chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Chills, Cough, Fatigue, Hilar lymphadenopathy
Clinical narrative: Patient is a 76 y.o. female patient of, MD with history of HTN, HLD, DM Type II, osteoarthritis, secondary adrenal insufficiency, RUL metastatic melanoma, asthma who presented to Hospital with generalized weakness and fatigue.   Covid-19 Virus Infection Date of onset of symptoms: 5/16/2023 Symptoms present on admission: generalized weakness, fatigue, cough, chills Date of covid positive test: 05/18/2023           Vaccination status: vaccinated Anticipated special isolation end date: 05/26/2023 Initially was on cefepime and vancomycin, discontinued on 5/19 Patient started on remdesivir on 5/19 per ID recommendations  IV remdesivir and dexamethasone in the hospital I discussed with Dr. recommendation no need for patient to finish IV remdesivir course as long as oxygen stable on room air and no symptoms Discharge home   Acute Hypoxemic Respiratory Failure CTA pulmonary arteries on 5/19/2023: negative for PE, aortic dissection. Interval decrease in size of ovoid mass in the medial suprahilar, nonspecific hilar and mediastinal adenopathy. Currently requiring room air Wean as tolerated maintaining O2 sats >90. Breathing treatment as needed  urine strep/legionella antigen negative sputum culture in progress ,MRSA DNA amplified probe.  Negative Patient initially required oxygen via nasal cannula 3 to 4 L, currently oxygen stable on room air   Malignant Melanoma of the RUL  Metastasis to brain.  Managed by Dr.   Consult oncology, pending evaluation Last treatment on 4/20/2023.   Immunotherapy induced hypophysitis Secondary adrenal insufficiency Continue Levothyroxine Solucortef increased to 30mg in AM/20mg in afternoon due to acute illness Consult endocrinology, recommendations stress dose of hydrocortisone while patient receiving IV remdesivir for COVID-19, resume outpatient dose if stable when remdesivir is discontinued   Mild hyponatremia with sodium 133 might be related to dose of hydrocortisone and poor oral intake Osmolality 283 Possibly related to poor oral intake Gentle hydration initially then discontinued Endocrinology consult, recommended stress dose of hydrocortisone while the patient on IV remdesivir   Obesity due to excessive calories Weight loss Imaging: CTA pulmonary arteries Oxygen requirements on admission: room air Current oxygen requirements: Room air Medical therapy: steroids, remdesivir Consultants following: oncology; infectious disease Anticipated special isolati
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hyponatraemia, Hypophagia, Hypophysitis, Illness, Legionella test
Clinical narrative: Patient is a 76 y.o. female patient of, MD with history of HTN, HLD, DM Type II, osteoarthritis, secondary adrenal insufficiency, RUL metastatic melanoma, asthma who presented to Hospital with generalized weakness and fatigue.   Covid-19 Virus Infection Date of onset of symptoms: 5/16/2023 Symptoms present on admission: generalized weakness, fatigue, cough, chills Date of covid positive test: 05/18/2023           Vaccination status: vaccinated Anticipated special isolation end date: 05/26/2023 Initially was on cefepime and vancomycin, discontinued on 5/19 Patient started on remdesivir on 5/19 per ID recommendations  IV remdesivir and dexamethasone in the hospital I discussed with Dr. recommendation no need for patient to finish IV remdesivir course as long as oxygen stable on room air and no symptoms Discharge home   Acute Hypoxemic Respiratory Failure CTA pulmonary arteries on 5/19/2023: negative for PE, aortic dissection. Interval decrease in size of ovoid mass in the medial suprahilar, nonspecific hilar and mediastinal adenopathy. Currently requiring room air Wean as tolerated maintaining O2 sats >90. Breathing treatment as needed  urine strep/legionella antigen negative sputum culture in progress ,MRSA DNA amplified probe.  Negative Patient initially required oxygen via nasal cannula 3 to 4 L, currently oxygen stable on room air   Malignant Melanoma of the RUL  Metastasis to brain.  Managed by Dr.   Consult oncology, pending evaluation Last treatment on 4/20/2023.   Immunotherapy induced hypophysitis Secondary adrenal insufficiency Continue Levothyroxine Solucortef increased to 30mg in AM/20mg in afternoon due to acute illness Consult endocrinology, recommendations stress dose of hydrocortisone while patient receiving IV remdesivir for COVID-19, resume outpatient dose if stable when remdesivir is discontinued   Mild hyponatremia with sodium 133 might be related to dose of hydrocortisone and poor oral intake Osmolality 283 Possibly related to poor oral intake Gentle hydration initially then discontinued Endocrinology consult, recommended stress dose of hydrocortisone while the patient on IV remdesivir   Obesity due to excessive calories Weight loss Imaging: CTA pulmonary arteries Oxygen requirements on admission: room air Current oxygen requirements: Room air Medical therapy: steroids, remdesivir Consultants following: oncology; infectious disease Anticipated special isolati
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lymphadenopathy mediastinal, Mass, Metastases to central nervous system, Obesity, SARS-CoV-2 test positive
Clinical narrative: Patient is a 76 y.o. female patient of, MD with history of HTN, HLD, DM Type II, osteoarthritis, secondary adrenal insufficiency, RUL metastatic melanoma, asthma who presented to Hospital with generalized weakness and fatigue.   Covid-19 Virus Infection Date of onset of symptoms: 5/16/2023 Symptoms present on admission: generalized weakness, fatigue, cough, chills Date of covid positive test: 05/18/2023           Vaccination status: vaccinated Anticipated special isolation end date: 05/26/2023 Initially was on cefepime and vancomycin, discontinued on 5/19 Patient started on remdesivir on 5/19 per ID recommendations  IV remdesivir and dexamethasone in the hospital I discussed with Dr. recommendation no need for patient to finish IV remdesivir course as long as oxygen stable on room air and no symptoms Discharge home   Acute Hypoxemic Respiratory Failure CTA pulmonary arteries on 5/19/2023: negative for PE, aortic dissection. Interval decrease in size of ovoid mass in the medial suprahilar, nonspecific hilar and mediastinal adenopathy. Currently requiring room air Wean as tolerated maintaining O2 sats >90. Breathing treatment as needed  urine strep/legionella antigen negative sputum culture in progress ,MRSA DNA amplified probe.  Negative Patient initially required oxygen via nasal cannula 3 to 4 L, currently oxygen stable on room air   Malignant Melanoma of the RUL  Metastasis to brain.  Managed by Dr.   Consult oncology, pending evaluation Last treatment on 4/20/2023.   Immunotherapy induced hypophysitis Secondary adrenal insufficiency Continue Levothyroxine Solucortef increased to 30mg in AM/20mg in afternoon due to acute illness Consult endocrinology, recommendations stress dose of hydrocortisone while patient receiving IV remdesivir for COVID-19, resume outpatient dose if stable when remdesivir is discontinued   Mild hyponatremia with sodium 133 might be related to dose of hydrocortisone and poor oral intake Osmolality 283 Possibly related to poor oral intake Gentle hydration initially then discontinued Endocrinology consult, recommended stress dose of hydrocortisone while the patient on IV remdesivir   Obesity due to excessive calories Weight loss Imaging: CTA pulmonary arteries Oxygen requirements on admission: room air Current oxygen requirements: Room air Medical therapy: steroids, remdesivir Consultants following: oncology; infectious disease Anticipated special isolati
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Sputum culture, Staphylococcus test negative, Streptococcus test negative, Weight decreased
Clinical narrative: Patient is a 76 y.o. female patient of, MD with history of HTN, HLD, DM Type II, osteoarthritis, secondary adrenal insufficiency, RUL metastatic melanoma, asthma who presented to Hospital with generalized weakness and fatigue.   Covid-19 Virus Infection Date of onset of symptoms: 5/16/2023 Symptoms present on admission: generalized weakness, fatigue, cough, chills Date of covid positive test: 05/18/2023           Vaccination status: vaccinated Anticipated special isolation end date: 05/26/2023 Initially was on cefepime and vancomycin, discontinued on 5/19 Patient started on remdesivir on 5/19 per ID recommendations  IV remdesivir and dexamethasone in the hospital I discussed with Dr. recommendation no need for patient to finish IV remdesivir course as long as oxygen stable on room air and no symptoms Discharge home   Acute Hypoxemic Respiratory Failure CTA pulmonary arteries on 5/19/2023: negative for PE, aortic dissection. Interval decrease in size of ovoid mass in the medial suprahilar, nonspecific hilar and mediastinal adenopathy. Currently requiring room air Wean as tolerated maintaining O2 sats >90. Breathing treatment as needed  urine strep/legionella antigen negative sputum culture in progress ,MRSA DNA amplified probe.  Negative Patient initially required oxygen via nasal cannula 3 to 4 L, currently oxygen stable on room air   Malignant Melanoma of the RUL  Metastasis to brain.  Managed by Dr.   Consult oncology, pending evaluation Last treatment on 4/20/2023.   Immunotherapy induced hypophysitis Secondary adrenal insufficiency Continue Levothyroxine Solucortef increased to 30mg in AM/20mg in afternoon due to acute illness Consult endocrinology, recommendations stress dose of hydrocortisone while patient receiving IV remdesivir for COVID-19, resume outpatient dose if stable when remdesivir is discontinued   Mild hyponatremia with sodium 133 might be related to dose of hydrocortisone and poor oral intake Osmolality 283 Possibly related to poor oral intake Gentle hydration initially then discontinued Endocrinology consult, recommended stress dose of hydrocortisone while the patient on IV remdesivir   Obesity due to excessive calories Weight loss Imaging: CTA pulmonary arteries Oxygen requirements on admission: room air Current oxygen requirements: Room air Medical therapy: steroids, remdesivir Consultants following: oncology; infectious disease Anticipated special isolati
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Dental caries, Endodontic procedure, Immediate post-injection reaction, Injection site pain, Injection site reaction
Clinical narrative: pain at site of injection immediately during and after injection  deltoid muscle soreness x1 week - gradually improving, but then developed soreness and stiffness of left shoulder joint with pain during lateral extension of left shoulder sensation and strength remained intact, was ultimately able to still full range of motion left arm, but had pain seen in office 1 week after injection, still having symptoms, but seemed to start to improve from day prior  no obvious joint swelling, non tender to deltoid muscle, no obvious deformity or abnormality no fever or warmth of the joint advised ibuprofen pen for pain and warm compresses and to continue to try and gently range of motion the shoulder
Age: 10.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Pain, Tooth infection
Clinical narrative: pain at site of injection immediately during and after injection  deltoid muscle soreness x1 week - gradually improving, but then developed soreness and stiffness of left shoulder joint with pain during lateral extension of left shoulder sensation and strength remained intact, was ultimately able to still full range of motion left arm, but had pain seen in office 1 week after injection, still having symptoms, but seemed to start to improve from day prior  no obvious joint swelling, non tender to deltoid muscle, no obvious deformity or abnormality no fever or warmth of the joint advised ibuprofen pen for pain and warm compresses and to continue to try and gently range of motion the shoulder
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Blood bicarbonate decreased, Blood creatinine increased, Blood urea increased, COVID-19, COVID-19 pneumonia
Clinical narrative: Patient is a 61 y.o. male patient of, DO with history of diabetes mellitus that presented to Hospital with cough, nausea, shortness of breath. Patient found to have COVID pneumonia and initially required 6 L O2 via nasal cannula on admission.  Patient was steroids, treatments and able to be weaned off O2.  Patient demanded to leave AMA because he did not want to stay in the hospital, he stated he did not even want to come to the hospital initially but his wife made him.  After extensive discussion with patient as to potentially danger to his life by leaving at this time after coming in with hypoxia yesterday requiring O2, patient did not want to stay, removed and he removed his IVs. Discussed with with the patient the necessity to follow-up with his PCP, monitoring his O2 at home at home with his wife's O2 monitoring, and that steroids will be sent to his pharmacy patient left AGAINST MEDICAL ADVICE.   Multifocal COVID pneumonia Hypoxia, secondary to pneumonia Patient's initial O2 was 84% on room air The patient is COVID-positive. CT scan of the abdomen was negative for pulmonary embolism.  There is extensive bibasilar consolidation and additional scattered patchy groundglass opacities. Patient was given treatments, supplemental O2, and Decadron Patient was in the low 90s off O2 when he left AMA    Diabetes mellitus type 2 with hyperglycemia Continue home meds  Hyponatremia Given IV fluids  Acute on chronic kidney disease stage III Metabolic acidosis Serum creatinine is 1.79 with BUN of 37 and a GFR of 43, serum bicarb 19 Baseline GFR is around 50 Given IV fluids
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Chronic kidney disease, Computerised tomogram abdomen abnormal, Condition aggravated, Cough, Dyspnoea
Clinical narrative: Patient is a 61 y.o. male patient of, DO with history of diabetes mellitus that presented to Hospital with cough, nausea, shortness of breath. Patient found to have COVID pneumonia and initially required 6 L O2 via nasal cannula on admission.  Patient was steroids, treatments and able to be weaned off O2.  Patient demanded to leave AMA because he did not want to stay in the hospital, he stated he did not even want to come to the hospital initially but his wife made him.  After extensive discussion with patient as to potentially danger to his life by leaving at this time after coming in with hypoxia yesterday requiring O2, patient did not want to stay, removed and he removed his IVs. Discussed with with the patient the necessity to follow-up with his PCP, monitoring his O2 at home at home with his wife's O2 monitoring, and that steroids will be sent to his pharmacy patient left AGAINST MEDICAL ADVICE.   Multifocal COVID pneumonia Hypoxia, secondary to pneumonia Patient's initial O2 was 84% on room air The patient is COVID-positive. CT scan of the abdomen was negative for pulmonary embolism.  There is extensive bibasilar consolidation and additional scattered patchy groundglass opacities. Patient was given treatments, supplemental O2, and Decadron Patient was in the low 90s off O2 when he left AMA    Diabetes mellitus type 2 with hyperglycemia Continue home meds  Hyponatremia Given IV fluids  Acute on chronic kidney disease stage III Metabolic acidosis Serum creatinine is 1.79 with BUN of 37 and a GFR of 43, serum bicarb 19 Baseline GFR is around 50 Given IV fluids
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Glomerular filtration rate decreased, Hyperglycaemia, Hyponatraemia, Hypoxia, Intentional medical device removal by patient
Clinical narrative: Patient is a 61 y.o. male patient of, DO with history of diabetes mellitus that presented to Hospital with cough, nausea, shortness of breath. Patient found to have COVID pneumonia and initially required 6 L O2 via nasal cannula on admission.  Patient was steroids, treatments and able to be weaned off O2.  Patient demanded to leave AMA because he did not want to stay in the hospital, he stated he did not even want to come to the hospital initially but his wife made him.  After extensive discussion with patient as to potentially danger to his life by leaving at this time after coming in with hypoxia yesterday requiring O2, patient did not want to stay, removed and he removed his IVs. Discussed with with the patient the necessity to follow-up with his PCP, monitoring his O2 at home at home with his wife's O2 monitoring, and that steroids will be sent to his pharmacy patient left AGAINST MEDICAL ADVICE.   Multifocal COVID pneumonia Hypoxia, secondary to pneumonia Patient's initial O2 was 84% on room air The patient is COVID-positive. CT scan of the abdomen was negative for pulmonary embolism.  There is extensive bibasilar consolidation and additional scattered patchy groundglass opacities. Patient was given treatments, supplemental O2, and Decadron Patient was in the low 90s off O2 when he left AMA    Diabetes mellitus type 2 with hyperglycemia Continue home meds  Hyponatremia Given IV fluids  Acute on chronic kidney disease stage III Metabolic acidosis Serum creatinine is 1.79 with BUN of 37 and a GFR of 43, serum bicarb 19 Baseline GFR is around 50 Given IV fluids
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Lung consolidation, Lung opacity, Metabolic acidosis, Nausea, SARS-CoV-2 test positive
Clinical narrative: Patient is a 61 y.o. male patient of, DO with history of diabetes mellitus that presented to Hospital with cough, nausea, shortness of breath. Patient found to have COVID pneumonia and initially required 6 L O2 via nasal cannula on admission.  Patient was steroids, treatments and able to be weaned off O2.  Patient demanded to leave AMA because he did not want to stay in the hospital, he stated he did not even want to come to the hospital initially but his wife made him.  After extensive discussion with patient as to potentially danger to his life by leaving at this time after coming in with hypoxia yesterday requiring O2, patient did not want to stay, removed and he removed his IVs. Discussed with with the patient the necessity to follow-up with his PCP, monitoring his O2 at home at home with his wife's O2 monitoring, and that steroids will be sent to his pharmacy patient left AGAINST MEDICAL ADVICE.   Multifocal COVID pneumonia Hypoxia, secondary to pneumonia Patient's initial O2 was 84% on room air The patient is COVID-positive. CT scan of the abdomen was negative for pulmonary embolism.  There is extensive bibasilar consolidation and additional scattered patchy groundglass opacities. Patient was given treatments, supplemental O2, and Decadron Patient was in the low 90s off O2 when he left AMA    Diabetes mellitus type 2 with hyperglycemia Continue home meds  Hyponatremia Given IV fluids  Acute on chronic kidney disease stage III Metabolic acidosis Serum creatinine is 1.79 with BUN of 37 and a GFR of 43, serum bicarb 19 Baseline GFR is around 50 Given IV fluids
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Type 2 diabetes mellitus
Clinical narrative: Patient is a 61 y.o. male patient of, DO with history of diabetes mellitus that presented to Hospital with cough, nausea, shortness of breath. Patient found to have COVID pneumonia and initially required 6 L O2 via nasal cannula on admission.  Patient was steroids, treatments and able to be weaned off O2.  Patient demanded to leave AMA because he did not want to stay in the hospital, he stated he did not even want to come to the hospital initially but his wife made him.  After extensive discussion with patient as to potentially danger to his life by leaving at this time after coming in with hypoxia yesterday requiring O2, patient did not want to stay, removed and he removed his IVs. Discussed with with the patient the necessity to follow-up with his PCP, monitoring his O2 at home at home with his wife's O2 monitoring, and that steroids will be sent to his pharmacy patient left AGAINST MEDICAL ADVICE.   Multifocal COVID pneumonia Hypoxia, secondary to pneumonia Patient's initial O2 was 84% on room air The patient is COVID-positive. CT scan of the abdomen was negative for pulmonary embolism.  There is extensive bibasilar consolidation and additional scattered patchy groundglass opacities. Patient was given treatments, supplemental O2, and Decadron Patient was in the low 90s off O2 when he left AMA    Diabetes mellitus type 2 with hyperglycemia Continue home meds  Hyponatremia Given IV fluids  Acute on chronic kidney disease stage III Metabolic acidosis Serum creatinine is 1.79 with BUN of 37 and a GFR of 43, serum bicarb 19 Baseline GFR is around 50 Given IV fluids
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: donor had redness, swelling and a nodule  on right arm
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Alcohol poisoning, Anaphylactic reaction, Chest discomfort, Hypersensitivity, Muscle spasms
Clinical narrative: Patient diagnosed with anaphylaxis after presenting to emergency department. Patient reports "twitching"/"spasms", "vomiting", and "scratching", which started the day after her first Pfizer bivalent booster. She immediately went to the hospital. After Visit Summary notes diagnoses of "anaphylaxis, initial encounter", "allergic reaction, initial encounter", "chest discomfort", and "alcoholic intoxication without complication (HCC)". After Visit Summary notes patient was given diphenhydramine, epinephrine, famotidine, ketorolac, SOLU-Medrol, NaCl 0.9%, and NICODERM. Rxs sent to pharmacy included: prednisone, Epipen, diphenhydramine, and famotidine.
Age: 50.0
Sex: F
Vaccine: COVID19-2
Symptoms: Muscle twitching, Pruritus, Vomiting
Clinical narrative: Patient diagnosed with anaphylaxis after presenting to emergency department. Patient reports "twitching"/"spasms", "vomiting", and "scratching", which started the day after her first Pfizer bivalent booster. She immediately went to the hospital. After Visit Summary notes diagnoses of "anaphylaxis, initial encounter", "allergic reaction, initial encounter", "chest discomfort", and "alcoholic intoxication without complication (HCC)". After Visit Summary notes patient was given diphenhydramine, epinephrine, famotidine, ketorolac, SOLU-Medrol, NaCl 0.9%, and NICODERM. Rxs sent to pharmacy included: prednisone, Epipen, diphenhydramine, and famotidine.
Age: 56.0
Sex: M
Vaccine: HEPAB
Symptoms: Exposure via skin contact, Syringe issue
Clinical narrative: When I pushed the plunger to inject the  vacccine, most of the vaccine did not go into the arm and flowed down his arm onto the floor. The patient agreed that he felt most of it, go down his arm.  Since most of the vaccine did not enter the muscle, I used my professional judgement and assembled another dose and administered the second vaccine.
Age: 55.0
Sex: F
Vaccine: PNC20
Symptoms: Diabetes mellitus, Erythema, Mobility decreased, Peripheral swelling, Pyrexia
Clinical narrative: Patient received Prevnar 20 vaccination on Wednesday 07/19/2023. Patient came in on Sunday 07/23/2023. "Does this look normal to you?" Patient had red, hot, swollen arm. She had been marking the swelling from Friday to Sunday. The redness was moving down her arm. Stated Thursday she could not move her arm, was running fever, and arm started swelling. I informed her to go to urgent care to receive treatment as she might be having a late allergic reaction to the vaccination. I told her to put an ice pack in the mean time to help slow/reduce the swelling. I also told her that I would follow up/report with her MD and report this. If anything else were to happen, please let us know so we can report more. I gave patient scan receipt so they could help urgent care know what vaccine she received.
Age: 55.0
Sex: F
Vaccine: PNC20
Symptoms: Skin warm
Clinical narrative: Patient received Prevnar 20 vaccination on Wednesday 07/19/2023. Patient came in on Sunday 07/23/2023. "Does this look normal to you?" Patient had red, hot, swollen arm. She had been marking the swelling from Friday to Sunday. The redness was moving down her arm. Stated Thursday she could not move her arm, was running fever, and arm started swelling. I informed her to go to urgent care to receive treatment as she might be having a late allergic reaction to the vaccination. I told her to put an ice pack in the mean time to help slow/reduce the swelling. I also told her that I would follow up/report with her MD and report this. If anything else were to happen, please let us know so we can report more. I gave patient scan receipt so they could help urgent care know what vaccine she received.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Electrocardiogram, Troponin
Clinical narrative: Nstemi
Age: 80.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pfizer Bivalent Booster was given beyond use date, by mistake; patient had no adverse effects. Patient has been contacted, counseled and informed and advised to get revaccinated.
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pfizer Bivalent Booster was given beyond use date, by mistake; patient had no adverse effects. Patient has been contacted, counseled and informed and advised to get revaccinated.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Anal incontinence, Balance disorder, Bedridden, Blood iron decreased, Blood potassium decreased
Clinical narrative: Low hemoglobin. Low iron and potassium. Unable to walk due to losing balance. Infection in right leg. Stool spilled into body which caused leg infection and dark spots in face. Unable to control bowels which resulted in now having to wear diapers and bed ridden.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Haemoglobin decreased, Localised infection, Skin discolouration
Clinical narrative: Low hemoglobin. Low iron and potassium. Unable to walk due to losing balance. Infection in right leg. Stool spilled into body which caused leg infection and dark spots in face. Unable to control bowels which resulted in now having to wear diapers and bed ridden.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: administered shingrix believing it was the patient's 1st shingles shot; upon further investigation when the patient asked about pneumonia vaccines, we discovered she had already received the complete series of 2 vaccines.  dose 1 01/22/2019 and dose 2 07/27/2019
Age: 23.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Pfizer Bivalent Booster was given beyond use date, by mistake; patient had no adverse effects. Patient has been contacted, counseled and informed and advised to get revaccinated.
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pfizer Bivalent Booster was given beyond use date, by mistake; patient had no adverse effects. Patient has been contacted, counseled and informed and advised to get revaccinated.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pfizer Bivalent Booster was given beyond use date, by mistake; patient had no adverse effects. Patient has been contacted, counseled and informed and advised to get revaccinated.
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pfizer Bivalent Booster was given beyond use date, by mistake; patient had no adverse effects. Patient has been contacted, counseled and informed and advised to get revaccinated.
Age: 43.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Pfizer Bivalent Booster was given beyond use date, by mistake; patient had no adverse effects. Patient has been contacted, counseled and informed and advised to get revaccinated.
Age: 49.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: PFIZER Bivalent Booster was given beyond use date, by mistake; patient had no adverse effects. Patient has been contacted, counseled and informed and advised to get revaccinated.
Age: 58.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Patient reported that his left leg started to swell on 7/22/23, the whole calf, tender to touch, painful, little redness. He applied cold compress for an hour but no help.  He took ibuprofen today in the morning before calling pharmacy.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Nerve injury, Neuropathic pruritus, Skin test
Clinical narrative: I developed a severe neuropathic itch that has been hard to treat. It's awful! The Dr.s have had me try capsicum, lidocaine and nortriptyline with no luck. I wish I had never received this shot. It's a daily itch that can get really intense. The shot has caused me nerve damage instead of protecting me. I've been treated by both my primary Dr. and Dermatologist for this,
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: Rash, Urticaria
Clinical narrative: No rash at injection site; however, patient has rash (hives) on forearms, back, behind the left ear, around neck. After taking two diphenhydramine capsules, rash has improved. Patient has been advised to follow up with urgent care as soon as possible.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Pain in Left arm and injection site, swelling, redness - I still have pain in the Left upper arm at the injection site and surrounding the upper arm and shoulder 9 days after the injection. The arm is quite painful and presents difficulties with some movements.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Pain in Left arm and injection site, swelling, redness - I still have pain in the Left upper arm at the injection site and surrounding the upper arm and shoulder 9 days after the injection. The arm is quite painful and presents difficulties with some movements.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Periarthritis, Product administered at inappropriate site
Clinical narrative: I just had a tetanus shot and you did not have the word "tetanus" to choose from. The Practitioner put the shot into my left shoulder bursa  and NOT in my deltoid. My orthopedic doctor said I got adhesive capsulitis from the nurse shooting tetanus into my shoulder joint and am developing a frozen shoulder. My shoulder was fine and never had a problem with it before this happened.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Site of injection is a  large 3" raised welt, red, hot and tender to touch.  Vomiting begin about 3 hours after injection, headache and minor dizziness with fatigue.  Day after some minor vomiting, headache, fatigue continued.  Day 2 & 3 no vomiting, nausea, lessened headache, fatigue lessened but continued.   Day 3 p.m. feeling very tired but mostly recovered.  Red welt is down to 2", still tender to touch, warm instead of hot.  Feeling mostly recovered but not 100%.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Injection site warmth, Nausea, Urticaria
Clinical narrative: Site of injection is a  large 3" raised welt, red, hot and tender to touch.  Vomiting begin about 3 hours after injection, headache and minor dizziness with fatigue.  Day after some minor vomiting, headache, fatigue continued.  Day 2 & 3 no vomiting, nausea, lessened headache, fatigue lessened but continued.   Day 3 p.m. feeling very tired but mostly recovered.  Red welt is down to 2", still tender to touch, warm instead of hot.  Feeling mostly recovered but not 100%.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Site of injection is a  large 3" raised welt, red, hot and tender to touch.  Vomiting begin about 3 hours after injection, headache and minor dizziness with fatigue.  Day after some minor vomiting, headache, fatigue continued.  Day 2 & 3 no vomiting, nausea, lessened headache, fatigue lessened but continued.   Day 3 p.m. feeling very tired but mostly recovered.  Red welt is down to 2", still tender to touch, warm instead of hot.  Feeling mostly recovered but not 100%.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site mass
Clinical narrative: A few days after having the vaccine administered, Patient developed a lump at the injection site. Lump is under the skin and in time has grown to be firm. Lump is non-painful. Does not appear to be becoming larger in size.  No erythema or unusual warmth at the site. Continues to persist almost 3 weeks after the vaccine was given.
Age: 22.0
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient scheduled appt. for 3 shots. When he came in he sad that he didn't have any live vaccines in last 4 weeks and these were primary doses. Afterwards, realized he received MMR 1 week to early
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Chills, Chronic obstructive pulmonary disease, Condition aggravated, Dyspnoea
Clinical narrative: Presented with chills and SOB and found to have covid PNA and COPD exacerbation; Tx w/O2, abx, remdesivir, zinc; weaned to RA for dc home
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Patient Deceased
Age: 36.0
Sex: M
Vaccine: PNC15, PPV
Symptoms: Cough, Eosinophil count abnormal, Fatigue, Hypoaesthesia, Influenza like illness
Clinical narrative: Shortly after injection patient developed flu-like symptoms. A day or two later he developed numbness and tingling in his upper extremities. This continued for several months.
Age: 36.0
Sex: M
Vaccine: PNC15, PPV
Symptoms: Laboratory test normal, Malaise, Paraesthesia, Reversed hot-cold sensation, Sinusitis
Clinical narrative: Shortly after injection patient developed flu-like symptoms. A day or two later he developed numbness and tingling in his upper extremities. This continued for several months.
Age: 36.0
Sex: M
Vaccine: PNC15, PPV
Symptoms: C-reactive protein normal, Full blood count, HIV test negative, Hepatitis C test negative, Hypoaesthesia
Clinical narrative: Shortly after injection patient developed flu-like symptoms. A day or two later he developed numbness and tingling in his upper extremities. This continued for several months.
Age: 36.0
Sex: M
Vaccine: PNC15, PPV
Symptoms: Immunology test normal, Influenza like illness, Laboratory test abnormal, Metabolic function test, Paraesthesia
Clinical narrative: Shortly after injection patient developed flu-like symptoms. A day or two later he developed numbness and tingling in his upper extremities. This continued for several months.
Age: 36.0
Sex: M
Vaccine: PNC15, PPV
Symptoms: Red blood cell sedimentation rate normal, Vitamin B1, Vitamin B12 normal, Vitamin B6 normal
Clinical narrative: Shortly after injection patient developed flu-like symptoms. A day or two later he developed numbness and tingling in his upper extremities. This continued for several months.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pain, Pain in extremity
Clinical narrative: Myalgia chills, body aches, arm sore Narrative:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller states that product was administered to patient following the temperature excursion; No additional AE; This spontaneous report was received from a medical assistant and referred to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On an unknown date, the suspect vaccine was improperly stored at temperature of 34.4 degrees Fahrenheit for a time frame of 15 hours (product storage error). On 27-APR-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 ml, once, lot #W004648, expiration date: 06-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided) following the temperature excursion. No symptomatic adverse events were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE.; the patient received a dose of MMRII on 6/30/2023, after the product was involved in a temperature excursion.; This spontaneous report was received from a registered nurse regarding a patient of an unknown age and gender. The patient's medical history and concurrent conditions were not reported. The patient's concomitant medications included varicella virus vaccine live (oka/merck) (VARIVAX).   On 30-JUN-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) injection, 1 dose, lot #W035041, expiration date: 24-MAY-2024, administered as prophylaxis (strength, and route of administration were not provided) (Product storage error).  The improperly stored vaccine underwent a temperature excursion of 48.8 degrees Fahrenheit (F) for an unknown time, and it was unspecified previous excursions. The patient did not experience any other adverse event.  This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2307USA006400: US-009507513-2307USA006038: US-009507513-2307USA006117: US-009507513-2307USA006253: US-009507513-2307USA006048: US-009507513-2307USA006043: US-009507513-2307USA005725:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HBP reporting that PROQUAD was administered after it experienced a supported temperature excursion.; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions and concomitant medications was not provided.  On 12-JUL-2023, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) albumin status rHA (second dose, 0.5 mL, lot #W036940, expiration date was reported as 15-APR-2024, but upon internal review was established as 19-MAY-2024, route of administration and anatomical location were not provided) for prophylaxis (Product storage error).   On unknown day, the suspect vaccine experienced a temperature excursion of -8.6 degrees Celsius (C) for 51 minutes. There was previous temperature excursion of -11.5 C for 1 hour and 16 minutes. No additional adverse events (AEs) or product quality complaints (PQC) were reported (No adverse event). No further details given.  This is one of several reports from the same reporter.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: received VARIVAX during Temp Excursion; No additional AE; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On an unknown date, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (single dose, lot#: W031815, expiration date: 05-OCT-2024; strength, and route of administration were not reported) for prophylaxis. The vaccine administered experienced temperature excursion before (product storage error). No additional adverse events (AE) (no adverse event).  This case was received from the same reporter with the case 2307USA009505 and 2307USA009506.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: received VARIVAX during Temp Excursion; No additional AE; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On an unknown date, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (single dose, lot#: W012166, expiration date: 12-APR-2024; strength, and route of administration were not reported) for prophylaxis. The vaccine administered experienced temperature excursion before (product storage error). No additional adverse events (AE) (no adverse event).  This case was received from the same reporter with the case 2307USA007631 and 2307USA009506.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: received VARIVAX during Temp Excursion; No additional AE; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On an unknown date, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (single dose, lot#: W012166, expiration date: 12-APR-2024; strength, and route of administration were not reported) for prophylaxis. The vaccine administered experienced temperature excursion before (product storage error). No additional adverse events (AE) (no adverse event).  This case was received from the same reporter with the case 2307USA007631 and 2307USA009505.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product confusion, Wrong product administered
Clinical narrative: Product confusion; No additional AE/No PQC.; inappropriate age at vaccine administration; HCP called to report a product confusion AE with GARDASIL 9.  HCP stated that a 9 month old infant was inadvertently administered GARDASIL 9 today, July 19, 2023, instead of VAXNEUVANCE.  No additional adverse effects were reported.  HCP is also requ; This spontaneous report was received from Other Health Professional and refers to a 9-month-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 19-JUL-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 ml, lot #W028573, expiration date: 06-JAN-2025, administered for prophylaxis (strength, and route of administration were not provided). On an unknown date, the patient started therapy with pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, , administered for prophylaxis (strength, dose description, lot #, expiry date, and route of administration were not provided).   On 19-JUL-2023, HCP called to report a product confusion AE with GARDASIL 9. HCP stated that a 9 month old infant was inadvertently administered GARDASIL 9 today, 19-JUL-2023, instead of VAXNEUVANCE. No additional adverse effects were reported. HCP is also requesting a callback from GMI to discuss potential safety issues and symptoms to watch for to identify any future adverse effects that might arise as a result of the inadvertent administration. Request case reference 02430672. Consent to contact is yes. No additional AE/No PQC
Age: 1.83
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller reported AE for inadvertent administration of PEDVAXHIB after TE.; This spontaneous report was received from other and refers to a 22-months-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-MAY-2023, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection,lot # W002453, expiration date:24-JUN-2024, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) which underwent temperature excursion before administration (Product storage error). Temperature excursion was in 65.2 Farenheit (F) for 9 hours 45 minutes and 32.4 Farenheit (F) for 42 hours 45 minutes. No additional adverse event was reported. .
Age: 1.42
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; inadvertent administration of PEDVAXHIB after TE; This spontaneous report was received from a reporter (other) and refers to a 17-month-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-MAY-2023, the patient was vaccinated with improperly stored (Product storage error) dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot # reported and confirmed as: W002453, expiration date reported and confirmed as: 24-JUN-2024 (exact dose, site and route of administration were not provided) for prophylaxis. Temperature excursion details: 65.2 degree Fahrenheit for 9 hours 45 minutes; 32.4 degree Fahrenheit for 42 hours 45 minutes. No symptoms or additional adverse event reported.
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Headache, Pain, Pyrexia
Clinical narrative: back pain; fever; headache; body aches; This non-serious case was reported by a consumer via call center representative and described the occurrence of back pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included celiac disease.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular, unknown arm). On an unknown date, 1 day after receiving Shingrix, the patient experienced back pain (Verbatim: back pain), fever (Verbatim: fever), headache (Verbatim: headache) and general body pain (Verbatim: body aches). The outcome of the back pain, fever, headache and general body pain were resolved (duration 1 day).   It was unknown if the reporter considered the back pain, fever, headache and general body pain to be related to Shingrix.     It was unknown if the company considered the back pain, fever, headache and general body pain to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR100025   Additional Information: GSK Receipt date: 17-JUL-2023 The reporter reported about herself the day after her first Shingrix dose she developed back pain, headache, fever and body aches. These resolved the next day. The reporter consented to follow up. For tolerance of 2nd dose refer case US2023AMR100025.; Sender's Comments:  US-GSK-US2023AMR100025:same patient second dose
Sex: F
Vaccine: VARZOS
Symptoms: Dysphonia, Oropharyngeal pain
Clinical narrative: Sore throat; Hoarseness that has not lifted after a couple of days; This non-serious case was reported by a consumer and described the occurrence of sore throat in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included back pain. Concomitant products included tramadol.   On 11-JUL-2023, the patient received Shingrix. On 18-JUL-2023, 7 days after receiving Shingrix, the patient experienced sore throat (Verbatim: Sore throat) and hoarseness (Verbatim: Hoarseness that has not lifted after a couple of days). The outcome of the sore throat and hoarseness were not resolved.   It was unknown if the reporter considered the sore throat and hoarseness to be related to Shingrix.     It was unknown if the company considered the sore throat and hoarseness to be related to Shingrix.   Additional Information: GSK Receipt date: 18-JUL-2023 A reporter reported about her self after shingrix vaccination experienced Sore throat and Hoarseness that had not lifted after a couple of days and she wanted to see the ingredients and the website will not show them. The reporter was did not consent to follow up.