chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Alphavirus test, Aspiration bone marrow, Biopsy bone marrow abnormal, Blood fibrinogen normal, Blood lactate dehydrogenase decreased
Clinical narrative: Multi-system inflammatory process - started the day after the shot with muscle pain, chest pain, back pain refractory to PPI, ibuprofen.  Seen by PCP, rheumatology, GI, and hem/onc  Elevations in ESR, CRP, Ferritin, LDH, AlkPhos, and ALT.  Broad workup for autoimmune conditions, all of which were negative.  Incidental finding of H Pylori gastritis.  Symptoms responded to steroids, labs seemed to improve as well.  When steroids were decreased, symptoms reoccured.  When steroids decreased in late January symptoms returned and were accompanied by marked drop in platelets (nadir = 10 on 1/29), which improved rapidly once steroids restarted.  Treatment ongoing and patient remains hospitalized as of 2/4/22
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Blood smear test abnormal, Bone marrow necrosis, Chest pain, Coagulation test normal, Dengue virus test negative
Clinical narrative: Multi-system inflammatory process - started the day after the shot with muscle pain, chest pain, back pain refractory to PPI, ibuprofen.  Seen by PCP, rheumatology, GI, and hem/onc  Elevations in ESR, CRP, Ferritin, LDH, AlkPhos, and ALT.  Broad workup for autoimmune conditions, all of which were negative.  Incidental finding of H Pylori gastritis.  Symptoms responded to steroids, labs seemed to improve as well.  When steroids were decreased, symptoms reoccured.  When steroids decreased in late January symptoms returned and were accompanied by marked drop in platelets (nadir = 10 on 1/29), which improved rapidly once steroids restarted.  Treatment ongoing and patient remains hospitalized as of 2/4/22
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: HIV test negative, Haptoglobin normal, Hepatitis viral test negative, Immune thrombocytopenia, Myalgia
Clinical narrative: Multi-system inflammatory process - started the day after the shot with muscle pain, chest pain, back pain refractory to PPI, ibuprofen.  Seen by PCP, rheumatology, GI, and hem/onc  Elevations in ESR, CRP, Ferritin, LDH, AlkPhos, and ALT.  Broad workup for autoimmune conditions, all of which were negative.  Incidental finding of H Pylori gastritis.  Symptoms responded to steroids, labs seemed to improve as well.  When steroids were decreased, symptoms reoccured.  When steroids decreased in late January symptoms returned and were accompanied by marked drop in platelets (nadir = 10 on 1/29), which improved rapidly once steroids restarted.  Treatment ongoing and patient remains hospitalized as of 2/4/22
Age: 38.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Petechiae, Platelet count decreased, Red blood cell schistocytes present, Systemic inflammatory response syndrome
Clinical narrative: Multi-system inflammatory process - started the day after the shot with muscle pain, chest pain, back pain refractory to PPI, ibuprofen.  Seen by PCP, rheumatology, GI, and hem/onc  Elevations in ESR, CRP, Ferritin, LDH, AlkPhos, and ALT.  Broad workup for autoimmune conditions, all of which were negative.  Incidental finding of H Pylori gastritis.  Symptoms responded to steroids, labs seemed to improve as well.  When steroids were decreased, symptoms reoccured.  When steroids decreased in late January symptoms returned and were accompanied by marked drop in platelets (nadir = 10 on 1/29), which improved rapidly once steroids restarted.  Treatment ongoing and patient remains hospitalized as of 2/4/22
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Agranulocytosis, Biopsy bone marrow abnormal, Biopsy liver abnormal, Chills, Computerised tomogram abdomen abnormal
Clinical narrative: Headache started almost immediately. Fever started a few days after. Symptoms included fatigue, severe headache, and fever up to 103.  Upon hospital admission in October, diagnosed with adult onset stills disease. On December 14 he was admitted back to the hospital related to fever and abnormal labs that included elevated liver enzymes, bilirubin, thrombocytopenia, elevated ferritin. He was diagnosed with HLH that was resistant to the 2004 HLH treatment protocol and died January 28,2022 off multi organ failure.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cytopenia, Death, Dyspnoea exertional, Haemophagocytic lymphohistiocytosis, Headache
Clinical narrative: Headache started almost immediately. Fever started a few days after. Symptoms included fatigue, severe headache, and fever up to 103.  Upon hospital admission in October, diagnosed with adult onset stills disease. On December 14 he was admitted back to the hospital related to fever and abnormal labs that included elevated liver enzymes, bilirubin, thrombocytopenia, elevated ferritin. He was diagnosed with HLH that was resistant to the 2004 HLH treatment protocol and died January 28,2022 off multi organ failure.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Infection, Infectious mononucleosis, Laboratory test abnormal, Liver function test increased, Liver injury
Clinical narrative: Headache started almost immediately. Fever started a few days after. Symptoms included fatigue, severe headache, and fever up to 103.  Upon hospital admission in October, diagnosed with adult onset stills disease. On December 14 he was admitted back to the hospital related to fever and abnormal labs that included elevated liver enzymes, bilirubin, thrombocytopenia, elevated ferritin. He was diagnosed with HLH that was resistant to the 2004 HLH treatment protocol and died January 28,2022 off multi organ failure.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lumbar puncture normal, Magnetic resonance imaging abnormal, Multiple organ dysfunction syndrome, Pancytopenia, Platelet count decreased
Clinical narrative: Headache started almost immediately. Fever started a few days after. Symptoms included fatigue, severe headache, and fever up to 103.  Upon hospital admission in October, diagnosed with adult onset stills disease. On December 14 he was admitted back to the hospital related to fever and abnormal labs that included elevated liver enzymes, bilirubin, thrombocytopenia, elevated ferritin. He was diagnosed with HLH that was resistant to the 2004 HLH treatment protocol and died January 28,2022 off multi organ failure.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pyrexia, Rash, Splenic lesion, Splenomegaly, Still's disease
Clinical narrative: Headache started almost immediately. Fever started a few days after. Symptoms included fatigue, severe headache, and fever up to 103.  Upon hospital admission in October, diagnosed with adult onset stills disease. On December 14 he was admitted back to the hospital related to fever and abnormal labs that included elevated liver enzymes, bilirubin, thrombocytopenia, elevated ferritin. He was diagnosed with HLH that was resistant to the 2004 HLH treatment protocol and died January 28,2022 off multi organ failure.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thrombocytopenia, White blood cell count decreased
Clinical narrative: Headache started almost immediately. Fever started a few days after. Symptoms included fatigue, severe headache, and fever up to 103.  Upon hospital admission in October, diagnosed with adult onset stills disease. On December 14 he was admitted back to the hospital related to fever and abnormal labs that included elevated liver enzymes, bilirubin, thrombocytopenia, elevated ferritin. He was diagnosed with HLH that was resistant to the 2004 HLH treatment protocol and died January 28,2022 off multi organ failure.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Biopsy bone marrow abnormal, Blood bilirubin, Blood creatinine increased, Blood fibrinogen decreased, Blood urea increased
Clinical narrative: Headache started almost immediately. Fever started a few days after. Symptoms included fatigue, severe headache, and fever up to 103.  Upon hospital admission in October, diagnosed with adult onset stills disease. On December 14 he was admitted back to the hospital related to fever and abnormal labs that included elevated liver enzymes, bilirubin, thrombocytopenia, elevated ferritin. He was diagnosed with HLH that was resistant to the 2004 HLH treatment protocol and died January 28,2022 off multi organ failure.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Fatigue, Haematocrit decreased, Haemoglobin decreased, Haemophagocytic lymphohistiocytosis
Clinical narrative: Headache started almost immediately. Fever started a few days after. Symptoms included fatigue, severe headache, and fever up to 103.  Upon hospital admission in October, diagnosed with adult onset stills disease. On December 14 he was admitted back to the hospital related to fever and abnormal labs that included elevated liver enzymes, bilirubin, thrombocytopenia, elevated ferritin. He was diagnosed with HLH that was resistant to the 2004 HLH treatment protocol and died January 28,2022 off multi organ failure.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Hepatic enzyme increased, Multiple organ dysfunction syndrome, Platelet count decreased, Pyrexia
Clinical narrative: Headache started almost immediately. Fever started a few days after. Symptoms included fatigue, severe headache, and fever up to 103.  Upon hospital admission in October, diagnosed with adult onset stills disease. On December 14 he was admitted back to the hospital related to fever and abnormal labs that included elevated liver enzymes, bilirubin, thrombocytopenia, elevated ferritin. He was diagnosed with HLH that was resistant to the 2004 HLH treatment protocol and died January 28,2022 off multi organ failure.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Serum ferritin increased, Still's disease, Thrombocytopenia
Clinical narrative: Headache started almost immediately. Fever started a few days after. Symptoms included fatigue, severe headache, and fever up to 103.  Upon hospital admission in October, diagnosed with adult onset stills disease. On December 14 he was admitted back to the hospital related to fever and abnormal labs that included elevated liver enzymes, bilirubin, thrombocytopenia, elevated ferritin. He was diagnosed with HLH that was resistant to the 2004 HLH treatment protocol and died January 28,2022 off multi organ failure.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Autoimmune disorder, Chills, Fatigue, Full blood count abnormal, Haemophagocytic lymphohistiocytosis
Clinical narrative: Headache started almost immediately. Fever started a few days after. Symptoms included fatigue, severe headache, and fever up to 103.  Upon hospital admission in October, diagnosed with adult onset stills disease. On December 14 he was admitted back to the hospital related to fever and abnormal labs that included elevated liver enzymes, bilirubin, thrombocytopenia, elevated ferritin. He was diagnosed with HLH that was resistant to the 2004 HLH treatment protocol and died January 28,2022 off multi organ failure.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Hepatic enzyme increased, Multiple organ dysfunction syndrome, Night sweats, Pyrexia
Clinical narrative: Headache started almost immediately. Fever started a few days after. Symptoms included fatigue, severe headache, and fever up to 103.  Upon hospital admission in October, diagnosed with adult onset stills disease. On December 14 he was admitted back to the hospital related to fever and abnormal labs that included elevated liver enzymes, bilirubin, thrombocytopenia, elevated ferritin. He was diagnosed with HLH that was resistant to the 2004 HLH treatment protocol and died January 28,2022 off multi organ failure.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood test, Chills, Goitre, Headache, Heart rate increased
Clinical narrative: After booster shot taken symptoms started after one week. Severe headache, chills,fever. 101.1,102 for almost 3 weeks and then 4th week neck pain and others same symptoms. Twice I checked with urgent care and the ER and after that Physician and now appointments with Endocrinologyst.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Hyperthyroidism, Neck pain, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: After booster shot taken symptoms started after one week. Severe headache, chills,fever. 101.1,102 for almost 3 weeks and then 4th week neck pain and others same symptoms. Twice I checked with urgent care and the ER and after that Physician and now appointments with Endocrinologyst.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Streptococcus test
Clinical narrative: After booster shot taken symptoms started after one week. Severe headache, chills,fever. 101.1,102 for almost 3 weeks and then 4th week neck pain and others same symptoms. Twice I checked with urgent care and the ER and after that Physician and now appointments with Endocrinologyst.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Blood test abnormal, Chills, Headache, Heart rate increased, Neck pain
Clinical narrative: After booster shot taken symptoms started after one week. Severe headache, chills,fever. 101.1,102 for almost 3 weeks and then 4th week neck pain and others same symptoms. Twice I checked with urgent care and the ER and after that Physician and now appointments with Endocrinologyst.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pyrexia, Thyroid hormones increased, Thyroiditis, Ultrasound thyroid abnormal, Viral infection
Clinical narrative: After booster shot taken symptoms started after one week. Severe headache, chills,fever. 101.1,102 for almost 3 weeks and then 4th week neck pain and others same symptoms. Twice I checked with urgent care and the ER and after that Physician and now appointments with Endocrinologyst.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardio-respiratory arrest, Chest discomfort, Dyspnoea, Electrocardiogram, Pharyngeal swelling
Clinical narrative: Patient had an itchy throat, neck rash, elevated heart rate, trouble swallowing and taking a deep breath. Gave Benadryl 25mg and standard Epinephrine dose.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Patient had an itchy throat, neck rash, elevated heart rate, trouble swallowing and taking a deep breath. Gave Benadryl 25mg and standard Epinephrine dose.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Dyspnoea, Heart rate increased, Rash, Throat irritation
Clinical narrative: Patient had an itchy throat, neck rash, elevated heart rate, trouble swallowing and taking a deep breath. Gave Benadryl 25mg and standard Epinephrine dose.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pruritus, Urticaria
Clinical narrative: local inflammation at injection site and hives
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site inflammation, Urticaria
Clinical narrative: local inflammation at injection site and hives
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram cerebral, Aortic stenosis, Aphasia, Arteriogram carotid, Blood glucose increased
Clinical narrative: 01/26-28 see prior report In the interim (Jan-Aug) Patient was very active with PT, OT, Speech Therapy, walking, gardening, successfully managing DM. 09/01-03/2021 pt presents with renewed expressive aphasia nonconvulsive status epilepticus eminating from Lt frontoparietal region, expressive aphasia worsening bilateral paresthesia - burning and cooling in both upper extremities, face and scalp Patient released to home care, and neurological follow-up, 750mg Keppra twice daily.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysarthria, Echocardiogram abnormal, Ejection fraction normal, Electrocardiogram abnormal, Electroencephalogram abnormal
Clinical narrative: 01/26-28 see prior report In the interim (Jan-Aug) Patient was very active with PT, OT, Speech Therapy, walking, gardening, successfully managing DM. 09/01-03/2021 pt presents with renewed expressive aphasia nonconvulsive status epilepticus eminating from Lt frontoparietal region, expressive aphasia worsening bilateral paresthesia - burning and cooling in both upper extremities, face and scalp Patient released to home care, and neurological follow-up, 750mg Keppra twice daily.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Generalised tonic-clonic seizure, Hypoaesthesia, Left ventricular hypertrophy, Magnetic resonance imaging head normal, Muscular weakness
Clinical narrative: 01/26-28 see prior report In the interim (Jan-Aug) Patient was very active with PT, OT, Speech Therapy, walking, gardening, successfully managing DM. 09/01-03/2021 pt presents with renewed expressive aphasia nonconvulsive status epilepticus eminating from Lt frontoparietal region, expressive aphasia worsening bilateral paresthesia - burning and cooling in both upper extremities, face and scalp Patient released to home care, and neurological follow-up, 750mg Keppra twice daily.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Orthostatic hypotension, Paraesthesia, Scan with contrast, Seizure
Clinical narrative: 01/26-28 see prior report In the interim (Jan-Aug) Patient was very active with PT, OT, Speech Therapy, walking, gardening, successfully managing DM. 09/01-03/2021 pt presents with renewed expressive aphasia nonconvulsive status epilepticus eminating from Lt frontoparietal region, expressive aphasia worsening bilateral paresthesia - burning and cooling in both upper extremities, face and scalp Patient released to home care, and neurological follow-up, 750mg Keppra twice daily.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angiogram cerebral, Aphasia, Burning sensation, Cerebral infarction, Computerised tomogram head
Clinical narrative: 01/26-28 see prior report In the interim (Jan-Aug) Patient was very active with PT, OT, Speech Therapy, walking, gardening, successfully managing DM. 09/01-03/2021 pt presents with renewed expressive aphasia nonconvulsive status epilepticus eminating from Lt frontoparietal region, expressive aphasia worsening bilateral paresthesia - burning and cooling in both upper extremities, face and scalp Patient released to home care, and neurological follow-up, 750mg Keppra twice daily.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electroencephalogram abnormal, Epilepsy, Feeling cold, Magnetic resonance imaging head abnormal, Paraesthesia
Clinical narrative: 01/26-28 see prior report In the interim (Jan-Aug) Patient was very active with PT, OT, Speech Therapy, walking, gardening, successfully managing DM. 09/01-03/2021 pt presents with renewed expressive aphasia nonconvulsive status epilepticus eminating from Lt frontoparietal region, expressive aphasia worsening bilateral paresthesia - burning and cooling in both upper extremities, face and scalp Patient released to home care, and neurological follow-up, 750mg Keppra twice daily.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Perfusion brain scan abnormal, Skin burning sensation, Status epilepticus
Clinical narrative: 01/26-28 see prior report In the interim (Jan-Aug) Patient was very active with PT, OT, Speech Therapy, walking, gardening, successfully managing DM. 09/01-03/2021 pt presents with renewed expressive aphasia nonconvulsive status epilepticus eminating from Lt frontoparietal region, expressive aphasia worsening bilateral paresthesia - burning and cooling in both upper extremities, face and scalp Patient released to home care, and neurological follow-up, 750mg Keppra twice daily.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Mechanical urticaria
Clinical narrative: I went to an allergist who said I have dermatographism
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding
Clinical narrative: Continue to have persistent bleeding while on birth control after receiving the booster shot of Moderna (no history of similar breakthrough bleeding while on birth control before), now with menorrhagia after stopping birth control
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Blood test abnormal, Chest X-ray, Chest pain, Chills, Delirium
Clinical narrative: Overnight symptoms on Monday night with severe chills, nerve pain, muscle pain, fever. Next day same  symptoms and also had delirium and difficulty breathing and chest pain. We consulted with a nurse who gave us a video Appt next day.  Felt somewhat better eventually, but by Thursday stated feeling lethargic and Friday morning had severe chest pain.  Given another video Appt after calling. Was brought in for EKG  and. bloodwork. Was called later to bring him to the ER due to elevated Troponin levels. Was advised at ER he would be hospitalized, next day told by Pedi Cardiologist my son had Myocarditis caused by Booster.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Echocardiogram, Electrocardiogram, Lethargy, Myalgia
Clinical narrative: Overnight symptoms on Monday night with severe chills, nerve pain, muscle pain, fever. Next day same  symptoms and also had delirium and difficulty breathing and chest pain. We consulted with a nurse who gave us a video Appt next day.  Felt somewhat better eventually, but by Thursday stated feeling lethargic and Friday morning had severe chest pain.  Given another video Appt after calling. Was brought in for EKG  and. bloodwork. Was called later to bring him to the ER due to elevated Troponin levels. Was advised at ER he would be hospitalized, next day told by Pedi Cardiologist my son had Myocarditis caused by Booster.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Myocarditis, Neuralgia, Pyrexia, Troponin increased
Clinical narrative: Overnight symptoms on Monday night with severe chills, nerve pain, muscle pain, fever. Next day same  symptoms and also had delirium and difficulty breathing and chest pain. We consulted with a nurse who gave us a video Appt next day.  Felt somewhat better eventually, but by Thursday stated feeling lethargic and Friday morning had severe chest pain.  Given another video Appt after calling. Was brought in for EKG  and. bloodwork. Was called later to bring him to the ER due to elevated Troponin levels. Was advised at ER he would be hospitalized, next day told by Pedi Cardiologist my son had Myocarditis caused by Booster.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Bradycardia, Capillary nail refill test, Chest discomfort, Chest pain, Echocardiogram normal
Clinical narrative: Overnight symptoms on Monday night with severe chills, nerve pain, muscle pain, fever. Next day same  symptoms and also had delirium and difficulty breathing and chest pain. We consulted with a nurse who gave us a video Appt next day.  Felt somewhat better eventually, but by Thursday stated feeling lethargic and Friday morning had severe chest pain.  Given another video Appt after calling. Was brought in for EKG  and. bloodwork. Was called later to bring him to the ER due to elevated Troponin levels. Was advised at ER he would be hospitalized, next day told by Pedi Cardiologist my son had Myocarditis caused by Booster.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Fatigue, Feeling abnormal, Laboratory test, Myalgia, Myocarditis
Clinical narrative: Overnight symptoms on Monday night with severe chills, nerve pain, muscle pain, fever. Next day same  symptoms and also had delirium and difficulty breathing and chest pain. We consulted with a nurse who gave us a video Appt next day.  Felt somewhat better eventually, but by Thursday stated feeling lethargic and Friday morning had severe chest pain.  Given another video Appt after calling. Was brought in for EKG  and. bloodwork. Was called later to bring him to the ER due to elevated Troponin levels. Was advised at ER he would be hospitalized, next day told by Pedi Cardiologist my son had Myocarditis caused by Booster.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Neuralgia, Pyrexia, Troponin I increased, Vaccination complication
Clinical narrative: Overnight symptoms on Monday night with severe chills, nerve pain, muscle pain, fever. Next day same  symptoms and also had delirium and difficulty breathing and chest pain. We consulted with a nurse who gave us a video Appt next day.  Felt somewhat better eventually, but by Thursday stated feeling lethargic and Friday morning had severe chest pain.  Given another video Appt after calling. Was brought in for EKG  and. bloodwork. Was called later to bring him to the ER due to elevated Troponin levels. Was advised at ER he would be hospitalized, next day told by Pedi Cardiologist my son had Myocarditis caused by Booster.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Blood test, Chest pain, Chills, Delirium, Dyspnoea
Clinical narrative: Overnight symptoms on Monday night with severe chills, nerve pain, muscle pain, fever. Next day same  symptoms and also had delirium and difficulty breathing and chest pain. We consulted with a nurse who gave us a video Appt next day.  Felt somewhat better eventually, but by Thursday stated feeling lethargic and Friday morning had severe chest pain.  Given another video Appt after calling. Was brought in for EKG  and. bloodwork. Was called later to bring him to the ER due to elevated Troponin levels. Was advised at ER he would be hospitalized, next day told by Pedi Cardiologist my son had Myocarditis caused by Booster.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Myocarditis, Neuralgia, Pain
Clinical narrative: Overnight symptoms on Monday night with severe chills, nerve pain, muscle pain, fever. Next day same  symptoms and also had delirium and difficulty breathing and chest pain. We consulted with a nurse who gave us a video Appt next day.  Felt somewhat better eventually, but by Thursday stated feeling lethargic and Friday morning had severe chest pain.  Given another video Appt after calling. Was brought in for EKG  and. bloodwork. Was called later to bring him to the ER due to elevated Troponin levels. Was advised at ER he would be hospitalized, next day told by Pedi Cardiologist my son had Myocarditis caused by Booster.
Age: 17.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Overnight symptoms on Monday night with severe chills, nerve pain, muscle pain, fever. Next day same  symptoms and also had delirium and difficulty breathing and chest pain. We consulted with a nurse who gave us a video Appt next day.  Felt somewhat better eventually, but by Thursday stated feeling lethargic and Friday morning had severe chest pain.  Given another video Appt after calling. Was brought in for EKG  and. bloodwork. Was called later to bring him to the ER due to elevated Troponin levels. Was advised at ER he would be hospitalized, next day told by Pedi Cardiologist my son had Myocarditis caused by Booster.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Chills, Lymphadenopathy, Neck pain
Clinical narrative: Received vaccine 1/31/2022 at 11AM.  2/1/2022- experienced chills and body aches begining around 4:30 PM.  2/2/2022- woke up around 6AM with Left axillary swelling and severe pain.  Called my Doctor?s office and was able to get a appointment for 2:40PM.  Doctor prescribed 40mg Prednisone daily x 5 days and 800mg Motrin for pain.  2/3 - Pain has lessened a little but has now spread to shoulder and neck.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Received vaccine 1/31/2022 at 11AM.  2/1/2022- experienced chills and body aches begining around 4:30 PM.  2/2/2022- woke up around 6AM with Left axillary swelling and severe pain.  Called my Doctor?s office and was able to get a appointment for 2:40PM.  Doctor prescribed 40mg Prednisone daily x 5 days and 800mg Motrin for pain.  2/3 - Pain has lessened a little but has now spread to shoulder and neck.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: UNDILUTED VACCINE HAS BEEN ADMINISTRED
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: UNDILUTED VACCINE ADMINISTRED
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: UNDILUTED VACCINE ADMINISTRED
Age: 1.17
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Rash vesicular, Varicella virus test positive
Clinical narrative: full blown varicella rash, +varicella antigen.  Saw Grandma 8 days earlier and she had shingles.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: UNDILUTED VACCINE ADMINISTRED
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Insomnia, Lethargy, Nausea, Pain, Tenderness
Clinical narrative: Tenderness started after receiving the shot. This was similar to the first dose. The difference occurred around 9pm when the tenderness started to spread more and my left side became more sore. I went to lay down and had trouble falling asleep because of the soreness. In the morning I wanted to go to work but I felt lethargic and the soreness was felt across my body. Around noon it was not any better and I felt a little nauseous. Around 5pm I ate some food and then went back to lay down. On 02/04/2022 at 12:10 am, feeling better and the soreness is mostly in my left deltoid. I will probably go into work if they symptoms from yesterday do not return.
Age: 54.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Epicondylitis, Pain in extremity
Clinical narrative: About 3 weeks after the 2nd injection,  I developed lateral epicondylitis pain in my left arm (note, I am right handed).   Then the following 3 weeks I also had pain in my distal left thumb joint.  As of this moment, I am only 70% recovered for both pains.  My doctor has now referred me to a physical therapist.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Rash and raised hives appeared, took Benadryl which relieved it but once that wore off they came back. Read a forum that a lot of people had this happen after 2nd dose and was told to report here. Hives between legs and back of thighs, groin area, wrists and sometimes on face. Raised and itchy. Going on day 2 and the hives have come back full force after antihistamines.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional adverse events reported; has missed her third dose; Information has been received from a female patient of unknown age referring to herself. Information about concurrent condition, concomitant medication, drug reactions/allergies and medical history was not provided.  The patient reported that she received her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot# and expiration date were not reported) for prophylaxis in February 2021 at the age of 22 years old and received her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot# and expiration date were not reported) for prophylaxis in August 2021.      The patient reported that she has missed her third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in December 2021. No additional adverse events or further details were reported.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: inappropriate schedule of vaccine administration; inappropriate schedule of vaccine administration; This spontaneous report has been received from a lawyer via a Plaintiff Fact Sheet from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS #2105USA001456), concerning a 63-year-old female patient. No information regarding the patient's medical history, concurrent conditions, concomitant medications was reported. Before vaccination with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), the patient received hepatitis B vaccine (26-AUG-2000, 21-SEP-2000 and 26-FEB-2001), influenza H5N1 vaccine (14-DEC-2009) and zoster vaccine live (ZOSTAVAX) (20-APR-2015). The patient was vaccinated with 3 doses of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) on 12-JUN-2015, 26-JUN-2017 and 29-JUL-2020, respectively (doses, routes of administration, lot numbers and expiration dates were not provided) at a clinic for prophylaxis (inappropriate schedule of product administration) .  This is one of three reports concerning the same patient.; Sender's Comments:  US-009507513-2105USA001456: US-009507513-2202USA000889:
Sex: F
Vaccine: HPV9
Symptoms: Product administration interrupted
Clinical narrative: Defective gardasil 9 syringe. The finger flanges were found to be broken; CALLER ST ATES IT WAS RECEIVED WRAPPED IN BUBBLE WRAP IN A PLASTIC BAG, THERE WAS NOT A TRAY / NO CARTON; Cut themself while handling Gardasil 9; Cut themself while handling Gardasil 9; This spontaneous report was received from the office manager concerning a female patient of unknown age.   The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 13-JAN-2022, the finger flanges (all the way around) of a defective hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) syringe (lot # U008315, expiration date reported as 14-AUG-2023, but upon internal validation stablished as 15-AUG-2023) were found to be broken when the nurse practitioner was going to attach the needle to the syringe. The product was received wrapped in bubble wrap in a plastic bag, there was not a tray and no carton. An unknown staff member at the facility cut herself while handling the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) with the broken flange. The product was not administered to a patient. The outcome of the wound was not reported.  The causality assessment was not reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient had no known side effects; Temperature excursion occure to ROTATEQ and one dose admnistered to a patient; This spontaneous report was received from an other health professional referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported.   On an unspecified date, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (Lot# 174228 and expiration date 09-JAN-2022, lot was not valid and did not match any company product) (exact dose and frequency were not reported) as prophylaxis. (product storage error). No additional adverse event reported, no further information provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No addtional AE; Administered a dose of expired MMR II to patient; This spontaneous report was received from a medical assistant referring to a 2-year-old patient. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not provided.    On 20-JAN-2022, the health care professional was accidently administered a dose of expired measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II) to a patient (expired product administered) once (lot number T001212, expiration date 12-JAN-2022; dose, vaccination scheme, route of administration, and anatomical location of vaccination were not reported) for prophylaxis. The measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II), had no prior temperature excursion. No product quality complaint (PQC) and no additional adverse event (AEs) was reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Blood test, Respiratory tract congestion
Clinical narrative: Permanent congestion starting a few weeks after the injection. I?ve visited the doctor numerous times and have been prescribed a few different medications but nothing has relieved the congestion. I have been congested since March 2021.
Sex: F
Vaccine: PPV
Symptoms: Occupational exposure to product, Syringe issue
Clinical narrative: They had one Pneumovax 23 syringe that had leaked out completely; Her hand (skin) got wet from touching the product; Caller reported not having issues and that she washed hands afterward; This spontaneous report was received from a female patient (nurse) concerning to herself. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On an unspecified date in January 2022 (reported as maybe first week), noted that one syringe of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # U018632, expiration date: 11-JAN-2023) had leaked out completely (syringe issue), but it was nothing visible to determine why  this occurred. It was reported that was the last syringe in the tray and she noted that the bottom of the tray was wet. The patient reported that the skin of her hand got wet from touching the product (occupational exposure to product), but she did not have issues from this and she washed her hands afterward. The patient stated that no other physical defects were identified with the syringe and that any patient received the vaccine.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Product was administered to patient after temperature excursions; This spontaneous report was received from a medical assistant referring to a 4 year old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On 21-JAN-2022, the patient was vaccinated with improperly storage measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) recombinant Human albumin (rHA)  lot # U022729 with expiration date 16-JAN-2023, for prophylaxis (strength, dose, route of administration were not reported). No additional adverse event (AE) was reported. It was stated that the vaccine was exposed to a temperature of 7.4 °F for 0 Hours 25 Minutes 0 Seconds; 6.4 °F for 0 Hours 20 Minutes 0 Seconds; and 5.9°F for 0 Hours 15 Minutes 0 Seconds. Additionally, the vaccine underwent previous temperature excursion as follows: 31. 3 °F for 10 Hours 28 Minutes 0 Seconds; between range of 6°F to 14°F; No exact temperature was provided; for 1 Hour 15 Minutes 0Seconds; and 11 °F for 4 Hours 6 Minutes 0 Seconds.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Illness, Influenza like illness, Lethargy, Myalgia
Clinical narrative: Flu-like symptoms; Super tired; Lethargic; Felt achy; Sick; Muscle ache; This case was reported by a consumer via patient support programs and described the occurrence of influenza-like symptoms in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th September 2019, the patient received Shingrix. On 26th September 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, tiredness, lethargy, pain, sickness and muscle pain. On 27th September 2019, the outcome of the tiredness, lethargy and muscle pain were recovered/resolved. On an unknown date, the outcome of the influenza-like symptoms and sickness were recovered/resolved and the outcome of the pain was unknown.   It was unknown if the reporter considered the influenza-like symptoms, tiredness, lethargy, pain, sickness and muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The vaccine was administered at a pharmacy, so patient did not have access to the vial of vaccine that was administered. The patient had flu-like symptoms for a day and a half after getting the Shingrix vaccine.  The patient was not sick to the patient's stomach but was super tired and lethargic and felt achy and sick.  The patient had to leave the call to take an incoming call from patient's daughter, so patient was unable to obtain additional information. The permission to contact HCP was not provided.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Flu-like symptoms; Super tired; Lethargic; Felt achy; Sick; Muscle ache; This case was reported by a consumer via patient support programs and described the occurrence of influenza-like symptoms in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th September 2019, the patient received Shingrix. On 26th September 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, tiredness, lethargy, pain, sickness and muscle pain. On 27th September 2019, the outcome of the tiredness, lethargy and muscle pain were recovered/resolved. On an unknown date, the outcome of the influenza-like symptoms and sickness were recovered/resolved and the outcome of the pain was unknown.   It was unknown if the reporter considered the influenza-like symptoms, tiredness, lethargy, pain, sickness and muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The vaccine was administered at a pharmacy, so patient did not have access to the vial of vaccine that was administered. The patient had flu-like symptoms for a day and a half after getting the Shingrix vaccine.  The patient was not sick to the patient's stomach but was super tired and lethargic and felt achy and sick.  The patient had to leave the call to take an incoming call from patient's daughter, so patient was unable to obtain additional information. The permission to contact HCP was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: feel bad; This case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was recovered/resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter that his/her sisters took the shot and it made them feel bad for 2 days. The reporter said 2 days was better than 2 months. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: arm hurt; slight fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever and pain in arm. On an unknown date, the outcome of the fever and pain in arm were recovered/resolved.   It was unknown if the reporter considered the fever and pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The patient experienced very slight fever for a day and patient's arm hurt for a couple of days.  The patient would saw what happened with the second dose. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: got the shingles shot / broke out on both sides/suspected vaccination failure; broke out on both sides; it hurt; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles shot then he/she broke out on both sides around mid-section. The patient informed that it hurt. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient received Shingrix vaccine and asked that could someone get an allergic reaction the day after or two days or usually happened right away any, after the shingles vaccine. The patient could call to talk about this from company. The call center representative did not get a chance to ask if the question was hypothetical or real
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st shingles shot on 11/13/20 / didn't get the 2nd one; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on 13th November 2020).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting the patient did not receive 2nd shot of Shingles vaccine, which led to incomplete course of vaccination. The patient asked that he/she need to start over. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Gout
Clinical narrative: Gout in my ankle; This case was reported by a consumer via interactive digital media and described the occurrence of gout in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 28th January 2022, the patient received the 2nd dose of Shingles vaccine. On 28th January 2022, 4 hrs after receiving Shingles vaccine, the patient experienced gout. On an unknown date, the outcome of the gout was unknown.   It was unknown if the reporter considered the gout to be related to Shingles vaccine.  Additional details were reported as follows: Age at vaccination was not reported. The patient received second dose of Shingles vaccine and 4 hours later experienced gout in ankle. Consent to follow up was not possible as no contact details were available.