Her long term prognosis is grimm.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tricuspid valve thickening, Ultrasound Doppler abnormal, Vertebral artery stenosis
Clinical narrative: She had reported 3-4 weeks of dizziness and ataxia following her bivalent booster injection and she was having difficulty functioning and concerned she may lose her job.  She presented to ED finally on Jan 26, 2023 with refractory neurologic symptoms and was found to have subacute stroke on MRI imaging.  Subsequent in May 2023, she has now been admitted with refractory severe MSSA sepsis with endocarditis, meningitis, epidural abscess and persistently positive blood cx with new multifocal strokes.  She has required epidural abscess drainage, long term antibiotics, vasopressor support, ventilatory support and will require heart valve replacement.  Her long term prognosis is grimm.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: vaccine that was given had expired on 12/13/22. Patient was notified and a replacement dose was recommended.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Chromaturia, Fatigue, Mobility decreased, Muscular weakness
Clinical narrative: Patient is a hospital worker who was due for a Tdap booster.  He had tolerated Tdap previously with no adverse event, and consented to receive the Tdap booster during a routine annual employee wellness visit.  The vaccine was given around 2:30 PM on 4/25/23 with no immediate reaction or concerns, and the patient returned home.  However, approximately 7 hours post-dose (at about 9:30 PM) patient developed severe chills and muscle weakness.  These symptoms quickly progressed and within 20 minutes the patient collapsed.  He could move his limbs but did not have the strength to stand and walk.  Patient remained laying for about 90 minutes, at which point he gathered sufficient strength to walk and get assistance.  His temperature at that time was measured at 102.8 F.  Patient was given aspirin 325 mg, acetaminophen 1000 mg and ketorolac 10 mg with no reduction in fever or symptoms.  He finally defervesced below 100.8 F at approximately 9 hours from symptom onset (around 6:30 AM on 4/26/23) after a dose of ibuprofen 800 mg was given.  Patient required scheduled doses of ibuprofen, acetaminophen and aspirin to maintain temperature below 100.8 F for approximately 36 hours from symptom onset.  During this time, muscle weakness and fatigue continued and patient's urine was dark.  Urine color returned to normal at approximately three days post-dose, at which point all symptoms appeared to be resolved.
Age: 41.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia, Syncope
Clinical narrative: Patient is a hospital worker who was due for a Tdap booster.  He had tolerated Tdap previously with no adverse event, and consented to receive the Tdap booster during a routine annual employee wellness visit.  The vaccine was given around 2:30 PM on 4/25/23 with no immediate reaction or concerns, and the patient returned home.  However, approximately 7 hours post-dose (at about 9:30 PM) patient developed severe chills and muscle weakness.  These symptoms quickly progressed and within 20 minutes the patient collapsed.  He could move his limbs but did not have the strength to stand and walk.  Patient remained laying for about 90 minutes, at which point he gathered sufficient strength to walk and get assistance.  His temperature at that time was measured at 102.8 F.  Patient was given aspirin 325 mg, acetaminophen 1000 mg and ketorolac 10 mg with no reduction in fever or symptoms.  He finally defervesced below 100.8 F at approximately 9 hours from symptom onset (around 6:30 AM on 4/26/23) after a dose of ibuprofen 800 mg was given.  Patient required scheduled doses of ibuprofen, acetaminophen and aspirin to maintain temperature below 100.8 F for approximately 36 hours from symptom onset.  During this time, muscle weakness and fatigue continued and patient's urine was dark.  Urine color returned to normal at approximately three days post-dose, at which point all symptoms appeared to be resolved.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Facial pain, Magnetic resonance imaging head normal, Trigeminal neuralgia
Clinical narrative: Began experiencing  sharp, sporadic, excruciating pain on L side of face, in 08/2022. Saw dentist on 09/09/2022, who ruled out TMJ.  Appointment with PCP, at the time, the MD on 09/22/2022.  Dr. diagnosed condition as Trigeminal Neuralgia, she prescribed  Carbamazepine 200 mg 3 x a day.  Referred me to a Dr.  Neurologist, appt on 10/03/2022, he concurred with diagnosis and the prescribed medication, he scheduled MRI for 10/17/2022. I experienced an allergic reaction to Cabamazepine, visited Urgent Care on 10/07/2022, for shot and medication, stopped Cabamazepine.  Started taking Advil and Extra Strength Tylenol 3 times a day, and mouth guard at night. I saw Dr. on 11/23/2022 for MRI results.  No abnormalities on MRI.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Haemorrhage, Head injury, Syncope
Clinical narrative: I was fainted, felt down, my head hit into toilet bowl, then I woke up with bleeding on head ?
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Rash, Rash pruritic, Vaccination site erythema, Vaccination site mass, Vaccination site reaction
Clinical narrative: Child's leg developed a walnut-sized hard lump around vaccine site. Over the following four days a red, slightly raised, itchy rash spread over the child's entire thigh, and began wrapping around the back. Nurse advice was contacted and Tylenol was prescribed. Rash continued to spread and the child was taken back into the pediatrician who prescribed antibiotics. Oral antibiotics, Sulfamethoxazole, were prescribed and may or may not have helped with the rash, which slowly began to recede. The lump remains and the pediatrician said that this is "normal" and can take months to resolve.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Vaccination site swelling
Clinical narrative: Child's leg developed a walnut-sized hard lump around vaccine site. Over the following four days a red, slightly raised, itchy rash spread over the child's entire thigh, and began wrapping around the back. Nurse advice was contacted and Tylenol was prescribed. Rash continued to spread and the child was taken back into the pediatrician who prescribed antibiotics. Oral antibiotics, Sulfamethoxazole, were prescribed and may or may not have helped with the rash, which slowly began to recede. The lump remains and the pediatrician said that this is "normal" and can take months to resolve.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site reaction, Injection site warmth, Urticaria
Clinical narrative: 4 inches by 3 inches urticial rash at injection site. Warm to touch
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest, Death, Syncope
Clinical narrative: fainted, cardiac arrest, outcome was death on feb 28 2021
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Multiple outbreaks of herpes zoster; This initial spontaneous report has been received from a lawyer regarding a case in litigation, concerning a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions, or allergies were not reported. On 05-NOV-2014, the pt was vaccinated with ZOSTAVAX subcutaneous injection (dose, strength, vaccination scheme, route of administration, anatomical location lot number, and expiration date were not provided), administered for long-term prevention of shingles and zoster-related conditions, at physician's office. Subsequently, the pt was treated by providers for the following injuries resulting from the pt's ZOSTAVAX use: multiple outbreaks of herpes zoster. The outcome of the claimed event was not recovered. The causality of the claimed event was considered related.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) in a 40-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown if the patient was ever diagnosed with/ tested positive for COVID-19.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023).    No concomitant medication details was reported. Vial size was reported as 10 dose vial. The vial was initially stored in the refrigerator on 14-MAR-2023  The vial did not undergo any temperature excursions. It was reported that HCP states that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 patients on 15-MAR-2023. There was potentially a second lot number that was expired and was administered to patients on 3-MAR-2023, but HCP did not had any details on that event at the time of report. HCP wanted to know if the vaccine administered on 15-MAR-2023 would be considered valid for the patients.  No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023; No adverse event; She had expired vaccine that was administered on 15-Mar-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023), PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 36-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023), PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on 15-Mar-2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26-Feb-2023, moved to refrigerator on 14-Mar-2023 and administered on 15-Mar-2023).    Concomitant medications of the patient were not reported.  The vial was initially stored in the refrigerator on 14-Mar-2023. The vial did not undergo any temperature excursions.  HCP stated that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 patients on 15-Mar-2023. There was potentially a second lot number that was expired and was administered to patients on 03-Mar-2023, but HCP did not have any details on this event at the time of reporting.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case