chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Red blood cells urine positive, Respiratory failure, Stool analysis normal, Thrombocytopenia, Urine output decreased
Clinical narrative: This case was reported in a literature article and described the occurrence of Atypical Haemolytic Uremic Syndrome in a 76-year-old male subject who was vaccinated with Influenza vaccine unspecified (manufacturer unspecified). No information regarding the subject's medical, family history or concurrent medication has been provided. On an unspecified date, the subject received unspecified dose of Influenza vaccine unspecified (unknown route and injection site; lot number not provided). At an unspecified time after vaccination with Influenza vaccine unspecified, the subject experienced generalized weakness and unsteady gait, as well as 2 episodes of non-bloody diarrhoea and decreased urine output. On clinical examination the subject was confused, lethargic and had dry mucosal membranes. The subject was hospitalised and the author considered the events were life threatening. Laboratory tests revealed creatinine of 1.8 mg/dL, blood urea nitrogen of 50mg/dL, haemoglobin of 12.1 g/dl, haematocrit of 35.6%, platelet count of 35,000/nL, LDH of 590U/L and haptoglobin of 10mg/dL. C3 and C4 complement levels were both low at 58 mg/dL and 12 mg/dL respectively. Schistocytes were seen on peripheral smear. Urinalysis showed a trace of proteinuria and 1 rbc/hpf. Plasma ADAMTS13 activity was normal and his stool was negative for Shiga toxin-producing Escherichia coli. Genetic analysis did not demonstrate any factor H gene mutation. The subject was diagnosed with Atypical Haemolytic Uremic Syndrome. The subject was treated initially with 7 days of therapeutic plasma exchange after which the haemolysis still persisted, the thrombocytopenia had worsened and the subject had developed multi-organ failure. In view of this haemodialysis was introduced on day 10 of admission for controlling the uremia and volume overload and he was started on eculizumab (900 mg weekly for 4 weeks; 1200 mg in the fifth week followed by 1200 mg bi-weekly for a total of 16 doses). No further therapeutic plasma exchange was performed. Subject's platelets normalised, LDH improved and he came off haemodialysis by the fourth dose of eculizumab. His creatinine stabilized at 1.1 mg/dL and his respiratory failure and hepatic injury also resolved. At the time of reporting the events were resolved. Author's conclusion: None related to the vaccination included.
Sex: M
Vaccine: ADEN_4_7, DTAP, FLU3, IPV, MNQ
Symptoms: Anaphylactic shock, Hypersensitivity, Urine analysis normal
Clinical narrative: A report was received from an observational study. This report is based on data abstracted from a retrospective review. This report is a follow up report to the master case 353398USA. A male between the ages of 19-24 years old experienced OTHER ANAPHYLACTIC SHOCK, NEC (Serious, since 20-Jun-2012, until 20-Jun-2012) while enrolled in a study. Adenovirus Vaccine was administered on 01-Jun-2012 LOT # 34600029. The event occurred on 20-Jun-2012. Treatment was given at an outpatient visit, the patient received medication and non drug treatment. The severity was not assessed. The patient was seen for an Allergic Reaction follow up on 21-Jun-2012 as an outpatient visit and treated with medication. The outcome, severity and seriousness of this visit was not assessed. Treatment provided: Epinephrine, ZOFRAN, and BENADRYL given on 20-Jun-2012; ZANTAC 150 mg IV push, Prednisone/Solus Medrol 125 mg IV push also given 20-Jun-2012. LORATADINE 10 mg BID oral given 21-Jun-2012; Ranitidine 150 mg oral started 21-Jun-2012 and last dose 28-Jun-2012; Penicillin G 600 mL injection started 19-Jun-2012 and last dose 08-Jul-2012; Polyvinyl Alcohol 1-2 gtts optical on 21-Jun-2012. At the time of the report the outcome of the AEs were: OTHER ANAPHYLACTIC SHOCK, NEC: not recovered/not resolved. The patient's medical history was not reported. The patient's concomitant medication included DIPHTHERIA-TETANUS-PERTUSSIS VACCINE (on 01-Jun-2012); MENINGOCOCCAL VACCINE (on 01-Jun-2012); INFLUENZA VACCINE (on 01-Jun-2012); POLIO-VACCINE (on 01-Jun-2012). The patient's past medications were unspecified. This case was considered serious based on the following criteria: (Other Serious (Important Medical Events). This medical monitor's causality assessment; No reasonable possibility that Adenovirus vaccine is related to event OTHER ANAPHYLACTIC SHOCK, NEC.
Age: 56.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Blood aldosterone, Blood potassium decreased, Blood sodium decreased, Blood uric acid decreased, Brain natriuretic peptide increased
Clinical narrative: This medically confirmed literature report (initial receipt 20-May-2014) concerns a 56 year old female patient. On an unspecified date, the patient received an influenza vaccine (manufacturer and batch number not reported). A few days following the influenza vaccination, the patient developed vomiting, progressive weakness and tingling that began in the bilateral lower followed by upper extremities. The patient had experienced these symptoms for two weeks before presenting for medical advice. Neurological and cerebral spinal fluid evaluations suggested Guillain-Barre Syndrome (GBS) associated renal salt-wasting complication. Within two days of admission, the patient rapidly deteriorated and required mechanical ventilation. Intravenous immunoglobulin was not initiated. By day 3, her serum sodium (S[NA+]) decreased from 137 mEq/L to 122 mEq/L over 26 hours, while serum potassium (S[K+]) ranged 3.2-3.7 mEq/L and uric acid 1.5 mg/dL. The patient was presumed hypo-to euvolemic based on recent poor oral intake and recorded admission net fluid gain of only 73 mL. Input and output over 26 hours were 1.2L 5% dextrose 1/2 normal saline, urine volume 2.2L, urine sodium (U[Na+]) 235 mEq/L, urine potassium (U[K+]) 41 mEq/L, net volume -1.0 L, net [Na+ and K+] -526 mEq. Other studies included brain natriuretic peptide 964 pg/mL, plasma renin activity 2.2 ng/mL/h and serum aldosterone 12 ng/dL. Patient required 3% saline at 80-100 ml/hour with poor response until fludrocortisone 0.1 mg daily was added (for three days). U[Na+] was promptly reduced to 10mEq/L. Plasmapheresis was initiated with neurological and S [Na+] improvement (to 6-8 mEq/day). Outcome was recovering.
Age: 56.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: CSF test abnormal, General physical health deterioration, Guillain-Barre syndrome, Hypophagia, Hypovolaemia
Clinical narrative: This medically confirmed literature report (initial receipt 20-May-2014) concerns a 56 year old female patient. On an unspecified date, the patient received an influenza vaccine (manufacturer and batch number not reported). A few days following the influenza vaccination, the patient developed vomiting, progressive weakness and tingling that began in the bilateral lower followed by upper extremities. The patient had experienced these symptoms for two weeks before presenting for medical advice. Neurological and cerebral spinal fluid evaluations suggested Guillain-Barre Syndrome (GBS) associated renal salt-wasting complication. Within two days of admission, the patient rapidly deteriorated and required mechanical ventilation. Intravenous immunoglobulin was not initiated. By day 3, her serum sodium (S[NA+]) decreased from 137 mEq/L to 122 mEq/L over 26 hours, while serum potassium (S[K+]) ranged 3.2-3.7 mEq/L and uric acid 1.5 mg/dL. The patient was presumed hypo-to euvolemic based on recent poor oral intake and recorded admission net fluid gain of only 73 mL. Input and output over 26 hours were 1.2L 5% dextrose 1/2 normal saline, urine volume 2.2L, urine sodium (U[Na+]) 235 mEq/L, urine potassium (U[K+]) 41 mEq/L, net volume -1.0 L, net [Na+ and K+] -526 mEq. Other studies included brain natriuretic peptide 964 pg/mL, plasma renin activity 2.2 ng/mL/h and serum aldosterone 12 ng/dL. Patient required 3% saline at 80-100 ml/hour with poor response until fludrocortisone 0.1 mg daily was added (for three days). U[Na+] was promptly reduced to 10mEq/L. Plasmapheresis was initiated with neurological and S [Na+] improvement (to 6-8 mEq/day). Outcome was recovering.
Age: 56.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Mechanical ventilation, Muscular weakness, Neurological examination abnormal, Paraesthesia, Plasmapheresis
Clinical narrative: This medically confirmed literature report (initial receipt 20-May-2014) concerns a 56 year old female patient. On an unspecified date, the patient received an influenza vaccine (manufacturer and batch number not reported). A few days following the influenza vaccination, the patient developed vomiting, progressive weakness and tingling that began in the bilateral lower followed by upper extremities. The patient had experienced these symptoms for two weeks before presenting for medical advice. Neurological and cerebral spinal fluid evaluations suggested Guillain-Barre Syndrome (GBS) associated renal salt-wasting complication. Within two days of admission, the patient rapidly deteriorated and required mechanical ventilation. Intravenous immunoglobulin was not initiated. By day 3, her serum sodium (S[NA+]) decreased from 137 mEq/L to 122 mEq/L over 26 hours, while serum potassium (S[K+]) ranged 3.2-3.7 mEq/L and uric acid 1.5 mg/dL. The patient was presumed hypo-to euvolemic based on recent poor oral intake and recorded admission net fluid gain of only 73 mL. Input and output over 26 hours were 1.2L 5% dextrose 1/2 normal saline, urine volume 2.2L, urine sodium (U[Na+]) 235 mEq/L, urine potassium (U[K+]) 41 mEq/L, net volume -1.0 L, net [Na+ and K+] -526 mEq. Other studies included brain natriuretic peptide 964 pg/mL, plasma renin activity 2.2 ng/mL/h and serum aldosterone 12 ng/dL. Patient required 3% saline at 80-100 ml/hour with poor response until fludrocortisone 0.1 mg daily was added (for three days). U[Na+] was promptly reduced to 10mEq/L. Plasmapheresis was initiated with neurological and S [Na+] improvement (to 6-8 mEq/day). Outcome was recovering.
Age: 56.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Renal salt-wasting syndrome, Renin, Urine output increased, Urine potassium normal, Urine sodium increased
Clinical narrative: This medically confirmed literature report (initial receipt 20-May-2014) concerns a 56 year old female patient. On an unspecified date, the patient received an influenza vaccine (manufacturer and batch number not reported). A few days following the influenza vaccination, the patient developed vomiting, progressive weakness and tingling that began in the bilateral lower followed by upper extremities. The patient had experienced these symptoms for two weeks before presenting for medical advice. Neurological and cerebral spinal fluid evaluations suggested Guillain-Barre Syndrome (GBS) associated renal salt-wasting complication. Within two days of admission, the patient rapidly deteriorated and required mechanical ventilation. Intravenous immunoglobulin was not initiated. By day 3, her serum sodium (S[NA+]) decreased from 137 mEq/L to 122 mEq/L over 26 hours, while serum potassium (S[K+]) ranged 3.2-3.7 mEq/L and uric acid 1.5 mg/dL. The patient was presumed hypo-to euvolemic based on recent poor oral intake and recorded admission net fluid gain of only 73 mL. Input and output over 26 hours were 1.2L 5% dextrose 1/2 normal saline, urine volume 2.2L, urine sodium (U[Na+]) 235 mEq/L, urine potassium (U[K+]) 41 mEq/L, net volume -1.0 L, net [Na+ and K+] -526 mEq. Other studies included brain natriuretic peptide 964 pg/mL, plasma renin activity 2.2 ng/mL/h and serum aldosterone 12 ng/dL. Patient required 3% saline at 80-100 ml/hour with poor response until fludrocortisone 0.1 mg daily was added (for three days). U[Na+] was promptly reduced to 10mEq/L. Plasmapheresis was initiated with neurological and S [Na+] improvement (to 6-8 mEq/day). Outcome was recovering.
Age: 56.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Vomiting
Clinical narrative: This medically confirmed literature report (initial receipt 20-May-2014) concerns a 56 year old female patient. On an unspecified date, the patient received an influenza vaccine (manufacturer and batch number not reported). A few days following the influenza vaccination, the patient developed vomiting, progressive weakness and tingling that began in the bilateral lower followed by upper extremities. The patient had experienced these symptoms for two weeks before presenting for medical advice. Neurological and cerebral spinal fluid evaluations suggested Guillain-Barre Syndrome (GBS) associated renal salt-wasting complication. Within two days of admission, the patient rapidly deteriorated and required mechanical ventilation. Intravenous immunoglobulin was not initiated. By day 3, her serum sodium (S[NA+]) decreased from 137 mEq/L to 122 mEq/L over 26 hours, while serum potassium (S[K+]) ranged 3.2-3.7 mEq/L and uric acid 1.5 mg/dL. The patient was presumed hypo-to euvolemic based on recent poor oral intake and recorded admission net fluid gain of only 73 mL. Input and output over 26 hours were 1.2L 5% dextrose 1/2 normal saline, urine volume 2.2L, urine sodium (U[Na+]) 235 mEq/L, urine potassium (U[K+]) 41 mEq/L, net volume -1.0 L, net [Na+ and K+] -526 mEq. Other studies included brain natriuretic peptide 964 pg/mL, plasma renin activity 2.2 ng/mL/h and serum aldosterone 12 ng/dL. Patient required 3% saline at 80-100 ml/hour with poor response until fludrocortisone 0.1 mg daily was added (for three days). U[Na+] was promptly reduced to 10mEq/L. Plasmapheresis was initiated with neurological and S [Na+] improvement (to 6-8 mEq/day). Outcome was recovering.
Age: 56.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Asthenia, Autonomic nervous system imbalance, Blood aldosterone normal, Blood potassium decreased, Blood sodium decreased
Clinical narrative: This medically confirmed literature report (initial receipt 20-May-2014) concerns a 56 year old female patient. On an unspecified date, the patient received an influenza vaccine (manufacturer and batch number not reported). A few days following the influenza vaccination, the patient developed vomiting, progressive weakness and tingling that began in the bilateral lower followed by upper extremities. The patient had experienced these symptoms for two weeks before presenting for medical advice. Neurological and cerebral spinal fluid evaluations suggested Guillain-Barre Syndrome (GBS) associated renal salt-wasting complication. Within two days of admission, the patient rapidly deteriorated and required mechanical ventilation. Intravenous immunoglobulin was not initiated. By day 3, her serum sodium (S[NA+]) decreased from 137 mEq/L to 122 mEq/L over 26 hours, while serum potassium (S[K+]) ranged 3.2-3.7 mEq/L and uric acid 1.5 mg/dL. The patient was presumed hypo-to euvolemic based on recent poor oral intake and recorded admission net fluid gain of only 73 mL. Input and output over 26 hours were 1.2L 5% dextrose 1/2 normal saline, urine volume 2.2L, urine sodium (U[Na+]) 235 mEq/L, urine potassium (U[K+]) 41 mEq/L, net volume -1.0 L, net [Na+ and K+] -526 mEq. Other studies included brain natriuretic peptide 964 pg/mL, plasma renin activity 2.2 ng/mL/h and serum aldosterone 12 ng/dL. Patient required 3% saline at 80-100 ml/hour with poor response until fludrocortisone 0.1 mg daily was added (for three days). U[Na+] was promptly reduced to 10mEq/L. Plasmapheresis was initiated with neurological and S [Na+] improvement (to 6-8 mEq/day). Outcome was recovering.
Age: 56.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Blood uric acid decreased, Brain natriuretic peptide increased, CSF test abnormal, General physical health deterioration, Guillain-Barre syndrome
Clinical narrative: This medically confirmed literature report (initial receipt 20-May-2014) concerns a 56 year old female patient. On an unspecified date, the patient received an influenza vaccine (manufacturer and batch number not reported). A few days following the influenza vaccination, the patient developed vomiting, progressive weakness and tingling that began in the bilateral lower followed by upper extremities. The patient had experienced these symptoms for two weeks before presenting for medical advice. Neurological and cerebral spinal fluid evaluations suggested Guillain-Barre Syndrome (GBS) associated renal salt-wasting complication. Within two days of admission, the patient rapidly deteriorated and required mechanical ventilation. Intravenous immunoglobulin was not initiated. By day 3, her serum sodium (S[NA+]) decreased from 137 mEq/L to 122 mEq/L over 26 hours, while serum potassium (S[K+]) ranged 3.2-3.7 mEq/L and uric acid 1.5 mg/dL. The patient was presumed hypo-to euvolemic based on recent poor oral intake and recorded admission net fluid gain of only 73 mL. Input and output over 26 hours were 1.2L 5% dextrose 1/2 normal saline, urine volume 2.2L, urine sodium (U[Na+]) 235 mEq/L, urine potassium (U[K+]) 41 mEq/L, net volume -1.0 L, net [Na+ and K+] -526 mEq. Other studies included brain natriuretic peptide 964 pg/mL, plasma renin activity 2.2 ng/mL/h and serum aldosterone 12 ng/dL. Patient required 3% saline at 80-100 ml/hour with poor response until fludrocortisone 0.1 mg daily was added (for three days). U[Na+] was promptly reduced to 10mEq/L. Plasmapheresis was initiated with neurological and S [Na+] improvement (to 6-8 mEq/day). Outcome was recovering.
Age: 56.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Hypophagia, Immunoglobulin therapy, Inappropriate antidiuretic hormone secretion, Mechanical ventilation, Neurological examination abnormal
Clinical narrative: This medically confirmed literature report (initial receipt 20-May-2014) concerns a 56 year old female patient. On an unspecified date, the patient received an influenza vaccine (manufacturer and batch number not reported). A few days following the influenza vaccination, the patient developed vomiting, progressive weakness and tingling that began in the bilateral lower followed by upper extremities. The patient had experienced these symptoms for two weeks before presenting for medical advice. Neurological and cerebral spinal fluid evaluations suggested Guillain-Barre Syndrome (GBS) associated renal salt-wasting complication. Within two days of admission, the patient rapidly deteriorated and required mechanical ventilation. Intravenous immunoglobulin was not initiated. By day 3, her serum sodium (S[NA+]) decreased from 137 mEq/L to 122 mEq/L over 26 hours, while serum potassium (S[K+]) ranged 3.2-3.7 mEq/L and uric acid 1.5 mg/dL. The patient was presumed hypo-to euvolemic based on recent poor oral intake and recorded admission net fluid gain of only 73 mL. Input and output over 26 hours were 1.2L 5% dextrose 1/2 normal saline, urine volume 2.2L, urine sodium (U[Na+]) 235 mEq/L, urine potassium (U[K+]) 41 mEq/L, net volume -1.0 L, net [Na+ and K+] -526 mEq. Other studies included brain natriuretic peptide 964 pg/mL, plasma renin activity 2.2 ng/mL/h and serum aldosterone 12 ng/dL. Patient required 3% saline at 80-100 ml/hour with poor response until fludrocortisone 0.1 mg daily was added (for three days). U[Na+] was promptly reduced to 10mEq/L. Plasmapheresis was initiated with neurological and S [Na+] improvement (to 6-8 mEq/day). Outcome was recovering.
Age: 56.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Paraesthesia, Plasmapheresis, Renal salt-wasting syndrome, Renin, Urine potassium normal
Clinical narrative: This medically confirmed literature report (initial receipt 20-May-2014) concerns a 56 year old female patient. On an unspecified date, the patient received an influenza vaccine (manufacturer and batch number not reported). A few days following the influenza vaccination, the patient developed vomiting, progressive weakness and tingling that began in the bilateral lower followed by upper extremities. The patient had experienced these symptoms for two weeks before presenting for medical advice. Neurological and cerebral spinal fluid evaluations suggested Guillain-Barre Syndrome (GBS) associated renal salt-wasting complication. Within two days of admission, the patient rapidly deteriorated and required mechanical ventilation. Intravenous immunoglobulin was not initiated. By day 3, her serum sodium (S[NA+]) decreased from 137 mEq/L to 122 mEq/L over 26 hours, while serum potassium (S[K+]) ranged 3.2-3.7 mEq/L and uric acid 1.5 mg/dL. The patient was presumed hypo-to euvolemic based on recent poor oral intake and recorded admission net fluid gain of only 73 mL. Input and output over 26 hours were 1.2L 5% dextrose 1/2 normal saline, urine volume 2.2L, urine sodium (U[Na+]) 235 mEq/L, urine potassium (U[K+]) 41 mEq/L, net volume -1.0 L, net [Na+ and K+] -526 mEq. Other studies included brain natriuretic peptide 964 pg/mL, plasma renin activity 2.2 ng/mL/h and serum aldosterone 12 ng/dL. Patient required 3% saline at 80-100 ml/hour with poor response until fludrocortisone 0.1 mg daily was added (for three days). U[Na+] was promptly reduced to 10mEq/L. Plasmapheresis was initiated with neurological and S [Na+] improvement (to 6-8 mEq/day). Outcome was recovering.
Age: 56.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Urine sodium increased, Vomiting
Clinical narrative: This medically confirmed literature report (initial receipt 20-May-2014) concerns a 56 year old female patient. On an unspecified date, the patient received an influenza vaccine (manufacturer and batch number not reported). A few days following the influenza vaccination, the patient developed vomiting, progressive weakness and tingling that began in the bilateral lower followed by upper extremities. The patient had experienced these symptoms for two weeks before presenting for medical advice. Neurological and cerebral spinal fluid evaluations suggested Guillain-Barre Syndrome (GBS) associated renal salt-wasting complication. Within two days of admission, the patient rapidly deteriorated and required mechanical ventilation. Intravenous immunoglobulin was not initiated. By day 3, her serum sodium (S[NA+]) decreased from 137 mEq/L to 122 mEq/L over 26 hours, while serum potassium (S[K+]) ranged 3.2-3.7 mEq/L and uric acid 1.5 mg/dL. The patient was presumed hypo-to euvolemic based on recent poor oral intake and recorded admission net fluid gain of only 73 mL. Input and output over 26 hours were 1.2L 5% dextrose 1/2 normal saline, urine volume 2.2L, urine sodium (U[Na+]) 235 mEq/L, urine potassium (U[K+]) 41 mEq/L, net volume -1.0 L, net [Na+ and K+] -526 mEq. Other studies included brain natriuretic peptide 964 pg/mL, plasma renin activity 2.2 ng/mL/h and serum aldosterone 12 ng/dL. Patient required 3% saline at 80-100 ml/hour with poor response until fludrocortisone 0.1 mg daily was added (for three days). U[Na+] was promptly reduced to 10mEq/L. Plasmapheresis was initiated with neurological and S [Na+] improvement (to 6-8 mEq/day). Outcome was recovering.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Endotracheal intubation, Guillain-Barre syndrome
Clinical narrative: Pt given FLUARIX 9/13/12. Pt diagnosed with Guillain-Barre and intubated on 10/3/12.
Age: 81.0
Sex: F
Vaccine: TDAP
Symptoms: Cerebrovascular accident
Clinical narrative: Husband reported that client suffered a stroke "shortly after leaving the health department". Client is currently hospitalized.
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event, Product lot number issue
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 5 year old female patient. On 27-MAY-2014 the patient was vaccinated with MMR II, injection, (lot# 1579AA, expiration date: 12-OCT-2013), (dose and frequency were not reported). Concomitant therapy was not reported. The reporter pulled a vaccine out of the carton of ten and gave it to another Medical Assistant in her office who gave the patient the injection. As Medical Assistant was recording the lot numbers on the patient records, she noticed the lot number on the vial did not match the lot number on the carton. Also, the expiration date for the vaccine given to the child was expired. A PQC was filed. No AE symptoms were reported. The therapy with MMR II was not discontinued. The patient had not sought medical attention. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: DT
Symptoms: Diarrhoea, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Fever 102.5, body aches, severe nausea, vomiting, diarrhea.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Induration, Pain, Skin warm, Swelling
Clinical narrative: Localized soreness; 3x3 1/2" area of firm swelling; redness; warm to the touch. Parent and school nurse have provided Tylenol and Advil and cold compress.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. In November 2013 the patient was vaccinated with ZOSTAVAX vial, 19400 PFU 10 vials of 1, lot # J007207 expired date 20-SEP-2014 (dose, route and indication not reported). Since unspecified date the patient experienced itchy red spot at the injection site. The outcome of itchy red spot at the injection site was reported as not recovered. The relationship between the events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling, Local swelling
Clinical narrative: This spontaneous report as received from a Health care worker refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot# J014809, expiration date 20-FEB-2015), 0.65 ml, subcutaneous. One to two days post vaccination, the patient had reactions. It was reported that the patient developed severe rash from shoulder all the way down below the elbow of the vaccinated arm, with pain, swelling, and itching. The patient sought for medical attention by contacting office. The treatment given for the adverse event was reported as "over the counter BENADRYL and CLARITIN". The reporter stated she did not think it was shingles, since the patient recovered within one week time. This is one of several reports received from the same source. There were another 2 patient have the same reactions from the same lot number. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus, Rash
Clinical narrative: This spontaneous report as received from a Health care worker refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot# J014809, expiration date 20-FEB-2015), 0.65 ml, subcutaneous. One to two days post vaccination, the patient had reactions. It was reported that the patient developed severe rash from shoulder all the way down below the elbow of the vaccinated arm, with pain, swelling, and itching. The patient sought for medical attention by contacting office. The treatment given for the adverse event was reported as "over the counter BENADRYL and CLARITIN". The reporter stated she did not think it was shingles, since the patient recovered within one week time. This is one of several reports received from the same source. There were another 2 patient have the same reactions from the same lot number. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse concerning unspecified number of patients. The patients medical history and current condition was unknown. On an unknown date the patients were vaccinated with 7 doses of VARIVAX (lot#, expiry not reported) that were improperly stored at a temperature outside the patient insert. Concomitant medications were not reported. No adverse effects reported and no product quality issue reported. This is one of the two reports from the same reporter. Additional information is not expected.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 2 month old patient of unknown gender. Concomitant medication and pertinent medical history were not provided. On 21-MAY-2014, 2 ml expired does of ROTATEQ (lot # H020560, expiration date 18-APR-2014) was administered to the patient orally. No adverse effects reported. Additional information has been requested.
Age: 65.0
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 65 year old patient. On 02-JUN-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # H011780, exp. date 16-FEB-2014) (dose and route not reported), that was expired. The dose of PNEUMOVAX 23 had not been exposed to any temperature excursions, and the patient had never received a dose of PNEUMOVAX 23 in the past. No adverse effect has been observed or reported. Additional information has been requested.
Age: 12.0
Sex: U
Vaccine: TDAP
Symptoms: Bordetella test positive, Cough, Pertussis, Polymerase chain reaction
Clinical narrative: Initial case received from a healthcare professional on 29 May 2014. It is part of a cluster of six patients who were diagnosed with pertussis after receiving either DAPTACEL or ADACEL. The other patients are captured in case numbers 2014SA071241, 2014SA071253, 2014SA071262, 2014SA071266, and 2014SA071268. A 12-year old patient (gender and date of birth not reported) received ADACEL and/or DAPTACEL and subsequently developed a mild cough and tested positive for pertussis (positive PCR). According to the reporter, there was currently a pertussis outbreak in the county where the patient resided. Lot numbers, dates of vaccination, and event onset dates, and outcome were not reported. Additional documents held by sender: None.
Age: 16.0
Sex: U
Vaccine: TDAP
Symptoms: Bordetella test positive, Cough, Pertussis, Polymerase chain reaction
Clinical narrative: Initial case received from a healthcare professional on 29 May 2014. It is part of a cluster of six patients who were diagnosed with pertussis after receiving either DAPTACEL or ADACEL. The other patients are captured in case numbers 2014SA071253, 2014SA071260, 2014SA071262, 2014SA071266, 2014SA071268. A 16 year-old patient had received ADACEL and/or DAPTACEL and developed a mild cough. The patient tested PCR positive for pertussis. According to the reporter, there was an outbreak of pertussis in the county where the patient resided. Outcome was not reported. Note: The patient's gender, date of birth, date of vaccination, date of event onset, vaccine lot number, route and site of administration were not reported. Documents held by sender: none.
Age: 5.0
Sex: U
Vaccine: DTAP
Symptoms: Bordetella test positive, Cough, Pertussis, Polymerase chain reaction
Clinical narrative: Initial case received from a healthcare professional on 29 May 2014. It is part of a cluster of six patients who were diagnosed with pertussis after receiving either DAPTACEL or ADACEL. The other patients are captured in cases: 2014SA071241, 2014SA071260, 2014SA071262, 2014SA071266 and 2014SA071268. A 5-year old patient (gender and date of birth not reported) received ADACEL and/or DAPTACEL and subsequently developed a mild cough and tested positive for pertussis (positive PCR). According to the reporter, there was currently a pertussis outbreak in the county where the patient resided. Lot numbers, dates of vaccination, and event onset dates, and outcome were not reported. Additional documents held by sender: None.
Age: 1.0
Sex: M
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Angioedema, Cough, Crying, Diarrhoea
Clinical narrative: Initial report received from literature on 27 May 2014. The following is the verbatim for the article abstract: The Brighton Collaboration is a global research network focused on vaccine safety. The Collaboration has created case definitions to determine diagnostic certainty for several adverse events. Currently nested within multi-page publications, these definitions can be cumbersome for use. We report the results of a randomized trial in which the case definition for anaphylaxis was converted into a user-friendly algorithm and compared the algorithm with the standard case definition. The primary outcomes were efficiency and accuracy. Forty medical students determined the Brighton Level of diagnostic certainty of a sample case of anaphylaxis using either the algorithm or the original case definition. Most participants in both groups selected the correct Brighton Level. Participants using the algorithm required significantly less time to review the case and determine the level of diagnostic certainty [mean difference=107s (95% CI: 13-200; p=0.026)], supporting that the algorithm was more efficient without impacting accuracy. The following is the verbatim for the article full text: A 12-month-old male patient had medical history of atopic dermatitis, egg allergy (prick +) and report of hives after eating carrots. The patient visited the allergist's office to receive his 1st influenza vaccine. Due to the patient's history of egg allergy, the Influenza, Inactivated Vaccine (TIV) was administered per 2-part protocol to right quadriceps. 1. TIV 0.05cc intramuscularly: The patient was noted to have full -strength, which was monitored for 30 minutes. No other adverse reaction was noted. 2. TIV 0.20cc intramuscularly: Within 30 minutes of the 2nd dose, the patient experienced urticaria of neck, anterior torso, and both arms. He also became fussy and started crying. Baby B had increased work of breathing, coughing, stridor, retractions, mild erythema, and angioedema of uvula. The following lab values were noted; Respiratory rate 24 BPM before first vaccine and 42 bpm after second vaccine; O2 saturation 97% before first vaccine and 93% after second vaccine; Pulse 124 bpm 97% before first vaccine and 137% after second vaccine; Systolic blood pressure 110 before first vaccine and 176 after second vaccine. The patient was treated with epinephrine intramuscularly along with cetirizine, prednisolone, and albuterol. The child went home, and the night after the clinic visit, the child experienced diarrhea, mild wheezing, and a blotchy rash. He was treated in the clinic with albuterol and BENADRYL. The family reports that the child had not eaten any eggs, nuts, or carrots, and there were no changes in the home.
Age: 1.0
Sex: M
Vaccine: FLUX
Symptoms: Dyspnoea, Erythema, Irritability, Rash macular, Stridor
Clinical narrative: Initial report received from literature on 27 May 2014. The following is the verbatim for the article abstract: The Brighton Collaboration is a global research network focused on vaccine safety. The Collaboration has created case definitions to determine diagnostic certainty for several adverse events. Currently nested within multi-page publications, these definitions can be cumbersome for use. We report the results of a randomized trial in which the case definition for anaphylaxis was converted into a user-friendly algorithm and compared the algorithm with the standard case definition. The primary outcomes were efficiency and accuracy. Forty medical students determined the Brighton Level of diagnostic certainty of a sample case of anaphylaxis using either the algorithm or the original case definition. Most participants in both groups selected the correct Brighton Level. Participants using the algorithm required significantly less time to review the case and determine the level of diagnostic certainty [mean difference=107s (95% CI: 13-200; p=0.026)], supporting that the algorithm was more efficient without impacting accuracy. The following is the verbatim for the article full text: A 12-month-old male patient had medical history of atopic dermatitis, egg allergy (prick +) and report of hives after eating carrots. The patient visited the allergist's office to receive his 1st influenza vaccine. Due to the patient's history of egg allergy, the Influenza, Inactivated Vaccine (TIV) was administered per 2-part protocol to right quadriceps. 1. TIV 0.05cc intramuscularly: The patient was noted to have full -strength, which was monitored for 30 minutes. No other adverse reaction was noted. 2. TIV 0.20cc intramuscularly: Within 30 minutes of the 2nd dose, the patient experienced urticaria of neck, anterior torso, and both arms. He also became fussy and started crying. Baby B had increased work of breathing, coughing, stridor, retractions, mild erythema, and angioedema of uvula. The following lab values were noted; Respiratory rate 24 BPM before first vaccine and 42 bpm after second vaccine; O2 saturation 97% before first vaccine and 93% after second vaccine; Pulse 124 bpm 97% before first vaccine and 137% after second vaccine; Systolic blood pressure 110 before first vaccine and 176 after second vaccine. The patient was treated with epinephrine intramuscularly along with cetirizine, prednisolone, and albuterol. The child went home, and the night after the clinic visit, the child experienced diarrhea, mild wheezing, and a blotchy rash. He was treated in the clinic with albuterol and BENADRYL. The family reports that the child had not eaten any eggs, nuts, or carrots, and there were no changes in the home.
Age: 1.0
Sex: M
Vaccine: FLUX
Symptoms: Urticaria, Use of accessory respiratory muscles, Wheezing
Clinical narrative: Initial report received from literature on 27 May 2014. The following is the verbatim for the article abstract: The Brighton Collaboration is a global research network focused on vaccine safety. The Collaboration has created case definitions to determine diagnostic certainty for several adverse events. Currently nested within multi-page publications, these definitions can be cumbersome for use. We report the results of a randomized trial in which the case definition for anaphylaxis was converted into a user-friendly algorithm and compared the algorithm with the standard case definition. The primary outcomes were efficiency and accuracy. Forty medical students determined the Brighton Level of diagnostic certainty of a sample case of anaphylaxis using either the algorithm or the original case definition. Most participants in both groups selected the correct Brighton Level. Participants using the algorithm required significantly less time to review the case and determine the level of diagnostic certainty [mean difference=107s (95% CI: 13-200; p=0.026)], supporting that the algorithm was more efficient without impacting accuracy. The following is the verbatim for the article full text: A 12-month-old male patient had medical history of atopic dermatitis, egg allergy (prick +) and report of hives after eating carrots. The patient visited the allergist's office to receive his 1st influenza vaccine. Due to the patient's history of egg allergy, the Influenza, Inactivated Vaccine (TIV) was administered per 2-part protocol to right quadriceps. 1. TIV 0.05cc intramuscularly: The patient was noted to have full -strength, which was monitored for 30 minutes. No other adverse reaction was noted. 2. TIV 0.20cc intramuscularly: Within 30 minutes of the 2nd dose, the patient experienced urticaria of neck, anterior torso, and both arms. He also became fussy and started crying. Baby B had increased work of breathing, coughing, stridor, retractions, mild erythema, and angioedema of uvula. The following lab values were noted; Respiratory rate 24 BPM before first vaccine and 42 bpm after second vaccine; O2 saturation 97% before first vaccine and 93% after second vaccine; Pulse 124 bpm 97% before first vaccine and 137% after second vaccine; Systolic blood pressure 110 before first vaccine and 176 after second vaccine. The patient was treated with epinephrine intramuscularly along with cetirizine, prednisolone, and albuterol. The child went home, and the night after the clinic visit, the child experienced diarrhea, mild wheezing, and a blotchy rash. He was treated in the clinic with albuterol and BENADRYL. The family reports that the child had not eaten any eggs, nuts, or carrots, and there were no changes in the home.
Age: 16.0
Sex: U
Vaccine: TDAP
Symptoms: Bordetella test positive, Cough, Pertussis, Polymerase chain reaction
Clinical narrative: Initial case received from a healthcare professional on 29 May 2014. It is part of a cluster of six patients who were diagnosed with pertussis after receiving either DAPTACEL or ADACEL. The other patients are captured in case numbers 2014SA071241, 2014SA071253, 2014SA071260, 2014SA071266, and 2014SA071268. A 16-year old patient (gender and date of birth not reported) received ADACEL and/or DAPTACEL and subsequently developed a mild cough and was tested positive for pertussis (positive PCR). According to the reporter, there was currently a pertussis outbreak in the county where the patient resided. Lot numbers, dates of vaccination, and event onset dates, and outcome were not reported. Additional documents held by sender: None.
Age: 15.0
Sex: U
Vaccine: TDAP
Symptoms: Bordetella test positive, Cough, Pertussis, Polymerase chain reaction
Clinical narrative: Initial case received from a healthcare professional on 29 May 2014. It is part of a cluster of six patients who were diagnosed with pertussis after receiving either DAPTACEL or ADACEL. The other patients are captured in cases: 2014SA07124, 2014SA071260, 2014SA0762, 2014SA071266 and 2014SA071268. A 15-year old patient (gender and date of birth not reported) received ADACEL and/or DAPTACEL and subsequently developed a mild cough and tested positive for pertussis (positive PCR). According to the reporter, there was currently a pertussis outbreak in the county where the patient resided. Lot numbers, dates of vaccination, and event onset dates, and outcome were not reported. Additional documents held by sender: None.
Age: 13.0
Sex: U
Vaccine: TDAP
Symptoms: Bordetella test positive, Cough, Pertussis, Polymerase chain reaction
Clinical narrative: Initial case received from a healthcare professional on 29 May 2014. It is part of a cluster of six patients who were diagnosed with pertussis after receiving either DAPTACEL or ADACEL. The other patients are captured in case numbers 2014SA071241, 2014SA071253, 2014SA071262, 2014SA071266, and 2014SA071260. A 13-year old patient (gender and date of birth not reported) received ADACEL and/or DAPTACEL and subsequently developed a mild cough and tested positive for pertussis (positive PCR). According to the reporter, there was currently a pertussis outbreak in the county where the patient resided. Lot numbers, dates of vaccination, and event onset dates, and outcome were not reported. Additional documents held by sender: None.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Pain, Pruritus, Swelling
Clinical narrative: This spontaneous report as received from a Health care worker refers to a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (lot# J014809, expiration date 20-FEB-2015), 0.65 ml, subcutaneous. One to two days post vaccination, the patient had reactions. It was reported that the patient developed severe rash from shoulder all the way down below the elbow of the vaccinated arm, with pain, swelling, and itching. The patient sought for medical attention by contacting office. The treatment given for the adverse event was reported as "over the counter BENADRYL and CLARITIN". The reporter stated she did not think it was shingles, since the patient recovered within one week time. This is one of several reports received from the same source. There were another 2 patient have the same reactions from the same lot number. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a nurse from the Vaccine for Children program refers to unspecified number of unspecified patients. The nurse reported that a physician's office stated that doses of VARIVAX (Merck) underwent defrost cycling due to the freezer, and therefore an unspecified number of doses of VARIVAX (Merck) injection (each single dose was 0.5 ml, subcutaneously, once) (indication and lot # not reported) improperly stored had been administered to an unspecified number of unspecified patients on unspecified dates. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse concerning unspecified number of patients. The patient's medical history and current condition was unknown. On an unknown date the patients were vaccinated with 8 doses of PROQUAD (Oka-Merck) that were improperly stored at a temperature outside the patient insert. Concomitant medications were not reported. No adverse effects reported and no product quality issue reported. This is one of the two reports received from the same reporter. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare student (degree: doctor of pharmacy) refers to unspecified female patient of unknown age. In March 2008 the patient was vaccinated with the first dose of GARDASIL (lot#, strength, dose, route and indication unknown). In May 2008 the patient was vaccinated with the second dose of GARDASIL (lot#, strength, dose, route and indication unknown). On approximately 16-MAY-2014 (reported as within the last one to two weeks) the patient was vaccinated with the third dose of GARDASIL (lot#, strength, dose, route and indication unknown). No adverse event was reported. Action taken with GARDASIL was unknown. The outcome of the event was not provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report is received from a health care worker refers to two unspecified patients of unknown age. On 27-MAY-2014 the two unspecified patients were vaccinated with expired MMR II (lot# H010134, expiration date 17-MAY-2014, dose, frequency and route were unknown). No adverse effect was reported. Additional information is expected.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 08-MAY-2013 the patient was vaccinated with GARDASIL dose 1, 1DF, intramuscular (strength, lot # and expiration date not reported). Concomitant medications and other relevant medical history were not reported. The patient received the second dose of GARDASIL on 21-MAY-2014. No adverse effects were reported. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose number, dose, frequency, route of administration, anatomical location, lot number was not reported). Concomitant medications were not reported. The reporter stated that possibly one dose of PNEUMOVAX 23 that was store at temperatures below the storage temperature range recommended in the prescribing information, may have been administered to an unspecified patient. No adverse effect reported. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Nausea and vomiting, dizziness.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse regarding a male patient of unknown age, with no pertinent medical history reported. In February 2013 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not provided) (0.5 ml, intramuscular). No other suspect therapies or concomitant medications were reported. The registered nurse reported that the patient received his second dose of GARDASIL on 02-JUN-2014, reported as "today". No adverse effect was reported. Additional information has been requested.